Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials. Laparoscopic vs open total mesorectal excision for rectal cancer: an evaluation of the mesorectum's macroscopic quality. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Laparoscopic total mesorectal excision: a consecutive series of 100 patients. Laparoscopic rectal resection with anal sphincter preservation for rectal cancer: long-term outcome. The surgeon as a prognostic factor after the introduction of total mesorectal excision in the treatment of rectal cancer. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial. Variability in the quality of rectal cancer care in public hospitals in Catalonia (Spain): clinical audit as a basis for action. Influence of hospital volume on the frequency of abdominoperineal resection and long-term oncological outcomes in low rectal cancer. Actionable indicators for short and long term outcomes in rectal cancer. Neo-adjuvant chemotherapy for operable gastric cancer: long term results of the Dutch randomised FAMTX trial. Adjuvant VHF therapy in locally recurrent and primary unresectable rectal cancer. Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer. Colorectal cancer with non-resectable synchronous metastases: should the primary tumor be resected? Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy. Laparoscopic-assisted total mesorectal excision and colonic J pouch reconstruction in the treatment of rectal cancer. The Stockholm I trial of preoperative short term radiotherapy in operable rectal carcinoma. A prospective randomized trial. Stockholm Colorectal Cancer Study Group. Randomized study on preoperative radiotherapy in rectal carcinoma. Stockholm Colorectal Cancer Study Group. Assessment of quality of life in patients with rectal cancer treated by preoperative radiotherapy: a longitudinal prospective study. Longitudinal assessment of quality of life in rectal cancer patients with or without stomas following primary resection. Efficacy of oral adjuvant therapy after resection of colorectal cancer: 5-year results from three randomized trials. [Cooperative study of surgical adjuvant chemotherapy for colorectal cancer (third report): five-year results. Cooperative Study Group of Surgical Adjuvant Chemotherapy for Colorectal Cancer in Japan]. Randomized, controlled study of continuous 5-FU infusion starting immediately after curative surgery for advanced colorectal cancer. [Prospective controlled study on the usefulness of Carmofur as a postoperative adjuvant chemotherapy for colorectal cancer]. Prospective evaluation of laparoscopic surgery for rectosigmoidal and rectal carcinoma. Laparoscopic versus open total mesorectal excision with anal sphincter preservation for low rectal cancer. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. Randomised clinical trial of adjuvant postoperative RT vs. sequential postoperative RT plus 5-FU and levamisole in patients with stage II-III resectable rectal cancer: a final report. A case-control-study comparing laparoscopic versus open surgery for rectosigmoidal and rectal cancer. Laparoscopic versus conventional open resection of rectal carcinoma: A clinical comparative study. Impact of preoperative radiotherapy on general and disease-specific health status of rectal cancer survivors: a population-based study. Quality of life in rectal cancer patients: a four-year prospective study. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer. Laparoscopic resection of rectosigmoid carcinoma: prospective randomised trial. Long-term results of laparoscopic versus open resections for rectal cancer for 124 unselected patients. Laparoscopic resection for rectal cancer: outcomes in 194 patients and review of the literature. Effective surgical adjuvant therapy for high-risk rectal carcinoma. Initial results of a randomized controlled trial comparing clinical and pathological downstaging of rectal cancer after preoperative short-course radiotherapy or long-term chemoradiotherapy, both with delayed surgery. Similar outcome after colonic pouch and side-to-end anastomosis in low anterior resection for rectal cancer: a prospective randomized trial. Postoperative surveillance in patients with colorectal cancer who have undergone curative resection: a prospective, multicenter, randomized, controlled trial.
The survival of 78 patients with resected non-small cell lung cancer entered in prospective, randomized investigational trials is compared to that of a population-based group of control patients not included in such trials. The survival of trial patients is significantly better than that of controls (P less than 0.001). This survival advantage for trial participants is most apparent among late Stage I patients, and is observed after matching for known prognostic factors (i.e., primary tumor size, nodal status, tumor histology) and after adjusting in the analysis for age, sex, and the administration of radiation therapy. Several explanations for the improved outcome for trial patients are explored, including differences in preoperative evaluation, staging, surgical technique, placebo effects, and patient motivation. These results suggest the possibility that inclusion in these controlled cancer trials may have had an inherent advantage for all participants. Next to surgical margins, yield of lymph nodes, and length of bowel resected, macroscopic completeness of mesorectal excision may serve as another quality control of total mesorectal excision (TME). In this study, the macroscopic completeness of laparoscopic TME was evaluated.
                A series of 25 patients with rectal cancer were managed laparoscopically (LTME) and included in this study. The pathologic specimens of the LTME group were prospectively examined and matched with a historical group of resection specimens from patients who had undergone open TME (OTME). The two groups were matched for gender and type of resection (low anterior or abdominoperineal resection). Special care was given to the macroscopic judgment concerning the completeness of the mesorectum.
                A three-grade scoring system showed no differences between the LTME and OTME groups.
                The current study supports the hypothesis that oncologic resection using laparoscopic TME is feasible and adequate. A prospective randomized controlled trial (RCT) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
                This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT.
                Patients for elective resection for colorectal cancer were offered trial entry. Participants were stratified by sex and requirement for a total mesorectal excision and centrally randomized. Multimodal patients received intravenous fluid restriction, unrestricted oral intake with prokinetic agents, early ambulation, and fixed regimen epidural analgesia. Control patients received intravenous fluids to prevent oliguria, restricted oral intake until return of bowel motility, and weaning regimen epidural analgesia. Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets. Discharge decision was made using pre-agreed criteria. The primary endpoint was postoperative stay, and achievement of independence milestones. Secondary endpoints were postoperative complications, readmission rates, and mortality. Analysis was by intention to treat.
                Seventy patients were recruited. Approximately one fourth underwent TME. Median ages were similar (69.3 vs. 73.0 years). The median stay was significantly reduced in the multimodal group (5 vs. 7 days; P < 0.001, Mann-Whitney U test). Patients in the control arm were 2.5 times as likely to require a postoperative stay of more than 5 days. Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions. There were 2 deaths, both controls.
                This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery. Morbidity and mortality are not increased. In the latter 1990s, adjuvant chemotherapy for completely resected Stage III colorectal cancer remained controversial in Japan. We conducted two independent randomized controlled trials in patients with Stage III colon and rectal cancer.
                Patients were randomly assigned to receive surgery alone or surgery followed by treatment with UFT (400 mg/m²/day), given for five consecutive days per week for 1 year. The primary endpoint was relapse-free survival (RFS), and the secondary endpoint was overall survival (OS).
                A total of 334 patients with colon cancer and 276 with rectal cancer were enrolled. The patients' characteristics were similar between the UFT group and the Surgery-alone group. There was no significant difference in RFS or OS in colon cancer. In rectal cancer, however, RFS and OS were significantly better in the UFT group than in the Surgery-alone group. The only grade 4 toxicity in the UFT group was diarrhea, occurring in one patient with colon cancer and one patient with rectal cancer.
                Postoperative adjuvant chemotherapy with UFT is successfully tolerated and improves RFS and OS in patients with Stage III rectal cancer. In colon cancer, the expected benefits were not obtained (hazard ratio = 0.89). To analyze total mesorectal excision (TME) for rectal cancer by the laparoscopic approach during a prospective nonrandomized trial.
                Improved local control and survival rates in the treatment of rectal cancer have been reported after TME.
                The authors conducted a prospective consecutive series of 100 laparoscopic TMEs for low and mid-rectal tumors. All patients had a sphincter-saving procedure. Case selection, surgical technique, and clinical and oncologic results were reviewed.
