INTRODUCTION: Recent clinical trials have shown significant survival benefits from postoperative adjuvant chemotherapy for resected non-small-cell lung cancer (NSCLC). However, due to the comparatively low compliance in recent clinical trials, this study investigated the feasibility of adjuvant chemotherapy with gemcitabine plus split-dose cisplatin for completely resected NSCLC. METHODS: Gemcitabine at a dose of 1000 mg m(-2) and cisplatin at 40 mg m(-2) were given intravenously on days 1 and 8 every 4 weeks for a maximum of four cycles. According to Simon's minimax two-stage design, if the regimen was judged to be safe and tolerable in five or more of the seven patients in the first stage, then enrollment would increase to a total of 20 patients. The feasibility of this regimen was proven if four cycles of chemotherapy were completed in more than 14 patients. The primary endpoint was the compliance to this regimen in the adjuvant setting, while the secondary endpoints were safety and toxicity. RESULTS: The regimen was judged to be safe and tolerable in the first stage, and therefore 21 patients were accrued as planned. Twenty patients (95%) received four cycles of chemotherapy; therefore chemotherapy compliance in the four cycles was 95%. The relative dose intensity was 97% for both gemcitabine and cisplatin. Grade 3/4 toxicities of neutropenia occurred in 33% and thrombocytopenia in 20%. Nonhematological adverse effects were extremely rare. CONCLUSION: Adjuvant chemotherapy with gemcitabine and split-dose cisplatin showed a favorable feasibility and acceptable toxicity in Japanese NSCLC patients. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.
INTRODUCTION: Recent clinical trials have shown significant survival benefits from postoperative adjuvant chemotherapy for resected non-small-cell lung cancer (NSCLC). However, due to the comparatively low compliance in recent clinical trials, this study investigated the feasibility of adjuvant chemotherapy with gemcitabine plus split-dose cisplatin for completely resected NSCLC. METHODS:Gemcitabine at a dose of 1000 mg m(-2) and cisplatin at 40 mg m(-2) were given intravenously on days 1 and 8 every 4 weeks for a maximum of four cycles. According to Simon's minimax two-stage design, if the regimen was judged to be safe and tolerable in five or more of the seven patients in the first stage, then enrollment would increase to a total of 20 patients. The feasibility of this regimen was proven if four cycles of chemotherapy were completed in more than 14 patients. The primary endpoint was the compliance to this regimen in the adjuvant setting, while the secondary endpoints were safety and toxicity. RESULTS: The regimen was judged to be safe and tolerable in the first stage, and therefore 21 patients were accrued as planned. Twenty patients (95%) received four cycles of chemotherapy; therefore chemotherapy compliance in the four cycles was 95%. The relative dose intensity was 97% for both gemcitabine and cisplatin. Grade 3/4 toxicities of neutropenia occurred in 33% and thrombocytopenia in 20%. Nonhematological adverse effects were extremely rare. CONCLUSION: Adjuvant chemotherapy with gemcitabine and split-dose cisplatin showed a favorable feasibility and acceptable toxicity in Japanese NSCLCpatients. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.