text:
- Assess the capabilities of partners by learning about the local culture, health care, and research networks.
- Nurture personal relationships with collaborators to reinforce institutional commitment.
- Communicate with cultural propriety. Language is only a technical barrier; the real barrier is how to communicate in a way that respects another country's culture and customs.
- Take every opportunity to train, share, and educate on site.
- Leave behind a structure that will continue to serve institutions, investigators, and patients.
- Create opportunities to allow exchange of investigators through short visits and at all levels.
- Develop plans to manage data and analysis in collaboration with foreign investigators.
- Agree in advance on policies regarding publications, authorship, and presentations at national and international meetings. This will help to establish a level playing field and will build mutual trust and respect.
- Include travel to meetings in budget planning, as well as money for other forms of collaboration.
- Ensure that the appropriate laws and regulations of the country are being followed. Follow the U.S. Office for Human Research Protections rules and regulations, as well as the local IRB policies and regulations.
Where Science Meets Culture: The Art of Health Diplomacy
by Dr. Jorge Gomez
In this special issue of the NCI Cancer Bulletin, you will read about some of the ways NCI is supporting international collaboration for research, training, communications, and other activities related to understanding cancer and treating patients who have cancer, as well as providing information to those who may be at high risk for developing it. These collaborations are critical to our success—cancer is a problem so immense that we must gather all the ideas so that we can confront the disease in the most comprehensive way possible. Read more > >
In Bangladesh, Developing Models for Cancer Care
In early November, Dr. Richard Love traveled from his home in Wisconsin to Khulna, Bangladesh, where he is working to develop a radiation therapy center for people with cancer. The trip included a visit to a free breast health clinic that his organization, the International Breast Cancer Research Foundation (IBCRF), and its local partners created nearly 4 years ago in Bagerhat, in southwestern Bangladesh. Read more > >
The Cancer Expert Corps: An Idea for Building Human CapitalThis program aims to address the "brain drain" that plagues low-resource countries
Cancer Communicators in Latin America Get Support at NCI WorkshopMedia relations officials and journalists met to discuss best practices
Considering Culture When Providing Cancer CareMiddle East Cancer Consortium is building the capacity for palliative care and related research
NCI's International Cancer Research ResourcesFind resources by topic and region
Prostate Cancer Hormone Treatments May Raise Risk of Colorectal CancerRisk increased about 20 to 40 percent in men who took gonadotropin-releasing hormone agonists
Strategy to Screen for Lynch Syndrome May Save Lives and Be Cost EffectiveApproach reduces incidence of several cancers in those with hereditary syndrome
Anemia Drug May Interfere with Trastuzumab's Anticancer EffectsRecombinant human erythropoietin appears to reactivate pathway that allows cancer cells to grow
Possible Causes of Resistance to Melanoma Drug ReportedTwo studies suggest mechanisms that may cause PLX4032 to stop working
Radiation Treatment for Head and Neck Cancer May Produce Hearing LossLoss of hearing function can be significant and harm quality of life
FDA Update
- Another Option Added for Treating Late-Stage Breast Cancer
- Denosumab Approved to Prevent Bone Problems in Cancer Patients
CMS Update
- Medicare Advisory Panel Reviews Data on Provenge
Cancer.gov Update
- New Content on NCI's YouTube Network
- NCI Recovery Act Web Site Highlights NCI's Smoking Cessation Program
- In Memoriam: Dr. Elaine Ron, Senior Investigator in DCEG
- EEMS Accepting Proposals for Use of PLCO Data and Biospecimens
- Next NCAB Meeting Scheduled for December 7
- President's Cancer Panel Discusses the Future of Cancer Research
Selected articles from past issues of the NCI Cancer Bulletin are available in Spanish.
The NCI Cancer Bulletin is produced by the National Cancer Institute (NCI), which was established in 1937. Through basic, clinical, and population-based biomedical research and training, NCI conducts and supports research that will lead to a future in which we can identify the environmental and genetic causes of cancer, prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases.
For more information about cancer, call 1-800-4-CANCER or visit http://www.cancer.gov.
NCI Cancer Bulletin staff can be reached at firstname.lastname@example.com.
Special Issue: Global Collaboration
Where Science Meets Culture: The Art of Health Diplomacy
In this special issue of the NCI Cancer Bulletin, you will read about some of the ways NCI is supporting international collaboration for research, training, communications, and other activities related to understanding cancer and treating patients who have cancer, as well as providing information to those who may be at high risk for developing it. These collaborations are critical to our success—cancer is a problem so immense that we must gather all the ideas so that we can confront the disease in the most comprehensive way possible.
This is one of the reasons that international collaboration in clinical research has become of paramount importance to the United States. But, in addition to forging ahead with partnerships that have data as the chief priority, researchers and organizations should allow time to plan for other aspects of their projects that can produce surprising, long-lasting, and mutual rewards.
Representatives from developed countries who partner with colleagues from less developed nations, where the burden of cancer is often very high, serve as ambassadors. As ambassadors, we need to recognize that our collaborators in developing countries may struggle to acquire the technologies, systems, and information that we take for granted.
Another important consideration is the protocol for our collaboration. Many of the policies and safeguards upheld by NIH and other U.S. federal agencies for the protection of human subjects participating in clinical research, as well as data integrity and monitoring, may be difficult to enforce beyond our borders. We must encourage and promote "best practices" in research outside of this country as we do within the United States.
And, our interactions with foreign collaborators must be respectful of their customs, culture, and the idiosyncrasies of their nations as a whole—at the local, regional, and national levels—as well as of their laws and regulations. Every project affords the opportunity to enhance their research infrastructure and research capacity, such as biospecimen repositories. Moreover, our interactions must be based on our mutual professional respect, where foreign collaborators are an integral component of the team. This should be evident in the planning, implementation, data analysis, and publications.
In short, these collaborations should contribute to science, but they should also strengthen the relationships between countries, increase research capacity for both nations, and serve as a model for others to follow.
What does such an international collaboration look like? Earlier this month, the United States–Latin America Cancer Research Network provided a great example with the launch of a new breast cancer pilot project.
The study, which will involve staff at more than 20 hospitals and research facilities in Argentina, Brazil, Chile, Mexico, and Uruguay, has the goal of characterizing the distribution of molecular profiles in Latin American women who have stage II or III breast cancer. These investigators will determine the correlation between the molecular profiles of the tumors in these women and their response to neoadjuvant therapy.
We already know that breast cancer is a collection of many subtypes with different genetic and clinical characteristics. We also know that breast cancer is less common in Latin American women than in women from developed countries. What we learn about the genetics, molecular profiles, and clinical responses of women in this study will help us better understand how to categorize breast cancer, as well as to determine the most effective treatment for different breast cancer subtypes.
The health diplomacy of this project lies in the details. The study design, clinical protocol, informed consent, and case report forms were developed in collaboration with international partners through committees that brought together the disciplines of public health, international affairs, management, law, and economics. The collaborators participated in workshops and webinars and contributed to the development of standardized procedures for biospecimen collection, pathology, biomarker assessment, and evaluation of patient response to therapy.
Although some countries have existing biobanks and IT systems, the five participating Latin American countries will establish these infrastructures in their own countries based on best practices for storing specimens collected in this study, as well as plans and systems for bioinformatics.
In essence, we are enhancing their research infrastructure so that they will be able to conduct clinical trials in the future that incorporate the latest genomic and applied technologies that are becoming standard in the United States and other developed countries.
Improving infrastructure is just one element of good diplomacy in international research collaboration. (See the sidebar for other examples.) The goal is to treat our collaborators as equal partners and provide resources to enhance the development of areas where they may be lacking, such as training or applied technologies.
As we continue to forge these collaborations, the emphasis should continue to be on the science and the potential benefits for cancer patients and their physicians. This is the distinction between elitism and leadership; this is what makes a true partnership.
Dr. Jorge Gomez
Special Issue: Global Collaboration
In Bangladesh, Developing Models for Cancer Care
In early November, Dr. Richard Love traveled from his home in Wisconsin to Khulna, Bangladesh, where he is working to develop a radiation therapy center for people with cancer. The trip included a visit to a free breast health clinic that his organization, the International Breast Cancer Research Foundation (IBCRF), and its local partners created nearly 4 years ago in Bagerhat, in southwestern Bangladesh.
At the clinic, he saw a young woman who was diagnosed with advanced breast cancer in 2006 and became one of the first Bangladeshi women to join an international clinical trial sponsored by IBCRF. Thanks largely to the care she received through the trial, the woman has survived a life-threatening recurrence and has recently had no symptoms of cancer.