                The distal limit of rectal neoplasm was on average 6.1 (range 3-12) cm from the anal verge. The mean operative time was 250 (range 110-540) minutes. The conversion rate was 12%. Excluding the patient who stayed 104 days after a severe fistula and reoperation, the mean postoperative stay was 12.05 (range 5-53) days. The 30-day mortality was 2% and the overall postoperative morbidity was 36%, including 17 anastomotic leaks. Of 87 malignant cases, 70 (80.4%) had a minimum follow-up of 12 months, with a median follow-up of 45.7 (range 12-72) months. During this period 18.5% (13/70) died of cancer and 8.5% (6/70) are alive with metastatic disease. The port-site metastasis rate was 1.4% (1/70): a rectal cancer stage IV presented with a parietal recurrence at 17 months after surgery. The locoregional pelvic recurrence rate was 4.2% (3/70): three rectal cancers stage III at 19, 13, and 7 postoperative months.
                Laparoscopic TME is a feasible but technically demanding procedure (12% conversion rate). This series confirms the safety of the procedure, while oncologic results are at present comparable to the open published series with the limitation of a short follow-up period. Further studies and possibly randomized series will be necessary to evaluate long-term clinical outcome in cancer patients. Total mesorectal excision (TME) is the surgical gold standard treatment for middle and low third rectal carcinoma. Laparoscopy has gradually become accepted for the treatment of colorectal malignancy after a long period of questions regarding its safety. The purposes of this study were to examine prospectively our experience with laparoscopic TME and high rectal resections, to evaluate the surgical outcomes and oncologic adequacy, and to discuss the role of this procedure in the treatment of rectal cancer.
                Between December 1992 and December 2004, all patients who underwent elective laparoscopic sphincter preserving rectal resection for rectal cancer were enrolled prospectively in this study. Data collection included preoperative, operative, postoperative and oncologic results with long-term follow-up.
                A total of 218 patients were operated on during the study period: 142 patients underwent laparoscopic TME and 76 patients underwent anterior resection. Of the TME patients, 122 patients were operated using the double-stapling technique, and 20 patients underwent colo-anal anastomosis with hand-sewn sutures. Mean operative time was 138 min (range, 107-205), and mean blood loss was 120 ml (range, 30-350). Conversion to open surgery occurred in 26 cases (12%). Mortality rate during the first 30 days was 1%. Anastomotic leaks were observed in 10.5% of the patients. Of these, 61.9% needed reoperation and diverting stoma, and the rest were treated conservatively. Three patients had postoperative bleeding requiring relaparoscopy. Other minor complications (infection and urinary retention) occurred in 9.1% of patients. Mean ambulation time and mean hospital stay were 1.6 days (range, 1-5) and 6.4 days (range, 3-28) , respectively. Patients were followed for a mean period of 57 months. No port site metastases were observed during follow-up. The recurrence rate was 6.8 %. Overall survival rate was 67% after 5 years and 53.5% after 10 years.
                Laparoscopic anterior resection and TME with anal sphincter preservation for rectal cancer is feasible and safe. The short- and long-term outcomes reported in this series are comparable with those of conventional surgery. With conventional blunt surgical resection of rectal cancer, local recurrence rates are high and the individual surgeon putatively influences patient outcome. With total mesorectal excision (TME) local recurrence rates have been reduced and intersurgeon variability may be less important. The 'TME project' was a collaborative project that included surgical workshops in Stockholm between 1994 and 1997. The aim of this study was to assess the impact of the project on the practice of rectal cancer surgery in Stockholm and to analyse whether surgeon case volume and participation in the workshops influenced patient outcome.
                All 652 patients who had an abdominal resection for rectal cancer in Stockholm between 1995 and 1997 were included. Outcome was compared in patients operated on by teams that included high-volume surgeons (more than 12 operations per year) with teams that included low-volume surgeons (12 operations or fewer per year), as well as between teams that including workshop participants and non-participants.
                Forty-six surgeons operated on the 652 patients. Five high-volume surgeons operated on 48 per cent of the patients. In these, outcome was significantly better than in patients treated by low-volume surgeons (local recurrence rate 4 versus 10 per cent (P = 0.02); rate of rectal cancer death 11 versus 18 per cent (P = 0.007)). Twenty-six surgeons were workshop participants and performed 93 per cent of the operations. Radiotherapy, TME and sphincter-preserving surgery were more common among patients treated by workshop participants.
                The TME project has had an impact on rectal cancer surgical practice in Stockholm. Variability in patient outcome was mainly related to case volume, with better results obtained in patients treated by high-volume surgeons. The aim of the current study is to report the long-term outcomes after laparoscopic-assisted surgery compared with conventional open surgery within the context of the UK MRC CLASICC trial. Results from randomized trials have indicated that laparoscopic surgery for colon cancer is as effective as open surgery in the short term. Few data are available on rectal cancer, and long-term data on survival and recurrence are now required.
                The United Kingdom Medical Research Council Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer (UK MRC CLASICC; clinical trials number ISRCTN 74883561) trial study comparing conventional versus laparoscopic-assisted surgery in patients with cancer of the colon and rectum. The randomization ratio was 2:1 in favor of laparoscopic surgery. Long-term outcomes (3-year overall survival [OS], disease-free survival [DFS], local recurrence, and quality of life [QoL]) have now been determined on an intention-to-treat basis.
                Seven hundred ninety-four patients were recruited (526 laparoscopic and 268 open). Overall, there were no differences in the long-term outcomes. The differences in survival rates were OS of 1.8% (95% CI, -5.2% to 8.8%; P = .55), DFS of -1.4% (95% CI, -9.5% to 6.7%; P = .70), local recurrence of -0.8% (95% CI, -5.7% to 4.2%; P = .76), and QoL (P > .01 for all scales). Higher positivity of the circumferential resection margin was reported after laparoscopic anterior resection (AR), but it did not translate into an increased incidence of local recurrence.
                Successful laparoscopic-assisted surgery for colon cancer is as effective as open surgery in terms of oncological outcomes and preservation of QoL. Long-term outcomes for patients with rectal cancer were similar in those undergoing abdominoperineal resection and AR, and support the continued use of laparoscopic surgery in these patients. To assess with a single-blinded, multicenter, randomized trial, the postoperative results in patients undergoing sphincter-saving rectal resection for cancer without preoperative mechanical bowel preparation (MBP).
                The collective evidence from literature strongly suggests that MBP, before elective colonic surgery, is of no benefit in terms of postoperative morbidity. Very few data and no randomized study are available for rectal surgery and preliminary results conclude toward the safety of rectal resection without MBP.
                From October 2007 to January 2009, patients scheduled for elective rectal cancer sphincter-saving resection were randomized to receive preoperative MBP (ie, retrograde enema and oral laxatives) or not. Primary endpoint was the overall 30-day morbidity rate. Secondary endpoints included mortality rate, anastomotic leakage rate, major morbidity rate (Dindo III or more), degree of discomfort for the patient, and hospital stay.
                A total of 178 patients (103 men), including 89 in both groups (no-MBP and MBP groups), were included in the study. The overall and infectious morbidity rates were significantly higher in no-MBP versus MBP group, 44% versus 27%, P = 0.018, and 34% versus 16%, P = 0.005, respectively. Regarding both anastomotic leakage and major morbidity rates, there was no significant difference between no-MBP and MBP group: 19% versus 10% (P = 0.09) and 18% versus 11% (P = 0.69), respectively. Moderate or severe discomfort was reported by 40% of prepared patients. Mortality rate (1.1% vs 3.4%) and mean hospital stay (16 vs 14 days) did not differ significantly between both groups.
                This first randomized trial demonstrated that rectal cancer surgery without MBP was associated with higher risk of overall and infectious morbidity rates without any significant increase of anastomotic leakage rate. Thus, it suggests continuing to perform MBP before elective rectal resection for cancer. Clinical practice guidelines in cancer are a relevant component of Catalonian Cancer Strategy aimed at promoting equity of access to therapy and quality of cancer care. The colorectal cancer (CRC) guideline was first published in 2003 and subsequently updated in 2008. This study examined the quality of therapy administered to patients with rectal cancer in public hospitals in Catalonia (Spain) in 2005 and 2007, according to CRC guideline recommendations.
