A Randomized Phase Ii Trial of Cisplatin Plus Gemcitabine Versus Carboplatin Plus Gemcitabine in Patients with Completely Resected Non-Small Cell Lung Cancer: Hokkaido Lung Cancer Clinical Study Group Trial (Hot0703)

Abstract

ABSTRACT Aim: The combination of platinum and gemcitabine (GEM) (P/G) is one of the most beneficial regimens in advanced non-small cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of P/G in adjuvant chemotherapy of postoperative NSCLC and select the P/G arm for a phase III trial. Methods: Patients with postoperative stage IB-IIIA NSCLC were randomly assigned to either cisplatin (CDDP) 40 mg/m2 on days 1 and 8 plus GEM 1000 mg/m2 on days 1 and 8 (GP arm) or carboplatin (CBDCA) AUC 5 on day 8 plus GEM 1000 mg/m2 on days 1 and 8 (GC arm) every 3 weeks for 4 cycles. The primary endpoint was 2-year disease-free survival (DFS); secondary endpoints were safety, feasibility, overall survival (OS), and biomarker analyses. Results: 102 patients were randomized (stages: 22% IB, 36% II, 42% IIIA; histology: 74% adenocarcinoma, 26% non-adenocarcinoma). Thirty-seven (73%) of 51 patients in each arm completed 4 cycles. Compliance was greater with GP than GC (dose intensity 87.6% vs. 77.9%, respectively; P Conclusions: Both P/G combination regimens were feasible and well-tolerated and, thus, may be potential options for adjuvant treatment in postoperative NSCLC. Although there were no significant differences in DFS between the two regimens, the data presented favor adopting GC for further evaluation. Disclosure: All authors have declared no conflicts of interest.