After formally meeting with the patient, Dr. Love saw her a little while later in the waiting room, and their eyes met. Culturally, eye contact between members of the opposite sex is discouraged in Bangladesh, but he smiled and she smiled. "During the interval since her diagnosis, many other similar women with breast cancer who had been treated at our center had died, and the lady knew this," Dr. Love explained. Sometimes, he added, "cultural mores get thrown to the wind."
Although he disregarded a cultural tradition in this case, Dr. Love, who is also a professor of medicine and public health at Ohio State University and an NCI grantee, believes that understanding the traditions of the people who live with cancer is critical to improving their health care. This understanding, he added, comes only from spending time in the places where the people live.
For 17 years, Dr. Love and his IBCRF colleagues have spent time in Vietnam, the Philippines, and Morocco, among other low-income countries. With their local collaborators, the researchers have opened clinical trials and investigated treatments that are cost effective, have limited side effects, and are affordable enough to be widely shared.
Four Clinics and a Center
Now, in Bangladesh, the researchers are trying to build a model program to improve the care of women with breast cancer who, in some cases, do not have enough money to feed their families. Over the last 4 years, the researchers have collaborated with a rural information technology organization called Amader Gram ("Our Village") to create four breast-problem clinics and one specialty outpatient diagnostic and treatment center in Bangladesh.
Because radiation therapy is standard for many breast cancers, the next step in the program is to develop a radiation therapy center. The planned center would also provide education for patients and training for people interested in working in the field. No facilities for this kind of treatment currently exist anywhere in the Khulna region of Bangladesh; the researchers estimate that there are perhaps 18 operational radiation therapy facilities in the entire country, whereas approximately 300 may be needed.
"Radiation is a really useful modality, especially for the locally advanced cancers you tend to see in this population," said Dr. Norman Coleman, who is associate director of the Radiation Research Program at NCI and who has consulted on the project as a private citizen. "Dr. Love has defined a need, and he's successfully conducted clinical trials in the region because he's there on the ground. The question now is whether he can get philanthropic support," said Dr. Coleman.
Dr. Love has been in talks with a private company that could potentially donate equipment for the center. "The capital equipment requirements and costs are a bit daunting when you are trying to develop a facility in circumstances like those of Bangladesh, where there is no health insurance and many people are very poor," said Dr. Love. "When these people are confronted with cancer, it's a health crisis and an economic crisis."
In addition to economic problems, there are also human rights challenges. Although Bangladesh has had two female prime ministers in power for the last 20 years, Dr. Love noted, the place of women in society has not improved much. "Human rights issues stand in the way of doing anything about cancer," he said. "If you can get over the economic issues and the health-system issues, you're still left with daunting cultural challenges and you need to find a way around these."
Overcoming Cultural Challenges
These challenges became evident when the researchers were trying to recruit women to a clinical trial. Accrual was slow in part because few health services existed for the women and most women felt that, because of their place in the family, they could not act on their inclinations to seek help. The researchers are now trying to develop a team of social scientists to investigate the complex issues that may explain this behavior and to test some interventions.
To make it easier for women to act in their own best interest and to boost enrollment in the trial, the researchers developed the country's first free walk-in breast clinic. Women are seen by a female doctor and a medical assistant, who provide advice and supportive care. More serious cases are referred to doctors at Khulna Medical College.
During his visit this month, Dr. Love met with the mayor of Khulna and discussed the acquisition of a 6-acre site where the radiation therapy center would be built. He also hired a local medical physicist to help with the project after the man presented an impressive 24-page proposal with pricing information for the radiation therapy center.
"I was really quite pleased," said Dr. Love. "We're close to having a reasonably comprehensive business plan that brings together the details of needed capital expenditures and possible revenue projections based on what we think are affordable costs for patients."
The current proposal estimates that many patients could receive a course of radiation treatments for $125, compared with thousands of dollars in the United States. The total start-up costs for the center would be approximately $1.3 million. These include land, building construction that meets nuclear regulatory agency codes, initial radiation therapy equipment, and staffing expenses.
Building a Social Business
The radiation therapy center is being developed as a "social business," and any profits would go to expanding the business. Muhammad Yunus, the Bangladeshi who received a Nobel Peace Prize for his pioneering work promoting microfinance and who has recently championed the idea of social businesses, is an adviser on the project. The hope is that the center could be a prototype for a successful social business in radiation therapy.
Through technologies that now exist, radiotherapists in the United States can work closely with colleagues in places like Bangladesh. Using "dummy" human tissues that have devices for measuring radiation, workers in a remote center can test their radiation machines to make sure they are delivering the specified dose. Furthermore, radiological data from remote locations can be deposited in a centralized location for a trial's principal investigators to review.
"These tools would be a good way to bring a place as remote as Bangladesh into cancer clinical trials," said Dr. James Deye, a colleague of Dr. Coleman's in NCI's Radiation Research Program. The technologies could provide assurance that a remote site is following the protocol of a particular trial and also be educational. A mentor in the United States and a mentee in Bangladesh could, for example, discuss the selection of targets and normal tissues to avoid.
"What Dr. Love is trying to do is noteworthy," said Dr. Deye. "There are so many problems to overcome, and it requires the patience of Job. But if anyone can pull it off, Dr. Love can."
The success of these kinds of projects depends on having "buy-in" from the country where the job is to be done and "a local idea champion" to work with, added Dr. Bhadrasain Vikram, who is also part of the Radiation Research Program and has worked on health projects for underserved populations. "Then the project becomes a question of money. But all the money in the world won't make a difference if you don't have people on the ground to put their shoulders against the grindstone."
Dr. Love believes there is no choice but to try to make progress. As he sees it, the two big stories in cancer right now are how the global burden of these diseases is growing, particularly in Asia, and the enormous costs of optimal treatments. Nonetheless, he remains an optimist. "There are good people in Bangladesh, and we have found some of them," he said. "If we keep working, we'll have some models for how to improve care that other people can replicate."
"Fellow Travelers on the Planet"
"Boy, would this be great if this could happen," said Dr. Coleman of the project. "This is an experiment, but the potential upside is enormous. What would one cancer radiation facility be worth? Well, if you could do one, then maybe you could do 10."
Dr. Love often speaks about the need for global initiatives in public health in terms of making connections with "fellow travelers on the planet." After visiting the Bagerhat breast clinic on his recent trip, his group gave a ride home to two slight young women who worked in the clinic. After turning off the main road, the car bumped along down a one-lane track for a mile or so. Then, in the pitch dark, they stopped to let off the two women, who walked down a narrow path into the jungle (about 15 miles from the Sunderban, the last refuge of the Bengal tiger).
"We know so very little about the details of the lives of such fellow travelers on this planet," he wrote in an e-mail message. "But when given a chance, they can and will participate meaningfully in evidence-based health care activities."
—Edward R. Winstead
Special Issue: Global Collaboration
The Cancer Expert Corps: An Idea for Building Human Capital
A recent editorial in the New England Journal of Medicine highlighted a little-publicized fact about global health: if current trends in cancer incidence continue, by 2020 a majority of cancer cases will occur in the developing world.
The projection threatens to outpace and overwhelm the medical infrastructure in developing countries, where physicians often do not have access to even the most basic chemotherapy drugs or radiation therapy equipment. In addition, developing countries often suffer "brain drain," whereby physicians and researchers leave their home countries in search of facilities and funding for their work abroad. "I think human capital can often be the more challenging thing to get and maintain," said Dr. Norman Coleman, associate director of the Radiation Research Program (RRP) in NCI's Division of Cancer Treatment and Diagnosis.
Since 2000, Dr. Coleman and Dr. Bhadrasain Vikram, chief of the Clinical Radiation Oncology Branch in RRP, have been working on the idea of a Cancer Expert Corps (CEC)—a cadre of tenure-track health care professionals dedicated to committing a percentage of their time to mentoring cancer care providers and cancer researchers in the developing world and to helping clinicians and researchers who want to return home in hopes of establishing world-class programs.
Committed to the Future
The idea of a dedicated, long-term commitment sets the CEC apart from other mentoring efforts, explained Dr. Vikram. "A lot of times people go and give a lecture or two and maybe spend a few days somewhere. But to really make a difference, to maintain progress, you have to stay engaged in a sustained manner, for a period of years," he said. "What is needed is a means of sustainability by which the time commitment for mentoring is a bona fide part of one's career," Dr. Coleman emphasized. "In-kind donations and volunteerism are welcome, but long-term commitment is crucial."