                We conducted a multicentre retrospective cohort study of patients who underwent curative-intent surgery for primary rectal cancer at Catalonian public hospitals in 2005 and 2007. Data were drawn from clinical records.
                The study covered 1831 patients with rectal cancer. Performance of total mesorectal excision (TME) was poorly reported by surgeons (46.4%) and pathologists (36.2%). Pre-operative radiotherapy was performed on 52% of stage-II and -III patients. Compared to high-caseload hospitals, those with a low caseload (≤11 cases/year) registered more Hartman's procedures, worse TME quality, a higher rate of post-operative complications and lower adherence to recommended pre-operative radio-chemotherapy.
                Reporting quality of care is essential for ascertaining current performance status and opportunities for improvement. In our case, there is a need for the quality of the information included in clinical records to be improved, and variability in adherence to guideline recommendations to be reduced. In view of the fact that heterogeneity in the quality of the health care process was linked to hospital caseload, the health authorities have decided to reorganise the provision of rectal cancer care.
                Copyright © 2011 Elsevier Ltd. All rights reserved. Studies analysing the outcome after resection of low rectal cancer that has not infiltrated the anal sphincter reveal poorer long-term outcomes after abdominoperineal resections (APR) in comparison with low anterior resections (LAR). Further, a relationship between the frequency of APR and LAR for low rectal cancer and hospital volume is known. Our aim was to investigate the independent impact of hospital volume and type of resection on oncological outcomes after resection of low rectal cancer.
                In a prospective multi-centre observational study of 1557 patients with low rectal cancer undergoing LAR or APR, the long-term oncological outcomes were analysed for their dependence on hospital volume and type of procedure.
                Univariate analysis revealed that patients undergoing APR had a higher local recurrence rate (p = 0.022) and shorter disease-free survival (p < 0.001) than patients undergoing LAR, while hospital volume showed merely a tendency to impact the local recurrence rate (p = 0.060). With regard to disease-free survival, no dependence on hospital volume was to be found (p = 0.201). The rate of APR was significantly associated with hospital volume (p < 0.001). Multivariate analysis revealed an independent impact of hospital volume on local recurrence rate, while disease-free survival was influenced by the type of surgical procedure performed.
                In the surgical treatment of low rectal cancer the hospital volume has a major impact on outcome. The type of procedure does not affect the local recurrence rate but the disease free survival. Although patient and tumour characteristics are the most important determinants for outcomes in rectal cancer care, actionable factors for improving these are still unclear. Therefore, the purpose of this study was to assess the impact of surgeon and hospital factors which can actually be influenced to improve on postoperative complications, disease-free survival (DFS) and relative survival (RS) in rectal cancer.
                For 819 curatively operated rectal cancer patients, staged I-III and diagnosed between 2001 and 2005, data were derived from the population-based Cancer Registry of the Comprehensive Cancer Centre North East and supplemented by medical record examination. (Multilevel) Logistic regression analysis was performed to examine the influence of relevant factors on postoperative complications and time from diagnosis to first treatment. Besides, Cox regression analysis for DFS and relative survival analysis was performed.
                Postoperative complications were dependent on type of surgery (p=0.024) and hospital volume (p=0.029). DFS was mainly influenced by stage (p<0.001) and time to treatment (p=0.018). Actionable indicators related to RS were type of surgery (p=0.011) and time to treatment (p=0.048). Time to treatment was found to be related to co-morbidity (p=0.007), preoperative radiotherapy (p=0.003) and referral for operation (p=0.048). Nevertheless, 18.2% unexplained variation in time to treatment remained on hospital level.
                We conclude that optimal outcomes for rectal cancer care can be achieved by focusing on early detection and timely diagnosis, as well as adequate choice and timeliness of treatment in hospitals with optimal logistics for rectal cancer patients.
                Copyright 2010 Elsevier Ltd. All rights reserved. Gastric cancer in Western countries is often diagnosed in an advanced stage and prognosis is poor. We performed a randomised trial with pre-operative FAMTX vs. surgery alone in order to evaluate the effect of pre-operative chemotherapy on resectability and survival.
                Patients with proven adenocarcinoma of the stomach were randomised to receive four courses of chemotherapy using 5-Fluorouracil, doxorubicin and methotrexate (FAMTX) prior to surgery or to undergo surgery alone.
                Fifty-nine patients were randomised; 29 patients were allocated to the FAMTX regimen prior to surgery and 30 patients had surgery alone. Resectability rates were equal for both groups. Complete or partial response was registered in 32% of the FAMTX group. With a median follow-up of 83 months the median survival since randomisation is 18 months in the FAMTX group vs. 30 months in the surgery alone group (p=0.17).
                This trial could not show a beneficial effect of pre-operative FAMTX. Until large randomised studies prove otherwise, adequate surgery without delay is the best treatment for operable gastric cancer. In a prospective randomized study, 434 mHz microwave therapy combined with external beam radiotherapy (VHF + RT) was compared with standard external beam radiotherapy (RT) in controlling locally recurrent or unresectable primary adenocarcinoma of the rectum. Independent assessors documented quality of life scores, performance status, toxicities, local response to treatment, and systemic disease progression before treatment and after treatment and every 8 weeks thereafter. Of 75 patients randomized, 73 were eligible for inclusion in the study. Forty-three of these patients had local pelvic tumour recurrence only and 21 also had distant metastases. In addition, nine patients had primary inoperable carcinomas, two of whom also had metastases. Thirty-seven patients were randomized to RT and 36 to VHF + RT. The median dose of radiation in the VHF+RT arm was 4275 cGy with a median fraction size of 150 cGy and median duration of therapy of 48.5 days versus 4500 cGy in the RT-only arm with a median fraction size of 180 cGy and median duration of therapy of 38 days. These doses are unlikely to be significantly different in biological effect. No significant difference between the two groups was observed in extent and duration of local control, measures of toxicity or quality of life scores. Additionally, survival and cumulative incidence of pelvic site of first progression did not differ significantly between the groups. We conclude that VHF microwave therapy in conjunction with radiotherapy produces no therapeutic advantage over conventional radiation therapy alone in the treatment of locally recurrent rectal carcinoma. Neoadjuvant chemoradiotherapy does not alter anal sphincter preservation or postoperative complications compared with short-course radiotherapy alone in patients with clinical stage T3 or T4 resectable rectal cancer. The aim of this study was to compare survival, local control and late toxicity in the two treatment groups.
                The study randomized 312 patients to receive either preoperative irradiation (25 Gy in five fractions of 5 Gy) and surgery within 7 days or chemoradiation (50.4 Gy in 28 fractions of 1.8 Gy, bolus 5-fluorouracil and leucovorin) and surgery 4-6 weeks later. The median follow-up of living patients was 48 (range 31-69) months.
                Early radiation toxicity was higher in the chemoradiation group (18.2 versus 3.2 per cent; P < 0.001). The actuarial 4-year overall survival was 67.2 per cent in the short-course group and 66.2 per cent in the chemoradiation group (P = 0.960). Disease-free survival was 58.4 versus 55.6 per cent (P = 0.820), crude incidence of local recurrence was 9.0 versus 14.2 per cent (P = 0.170) and severe late toxicity was 10.1 versus 7.1 per cent (P = 0.360) respectively.
                Neoadjuvant chemoradiation did not increase survival, local control or late toxicity compared with short-course radiotherapy alone. In asymptomatic patients presenting with non-resectable synchronous metastatic disease from colorectal adenocarcinoma, the beneficial effect of resecting the primary tumor remains to be documented. The aim of this study was to compare survival of patients with metastatic colorectal cancer who underwent elective resection of the primary tumor to those who did not.
                A retrospective analysis of patients with metastatic colo-rectal cancer treated between June, 1996 and December, 1999 was performed. Overall survival was compared between patients who underwent first-line resection of the primary colorectal tumor (group 1) or those who did not undergo elective resection of the primary (group 2). The probability of surgical resection of the primary tumor for gastrointestinal complications in group 2 was evaluated.
