31968
document
Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma : the V-325 Study Group . PURPOSE For patients with advanced gastric or gastroesophageal cancer ( AGGEC ) providing clinical benefit with improved palliation is highly desirable . However , a prospective evaluation of clinical benefit in AGGEC patients has never before been reported in a phase III setting . PATIENTS AND METHODS In a multinational trial ( V325 ) , 445 patients were randomly assigned and treated with either docetaxel plus cisplatin and fluorouracil ( DCF ) or cisplatin and fluorouracil ( CF ) . Clinical benefit was prospectively evaluated in this trial as a secondary end point . The primary measure for clinical benefit analysis was time to definitive worsening by one or more categories of Karnofsky performance status ( KPS ) . Secondary clinical benefit end points included time to 5 % definitive weight loss , time to definitive worsening of appetite by one grade , pain-free survival ( defined as time to first appearance of pain ) , and time to first cancer pain-related opioid intake . Clinical benefit assessments were recorded at each clinic visit . RESULTS Clinical benefit assessments were performed in more than 75 % of patients throughout V325 . DCF significantly prolonged time to definitive worsening of KPS compared with CF ( median , 6.1 v 4.8 months ; hazard ratio , 1.38 ; 95 % CI , 1.08 to 1.76 ; log-rank P = .009 ) . Although time to definitive weight loss and time to definitive worsening of appetite favored DCF , the results were not statistically significant . Pain-free survival and time to first cancer pain-related opioid intake were comparable . CONCLUSION To our knowledge , V325 is the first phase III trial to report clinical benefit in AGGEC patients . Clinical benefit was assessed beyond protocol-specific chemotherapy . The addition of D to CF not only significantly improved clinical benefit but also improved quality of life , time to progression , and overall survival compared with CF .
31969
Intervention_Pharmacological
docetaxel plus fluorouracil
31970
Intervention_Pharmacological
cisplatin
31971
Intervention_Pharmacological
cisplatin
31972
Intervention_Pharmacological
fluorouracil
31973
Intervention_Pharmacological
docetaxel plus cisplatin
31974
Intervention_Pharmacological
fluorouracil ( DCF )
31975
Intervention_Pharmacological
cisplatin
31976
Intervention_Pharmacological
fluorouracil ( CF )
31977
Intervention_Pharmacological
CF
31978
Intervention_Pharmacological
DCF
31979
Intervention_Physical
protocol-specific chemotherapy
31980
Intervention_Pharmacological
D
31981
Intervention_Pharmacological
CF
31982
Intervention_Pharmacological
CF
31983
Outcome_Physical
time to definitive worsening
31984
Outcome_Physical
Karnofsky performance status
31985
Outcome_Physical
time to 5 % definitive weight loss , time to definitive worsening of appetite by one grade ,
31986
Outcome_Mortality
pain-free survival
31987
Outcome_Physical
( defined as
31988
Outcome_Pain
time to first appearance of pain
31989
Outcome_Physical
) , and time to first cancer pain-related opioid intake .
31990
Outcome_Physical
time to definitive worsening of KPS
31991
Outcome_Physical
time to definitive weight loss and time to definitive worsening of appetite
31992
Outcome_Pain
Pain-free survival and time to first cancer pain-related opioid intake
31993
Outcome_Other
quality of life
31994
Outcome_Physical
, time to progression , and
31995
Outcome_Mortality
overall survival
31996
Participant_Condition
advanced gastric or gastroesophageal cancer adenocarcinoma
31997
Participant_Condition
advanced gastric or gastroesophageal cancer ( AGGEC )
31998
Participant_Sample-size
445