The two radiation oncologists envision funding for the CEC mentors coming from peer-reviewed grants that individuals and institutions would compete for through mechanisms similar to standard research grants. The funding allocated for one regular full-time equivalent clinician or researcher through a typical NIH grant could fund about 20 percent of the professional time of five CEC mentors and provide financial and institutional support for their mentoring activities.
"That would make mentoring a legitimate professional track, something that's valued by a mentor's institution, a 'Peace Corps for Cancer'—people wouldn't just have to do it on their nights and weekends," said Dr. Coleman. "That's what happens now—people use up their vacations, their weekends; they put all their free time into these projects and eventually they burn out," he continued.
Modern telemedicine technology, like that adopted in 2004 with NCI support at King Hussein Cancer Center in Amman, Jordan, would allow mentors to coordinate activities such as chart rounds and quality control without extensive travel time, explained Dr. Coleman. Investment in infrastructural technology would also allow its use by physicians working in other areas of medicine, such as diabetes and cardiovascular disease, perhaps someday allowing the expansion of the concept to a broader Medical Expert Corps, he continued. A similar concept of academic service has been proposed by other research groups.
Institutions interested in acquiring mentors would need to provide local investment, such as facilities and personnel. International partners, including the International Network for Cancer Treatment and Research, NIH's Fogarty International Center, and cancer centers in Singapore, Ireland, Canada, Switzerland, and Israel, have expressed interest in participating in the CEC, but for now the project remains in the planning phase.
A Twin Solution
As a proof-of-concept endeavor, the RRP has begun an informal "twinning project," attempting to connect international mentor–mentee pairs with appropriate funding opportunities. These research pairs were identified through a call for interested participants distributed by the American Society of Clinical Oncology, the International Union Against Cancer, and other professional groups. Out of about 50 interested teams, six pairs are now working with Dr. Vikram and Dr. Maithili Daphtary, a contractor with the RRP and coordinator for the CEC, to identify grants for which they can apply.
One pair of researchers working together through the twinning project is Dr. Lorenzo Leoncini, from the University of Siena in Italy, and Dr. Joshua Nyagol, from the University of Nairobi in Kenya. The two first met in Kenya during a visit by Dr. Leoncini to the Nairobi Hospital. Dr. Nyagol later received his Ph.D. in quantitative and molecular diagnostic pathology under the supervision of Dr. Leoncini at the University of Siena.
The two researchers remained in touch and are planning a collaborative project investigating the direct role of viruses such as HIV, Epstein-Barr virus, and human herpesvirus 8 in the pathogenesis of aggressive B-cell lymphomas, which are prevalent in Africa. Their research will examine the expression of biomarkers associated with the viruses, including microRNA expression profiles, and examine whether the viruses play an indirect oncogenic role by disrupting the immune system. "The results from our proposed study may allow the identification of new targets for treatment," said Dr. Leoncini.
The researchers have already collected biospecimens from several Kenyan lymphoma patients, but since "people have observed heterogeneity in disease presentation and disease patterns among different regions, in the future we hope to target the whole of East Africa to recruit study subjects," commented Dr. Nyagol.
Another pair of researchers working with the twinning project is Dr. Yoichi Watanabe from the University of Minnesota and Dr. Shanmugam Senthilkumar from the Government Rajaji Hospital and Madurai Medical College in Madurai, India. Dr. Watanabe sponsored Dr. Senthilkumar for an international cancer fellowship through the Union for International Cancer Control in 2008, while Dr. Senthilkumar was working on his doctoral thesis in medical physics.
"One of the realities of Dr. Senthilkumar's hospital in Madurai was that the institution had only one piece of rather outdated radiation therapy equipment but treated more patients than most radiation oncology clinics in the U.S.," said Dr. Watanabe. The two began working together on ideas to inexpensively improve radiation therapy in Dr. Senthilkumar's home state of Tamil Nadu.
They chose the combination of new motion-sensing technology developed by Dr. Senthilkumar with three-dimensional (3-D) arc therapy using a radioactive source (Cobalt-60) that is affordable and widely used in India. With 3-D arc therapy, "even a small movement from the patient during treatment significantly affects the accuracy of radiation delivery. The device developed by Dr. Senthilkumar is able to sense patient motion during treatment and automatically pause treatment delivery, to allow for the necessary readjustments," explained Dr. Watanabe. "This system should be able to deliver highly focused radiation to a tumor as precisely as more advanced technologies used in the United States."
The two researchers hope to obtain funding to build and test a pilot system at the Government Rajaji Hospital to determine if it works the way that they expect it to and whether it could be used in other community hospitals in the region.
These two international projects provide examples of how an effective mentor–mentee relationship could influence cancer research not just in a single institution, but in an entire country and beyond. "A program like the CEC could make a newly established center into a training and research hub for a whole region," said Dr. Coleman. "So a physician would be returning home not just to run a center, but to create a whole enterprise and become part of a major solution to the recalcitrant problem of sustainable care to the underserved," he explained.
—Sharon Reynolds
Special Issue: Global Collaboration
|This is the fifth article in a series of stories related to cancer communications. View a list of articles in this series.
Cancer Communicators in Latin America Get Support at NCI Workshop
More than 40 journalists and communications professionals from five countries in Latin America and the United States met November 11 and 12 at a workshop in Rio de Janeiro, Brazil, to discuss the challenges of communicating cancer information and research news. The event, titled "Cancer Research in the Media: An Inter-American Workshop on Scientific Journalism," was sponsored by NCI's Multicultural and International Communications group in the Office of Communications and Education.
The workshop, which was also supported by the Brazilian National Cancer Institute (INCA) and the Susan G. Komen for the Cure foundation, attracted attendees from Argentina, Brazil, Chile, Mexico, and Uruguay. Those nations participate, along with NCI and U.S. researchers, in the , which was launched last year. Workshop participants heard presentations by experts from Latin America and the United States about how to cover and evaluate cancer research studies, new technologies in cancer research and treatment, and updates on US-LA CRN initiatives. The meeting also offered numerous opportunities to network and share lessons learned.
Cláudia Collucci, a participant from Brazil and 20-year veteran of health care journalism, including time as a reporter for the daily Folha de São Paulo newspaper, was impressed by the quality of the presentations, particularly those about clinical research. "Journalists really need tools to better evaluate cancer research studies," she noted. "The exchanging of experiences with journalists from other countries also helped us to do a self-evaluation of our work and to find other ways to report issues related to cancer."
Collucci participated in a panel discussing "Science and the Media: Communicating Cancer Information to the Public." The panel focused on the special challenges of informing the public about the latest research findings in understandable, non-technical language that also touches upon the personal and societal impact of cancer. Mar Gonzalo Lopez, a reporter with the EFE Spanish-language news agency, noted, "I always try to be very clear and not use a lot of technical terms and give only a little bit of information that is very understandable by everyone. To do that, I always think about if my mother would understand what I am writing after just one reading of a news article."
Journalists in Latin America, like those in the United States, rely on experts at their national universities and research institutions for help interpreting the latest cancer research findings. INCA Public Affairs and Communications Division Project Manager Walter Zoss commented, "Our institute is recognized by all kinds of media as a referral center for cancer information in Brazil. We foster a strong and ongoing relationship with journalists from all sectors [TV, print, radio, and internet]."
The need for credible sources in medical reporting is critical in Latin America, Collucci explained. "We face a big challenge in finding reliable, expert sources free of conflicts-of-interest."
A similar authoritative role in patient education is played by institutions in Latin America, including Chile's Pontificia Universidad Católica School of Medicine, explained Ana María Bolumburo, US-LA CRN Communications Coordinator. "We produce materials about patient care and disease prevention," including a monthly newsletter "that includes easily understandable material aimed at teaching people how to care for themselves," she said.
Nelvis Castro, associate director of NCI Multicultural and International Communications, said the workshop was "successful both in increasing participants' understanding of different aspects of cancer research and in providing resources and tools for them to use in the future." The Latin American journalists "were very interested in the session on how to evaluate cancer research studies and reporting research results, particularly learning how to apply criteria to evaluate cancer research news stories," she said, adding that "learning to evaluate other media coverage of cancer research news helps the journalists hone their skills in reporting on cancer topics accurately, effectively, and responsibly."
