Objective: We evaluated the safety and efficacy of adjuvant chemotherapy with a split-dose regimen of cisplatin (CDDP) plus vinorelbine (VNR) in Japanese patients with completely resected stage II-IIIA non-small cell lung cancer (NSCLC). Patients and Methods: We retrospectively analyzed patients who received adjuvant chemotherapy after undergoing complete resection of NSCLC at Fujita Health University Hospital between May 2007 and December 2011. The patients were treated with CDDP (40 mg/m2) and VNR (25 mg/m2) on days 1 and 8 every 3 weeks for 4 cycles. We examined the toxicity, compliance with chemotherapy, relapse-free survival (RFS) and overall survival (OS). Results: The grade 3 or 4 hematological toxicities included neutropenia in 29 cases (97%), leukopenia in 18 cases (60%), anemia in 2 cases (7%) and febrile neutropenia in 3 cases (10%). The grade 3 or 4 nonhematological toxicities included infection in 5 cases (17%), transaminase increase in 1 case (3%) and injection site reaction in 1 case (3%). No treatment-related deaths were noted in this study. A total of 24 patients (80%) completed the planned 4 cycles of CDDP plus VNR. The median doses of CDDP and VNR were 320 and 178 mg/m2, respectively. The 1-, 2- and 3-year RFS rates were 82%, 63% and 46%, respectively, while the 1-, 2- and 3-year OS rates were 93%, 89% and 84%, respectively. Conclusions: Postoperative adjuvant chemotherapy consisting of 40 mg/m2 of CDDP and 25 mg/m2 of VNR administered on days 1 and 8 is feasible with acceptable efficacy in Japanese patients with surgically resected stage II and IIIA NSCLC in the daily clinical setting.
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