                Thirty-one and 23 patients were included in groups 1 and 2 respectively. Five patients (21.7%, 95% confidence interval CI95% 4.9-38.5%) in group 2 required surgical treatment for intestinal obstruction due to the primary tumor. Two clinical characteristics were significantly different between groups 1 and 2: rectal localization (9.7% versus 34.7%; P=0.03) and presence of fewer than three metastases (29.0% versus 4.3%; P=0.03). Survival curves were not significantly different (logrank). Median duration of survival was 21 and 14 Months, respectively (P=0.718).
                In patients with non-resectable synchronous metastatic disease, non-surgical management of the primary tumor is a rational alternative if asymptomatic. A prospective randomized trial integrating the quality-of-life factor should be organized. The aim was to verify whether preoperative conventionally fractionated chemoradiation offers an advantage in sphincter preservation in comparison with preoperative short-term irradiation.
                Patients with resectable T3-4 rectal carcinoma without sphincters' infiltration and with a lesion accessible to digital rectal examination were randomised into: preoperative 5x5Gy short-term irradiation with subsequent total mesorectal excision (TME) performed within 7 days or chemoradiation to a total dose of 50.4Gy (1.8Gy per fraction) concomitantly with two courses of bolus 5-fluorouracil and leucovorin followed by TME after 4-6 weeks. Surgeons were obliged to base the type of operation on the tumour status at the time of surgery.
                Between 1999 and 2002, 316 patients from 19 institutions were enrolled. The sphincter preservation rate was 61% in the 5x5Gy arm and 58% in the radiochemotherapy arm, P = 0.57. The tumour was on average 1.9 cm smaller (P < 0.001) among patients treated with chemoradiation compared with short-term schedule. For patients who underwent sphincter-preserving procedure, the surgeons generally followed the rule of tailoring the resection according to tumour downsizing; the median distal bowel margin was identical (2 cm) for both randomised groups. However, in the chemoradiation group, five patients underwent abdominoperineal resection despite clinical complete response.
                Despite significant downsizing, chemoradiation did not result in increased sphincter preservation rate in comparison with short-term preoperative radiotherapy. The surgeons' decisions were subjective and based on pre-treatment tumour volume at least in clinical complete responders. Total mesorectal excision (TME) and colonic J pouch reconstruction has been widely practiced for mid- or low-rectal cancer. However, the laparoscopic version of TME has never been described.
                Five patients suffering from newly diagnosed mid- to low-rectal cancer were seen between March and July 1999. These five patients were selected for laparoscopic TME and colonic J pouch reconstruction because preoperative investigations revealed resectable tumor without extrarectal disease.
                There were three men and two women with a mean age of 61 years. The average body weight was 69 kg (range, 57-80). None of the patients had had previous abdominal operations. In all five patients, the tumor was located within 9 cm from anal verge. The average size of the main incision was 5 cm. All patients had a covering ileostomy at the end of the procedure. The mean operating time was 208 min; average blood loss was 158 ml; and mean hospital stay was 10.6 days. Three patients had Dukes' B disease and two had Dukes' C disease. The resection margins (proximal, circumferential, and distal) were all clear. There were no deaths or major complications. Two patients suffered from transient urinary retention. After ileostomy closure, the median frequency of bowel motion was twice per day at 6-month follow-up. Neither incontinence nor nocturnal soiling was reported.
                To the best of our knowledge, this is the first published series of such an operation. With good patient selection, laparoscopic-assisted TME and colonic J pouch-anal anastomosis is safe and feasible. From 1980 to 1987, 849 patients with clinically resectable rectal adenocarcinoma were randomized into a controlled clinical trial to evaluate the role of preoperative radiotherapy.
                Patients were given either 25 Gy during 5 to 7 days before surgery or underwent surgery alone.
                At a median follow-up time of 107 months (range, 62-144 months) the incidence of pelvic recurrence among 684 "curatively" operated patients was significantly lower among those who also received radiotherapy (P < 0.001) in all Dukes' stages. No significant difference was observed between the treatment groups with regard to frequency of distant metastases or overall survival. The time to local recurrence or distant metastasis and survival was significantly prolonged in the irradiated group. However, the postoperative mortality was 8% in the radiotherapy group compared with 2% in the surgery only group (P = 0.01).
                Preoperative short term radiotherapy reduced the incidence of pelvic recurrences and prolonged survival related to rectal cancer compared with surgery alone. The postoperative morbidity was significantly higher in the irradiated group. A population based prospective randomized trial on preoperative radiotherapy in operable rectal cancer was conducted in Stockholm, Sweden. Five hundred fifty-seven patients from 12 institutions were included with histologically proven, clinically resectable rectal adenocarcinoma. Patients planned for local excision or previously irradiated to the pelvis were excluded.
                A total of 272 patients were allocated to preoperative irradiation with 25 Gy in five cycles during 5-7 days to the rectum and the pararectal tissues (RT+ group) and 285 patients were allocated to surgery only (RT- group). The median follow-up time was 50 months. No patient was lost to follow-up. Surgery was considered curative in 479 patients (86%).
                Locoregional recurrence occurred in 10% of the patients in the RT+ group versus 21% in the RT- group (p < 0.01). Among the curatively operated patients, distant metastases occurred in 19% in the RT+ group versus 26% in the RT- group (p = 0.02). The overall survival was improved in the irradiated patients (p = 0.02). Postoperative complications were more common after irradiation but were usually mild. The postoperative mortality was low in both groups.
                Preoperative short-term, high-dose radiotherapy as given in this trial reduces the risk of local and distant recurrence and improves survival after curative surgery for rectal carcinoma. To assess prospectively the quality of life (QOL) of patients treated by preoperative radiotherapy (RT) and surgery for locally advanced rectal cancer.
                We studied 53 patients treated with bi-fractionated RT (50 Gy in 40 fractions within 4 weeks) followed at a median interval of 45 days by abdominoperineal resection in 11 patients and low anterior resection in 42 patients. Their QOL was assessed using two self-rating questionnaires developed by the European Organization for Research and Treatment of Cancer (EORTC): one was cancer specific (EORTC QLQ-C30) and one was site specific (EORTC QLQ-C38). The questionnaires were completed before RT and 12-16 months after RT, at which time 17 patients had undergone colostomy. We hypothesized that at least some scores of the various scales would vary between the two analyses.
                Compared with the pre-RT scores, at 1 year, patients reported statistically significant improvement in their emotional state (median 75 vs. 100, p <0.0001), perspective of the future (67 vs. 100, p = 0.0004), and their global QOL (75 vs. 83, p = 0.0008), as well as a decrease in GI symptoms (13 vs. 0, p = 0.002). However, the sexual dysfunction score increased significantly, particularly in men (17 vs. 83, p = 0.0045), and a trend toward a lower body image score was observed (100 vs. 89, p = 0.068). At 1 year, patients with colostomies reported similar or significantly improved symptom scores for fatigue, pain, GI problems, and sleep disturbance, but no such improvements were observed in patients without stomas.
                One year after combined treatment for locally advanced rectal cancer, patients exhibited statistically significant improvement in some important QOL outcomes, including global QOL, despite a decrease in sexual function and body image. Any additional improvement in QOL outcome may require refinements in the RT and surgical techniques to reduce late sequelae, particularly sexual dysfunction. Our results suggest that QOL considerations do not justify sphincter-conserving approaches if locoregional tumor control would be compromised. The purpose of this study was to assess the longitudinal impact of stoma formation on the health-related quality of life of rectal cancer patients treated with adjuvant chemotherapy.
                Health-related quality of life data was prospectively collected in a randomized trial designed to compare 24 weeks of bolus 5-fluorouracil/leucovorin with 12 weeks of continuous 5-fluorouracil in patients with resected Dukes B and C colorectal cancer. Health-related quality of life data was collected at baseline, during adjuvant treatment, and at one and three years after completion of chemotherapy.
