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passages: document
passages: Randomized phase II study of two different schedules of gemcitabine and oral S-1 in chemo-naïve patients with advanced non-small cell lung cancer . INTRODUCTION This study was conducted to evaluate the efficacy and safety and to compare dosing schedules of gemcitabine combined with S-1 in chemo-naïve non-small cell lung cancer patients . METHODS Patients with chemo-naïve stage IIIB/IV non-small cell lung cancer were randomized into two treatment arms . Patients were given oral S-1 ( 60 mg/m/d , twice a day ) from days 1 to 14 with gemcitabine ( 1000 mg/m/d ) on days 1 and 8 ( arm A ) or on days 8 and 15 ( arm B ) . This cycle was repeated every 21 days . RESULTS A total of 80 patients were entered in this trial . The primary end point of this study was response rate . The response rates of arm A and arm B were 22.0 and 28.9 % , respectively ( p = 0.606 ) . Median time to treatment failure in arm A was 3.6 months and 4.8 months in arm B . Median time to progression in arm A was 4.1 months and 5.5 months in arm B . Median survival time in arm A and arm B was 15.5 months and 18.8 months , respectively . The toxicity profile was relatively mild and did not differ very much between two arms . CONCLUSION The combination of gemcitabine and S-1 was determined to be feasible and effective for advanced non-small cell lung cancer . We selected arm B for further studies because of its higher response rate and survival data .
entities: 1755
entities: Intervention_Pharmacological
entities: gemcitabine
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entities: Intervention_Pharmacological
entities: S-1
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entities: Intervention_Pharmacological
entities: gemcitabine
entities: 1758
entities: Intervention_Pharmacological
entities: S-1
entities: 1759
entities: Intervention_Pharmacological
entities: S-1
entities: 1760
entities: Intervention_Pharmacological
entities: gemcitabine
entities: 1761
entities: Intervention_Pharmacological
entities: gemcitabine
entities: 1762
entities: Intervention_Pharmacological
entities: S-1
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entities: Outcome_Other
entities: efficacy
entities: 1764
entities: Outcome_Other
entities: safety
entities: 1765
entities: Outcome_Physical
entities: response rate
entities: 1766
entities: Outcome_Physical
entities: response rates
entities: 1767
entities: Outcome_Physical
entities: Median time to treatment failure
entities: 1768
entities: Outcome_Physical
entities: Median time to progression
entities: 1769
entities: Outcome_Mortality
entities: Median survival time
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entities: Outcome_Adverse-effects
entities: toxicity profile
entities: 1771
entities: Outcome_Physical
entities: feasible
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entities: Outcome_Physical
entities: effective
entities: 1773
entities: Outcome_Physical
entities: response rate
entities: 1774
entities: Outcome_Mortality
entities: survival data
entities: 1775
entities: Participant_Condition
entities: chemo-naïve
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entities: Participant_Condition
entities: advanced non-small cell lung cancer
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entities: Participant_Condition
entities: chemo-naïve non-small cell lung cancer patients
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entities: Participant_Condition
entities: chemo-naïve stage IIIB/IV non-small cell lung cancer
entities: 1779
entities: Participant_Sample-size
entities: 80