The workshop provided participants an opportunity to share best practices and connections to trustworthy, relevant sources that can help them navigate scientific topics. It was also an opportunity for the reporters and editors to learn more about the US-LA CRN's new breast cancer study in Latin America, Castro noted. A presentation about the study at the workshop has already sparked coverage in El Mercurio, one of Chile's largest daily newspapers.
NCI and the US-LA CRN are planning follow-up cancer communications support activities, including a similar training workshop for communications professionals at research institutions, hospitals, and health ministries; media training for US-LA CRN National Coordinators in Latin America; and establishment of a network of journalists to continue dialogue and information exchange between the United States and Latin America.
—Bill Robinson and Meghan Byrne
Tools for Communicators
NCI has numerous resources to help journalists and health educators from around the globe understand and share news about cancer research. Here are some examples:
- In English, NCI provides the Physician Data Query (PDQ), which is a compilation of evidence-based summaries on a wide range of cancer topics, including treatment, genetics, prevention, screening/detection, supportive and palliative care, and complementary and alternative medicine. Many summaries are available in two versions: for patients, and for health professionals. Spanish versions of all of the treatment and the supportive and palliative care summaries (both patient and health professional) are available.
- NCI's Cancer Information Service provides general cancer information on the phone at 1-800-4-CANCER (1-800-422-6237) in the United States, through instant-messaging chat sessions, by e-mail, or by mailed correspondence. Information specialists can answer questions in English or in Spanish.
- NCI's Office of Media Relations has a newscenter for announcements about upcoming seminars and events, and other helpful media resources.
- NCI's Multicultural Media Outreach Program is a resource for journalists who are seeking cancer and research information, education materials, and culturally appropriate background or interviewees for their stories. The office can be reached at 301-496-9096 or by e-mail at email@example.com. Some materials are available online.
- NCI offers synopses of empirical findings in both English and in Spanish from its biennial administration of the Health Information National Trends Survey (HINTS). HINTS was funded to help communicators understand how changes in the communications environment may be influencing the public's understanding of cancer. The survey is conducted in both English and Spanish, with a recent administration in Puerto Rico.
Special Issue: Global Collaboration
Considering Culture When Providing Cancer Care
One of the hardest tasks an oncologist faces is telling children with cancer and their families that there is no longer hope of a cure and that the time has come to discuss end-of-life care. For Dr. Myriam Weyl Ben-Arush, head of the Pediatric Hematology Oncology Department at Rambam Medical Center in Haifa, Israel, this task is complicated by the fact that her young patients may be Israeli or Palestinian; Jewish, Muslim, Christian, or Druze; religious or nonreligious.
Working effectively in cross-cultural situations such as this is known as cultural competence. In medicine, cultural competence means providing health care services that are respectful of and responsive to the health beliefs, practices, and cultural and linguistic needs of diverse patients.
Palliative care improves the quality of life for patients who have a serious or life-threatening disease. The approach is not exclusively for patients who are dying but rather is meant to prevent or treat symptoms of a disease, side effects caused by the treatment of a disease, and psychological, social, and spiritual problems related to the disease or its treatment. Palliative care is more effective when it is provided early.
Read more about palliative care in a themed issue of the NCI Cancer Bulletin from earlier this year.
"In the area of palliative care, culture comes into it in a big way," said Dr. Joe Harford, director of NCI's Office of International Affairs. "Different cultures have different views of life, death, [and] pain, and those need to be appreciated." He noted that because of the cultural diversity found in the United States, sensitivity to these views is an important consideration for palliative care in this country, as well.
Dr. Harford's office oversees the Middle East Cancer Consortium (MECC), a partnership between the United States and the health ministries of Cyprus, Egypt, Israel, Jordan, the Palestinian Authority, and Turkey. In 2005, MECC launched a project to build capacity for palliative care and related research in the region. "The project was established to raise awareness of the palliative care problems shared by all MECC members," said MECC Executive Director Dr. Michael Silbermann, of Haifa, Israel. "It is based on identifying common ground across cultures and relying on their shared interest in establishing palliative care services, as a basis for developing dialogue and cooperation on sustainable cancer care in both hospitals and the communities."
As part of this effort, MECC has conducted workshops and training for nurses, physicians, and social workers, and provided opportunities to observe successful palliative care services in the United States. One of the consortium's goals is overcoming the fear of opioids, sometimes called "opiophobia," that is widespread in the Middle East and is a major barrier to providing adequate pain management for cancer patients.
"Palliative care is much more than pain relief," stressed Dr. Harford, "but at least three-quarters of cancer patients experience more than just moderate pain. For this reason, MECC has made training related to pain relief a high priority."
Because children make up a large proportion of the population in the Middle East, 2 years ago MECC formed a pediatric palliative care strategy group chaired by Dr. Aziza Shad, director of the Division of Pediatric Hematology/Oncology, Blood and Marrow Transplantation at Georgetown University Hospital in Washington, DC. "No matter what culture you come from, death is the same for everyone. What is important is how you accept it and deal with it," said Dr. Shad, who has taught palliative care in several developing nations. "The differences lie in how the family hierarchy works, and who decides how much information on prognosis or end-of-life should or should not be given to the family members or the dying child."
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Overcoming Cultural Taboos
Much of the initial focus in the MECC palliative care project has been on end-of-life care, because that's where the need is greatest. But discussions of death and dying, and even the mention of cancer, are still taboo in many countries in the Middle East. And, noted Dr. Harford, "the taboos against telling a child that he or she is dying are even stronger than about talking to an older person who is dying."
Despite the taboos, people are receptive to ideas about improving end-of-life care for their loved ones. "Oftentimes it's not really a cultural barrier, it's simply a barrier of education and understanding," Dr. Harford explained.
Indeed, said Dr. Silbermann, the key lies in education at all levels, including families as well as health care professionals, imams and rabbis, and politicians and ministers of health. Dr. Silbermann emphasized the importance of including the family in the discussion. "We have to educate the parents as well as the kids…don't lie, be honest," he said. "This multilevel education is an ongoing process and a very difficult process because this is a new idea for societies in the Middle East."
If caregivers don't tell the truth, Dr. Ben-Arush explained, "the child will lose his belief in the staff, and he won't cooperate any more…and he will suffer much more, because we need the child [to] explain to us how we can help him." Furthermore, she said, "I am convinced that most of the children know that they are dying, [and] without the support of the psychosocial staff, as well as the nurses, the physician won't find the way to help the children have a peaceful end of life."
To help care for patients from diverse cultures, Dr. Ben-Arush's staff includes Arabic-speaking nurses and social workers, as well as those who speak Hebrew. "We are lucky because we have one social worker [specifically] for the Palestinian children. I found donations to pay her salary," she said. "And for each Palestinian child she is so involved."
Dr. Ben-Arush noted that it's somewhat easier to talk about death with a Druze family that believes in reincarnation or an Arab Christian family whose child believes in Heaven. By contrast, she said, "it is much more difficult for Jewish families to accept that there is no more treatment." They are more likely to ask for experimental therapies for their child and less likely to sign a do-not-resuscitate order.
Taking spiritual beliefs into account is critical when discussing palliative care or developing an infrastructure for such care. These beliefs may influence factors such as whether patients prefer to die at home or in the hospital. Including clergy in the palliative care team is a relatively new approach but one that's been shown to improve the quality of life of terminally ill cancer patients, "thus increasing the utilization of more 'personal' and less aggressive care at the end of life," said Dr. Silbermann.
Another factor to consider in the Middle East and many developing nations, said Dr. Shad, is that strong family support systems are part of the culture of these nations. As a result, she said, there isn't always a need for psychologists, psychiatrists, and social workers, and "you learn not to push social work and psychiatry on them, because they get it in a different form." Rather, one should "understand what they have, and then try to fill in the holes."
Bridging the Divide
MECC leaders are now working to introduce basic guidelines for palliative care in the Middle East. After 5 years of effort, the project is starting to bear fruit, said Dr. Silbermann. "It will be slow, because palliative care has a very profound cultural [and] religious element, and we have to take that into consideration."
Approaching people in developing countries with a sense of humility and willingness to learn from them, as well as teach them, is critical for success, said Dr. Shad. "The [palliative care] initiative that MECC has undertaken is going to be a rewarding one, because, while you start with the Middle East, you can take that information and knowledge on how you did it to other developing countries as well."
Lessons learned from other cultures can also be applied at home. "In spite of all the medical miracles that we can perform here, death still happens," said Dr. Shad. "And maybe the understanding of that would help us face it better and deal with it better. There are some very simple things that could be done to improve a patient's life. Things like spending time with them, making sure that there's company around them, rather than relying exclusively on medication. We rely a lot on medication in the United States; there are many, many things in addition to medication that you can do to improve a patient's quality of life."
