Gemcitabine and Vinorelbine Followed by Docetaxel in Patients With Advanced Non-small-cell Lung Cancer: JMTO LC00-02 Study

概要

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Objective. to evaluate the efficacy and toxicity of nonplatinum sequential triplet combination chemotherapy for advanced non-small-cell lung cancer. Patients and Study Design. this is a multi-institutional phase II study in 44 chemotherapy-naive patients with advanced NSCLC were treated with gemcitabine 1000mg/m2 and vinorelbine 25mg/m2, iv, days 1, 8, q3 weeks for three cycles. Docetaxel 60mg/m2 was then administed, i. v, day 1, q3 weeks for three cycles. Results. objective response rate was 47.7% by RECEST. Median survival time was 15.7 months and 1- year survival rate was 59%. In the GEM/VNR cycles, grade 3/4 neutropenia occurred in 36.3%, grade 3/4 anemia in 4.5% and grade 3 thrombocytopenia in 2.3%. Grade 3 pneumonitis occurred in two patients (4.5%). In the DOC cycles, grade 3/4 neutropenia occurred in 39.4%. 33 patients completed three cycles of GEM/VNR and 22 patients completed six cycles of planned chemotherapy. There was no treatment related death. Conclusion, this regimen was very active and well tolerated. This study forms the basis for an ongoing phase III trial of Japan-SWOG common arm trial that compares this regimen and standard doublet combination (carbopaltin/paclitaxel).
特定非営利活動法人日本肺癌学会の論文