A multi-center, open-label, randomized phase III trial of first-line chemotherapy with capecitabine monotherapy versus capecitabine plus oxaliplatin in elderly patients with advanced gastric cancer

Objectives More than half of cases of gastric cancer (GC) are diagnosed in elderly patients (≥ 70 years). While doublet combination with fluoropyrimidines and platinum is currently considered standard first-line chemotherapy in advanced GC, the main goal of chemotherapy remains palliation. Materials and Methods In a multi-center phase III trial, patients with chemotherapy-naïve, metastatic GC, aged 70 years or older were randomized 1:1 to receive X monotherapy (capecitabine 1000 mg/m² bid po on days one to fourteen) or XELOX (X plus oxaliplatin 110 mg/m² iv on D1). Treatment was repeated every 21 days until disease progression, unacceptable toxicity, or withdrawal. Primary endpoint was overall survival (OS). Results In total, 50 patients with a median age of 77 (range, 70 to 84) were enrolled (X, n = 26; XELOX, n = 24). No treatment-related serious adverse events or unexpected toxicities were observed. The most frequently observed toxicities were nausea and hand-foot syndrome, with fatigue and peripheral neuropathy more common in XELOX than in X patients. Median OS was 11.1 months for XELOX arm and 6.3 months for X arm (HR 0.58, 95% CI 0.30–1.12, P = 0.108). Although the difference was not significant, on the basis of evidence of superiority of XELOX seen in the first interim analysis, an independent data monitoring committee recommended early stopping of the trial. PFS was significantly longer (HR 0.32, 95% CI 0.17–0.61, P < 0.001) with XELOX (7.1 months) than with X (2.6 months). Conclusion Platinum-based combination chemotherapy was associated with survival benefit, as compared with X monotherapy in elderly patients with GC.