                Between 1993 and 2003, 186 rectal cancer patients were enrolled. One hundred thirty-nine patients had anterior resection, of whom 46 had a temporary defunctioning colostomy. Forty-seven patients had abdominoperineal resection with formation of a permanent colostomy. There was no significant difference in global health-related quality of life between patients with and patients without a stoma at any time point. However, during adjuvant treatment, role (P = 0.04) and social (P = 0.005) functioning were significantly worse in stoma patients than in nonstoma patients. Moreover, the impairment in social functioning persisted at one (P = 0.03) and three years (P = 0.04) after adjuvant chemotherapy.
                Our results demonstrate important adverse effects of either temporary or permanent stoma formation on subsequent health-related quality of life in patients with rectal cancer. Adjuvant therapy of colorectal cancer with oral fluorinated pyrimidines is attractive because of its ease of administration and good tolerability. The purpose of this meta-analysis is to assess the survival and disease-free survival benefits of treating patients after surgical resection of a primary colorectal tumor with oral fluoropyrimidines for 1 year.
                This meta-analysis was performed on individual data from three randomized trials conducted by the Japanese Foundation for Multidisciplinary Treatment for Cancer involving a total of 5,233 patients with stages I to III colorectal cancer.
                The overall hazard ratio in favor of oral therapy was 0.89 for survival (95% CI, 0.80 to 0.99; P =.04), and 0.85 for disease-free survival (95% CI, 0.77 to 0.93; P <.001). Thus oral therapy reduced the risk of death by 11% and the risk of recurrence or death by 15%. There was no significant heterogeneity between trials, nor did the benefit of oral therapy depend on tumor stage (I, II, or III), tumor site (rectum or colon), patient age, or patient sex.
                Oral fluoropyrimidines improve disease-free survival and survival of patients after resection of early-stage colorectal cancer. These observations support the use of these agents alone after resection of early-stage disease, as well as further testing of oral agents in combination with new drugs that have recently shown antitumor activity in advanced colorectal cancer. A randomized controlled study was carried out by the envelope method with 491 institutions in participation across the country in order to find an optimal surgical adjuvant chemotherapy for curatively resected colorectal cancer. The schedules for drug administration were different in four districts: ACNU + Futraful (FT) group and FT alone group in the Hokkaido-Shikoku district; the same schedule groups plus untreated group in the Chubu-Kinki district; MMC+FT group, FT alone group in the Tohoku-Kanto district; and ADM+FT group and FT alone group in the Chugoku-Kyushu district. The numbers of patients admitted to this study were 2,450 cases with colon cancer and 2,456 cases met the evaluation criteria of this study. The 5-year survival rate on the whole did not differ from combination therapy to single drug therapy in either colon cancer or rectal cancer, but in Dukes C rectal cancer the five-year survival rate tended to be higher with the combination therapies. In n2 (+) or a2(s) rectal cancer in particular, combination therapies with MMC and FT and with ADM and FT achieved significantly higher five-year survival rate, and the rate of local recurrence was significantly lower with ADM+FT. The usefulness of adjuvant chemotherapy started immediately following surgery was evaluated.
                A randomized clinical trial was performed on 133 patients with advanced colorectal cancer using oral anticancer agents with one-week continuous 5-FU infusion starting immediately after curative surgery. In Group A and Group B, 300 mg/day of HCFU was orally administered for two years starting two weeks after surgery, and in addition, 333 mg/m2/day of 5-FU was drip infused from the central vein for seven days from the day of surgery in Group B.
                For 1919 days after surgery, there were no significant intergroup differences in overall survival (OS) and disease-free survival (DFS), but OS and DFS in Group B rectal cancer patients were significantly better when compared to Group A rectal cancer patients. On the other hand, OS tended to be better in Group A colon cancer patients, but no significant intergroup differences were seen, while intergroup differences tended to be smaller when corrected for disease stage.
                Continuous 5-FU infusion starting immediately after curative surgery for colorectal cancer was safe. While further investigation is necessary to elucidate the degree of improvement in postoperative prognosis, the results of the present study suggest that continuous 5-FU infusion improves prognosis in advanced rectal cancer. A prospective controlled study, the 7th cooperative study of the Japanese Foundation for Multidisciplinary Treatment, was conducted to evaluate the usefulness of concomitant therapy with MMC + HCFU as a postoperative adjuvant therapy in patients with colorectal cancer who had undergone curative resection for a period of 2 years and 11 months from February, 1986. The Dukes B and C patients with colorectal cancer classified by macroscopic examination who had an intravenous MMC 6 mg/m2 on the day of operation and followed by oral HCFU for 12 months from 2 weeks after operation (Group X) were compared with patients who had operation only (Group Y). Some 978 patients with colon cancer and 713 patients with rectal cancer were enrolled in the study, 85 (5.0%) of whom were not eligible. The 5-year survival rate of Group X in colon cancer was 79.3% and that of Group Y was 76.4%: thus the survival rate of Group X was slightly better than that of Group Y, but no significant difference was found between the two groups. Subset analysis revealed that the survival rate of Group X in advanced cancer of stage III b + IV, according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus in Japan, was 62.4% and that of Group Y was 46.2%. Thus, the survival rate of Group X was significantly better than that of Group Y (logrank test: p = 0.035, generalized Wilcoxon test: p = 0.025). The disease-free survival rate was not significantly different between the groups with colon cancer and rectal cancer. The above results suggest that HCFU is useful for patients with a high risk of recurrence who had advanced colon cancer (stage III b + IV). However, additional prospective studies are required to verify them. This study was designed to examine the short-term results of laparoscopy in the treatment of curative cases of rectosigmoidal and rectal carcinoma.
                A review was performed of a prospective registry of 70 patients who underwent curative laparoscopic resection for rectosigmoidal and rectal carcinoma between July 1993 and April 2001. Before 1997, only patients with early (Tis or T1) cancers located in the rectosigmoid and upper rectum that required bowel resection were candidates for laparoscopy. In 1997, we expanded the application of laparoscopy to include T2 cancers located anywhere in the rectum. Mesorectal transection was performed at least 5 cm below the tumor for rectosigmoidal and upper rectal lesions, and total mesorectal excision was performed for lower tumors. Primary anastomosis was performed by a double-stapling technique, or a handsewn coloanal anastomosis was performed. Patient demographics and outcomes were recorded prospectively.
                The median follow-up was 23 months. An anastomosis was performed in 92.9 percent of the operations. Oral intake was started on median postoperative Day 1, and the median length of hospitalization was 8 days. Two patients needed conversion to conventional open surgery. A total of 15 postoperative complications occurred in 13 patients (18.6 percent), including anastomotic leakage in 6 (8.6 percent) and bowel obstruction in 3 (4.3 percent). Reoperation was required in six patients. Two patients developed recurrence of cancer at the anastomotic site. The expected 5-year survival and disease-free survival rates were 100 and 92.1 percent, respectively.
                The findings of the present study demonstrate the feasibility and safety of laparoscopic surgery for selected patients with rectal carcinoma. Morbidity and mortality rates and oncologic outcome appear to be comparable with conventional surgery. The Laparoscopic approach has been applied to colorectal surgery for many years; however, there are only a few reports on laparoscopic low and ultralow anterior resection with construction of coloanal anastomosis. This study compares open versus laparoscopic low and ultralow anterior resections, assesses the feasibility and efficacy of the laparoscopic approach of total mesorectal excision (TME) with anal sphincter preservation (ASP), and analyzes the short-term results of patients with low rectal cancer.
                We analyzed our experience via a prospective, randomized control trail. From June 2001 to September 2002, 171 patients with low rectal cancer underwent TME with ASP, 82 by the laparoscopic procedure and 89 by the open technique. The lowest margin of tumors was below peritoneal reflection and 1.5-8 cm above the dentate line (1.5-4.9 cm in 104 cases and 5-8 cm in 67 cases). The grouping was randomized.
