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document
Improved local control of invasive bladder cancer by concurrent cisplatin and preoperative or definitive radiation . The National Cancer Institute of Canada Clinical Trials Group . PURPOSE A prospective randomized trial was conducted to determine whether the addition of concurrent cisplatin to preoperative or definitive radiation therapy in patients with muscle-invasive bladder cancer improved local control or survival . PATIENTS AND METHODS Ninety-nine eligible patients with T2 to T4b transitional cell bladder cancer participated , 64 % with cT3b or cT4 . Patients and their physicians selected either definitive radiotherapy or precystectomy radiotherapy ; patients were then randomly allocated to receive intravenous cisplatin 100 mg/m2 at 2-week intervals for three cycles concurrent with pelvic radiation , or to receive radiation without chemotherapy . Patients were stratified by clinical tumor stage and by radiation plan . The median follow-up duration is 6.5 years . RESULTS The occurrence of distant metastases was the same in both study arms . However , 25 of 48 control patients have had a first recurrence in the pelvis , compared with 15 of 51 cisplatin-treated patients ( P = .036 ) . The pelvic relapse rate in the two groups was significantly reduced by concurrent cisplatin ( P = .038 , log-rank test ) and this effect was preserved in a stepwise Cox regression model of prognostic factors ( hazards ratio , 0.50 ; 90 % confidence interval [ CI ] , 0.29 to 0.86 ; P = .036 ) . The hazard reduction was similar for both radiation plans . Pretreatment leukocytosis and high clinical stage were independent adverse factors in a Cox model of overall survival , but the effect of cisplatin was not significant . CONCLUSION Concurrent cisplatin may improve pelvic control of locally advanced bladder cancer with preoperative or definitive radiation , but has not been shown to improve overall survival . The use of concurrent cisplatin had no detectable effect on distant metastases .
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Intervention_Physical
concurrent cisplatin
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Intervention_Pharmacological
and
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Intervention_Physical
preoperative
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Intervention_Physical
definitive radiation
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Intervention_Physical
concurrent cisplatin to preoperative
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Intervention_Physical
radiotherapy
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Intervention_Physical
precystectomy radiotherapy
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Intervention_Pharmacological
intravenous cisplatin
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Intervention_Physical
concurrent with pelvic radiation
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Intervention_Physical
receive radiation without chemotherapy
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Intervention_Pharmacological
cisplatin-treated
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Intervention_Pharmacological
concurrent cisplatin
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
Concurrent cisplatin
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Intervention_Physical
preoperative or definitive radiation
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Intervention_Pharmacological
concurrent cisplatin
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Outcome_Mortality
local control or survival
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Outcome_Physical
occurrence of distant metastases
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Outcome_Physical
first recurrence
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Outcome_Physical
pelvic relapse rate
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Outcome_Other
hazard reduction
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Outcome_Mortality
overall survival
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Outcome_Physical
pelvic control
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Outcome_Mortality
overall survival
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Participant_Condition
muscle-invasive bladder cancer
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Participant_Sample-size
Ninety-nine
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Participant_Condition
T2 to T4b transitional cell bladder cancer
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Participant_Sample-size
64 %