Feasibility study of adjuvant vinorelbine and cisplatin in Japanese patients with completely resected stage II-IIIA non-small cell lung cancer.

Abstract

e17514 Background: Recent clinical trials have shown that adjuvant cisplatin (CDDP)-based chemotherapy improved survival for patients with completely resected stage II-IIIA non-small cell lung cancer (NSCLC). In combination with CDDP, vinorelbine (VNR) was the only third generation drug to demonstrate survival benefits. In this study the feasibility of postoperative CDDP and VNR was prospectively examined in Japanese patients. Methods: Patients with completely resected stage II-IIIA NSCLC were received CDDP 40 mg/m2 and VNR 25 mg/m2 on days 1 and 8, every 3-week, 4 cycles. The primary end point was completion rate (CR) of the therapy and the secondary end point was safety and toxicity. This study, with a planned sample size of 20, had 80% power to support the hypothesis that the true CR was >80%, and 5% significance to deny the hypothesis that the true CR was <50%. Results: Between May 2007 and February 2008, 20 patients with completely resected stage II-IIIA NSCLC were enrolled in the study and all patients were treated. Demographics: Male/Female 9/11; ECOG PS 0/1 8/12; median age 63 (range 35-74); p- stage IIA/IIB/IIIA 2/6/12; histological type adenocarcinoma/squamous cell carcinoma/large cell carcinoma 13/6/1; type of surgery lobectomy/neumonectomy 20/0. Twenty patients were enrolled, and the CR for the 4 cycles was 90% (18/20). Grade 3 or 4 hematology toxicities were observed neutropenia in 90%, leukopenia in 65%, anemia in 30%, and febrile neutropenia in 5%. Grade 3 or 4 non-hematology toxicities were not observed. Conclusions: Postoperative adjuvant chemotherapy consisting of CDDP 40 mg/m2 and VNR 25 mg/m2 on days 1 and 8 was shown to be well tolerable in Japanese patients with completely resected stage II-IIIA NSCLC. No significant financial relationships to disclose.