                Results of operation, postoperative recovery, and short-term oncological follow-up were compared between 82 laparoscopic procedures and 89 controls who underwent open surgery during the same period. In the laparoscopic group, 30 patients in whom low anterior resection was performed had the anastomosis below peritoneal reflection and more than 2 cm above the dentate line, 27 patients in whom ultralow anterior resection was performed had anastomotic height within 2 cm of the dentate line, and 25 patients in whom coloanal anastomosis was performed had the anastomosis at or below the dentate line. In the open group, the numbers were 35, 27, and 27, respectively. There was no statistical difference in operation time, administration of parenteral analgesics, start of food intake, and mortality rate between the two groups. However, blood loss was less, bowel function recovered earlier, and hospitalization time was shorter in the laparoscopic group.
                Totally laparoscopic TME with ASP is feasible, and it is a minimally invasive technique with the benefits of much less blood loss during operation, earlier return of bowel function, and shorter hospitalization. Laparoscopic-assisted colectomy (LAC) has emerged as the preferred minimally invasive surgical strategy for diseases of the colon. The safety and efficacy of LAC for colon cancer are unknown, and the nature and magnitude of any quality-of-life (QOL) benefit resulting from LAC for colon cancer is also unknown.
                To compare short-term QOL outcomes after LAC vs open colectomy for colon cancer.
                Multicenter, randomized controlled trial (Clinical Outcomes of Surgical Therapy [COST]). Between September 1994 and February 1999, 37 of 48 centers provided data for the QOL component of the trial for 449 consecutive patients with clinically resectable colon cancer.
                Scores on the Symptoms Distress Scale (SDS), Quality of Life Index, and a single-item global rating scale at 2 days, 2 weeks, and 2 months postoperative; duration of postoperative in-hospital analgesic use; and length of stay.
                Of 449 patients, 428 provided QOL data. In an intention-to-treat analysis comparing SDS pain intensity, SDS summary, QOL Index summary, and global rating scale scores at each time point, the only statistically significant difference observed between groups was the global rating scale score for 2 weeks postsurgery. The mean (median) global rating scale scores for 2 weeks postsurgery were 76.9 (80) for LAC vs 74.4 (75) for open colectomy (P =.009). While in the hospital, patients assigned to LAC required fewer days of both parenteral analgesics compared with patients assigned to open colectomy (mean [median], 3.2 [3] vs 4.0 [4] days; P<.001) and oral analgesics (mean [median], 1.9 [1] vs 2.2 [2] days; P =.03).
                Only minimal short-term QOL benefits were found with LAC for colon cancer compared with standard open colectomy. Until ongoing trials establish that LAC is as effective as open colectomy in preventing recurrence and death from colon cancer, this procedure should not be offered to patients with colon cancer. A randomised clinical trial was performed in patients undergoing radical surgery for rectal cancer to compare the efficacy and toxicity of adjuvant postoperative radiation therapy (RT) to sequential RT and chemotherapy (CT) with 5-fluorouracil (5-FU) plus levamisole (LEV). The primary end point was overall survival (OS); secondary end points were disease-free survival (DFS), the rate of loco-regional recurrence, and treatment-related toxicity; the final results of this trial are reported.
                Patients in arm I underwent RT (50 Gy) in daily fractions of 2 Gy, 5 days/week for 5 weeks. Patients in arm II began with 5-FU (450 mg/sqm/day intravenous (i.v.) bolus, days 1-5) plus LEV (150 mg/day orally, days 1-3); postoperative RT was delivered during week 2 at the same dosage and schedule as in arm I. The other five cycles of CT (5-FU every 28 days and LEV every 15 days for the length of 5-FU administration) continued after the end of RT if clinical and hemato-biochemical parameters were in the normal range.
                From May 1992 to December 1998, 218 patients were enrolled into the randomised clinical trial (144 men, 74 women; age range: 28-75, median 64 years). The median follow-up time was 58.1 months (range: 1-3,271 days). No significant difference was observed between the two arms of treatment as regards OS and DFS (P = 0.18 and P = 0.66, respectively). Cox regression analysis for OS confirmed what was observed by univariate analysis for all variables except age. Older age (>60 years) and pathologic lymph-node involvement defined the subgroups with the worst prognosis. Cox regression analysis for DFS confirmed what was observed by univariate analysis for all variables: the only independent variable in predicting DFS was pathologic lymph-node involvement.
                Our findings suggest no difference in OS, loco-regional and distant site progressions of postoperative RT alone compared to sequential postoperative RT and CT; notably, this latter regimen was associated with higher toxicity which seriously impaired the patient's compliance to CT. The low loco-regional recurrence rate (9.2%) observed in our patients undergoing postoperative RT alone compared to similarly treated patients in previously performed clinical trials (20-25%) underline the role of radical surgery (mesorectal excision) coupled with a complete postoperative RT regimen. On the other hand, the similar efficacy of these two adjuvant modalities of treatment might be conditioned by both the low compliance (59%) to the CT regimen as well as the sequential, instead of concurrent, schedule of administration of RT and CT, which may have decreased further the expected efficacy of the combined regimen.
                Copyright 2003 Wiley-Liss, Inc. This study compared laparoscopic with open surgery for the cure of cancer of the rectosigmoid and rectum. Results of surgery, postoperative recovery, and oncological follow-up were compared between 32 laparoscopic curative procedures (19 laparoscopic-assisted anterior resections for cancer of the rectosigmoid or upper rectum and 13 laparoscopic abdominoperineal resections for low rectal cancer) and 32 controls matched for age, UICC stage, tumor site, and type of resection who underwent open surgery during the same observation period. Morbidity was identical after laparoscopic and open resection (31.3%). Surgery was equally radical in the two groups regarding yield of lymph nodes and lateral and distal margins. Survival, recurrence, and cancer-related mortality showed no statistical differences. There was no port-site recurrence. The benefits of laparoscopic surgery were shown with a reduction in perioperative blood transfusion and earlier return of bowel function. However, the operative time was significantly increased in the laparoscopic group. This study shows that laparoscopic surgery for the cure of colorectal cancer is technically feasible, and that oncological short-term outcome does not differ from the results achieved by open techniques. However, prospective randomized trials are mandatory to evaluate the definite role of laparoscopic surgery for malignancy. To evaluate the feasibility of laparoscopic resection of rectal carcinoma and to compare the short-term outcome of laparoscopic procedure with conventional open surgery for rectal cancer.
                Thirty-eight patients with rectal cancer were included in a prospective non-randomized study. The patients were assigned to laparoscopic (n=18) or open (n=18) colorectal resection. Case selection, surgical technique, and clinical and pathological results were reviewed.
                The operative time was longer in laparoscopic resection group (LAP) than in open resection group (189+/-18 min vs 146+/-22 min, P<0.05). Intraoperative blood loss and postoperative complications were less in LAP resection group than in open resection group. An earlier return of bowel motility was observed after laparoscopic surgery. The overall postoperative morbidity was 5.6% in the LAP resection group and 27.8% in open resection group (P<0.05). No anastomotic leakage was found in both groups. The pathologic examination showed that the length of the resected specimen, the mean number of harvested lymph nodes in laparoscopic resection group were comparable to those in open resection group.
                Laparoscopic total mesorectal excision (TME) for rectal cancer is a feasible but technically demanding procedure. The present study demonstrates the safety of the procedure, while oncologic results are comparable to the open surgery, with a favorable short-term outcome. To date, few studies have evaluated the impact of preoperative radiotherapy (pRT) on long-term health status of rectal cancer survivors. Using a population-based sample, we assessed the impact of pRT on general and disease-specific health status of rectal cancer survivors up to 10 years post diagnosis. The health status of older (≥75 years old at diagnosis) pRT survivors was also compared with that of younger survivors.
                Survivors identified from the Eindhoven Cancer Registry treated with surgery only (SU) or with pRT between 1998 and 2007 were included. Survivors completed the Short Form-36 (SF-36) health survey questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 38 (EORTC QLQ-CR38) questionnaire. The SF-36 and EORTC QLQ-CR38 (sexuality subscale) scores of the survivors were compared to an age- and sex-matched Dutch normal population.
