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Low-dose versus standard-dose gemcitabine infusion and cisplatin for patients with advanced bladder cancer : a randomized phase II trial-an update . Prolonged infusion of low-dose gemcitabine and cisplatin ( GC ) proved to be an effective treatment for patients with advanced bladder cancer . One hundred and twenty untreated patients with stage III/IV bladder cancer were randomized to receive either gemcitabine ( 250 mg/m ( 2 ) ) 6-h infusion on days 1 and 8 , and cisplatin ( 70 mg/m ( 2 ) ) on day 2 every 21-day cycle ( arm 1 ) or gemcitabine ( 1,250 mg/m ( 2 ) ) 30-min infusion on days 1 and 8 , with the same dose of cisplatin ( arm 2 ) . The 92 males and 28 females included in the study had a median age of 62 years ( range 40-85 years ) . Among the 120 patient , complete response was achieved in 11.7 % ( 7/60 patients of arm 1 ) and 5 % ( 3/60 patients of arm 2 ) . Eighteen patients in arm 1 ( 30 % ) and 17 patients ( 28.3 % ) in arm 2 had partial response on therapy . Thus , the overall response rate of patients in arm 1 and arm 2 was 41.7 % ( 25/60 patients ) and 33.3 % ( 20/60 patients ) , respectively ( p = 0.37 ) . No significant difference in median time to disease progression ( 26 vs. 24 months , p = 0.4 ) , median survival ( 12 vs. 16 months , p = 0.8 ) , and 1-year survival ( 49.9 vs. 54.7 % , p = 0.8 ) was detected between arms 1 and 2 , respectively . Main toxicities were similar in both arms with no statistically significant differences . Low-dose , prolonged infusion gemcitabine in combination with cisplatin is not inferior to the standard GC regimen with favorable toxicity profile and less financial costs .
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Intervention_Pharmacological
gemcitabine infusion
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
gemcitabine and cisplatin ( GC )
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Intervention_Pharmacological
gemcitabine
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
gemcitabine
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
gemcitabine
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
standard GC regimen
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Outcome_Physical
overall response rate
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Outcome_Physical
median time to disease progression
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Outcome_Physical
median survival
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Outcome_Physical
1-year survival
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Outcome_Adverse-effects
Main toxicities
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Outcome_Adverse-effects
toxicity profile
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Outcome_Other
financial costs
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Participant_Condition
advanced bladder cancer
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Participant_Condition
advanced bladder cancer
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Participant_Sample-size
One hundred and twenty
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Participant_Condition
stage III/IV bladder cancer
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Participant_Sample-size
92
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Participant_Sex
males
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Participant_Sample-size
28 females
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Participant_Age
median age of 62 years
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Participant_Age
40-85 years