–Elia Ben-Ari
See also: A Conversation with…Dr. Joe Harford
Special Issue: Global Collaboration
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Basic and Clinical Research
AIDS Malignancy Consortium (AMC)
The Consortium is an NCI-supported clinical trials group founded in 1995 to support innovative trials for HIV-associated malignancies. The AMC is now composed of eight Domestic Core Sites, four International Core Sites, and a number of affiliated sites that involve patients in AMC trials. This effort is supported by NCI's Office of HIV and AIDS Malignancy.
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The Chernobyl Tissue Bank (CTB)
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Building Capacity and Infrastructure
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NCI, in cooperation with other parts of the National Institutes of Health, provides awards to establish and maintain several Centers for AIDS Research (CFARs) that conduct research on prevention, detection, and treatment of HIV, AIDS and AIDS-related malignancies in countries such as Brazil, Kenya, South Africa, Uganda, and India. CFAR is supported by NCI's Office of HIV and AIDS Malignancy.
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OLACPD, an innovative partnership between NCI and the Fogarty International Center, was launched in recognition of the opportunity to support and enhance cancer research and care in Latin America.
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Breast Health Global Initiative (BHGI)
To improve breast cancer outcomes in low- and middle-resource countries, the BHGI created comprehensive resource-sensitive, evidence-based clinical guidelines for breast health care and cancer control. NCI was a scientific partner.
Chemopreventive Agent Development Research Group
The Chemopreventive Agent Development Research Group supports scientific and administrative oversight for preclinical chemoprevention agent development up to early phase I chemopreventive clinical research using physiological endpoints in healthy volunteers. Research focuses on identifying and developing agents with the potential to block, reverse, or delay early stages of cancer. This program is supported by NCI's Division of Cancer Prevention (DCP).
InterSCOPE Consortium (no Web site)
This consortium examines the association between human papilloma virus (HPV) and risk of esophageal squamous cell carcinoma (ESCC). NCI investigators and colleagues from Australia, Brazil, China, France, Germany, Iran, and South Africa are examining whether HPV exposure increases the risk of ESCC. This effort is supported by NCI's Division of Cancer Epidemiology & Genetics (DCEG).
Cancer Detection and Diagnosis
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The ACSR was established by NCI in 1994 to acquire, store, and equitably distribute tumor tissues, biological fluids, and associated clinical information from patients with HIV-associated malignancies to the scientific research community-at-large. NCI holds that prospective and longitudinal clinical samples collected across the timeline of the HIV/AIDS crisis are pivotal to the understanding of the epidemic and its impact on cancer incidence. NCI's Office of HIV and AIDS Malignancy (OHAM) supports this effort.
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ICSN is a voluntary consortium of countries that have active population-based cancer screening programs. These programs can be national or subnational in scope, and established or pilot-based. Administered by the Applied Research Program of NCI, the consortium was established in December 1988 as the International Breast Cancer Screening Database Project during an international workshop that involved representatives from 11 countries. The consortium has since grown to include 28 countries, and it holds biennial meetings. In the interim, the specific activities are moved forward through working groups.
International Leukemia/Lymphoma Molecular Profiling Project
This project is an international 10-institution collaboration to establish a molecular classification of human lymphoid malignancies and define molecular correlations of clinical parameters that are useful in prognosis and in the choice of optimal therapy. Both NCI's Center for Cancer Research (CCR) and Division of Cancer Treatment & Diagnosis (DCTD) participate in this effort.
International Clinical Trials
The Cancer Therapy Evaluation Program (CTEP), part of NCI's Division of Cancer Treatment & Diagnosis (DCTD), works with members of the NCI-sponsored Clinical Trials Cooperative Groups and international partners to identify barriers to international collaboration and how best to overcome them. CTEP also shares best practices and provides technical assistance, and has developed a long-range plan for integrating sites outside of the U.S. and Canada into the Clinical Trials Cooperative Groups.
International Network for Cancer Treatment and Research (INCTR)
INCTR is a not-for-profit, non-governmental organization founded in 1998 by the UICC and the Institut Pasteur in Brussels. INCTR aims to reduce mortality and morbidity from cancer in developing countries through a coordinated program of education, training, and the conduct of long-term collaborative projects related to early detection, diagnosis, treatment, and palliative care. NCI helps the INCTR by providing financial, technical, and intellectual support.
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OCCAM supports a variety of international partnerships and collaborations since many complementary and alternative medicine therapies originate as traditional medicines from other countries.
NCI provides funding to international investigators to collaborate with the United States and conduct cancer research. Contact the following division and offices to learn more:
Division of Cancer Control and Population Sciences (DCCPS) Funding Opportunities
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IPCRC makes palliative care resources accessible for health care professionals, builds palliative care capacity worldwide, and provides a dynamic and constantly expanding Web site. NCI's Office of International Affairs provided funding for this collaborative effort.
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The Consortium recognizes the importance of building a workforce with the skills and knowledge necessary to practice cancer control and thus sponsors a number of fellowships and training opportunities for scientists, physicians, and other public health professionals from Ireland, Northern Ireland, and the United States. Interested individuals are encouraged to apply for fellowships or short-term training programs.
NCI's Summer Curriculum in Cancer Prevention
One- or four-week courses occur each summer in Maryland for U.S. and international health professionals. The one-week course focuses on molecular prevention, and the four-week course focuses on the principles and practice of cancer prevention and control, during which attendees from many countries present an international perspective on cancer prevention during International Day. This program is coordinated through NCI's Center for Cancer Training.
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Each year, approximately 1,000 visiting scientists from more than 74 countries contribute to intramural research projects at NCI's Center for Cancer Research through the NIH Visiting Program.
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NCI's Office of International Affairs (OIA) STSEP promotes collaborative research between established U.S. and foreign scientists from low-, middle-, and upper-middle-income countries by supporting, in part, exchange visits of cancer researchers from foreign laboratories.
United States-Japan Cooperative Cancer Research Program (USJCCRP)
Formal researcher exchange programs exist through the U.S.-Japan Cooperative Cancer Research program, administered by NCI's Office of International Affairs. The program supports scientific workshops and meetings to help advance cancer research and clinical care, creates networks among researchers and institutions, and promotes women and young researchers' active participation in cancer research.
Programs by Region
Centers for AIDS Research (CFAR) Program
NCI, in cooperation with other parts of NIH, provides awards to establish and maintain several Centers for AIDS Research (CFARs) that conduct research on prevention, detection, and treatment of HIV, AIDS, and AIDS-related malignancies. African CFAR collaborations include institutions in Botswana, Kenya, Malawi, Mozambique, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. CFAR is supported by NCI's Office of HIV and AIDS Malignancy.
Ghana Prostate Cancer Study
This study assesses the burden of prostate cancer among West African men through a population-based prostate cancer screening survey and a clinical survey of diagnosed prostate tumors. This population shares genetic ancestry but has different lifestyle factors compared with African Americans, a group that has one of the world's highest prostate cancer risks.
Strengthening Capacity for Research for HIV-Associated Malignancies in Africa
This initiative, supported by NCI's Office of HIV and AIDS Malignancy and co-funded by the Fogarty International Center, provides funding for innovative training programs designed to train African research teams in preparation for collaboration on future research projects.
Office of Cancer Complementary and Alternative Medicine (OCCAM)
OCCAM supports a variety of international partnerships and collaborations since many complementary and alternative medicine therapies originate as traditional medicines from other countries.
Office of China Cancer Programs (OCCP)
OCCP promotes, supports, and informs the development of cooperative research projects between U.S. and Chinese scientists, research teams, and institutions to accelerate progress against cancer.
Shanghai Women's Health Study
This cohort study is assessing the role of occupational and environmental factors in the development of cancer among women in Shanghai, China. A number of analytic projects are ongoing, including the assessment of specific cancer risks in relation to anthropometric measurements, physical activity, and reproductive factors.
Studies among workers exposed to benzene in China
NCI and the China Center for Disease Control have partnered to understand which cancers are caused by benzene exposure, the effect of exposure amount on risk, and mechanisms of carcinogenicity. Current work is examining the effect of genetics susceptibility to benzene poisoning and identifying biomarkers of exposure and cancer risk.
