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document
Phase II multi-institutional prospective randomised trial comparing S-1+paclitaxel with S-1+cisplatin in patients with unresectable and/or recurrent advanced gastric cancer . BACKGROUND A combination of S-1 and cisplatin has been shown to be effective with acceptable safety for the first-line treatment of far-advanced gastric cancer in Japan . This is the first randomised phase II trial to compare S-1+paclitaxel with S-1+cisplatin in this setting . METHODS Patients with unresectable and/or recurrent advanced gastric cancer were randomly assigned to receive one of the two regimens : S-1 ( 40 mg m ( -2 ) twice daily ) on days 1-14 plus paclitaxel ( 60 mg m ( -2 ) ) on days 1 , 8 , and 15 of a 4-week cycle ( S-1+paclitaxel ) or S-1 ( 40 mg m ( -2 ) twice daily ) on days 1-21 plus cisplatin ( 60 mg m ( -2 ) ) on day 8 of a 5-week cycle ( S-1+cisplatin ) . The primary end point was the response rate ( RR ) . Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , and safety . RESULTS A total of 83 patients were eligible for safety and efficacy analyses . In the S-1+paclitaxel and S-1+cisplatin groups , RRs ( 52.3 % vs 48.7 % ; P=0.74 ) and median PFS ( 9 vs 6 months ; P=0.50 ) were similar . The median OS was similar in the S-1+paclitaxel and S-1+cisplatin groups ( 16 vs 17 months ; P=0.84 ) . The incidence of grade 3 or higher haematological toxicity was 19.0 % with S-1+paclitaxel and 19.5 % with S-1+cisplatin . The incidence of grade 3 or higher non-haematological toxicity was 14.2 % with S-1+paclitaxel and 17.1 % with S-1+cisplatin . CONCLUSION S-1+paclitaxel was suggested to be a feasible and effective non-platinum-based regimen for chemotherapy in patients with advanced gastric cancer . Our results should be confirmed in multicenter , phase III-controlled clinical trials .
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Intervention_Pharmacological
S-1+paclitaxel
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Intervention_Pharmacological
S-1+cisplatin
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Intervention_Pharmacological
S-1
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
S-1 ( 40 mg m ( -2 ) twice daily ) on days 1-14 plus paclitaxel ( 60 mg m ( -2 ) ) on days 1 , 8 , and 15 of a 4-week cycle
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Intervention_Pharmacological
S-1 ( 40 mg m ( -2 ) twice daily ) on days 1-21 plus cisplatin ( 60 mg m ( -2 ) ) on day 8 of a 5-week cycle ( S-1+cisplatin )
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Intervention_Pharmacological
S-1+paclitaxel
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Intervention_Pharmacological
S-1+cisplatin
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Intervention_Pharmacological
S-1+cisplatin
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Intervention_Pharmacological
S-1+cisplatin
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Intervention_Pharmacological
S-1+paclitaxel
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Outcome_Other
response rate ( RR )
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Outcome_Other
progression-free survival ( PFS )
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Outcome_Other
overall survival ( OS )
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Outcome_Other
safety
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Outcome_Other
RRs
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Outcome_Other
median OS
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Outcome_Adverse-effects
incidence of grade 3 or higher haematological toxicity
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Outcome_Adverse-effects
incidence of grade 3 or higher non-haematological toxicity
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Participant_Condition
gastric cancer
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Participant_Condition
unresectable and/or recurrent advanced gastric cancer
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Participant_Condition
advanced gastric cancer