                A total of 340 survivors (response, 85%; pRT survivors, 71%) were analyzed. Overall, survivors had similar general health status. Both short-term (<5 years) and long-term (≥5 years) pRT survivors had significantly poorer body image and more problems with gastrointestinal function, male sexual dysfunction, and defecation than SU survivors. Survivors had comparable general health status but greater sexual dysfunction than the normal population. Older pRT survivors had general and disease-specific health status comparable to that of younger pRT survivors.
                For better survivorship care, rectal cancer survivors could benefit from increased clinical and psychological focus on the possible long-term morbidity of treatment and its effects on health status.
                Copyright © 2011 Elsevier Inc. All rights reserved. To assess long-term quality of life in a population-based sample of rectal cancer patients.
                Quality of life in rectal cancer patients who suffer reduced bowel and sexual function is very important. Few studies, however, have long term follow-up data or sufficient sample sizes for reliable comparisons between operation groups.
                A 4-year prospective study of rectal cancer patients' quality of life was assessed by using the European Organization for Research and Treatment of Cancer QLQ-30 and CR38 questionnaires.
                A total of 329 patients returned questionnaires. Overall, anterior resection patients had better quality of life scores than abdominoperineal extirpation patients. High-anterior resection patients had significantly better scores than both low-anterior resection and abdominoperineal extirpation patients. Low-anterior resection patients, however, overall had a better quality of life than abdominoperineal extirpation patients, especially after 4 years. Abdominoperineal extirpation patients' quality of life scores did not improve over time. Stoma patients had significantly worse quality of life scores than nonstoma patients. Quality of life improved greatly for patients whose stoma was reversed.
                Anterior resection and nonstoma patients, despite suffering micturition and defecation problems, had better quality of life scores than abdominoperineal extirpation and stoma patients. Comparisons between abdominoperineal extirpation and anterior resection patients should consider the effect of temporary stomas. Improvements in quality of life scores over time may be explained by reversal of temporary stomas or physiologic adaptation. We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed.
                The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated.
                Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival.
                For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients. Although laparoscopic resection of colorectal carcinoma improves post-operative recovery, long-term survival and disease control are the determining factors for its application. We aimed to test the null hypothesis that there was no difference in survival after laparoscopic and open resection for rectosigmoid cancer.
                From Sept 21, 1993, to Oct 21, 2002, 403 patients with rectosigmoid carcinoma were randomised to receive either laparoscopic assisted (n=203) or conventional open (n=200) resection of the tumour. Survival and disease-free interval were the main endpoints. Patients were last followed-up in March, 2003. Perioperative data were recorded and direct cost of operation estimated. Data were analysed by intention to treat.
                The demographic data of the two groups were similar. After curative resection, the probabilities of survival at 5 years of the laparoscopic and open resection groups were 76.1% (SE 3.7%) and 72.9% (4.0%) respectively. The probabilities of being disease free at 5 years were 75.3% (3.7%) and 78.3% (3.7%), respectively. The operative time of the laparoscopic group was significantly longer, whereas postoperative recovery was significantly better than for the open resection group, but these benefits were at the expense of higher direct cost. The distal margin, the number of lymph nodes found in the resected specimen, overall morbidity and operative mortality did not differ between groups.
                Laparoscopic resection of rectosigmoid carcinoma does not jeopardise survival and disease control of patients. The justification for adoption of laparoscopic technique would depend on the perceived value of its effectiveness in improving short-term post-operative outcomes. Controversy continues to surround laparoscopic rectal resection for malignancy. A longer follow-up period is required to evaluate the long-term efficacy of the procedure and its impact on survival. Furthermore, no data from ongoing randomized controlled trials are yet available. The aims of this study were to compare long-term outcomes for unselected patients undergoing either laparoscopic or open rectal resection for cancer.
                A series of 124 unselected consecutive patients with rectal cancer, who underwent surgery by the same surgical team, have been included in this study. Patients with T1N0 tumors underwent local excision, and emergency cases were excluded from the study. Written consent was submitted by each patient, and inclusion in either group (laparoscopic or open) was left to the patient's choice. The laparoscopic approach was chosen by 81 patients, and 43 patients chose open surgery. All the patients underwent preoperative radiotherapy (5,040 cGy), performed in selected cases with chemotherapy (for patients younger than 70 years). The following parameters were compared between the two groups: length of the surgical specimen, clearance of the margins of the specimen, number of lymph nodes identified, local recurrence rate, incidence of distant metastases, and survival probability analysis. The mean follow-up period for both groups was 43.8 months (range, l-9 years).
                We performed 60 laparoscopic and 27 open anterior resections, as well as 21 laparoscopic and 16 open abdomino perineal resections, respectively. No mortality occurred in either group. The mean length of the resected specimens was 24.3 cm in the laparoscopic group and 23.8 cm in the open group ( p = 0.47). The mean tumor-free margin was 3.0 cm in the laparoscopic group and 2.8 cm in the open group ( p = 0.57), and the mean number of lymph nodes identified was 10.3 in the laparoscopic group and 9.8 in the open group ( p = 0.63). Of the 124 patients, 86 (52 laparoscopic and 34 open) were included in out study. We excluded patients who underwent a palliative resection (6 laparoscopic and 6 open patients) or conversion to open surgery ( n = 10) and patients who had undergone surgery in the past year ( n = 16). One laparoscopic patient was lost to follow-up evaluation, whereas three laparoscopic patients and one open patient died of causes not related to cancer. No wound recurrence was observed. The local recurrence rate after laparoscopic resection was 20.8%, as compared with 16.6% after open resection ( p = 0.687). Distant metastases occurred in 18.2% of the patients in the laparoscopic group, as compared with 21.2% in the open group ( p = 0.528). Cumulative survival probability was 0.709 after laparoscopic resection after LR and 0.606 after open resection ( p = 0.162), whereas for Dukes' stages A, B, and C in the laparoscopic group versus the open group, it was 0.875 vs 0.889 ( p = 0.392), 0.722 vs 0.584 ( p = 0.199), and 0.500 vs 0.417 ( p = 0.320), respectively. At this writing 20 laparoscopic patients (62.5%) and 20 open patients (60.6%) are disease free ( p = 0.623).
                Oncologic surgical principles were respected. Long-term outcome after laparoscopic resection of rectal cancer was comparable with that after conventional resection. We should wait to draw conclusive scientific statements until the completion of ongoing international randomized controlled trials. There are few reports on laparoscopic rectum resection demonstrating its feasibility and efficacy in patients with rectal cancer. Most patient series are small, and results must be considered preliminary and medium-term. Our large prospective conducted study aimed to assess the effectiveness of a totally laparoscopic resection for rectum carcinoma with emphasis on perioperative and long-term oncological outcomes.
                Between November 1992 and July 2003, 194 unselected patients were resected laparoscopically for rectal carcinoma. Patients with locally advanced rectum carcinoma (uT3/uT4) and no evidence of distant metastases were candidates for neoadjuvant chemoradiation. Adjuvant treatment was administered to patients with UICC stage II/III disease. All patients were followed up prospectively to evaluate complications and late outcomes. Survival probability analysis was performed using the Kaplan-Meier method. Study selection was made by Medline search using the following key words: rectal cancer, rectal neoplasms, laparoscopy, and resection. Single case reports and abstracts were excluded. When surgical series were reported more than once, only the most recent reports were considered and listed.