U.S.-India Activities on Prevention of Sexually Transmitted Infections and HIV/AIDS
The U.S.-India Agreement supports innovative and basic research on strategies to prevent HIV infection and transmission through the collaborative efforts of U.S. and Indian investigators and their institutions. The program seeks to advance a multifaceted approach to prevention that addresses the role of other co-infections, behavioral and social interactions, epidemiological factors, and co-morbidities associated with HIV transmission.
United States-Japan Cooperative Cancer Research Program (USJCCRP)
USJCCRP supports scientific workshops and meetings to help advance cancer research and clinical care, creates networks among researchers and institutions, and promotes women and young researchers' active participation in cancer research.
Childhood Cancer Survivor Study
This cohort of more than 14,000 five-year survivors of childhood cancer diagnosed at 25 U.S. and Canadian hospitals between 1970 and 1986 is being followed to assess the long-term risks of radiation and chemotherapy for second cancers of the breast, brain, thyroid gland, bone and soft tissue, skin, and salivary glands.
Ireland-Northern Ireland-NCI Cancer Consortium (AICC)
AICC brings together the governments of the United States and both parts of the island to reduce the incidence and mortality of cancer on the island of Ireland, which has among the highest rates of cancer in the Western world.
OLACPD, an innovative partnership between NCI and the Fogarty International Center, was launched in recognition of the opportunity to support and enhance cancer research and care in Latin America.
The Network initially includes Argentina, Brazil, Chile, Mexico, and Uruguay and is responsible for developing a comprehensive understanding of the status of the disease burden, cancer research, and cancer care infrastructures, and building collaborative relationships to support high-quality research and clinical studies.
Middle East Cancer Consortium (MECC)
MECC was established 14 years ago and is a unique partnership between the United States and the Ministries of Health of Cyprus, Egypt, Israel, Jordan, the Palestinian Authority, and Turkey. MECC is administered by NCI's Office of International Affairs.
Cancer Research Highlights
Prostate Cancer Hormone Treatments May Raise Risk of Colorectal Cancer
A large, retrospective population study suggests that prostate cancer treatments that lower male sex hormones may increase the risk of colorectal cancer. Men treated with gonadotropin-releasing hormone (GnRH) agonists or surgical removal of their testicles (orchiectomy) to lower their testosterone and PSA levels experienced an increased risk of colorectal cancer of about 20 to 40 percent. The findings were reported online November 10 in the Journal of the National Cancer Institute.
More than half of nearly 108,000 prostate cancer patients identified in the linked SEER-Medicare database received androgen deprivation therapy between 1993 and 2002. Approximately 90 percent of those men had been treated with GnRH agonists, and the rest had had orchiectomy. They were followed for about 5 years after their prostate cancer diagnosis.
After adjusting for possible confounders such as obesity, diabetes, and radiotherapy, the researchers found a dose-response effect for GnRH agonists in which colorectal cancer risk increased with longer duration of treatment. Compared with prostate cancer patients who received no hormone treatments, those who had GnRH agonist therapy for 13 to 25 months had a 19 percent increase in colorectal cancer risk, those who had GnRH agonist therapy for longer than 25 months had a 31 percent increase in risk, and those who had orchiectomy had a 37 percent increase in risk.
Lead author Dr. Silke Gillessen of Kantonsspital St. Gallen in Switzerland and her colleagues noted that an inverse association between androgen levels and colorectal cancer risk is biologically plausible. "Androgen receptors are present in both normal and malignant human colonic tissues, and in various animal studies, administration of androgens protects against colon carcinogenesis, whereas androgen ablation promotes it," they wrote. The authors went on to say that their evidence "may have broader implications beyond the field of prostate cancer" because nearly half a million men in the United States develop androgen deficiency each year.
Strategy to Screen for Lynch Syndrome May Save Lives and Be Cost Effective
An expanded screening strategy that involves genetic testing for an inherited disorder that predisposes people to several cancers, including colorectal and endometrial cancer, would save lives and be cost effective, according to a new study. The disorder, called Lynch syndrome, is caused by mutations in four genes, the products of which are involved in DNA mismatch repair. Defective DNA mismatch repair increases the risk not only of different cancer types, but also of multiple cancers at a single time and often in younger people.
Published online November 18 in Cancer Prevention Research, the study used a computer simulation model called Archimedes to assess the impact of 20 different screening strategies for Lynch syndrome on cancer incidence and mortality in a large group that is representative of the U.S. population. The strategies differed in the age of initiating risk assessment and risk thresholds for implementing genetic testing.
A strategy that involves assessing risk with the PREMM1,2 risk model for people ages 25, 30, or 35, followed by genetic tests on those whose risk of having a mutation in a DNA mismatch repair gene exceeds 5 percent, could potentially reduce the incidence of colorectal and endometrial cancer by as much as 12.4 percent and 8.8 percent, respectively, the researchers found. The average cost for this strategy per quality-adjusted life year, a measure of health care cost effectiveness, was $26,000, which is in line with that of common screening modalities such as mammography, said study co-author Dr. Stephen Gruber of the University of Michigan during a press briefing on the study.
The study, said senior author Dr. Randall Burt of the Huntsman Cancer Institute in Utah, demonstrates "what is the most medically effective way [to screen for Lynch syndrome] and the most cost-effective way." Appropriate screening of people with Lynch syndrome, Dr. Burt added, reduces their risk of dying from colorectal cancer to that seen in the general population.
According to some estimates, approximately 1 in 375 people in the United States have Lynch syndrome, explained Heather Hampel of the Ohio State University Comprehensive Cancer Center, during the briefing. Current screening has focused on patients already diagnosed with cancers that can be caused by Lynch syndrome, said Hampel, who was not involved in the study. If the hallmark genetic mutations are identified in patients, then family members are screened for the mutations. But even this approach has been challenging to implement, Hampel stressed.
It's important to note that the findings are based solely on a computer simulation model, said Dr. Martin Brown of NCI's Division of Cancer Control and Population Sciences. And from a cost-effectiveness perspective, he noted, only Medicare costs were accounted for in the model, not additional out-of-pocket cost and time spent undergoing tests and associated procedures.
Anemia Drug May Interfere with Trastuzumab's Anticancer Effects
Recombinant human erythropoietin (rHuEPO), which some cancer patients take to combat anemia and fatigue, may interfere with the anticancer effects of trastuzumab (Herceptin), researchers led by Dr. Zhen Fan of the University of Texas M. D. Anderson Cancer Center reported November 16 in Cancer Cell. Doctors use trastuzumab to treat breast cancers that overexpress the protein HER2.
In experiments using breast cancer cell lines, the researchers found that 4 out of 10 lines expressed both HER2 and the receptor for erythropoietin (EpoR), the natural form of rHuEPO. They also found EpoR in 13 out of 15 samples from patients with HER2-positive breast cancer. When three breast cancer cell lines expressing both EpoR and HER2 were cultured with trastuzumab, cell survival and proliferation decreased. However, when the cells were cultured with both rHuEPO and trastuzumab, the percentage of cancer cells that survived treatment in all three cell lines increased substantially. Similarly, trastuzumab-induced inhibition of cell migration and invasion was decreased in the presence of rHuEPO.
When the researchers implanted tumors expressing both EpoR and HER2 in mice and treated them with trastuzumab, the tumors shrank or stopped growing. When the researchers added rHuEPO to treatment, the tumors continued to grow, albeit at a slower rate than without any treatment.
The authors found that rHuEPO activates cell signaling pathways that interact with and reactivate the pathway that trastuzumab blocks. In addition, rHuEPO appears to inactivate a tumor suppressor gene called PTEN that also mediates the effects of trastuzumab on cancer cells.
To examine whether this interference translates to the clinic, the researchers looked at medical records for 37 women with HER2-overexpressing metastatic breast cancer who had received both trastuzumab and rHuEPO during treatment and 74 who received trastuzumab but not rHuEPO. They found that 40 percent of women who received only trastuzumab were alive without progression of their disease 1 year after treatment, compared with 19 percent of women who received both trastuzumab and rHuEPO.
The authors cautioned that this analysis was retrospective and included only a small number of patients. The women who received rHuEPO may have been sicker than patients who did not require a boost to their blood-cell counts, which could influence the survival data. To confirm their observations, "prospective clinical trials are warranted," wrote the authors. "If confirmed, our findings would have a strong impact on clinical care for patients with HER2-overexpressing breast cancer," they concluded.
Possible Causes of Resistance to Melanoma Drug Reported
Just months after researchers demonstrated the promise of a new melanoma drug called PLX4032 in early-stage trials, two studies have examined the reasons the drug eventually stops working in some patients. Resistance to single-agent targeted therapies for cancer is considered to be nearly inevitable over time. The new studies, published November 24 in Nature, describe molecular changes that may cause resistance to PLX4032 and suggest strategies for overcoming this resistance.
