Adjuvant capecitabine and oxaliplatin for gastric cancer: Results of the phase III CLASSIC trial.

• DOI: 10.1200/jco.2011.29.18_suppl.lba4002
• Publication Date: 2017-02-23T18:42:09Z
• Authors: Y. Bang; Y. W. Kim; H. Yang; H. C. Chung; Y. Park; K. Lee; K. H. Lee; Y. H. Kim; S. Noh; J. Ji; M. Johnston; F. Sirzen; S. H. Noh
• Keywords: Interim analysis; Clinical endpoint; Regimen

LBA4002 Background: Surgical resection is a recommended treatment for operable gastric cancer (GC) in general, despite high recurrence rates (40%–80%). Adjuvant chemotherapy aims to reduce recurrences; however, there currently no universally accepted adjuvant regimen GC. Methods: CLASSIC randomized, open-label, multicenter, international (South Korea, China, and Taiwan) study of XELOX (capecitabine 1000mg/m 2 bid, d1–14, q3w oxaliplatin 130mg/m , d1, x 8 cycles) vs observation, following D2 gastrectomy. Eligible patients were chemotherapy- radiotherapy-naive, with stage II (T2N1, T1N2, T3N0), IIIa (T3N1, T2N2, T4N0), or IIIb (T3N2) GC resected within 6 weeks prior randomization. The primary endpoint 3-year disease-free survival (DFS). A sample size 512 per arm was planned observe the 385 DFS events required provide 80% power at 5% significance level hypothesized effect (hazard ratio [HR] 0.75). Independent Data Monitoring Committee full evaluation reporting results positive pre-planned interim analysis 266 events. Results: observation arms (ITT populations 520 515 patients, respectively) well balanced baseline characteristics. median duration follow-up 34.4 (16–51) months. XELOX-related grade 3/4 adverse (AEs) occurred 244/496 (49%) safety population. Neutropenia only AE observed >10% (21%, n=106/496). Serious AEs 34/496 (7%). There 62/496 (13%) 80/476 (17%) deaths on arms, respectively, mostly due disease progression. Efficacy ITT population are summarized below. Conclusions: This demonstrates superior efficacy alone Although OS data still immature, trend towards superiority XELOX. These support use [Table: see text]