                The most common procedures were low anterior resection with total mesorectum excision in 65.5% of patients and high anterior resection in 25.3%. Average operative time was 174 min. Average number of lymph nodes removed was 25.4 and length of specimen resected was 27.6 cm. Resection was curative in 145 patients and palliative in 49 cases. UICC tumor stages were as follows: stage I: 25.2%, stage II: 27.3%, stage III: 30.4%, and stage IV: 17%. Intraoperative complications were <1% for lesions of the ureter, urinary bladder, and deferent duct. Conversion to conventional surgery was necessary in two cases (1%). The most common postoperative complication was anastomotic leakage in 13.5% of patients. There was no postoperative mortality. Follow-up evaluation ranged from 1 to 128 months with a mean of 46.1 months. The most common late complication was incisional hernia in 3.6% of patients. Port-site metastases occurred in one patient (0.5%). Tumor recurrence developed in 23 of the 145 curative resected patients (11.7% distant metastases and 4.1% local recurrence). Overall local recurrence rate was 6.7% (4.1% after curative resection and 14.3% after palliative resection). Overall survival rate was 90.6% at 1 year, 74.5% at 3 years, and 66.3% at 5 years. Overall 5-year survival rate was 76.9% after curative resection and 31.8% after palliative resection. Cancer-related survival rate was 94% at 1 year, 82.4% at 3 years, and 78.9% at 5 years. At 5 years it was 87.7% after curative resection and 48.5% after palliative resection. At 5 years, the survival rate was 100% for stage I, 94.4% for stage II, 66.6% for stage III, and 44.6% for stage IV.
                Our results and the literature review clearly demonstrate that laparoscopic resection for rectal cancer is not associated with higher morbidity and mortality. Established oncological and surgical principles are respected and long-term outcomes are at least as good as those after open surgery. Radiation therapy as an adjunct to surgery for rectal cancer has been shown to reduce local recurrence but has not improved survival. In a previous study, combined radiation and chemotherapy improved survival significantly as compared with surgery alone, but not as compared with adjuvant radiation, which many regard as standard therapy. We designed a combination regimen to optimize the contribution of chemotherapy, decrease recurrence, and improve survival as compared with adjuvant radiation alone.
                Two hundred four patients with rectal carcinoma that was either deeply invasive or metastatic to regional lymph nodes were randomly assigned to postoperative radiation alone (4500 to 5040 cGy) or to radiation plus fluorouracil, which was both preceded and followed by a cycle of systemic therapy with fluorouracil plus semustine (methyl-CCNU).
                After a median follow-up of more than seven years, the combined therapy had reduced the recurrence of rectal cancer by 34 percent (P = 0.0016; 95 percent confidence interval, 12 to 50 percent). Initial local recurrence was reduced by 46 percent (P = 0.036; 95 percent confidence interval, 2 to 70 percent), and distant metastasis by 37 percent (P = 0.011; 95 percent confidence interval, 9 to 57 percent). In addition, combined therapy reduced the rate of cancer-related deaths by 36 percent (P = 0.0071; 95 percent confidence interval, 14 to 53 percent) and the overall death rate by 29 percent (P = 0.025; 95 percent confidence interval, 7 to 45 percent). Its acute toxic effects included nausea, vomiting, diarrhea, leukopenia, and thrombocytopenia. These effects were seldom severe. Severe, delayed treatment-related reactions, usually small-bowel obstruction requiring surgery, occurred in 6.7 percent of all patients receiving radiation, and the frequencies of these complications were comparable in both treatment groups.
                The combination of postoperative local therapy with radiation plus fluorouracil and systemic therapy with a fluorouracil-based regimen significantly and substantively improves the results of therapy for rectal carcinoma with a poor prognosis, as compared with postoperative radiation alone. The aim of this study was to compare the downstaging achieved after long-course chemoradiotherapy (chRT) and short-term radiotherapy (sRT) followed by delayed surgery.
                A randomized controlled trial was carried out. Eighty-three patients with resectable stage II and III rectal adenocarcinoma were randomized to receive long-course chemoradiotherapy (46) and short-term radiotherapy (5×5 Gy) (37). Surgery was performed 6 weeks after preoperative treatment in both groups.
                The R0 resection rate was 91.3% in the chRT and 86.5% in the sRT group (P=0.734). Sphincter preservation rates were 69.6%vs 70.3% (P=0.342) and postoperative complication rates were 26.1%vs 40.5% (P=0.221). There were more patients with early pT stage [pT0 (complete pathological response) pT1] in the chRT group [21.8%vs 2.7% (P=0.03)] and more patients with pT3 disease in the sRT group [75.7%vs 52.2% (P=0.036)]. There were no differences in pN stage and lymphatic or vascular invasion in either group. Pathological downstaging (stage 0 and I) was observed in eight (21.6%) patients in the sRT group and in 18 (39.1%) in the chRT group (P=0.07). Tumours were smaller after preoperative ChRT (2.5 cm vs 3.3 cm; P=0.04).
                Long-course preoperative chemoradiation resulted in greater statistically significant tumour downsizing and downstaging compared with short-term radiation, but there was no difference in the R0 resection rates. Similar postoperative morbidity was observed in each group.
                © 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland. To compare a colonic J-pouch or a side-to-end anastomosis after low-anterior resection for rectal cancer with regard to functional and surgical outcome.
                A complication after restorative rectal surgery with a straight anastomosis is low-anterior resection syndrome with a postoperatively deteriorated anorectal function. The colonic J-reservoir is sometimes used with the purpose of reducing these symptoms. An alternative method is to use a simple side-to-end anastomosis.
                One-hundred patients with rectal cancer undergoing total mesorectal excision and colo-anal anastomosis were randomized to receive either a colonic pouch or a side-to-end anastomosis using the descending colon. Surgical results and complications were recorded. Patients were followed with a functional evaluation at 6 and 12 months postoperatively.
                Fifty patients were randomized to each group. Patient characteristics in both groups were very similar regarding age, gender, tumor level, and Dukes' stages. A large proportion of the patients received short-term preoperative radiotherapy (78%). There was no significant difference in surgical outcome between the 2 techniques with respect to anastomotic height (4 cm), perioperative blood loss (500 ml), hospital stay (11 days), postoperative complications, reoperations or pelvic sepsis rates. Comparing functional results in the 2 study groups, only the ability to evacuate the bowel in <15 minutes at 6 months reached a significant difference in favor of the pouch procedure.
                The data from this study show that either a colonic J-pouch or a side-to-end anastomosis performed on the descending colon in low-anterior resection with total mesorectal excision are methods that can be used with similar expected functional and surgical results. Although systematic postoperative surveillance of patients with colorectal cancer has been demonstrated to improve survival, it remains unknown whether a more intensive strategy provides any significant advantage. This prospective, multicenter, randomized, controlled trial was aimed at comparing the efficacy of two different surveillance strategies in terms of both survival and recurrence resectability.
                Patients with stage II or III colorectal cancer were allocated randomly to either a simple surveillance strategy including clinical evaluation and serum carcinoembryonic antigen monitoring, or an intensive strategy in which abdominal computed tomography or ultrasonography, chest radiograph, and colonoscopy were added.
                A total of 259 patients were included: 132 were observed according to the simple strategy and 127 were observed according to the intensive strategy. Both groups were similar with respect to baseline characteristics and rate and type of tumor recurrence. After a median follow-up of 48 months, there was no difference in the probability of overall survival in the whole series (hazard ratio [HR] = 0.87; 95% CI, 0.49 to 1.54; P = .62). However, the intensive strategy was associated with higher overall survival in patients with stage II tumors (HR = 0.34; 95% CI, 0.12 to 0.98; P = .045) and in those with rectal lesions (HR = 0.09; 95% CI, 0.01 to 0.81; P = .03), mainly due to higher rate of resectability for recurrent tumors. Colonoscopy was responsible for the detection of the highest proportion (44%) of resectable tumor recurrence in the intensive arm.
                A more intensive surveillance strategy improves the prognosis of patients with stage II colorectal cancer or those with rectal tumors. Inclusion of regular performance of colonoscopy seems justified up to the fifth year of follow-up, at least.
Based on evidence mainly from non-randomized studies, LTME appears to have clinically measurable short-term advantages in patients with primary resectable rectal cancer. The long-term impact on oncological endpoints awaits the findings from large on-going randomized trials.