A Phase II Study of Capecitabine plus Oxaliplatin as First-Line Chemotherapy in Elderly Patients with Advanced Gastric Cancer

Abstract

Objective: This study aimed at assessing the efficacy and safety of oxaliplatin plus oral capecitabine (XELOX regimen) as first-line chemotherapy in elderly patients with advanced gastric cancer (AGC). Patients and Methods: Forty-six eligible patients aged ≧70 years with previously untreated AGC received oxaliplatin 130 mg/m² intravenously over a 2-hour period on day 1 plus oral capecitabine 850 mg/m² twice daily on days 1–14, every 3 weeks. Results: All patients were evaluable for toxicity and 45 patients for efficacy. A median of 6 cycles (range 1–8) was administered. The overall response rate was 48.9% (95% CI 34–64) with 1 complete response, 21 partial responses, 15 stable diseases and 8 progressions. Median time to progression was 6.0 months (95% CI 3.9–8.1), and the median overall survival was 10.0 months (95% CI 8.6–11.4). Toxicity was fairly mild. Grade 3 toxicities included neutropenia (6.5%), thrombocytopenia (2.2%), nausea (2.2%), vomiting (4.3%), diarrhea (4.3%) as well as peripheral neuropathy (2.2%); grade 4 toxicities occurred in none of the patients. Conclusion: The XELOX regimen with capecitabine at a lower dose of 850 mg/m² is active, fairly tolerable and conveniently delivered as first-line chemotherapy for elderly AGC patients.

Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

“…Regimens that have been specifically addressed in phase II trials in elderly patients with comparable survival results include capecitabine and oxaliplatin, FOLFOX (leucovorin, 5-FU and oxaliplatin), single-agent capecitabine and S1 (in Asian patients) [III, B] [66][67][68]. A phase II trial investigated the miniDOX (docetaxel, oxaliplatin and capecitabine) regimen in primarily older patients and also recruited patients with other poor prognostic markers (PS2, weight loss 10%-25%).…”

Capecitabine and oxaliplatin in combination as first- or second-line therapy for metastatic breast cancer: a Wisconsin Oncology Network trial

“…Xiang et al recently reported results of a study among 45 patients who received oxaliplatin 130 mg/m2 on day 1 and capecitabine 850 mg/m2 twice daily on days 1-14 of a 3-week cycle in the first line setting. The incidence of peripheral neuropathy was 2.2% [21]. Among our study population, 3 out of 9 received prior taxane or vinorelbine.…”

Antineoplastic Effect of WIN 55,212-2, a Cannabinoid Agonist, in a Murine Xenograft Model of Gastric Cancer

“…These patients have a median survival time of 3-5 months without chemotherapy even after a curative resection [2]. These data indicate the importance of effective chemotherapy in gastric cancer [3]. However, systemic chemotherapy usually results in gastric cancer-cell resistance, which is associated with a poor prognosis.…”