PLX4032 blocks overactive cell signaling through the MAPK pathway that is caused by a mutation known as V600E in the BRAF gene. One common mechanism of resistance is secondary mutations that prevent binding of a drug. However, both of the Nature studies found that resistance to the drug can occur in the absence of secondary mutations in the BRAF gene.
In one study, Dr. Levi Garraway of the Dana-Farber Cancer Institute and his colleagues described a strategy for identifying clinically relevant mechanisms of resistance and ways to overcome this resistance. Using this strategy, the researchers identified mutations in the gene encoding a protein called COT that lead to the activation of the MAPK pathway. The expression of COT was associated with resistance to PLX4032 in melanoma cells and in tissue from patients who relapsed following treatment with PLX4032 or a MEK inhibitor. (MEK is a component of the MAPK pathway.)
Some patients who have relapsed on PLX4032 have already been enrolled in a phase II trial of a MEK inhibitor based on the assumption that the MAPK pathway had been reactivated, noted the authors of the second study, which was led by Dr. Roger Lo of the University of California, Los Angeles. His team found that 5 of 12 patients with melanoma had acquired resistance to PLX4032 through the activation of the MAPK pathway. This appeared to occur due to mutations in a cancer-causing gene called N-RAS or increased levels of the growth factor receptor PDGFR-beta.
Combination therapies targeting multiple pathways may be able to overcome resistance, according to the authors of both studies. This was also the conclusion of a third study, published November 23 in Science Signaling. The researchers, led by Dr. Jeffrey Settleman of Massachusetts General Hospital Cancer Center and Harvard Medical School, found that extra copies of the BRAF gene (amplification) were a cause of resistance to both MEK and BRAF inhibitors. Further experiments suggested that combined MEK and BRAF inhibition could potentially overcome, or possibly prevent, this mechanism of resistance.
Radiation Treatment for Head and Neck Cancer May Produce Hearing Loss
Treatment for head and neck cancer that includes radiation therapy often induces hearing loss, and the damage can be substantial and permanent, Brazilian researchers have reported. Their findings were published in the November 2010 Archives of Otolaryngology—Head and Neck Surgery.
In the case-control study, which included 282 participants, case patients had head and neck cancer and had been treated with radiation therapy, either alone or in combination with chemotherapy, and the auditory system was included in the field of radiation. The control group included healthy individuals and patients with cancer who had not received therapy that affects hearing. The median age for both groups was approximately 61.
Over a median follow-up of 7 years, approximately 72 percent of case patients suffered hearing loss (as measured by standard audiologic assessment methods) compared with approximately 49 percent of the control group, reported Christiane Schultz from the Audiology Department at the A.C. Camargo Hospital in São Paulo, Brazil, and her colleagues.
The most common type of hearing loss in both groups was related to inner ear damage (sensorineural), but case patients were statistically significantly more likely than control subjects to experience severe hearing loss. Case patients were also far more likely to report (via a standardized questionnaire) that hearing loss represented a severe handicap (19.1 percent versus 2.8 percent).
Attention to this side effect is critical, the researchers wrote, because loss of hearing can promote social isolation and depression. "Concern for the quality of life of patients undergoing cancer treatment is necessarily growing," they continued, "and determination of hearing loss should form part of such investigations to enable better rehabilitation."
FDA Update
Another Option Added for Treating Late-Stage Breast Cancer
The FDA has approved eribulin mesylate (Halaven) for the treatment of metastatic breast cancer in women who have received at least two prior chemotherapy regimens for late-stage disease.
Eribulin is a synthetic form of a compound derived from the sea sponge Halichondria okadai; the drug is believed to suppress the growth of cancer cells by inhibiting microtubule formation. Before receiving eribulin, an injectable therapy, patients should have received prior anthracycline- and taxane-based chemotherapy for early- or late-stage breast cancer.
The FDA's approval was based on the phase III EMBRACE study. Preliminary results presented at the American Society of Clinical Oncology annual meeting in June showed a 2.5 month improvement in median overall survival among patients who received eribulin compared with the control group. The median overall survival for patients who received eribulin was 13.1 months, compared with 10.6 months for those who received other single-agent therapy.
The study included 762 women who had metastatic breast cancer and had received at least two prior chemotherapy regimens. The patients were randomly assigned to receive either eribulin or a different single-agent therapy chosen by their oncologist.
Common side effects included a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.
"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, in a statement. "Halaven shows a clear survival benefit and is an important new option for women."
Denosumab Approved to Prevent Bone Problems in Cancer Patients
Denosumab, a monoclonal antibody approved in June 2010 to treat osteoporosis in postmenopausal women at high risk for bone fractures, received supplemental approval at a higher dose to prevent skeletal problems in patients with bone metastases from solid tumors. In clinical trials, denosumab was superior to zoledronic acid (Zometa) at prolonging the time before patients with a variety of cancers had a fracture or spinal cord compression or required surgery or radiotherapy for bone pain.
When administered to patients with cancer, denosumab has a different safety profile than when given for osteoporosis and is known by a different trade name (Xgeva, instead of Prolia). Denosumab is also given more frequently and at a higher dose to patients with cancer, who receive injections of 120 mg every 4 weeks, than to patients with osteoporosis, who receive 60 mg every 6 months.
"Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer," said the FDA's Dr. Richard Pazdur. In three large international clinical trials that enrolled a total of 5,723 patients, denosumab was superior to zoledronic acid in women with breast cancer and men with prostate cancer. The drugs had a similar effect in patients with other cancers, including non-small cell lung cancer, multiple myeloma, kidney cancer, and small cell lung cancer. However, denosumab is not approved for patients with multiple myeloma or other cancers of the blood.
CMS Update
Medicare Advisory Panel Reviews Data on Provenge
On November 17, a Medicare advisory panel offered moderately strong support for the prostate cancer immunotherapy drug sipuleucel-T (Provenge). The Medicare Evidence Development & Coverage Advisory Committee, or MEDCAC, generally agreed that the available data indicate the therapy is effective for its FDA-approved use: the treatment of men with metastatic prostate cancer who are experiencing few or no symptoms from the disease. The panel's decision was part of a National Coverage Analysis (NCA) initiated earlier this year, which will determine whether Medicare will cover sipuleucel-T treatment for Medicare beneficiaries.
The FDA approved sipuleucel-T in April 2010. The approval was based on results from a phase III clinical trial called IMPACT, which showed that the treatment—called autologous cellular immunotherapy, because it uses a modified form of patients' own white blood cells—improved median overall survival for men with metastatic hormone-refractory prostate cancer by 4.1 months compared with men who received a placebo treatment. The treatment also had little evidence of serious side effects.
The NCA was initiated, agency officials said, because of questions that had been raised about whether the therapy—which consists of three vaccinations over a 4- to 6-week period at a total cost of $93,000—would be covered by all of Medicare's regional carriers.
The panel voted on a series of questions about the treatment using a rating system from 1 to 5, with 1 being a vote of low confidence and 5 representing a vote of high confidence. On the question of whether there was adequate evidence to support a survival improvement in men with asymptomatic/mildly symptomatic metastatic prostate cancer, the panel's average score was 3.6. In addition, an independent technology assessment conducted by the Blue Cross & Blue Shield Technology Evaluation Center concluded that the evidence to support sipuleucel-T's efficacy was "moderate."
The committee had less confidence that the survival results with sipuleucel-T could be expected for so-called off-label indications, such as men with heavily symptomatic metastatic prostate cancer or nonmetastatic prostate cancer. The panel's average score for that question was 1.2.
During the meeting's public comment session, both medical professionals and patient advocates voiced strong support for sipuleucel-T. The only other treatment approved for metastatic hormone-refractory prostate cancer, the chemotherapy drug docetaxel, has significant toxicities that deter many men from taking it, several presenters noted. With sipuleucel-T, said Dr. Mark Scholz of Prostate Oncology Specialists in California, there is now "an effective treatment that can be administered to relatively frail patients without ruining their quality of life."
During a committee debate, however, panel members raised a number of questions about sipuleucel-T and the trials that led to its FDA approval. Among them was whether the fact that many men in the sipuleucel-T arm of IMPACT eventually went on to receive docetaxel could have confounded the survival figures. But an additional analysis of the trial data presented at this year's American Society of Clinical Oncology annual meeting showed that the treatment's effect on overall survival appears to be independent of docetaxel use, Dr. Daniel Petrylak of the Herbert Irving Comprehensive Cancer Center at Columbia University told the committee.
In addition, approximately two-thirds of patients in the placebo arm "crossed over" (when they showed evidence of disease progression) to receive immunotherapy manufactured from cells obtained at trial entry but cryopreserved for possible later use, and several committee members expressed uncertainty about how that may have affected the survival results. However, according to Dr. Daniel George of the Duke University Comprehensive Cancer Center, an analysis to be presented at an upcoming meeting will show that there was a survival improvement in patients who received the frozen product.
"If anything," Dr. George said, "that would decrease the [survival] benefit associated with Provenge."
Based on an agreement with the FDA, Dendreon, which manufactures sipuleucel-T, is conducting a "registration trial" that will include at least 1,500 patients, to monitor efficacy and side effects associated with sipuleucel-T, said Dr. Mark Frohlich, the company's chief medical officer.
—Carmen Phillips
Cancer.gov Update
New Content on NCI's YouTube Network
Videos produced by NCI, including videos featured in the NCI Cancer Bulletin, are now easier to find on the NCI YouTube Network.
The Bulletin channel, http://www.youtube.com/NCIcancerbulletin, features videos from the following series: Cancer Research Now, In Their Own Words, and Inside NCI. The NCI YouTube Network also features several other playlists, including one for the Center for Cancer Research's (CCR's) Camera on Cancer Research series, which profiles CCR scientists and the progress they're making in the lab and the clinic.
New content is added regularly to the NCI YouTube Network, so check back often.
NCI Recovery Act Web Site Highlights NCI's Smoking Cessation Program
The NCI Recovery Act Web site has added a new article about NCI's smoking cessation program and describes how Recovery Act funding has allowed NCI to hire staff and expand services. Because smoking is a leading cause of cancer and continues to be a major public health issue, one of NCI's imperatives is to provide evidence-based interventions and new approaches to help smokers successfully quit. With the recent Recovery Act award, NCI will be able to evaluate and improve its smoking cessation services.
NCI's Cancer Information Service Contact Center has been helping smokers quit since the 1980s. Cessation resources, including NCI's Smoking Quitline 1-877-44U-QUIT (1-877-448-7848), were developed by the Office of Communications and Education, with content provided by NCI's Tobacco Control Research Branch.
In Memoriam: Elaine Ron, Senior Investigator in DCEG
Dr. Elaine Ron, a senior investigator in NCI's Division of Cancer Epidemiology and Genetics (DCEG), died of cancer on November 20 at her home in Bethesda, MD. She was 67.
Dr. Ron was renowned as one of the leading experts in radiation epidemiology and in the causes of thyroid cancer, as well as a champion of women in science. Over the course of her career she authored more than 200 scientific peer-reviewed papers and mentored researchers from around the world. She leaves as a legacy numerous junior investigators who were inspired by her example.
Dr. Ron conducted groundbreaking research. In her earliest work, in Israel, she identified the long-term cancer risk associated with radiation treatment for tinea capitis (a fungal infection of the scalp). Dr. Ron joined NCI in 1986 and served as chief of the Radiation Epidemiology Branch from 1997 to 2002. She participated in numerous international committees, including the International Commission on Radiological Protection, the Scientific Council of the International Agency for Research on Cancer, and the Public Health Committee of the American Thyroid Association.
"Elaine contributed enormously to our understanding of the cancer risks associated with radiation," reflected Dr. Joseph F. Fraumeni, Jr., director of DCEG. "Her interests included studies of the atomic bomb survivors in Japan, residents of the former Soviet Union exposed to radioactive compounds from the Chernobyl accident, and patients exposed to diagnostic and therapeutic radiation. In addition to addressing the biological mechanisms of disease, Dr. Ron was keenly focused on public health and policy implications of her research."
Her scientific achievements included the largest study of cancer risks among patients treated with radioactive iodine for hyperthyroidism and the first international effort to pool epidemiologic data on thyroid cancer. She had recently launched a major investigation into the potential adverse effects of CT screening among children and young adults.
Dr. Shelia Hoar Zahm, deputy director of DCEG, noted, "Elaine was passionate about fighting injustice. Whether it was promoting equity for women scientists at work, preventing cruelty to animals, or advancing human rights around the globe, she refused to accept the status quo."
Dr. Ron is survived by her son, Ariel Ron, her greatest joy.
EEMS Accepting Proposals for Use of PLCO Data and Biospecimens
Data and biospecimens from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial are available to qualified researchers through a peer-review process. The Etiologic and Early Marker Studies (EEMS) program accepts proposals for access to PLCO biospecimens twice a year, in June/July and December/January.
By collecting biologic materials and risk factor information from trial participants before the diagnosis of disease, EEMS—a component of the PLCO—provides a resource for cancer researchers who are focused on cancer etiology and early markers. Etiologic studies investigate the environmental, biochemical, and genetic risk factors for cancer. Early detection studies aim to develop reproducible, reliable biomarkers of early disease.
Proposals will be accepted for the next EEMS review cycle starting December 1. Applications will be accepted until January 14, 2011, at 5:00 p.m. EST. Details of the review process and application materials are available at http://www.plcostars.com. Questions may be directed to email@example.com or 240-314-2313.
Next NCAB Meeting Scheduled for December 7
The National Cancer Advisory Board (NCAB) will meet on December 7 from 9:00 a.m. to 4:15 p.m. in Building 31 on the NIH main campus in Bethesda, MD. The agenda is now available, and the meeting will be broadcast live online. An archived videocast of the meeting will be available a few days after the meeting.
President's Cancer Panel Discusses the Future of Cancer Research
The President's Cancer Panel held the second meeting of its 2010–2011 series, The Future of Cancer Research: Accelerating Scientific Innovation, on October 26 in Philadelphia. The meeting featured expert testimony and discussion on opportunities to facilitate progress within the National Cancer Program (NCP).
Presenters discussed the need to examine the cancer research environment. Attendees noted that current government funding mechanisms and the overall research and development strategy of the private sector do not foster high-risk, creative projects with the potential for innovative breakthroughs;rather, development programs support incremental innovations that build on already-known concepts. Presenters also further challenged the existing paradigm of research, stressing that true innovation will flourish at the point of care, where researchers and patients interact.
Many presenters said that health information technology, including electronic health records (EHR), will play a critical role in the future of cancer care and research. The widespread adoption of EHR would facilitate the collection and analysis of vast amounts of data from across the United States, they noted, and holds the promise of individualized guidelines for disease prevention and care. They stressed that researchers should have open access to such data collections.
The importance of biospecimens in cancer research in the coming years cannot be overstated, and participants said that efforts must be made to ensure an adequate supply of specimens are stored and that the quality of the specimens is sufficient to yield meaningful information for clinical and research applications. They agreed that developing standards for specimen collection and storage will be a key element of these efforts.
The Panel will summarize findings and recommendations from this meeting, along with the other meetings in the series, in its 2010–2011 Annual Report to the President of the United States.


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TREASURE COAST -As part of his mission to educate Floridians about critical financial issues that affect the security and prosperity of their futures and families, Jeff Atwater, Florida's chief financial officer, launched the Florida students $ave essay contest.
The contest will award hundreds to students who present the best research and planning in response to scenarios that reflect short- and long-term financial goals.
"The goal of our essay contest is to motivate young people to develop personal financial skills and better prepare them for college and the workplace," said Mr. Atwater.
The Department of Financial Services, which Mr. Atwater oversees, is sponsoring the contest in partnership with Florida Master Money Mentors, the James Madison Institute and the Florida Council on Economic Education. Students enrolled in grades 9-12 of a Florida educational program (public, private, charter, virtual or homeschool) for the 2012-13 school year can submit an essay of up to 1,200 words online at www.MyFloridaCFO.com/YMM for a chance to win a first-place prize of $250. Second- and third-place winners will receive $150 and $50 respectively.
Three winners will be chosen from each of five regions across Florida: Northwest Florida, Jacksonville, Orlando, Tampa and South Florida.
The Florida Master Money Mentor program, which is donating the contest prizes, provides financial education to rural and low-to-moderate-income Florida families.
Contest rules, essay guidance and options, and a map of contest regions are available at www.MyFloridaCFO.com/YMM. Essays must be submitted by 11:59 p.m. eastern on Nov. 30. Winners will be announced in February 2013.
For more information, visit www.MyFloridaCFO.com/YMM or call (877) MY-FL-CFO (693-5236).
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