Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second‐line therapy for patients with advanced pancreatic cancer

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Abstract
BACKGROUND.: To the authors' knowledge, there is no established second‐line chemotherapy for patients with pancreatic cancer who have received gemcitabine‐based therapy. A phase 2 trial was conducted to explore the efficacy of capecitabine and oxaliplatin (XELOX) in patients with advanced pancreatic cancer previously who were treated with gemcitabine.METHODS.: Patients aged ≤65 years who had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 received oxaliplatin at a dose of 130 mg/m2 given on Day 1 and capecitabine at a dose of 1000 mg/m2 twice daily for 14 days. For patients aged >65 years or with an ECOG PS of 2, the oxaliplatin dose was 110 mg/m2 on Day 1 and the capecitabine dose was 750 mg/m2 twice daily for 14 days. The treatment was repeated every 3 weeks. Tumor measurements were performed every 9 weeks and the primary study objective was 6‐month overall survival.RESULTS.: The study enrolled 41 patients. Of the 39 evaluable patients, 1 patient had a partial response and 10 patients demonstrated stable disease. The Kaplan‐Meier estimate of the overall median survival was 23 weeks (95% confidence interval [95% CI], 17.0‐31.0 weeks). Progression‐free survival was 9.9 weeks (95% CI, 9.6‐14.5 weeks). The 6‐month and 1‐year survival rates were 44% (95% CI, 31%‐62%) and 21% (95% CI, 11%‐38%), respectively. The most common grade 3‐4 nonhematologic toxicity was fatigue (toxicity was graded using the National Cancer Institute Common Toxicity Criteria [version 2.0]).CONCLUSIONS.: The combination of capecitabine and oxaliplatin is active in gemcitabine‐pretreated patients with advanced pancreatic cancer, especially in patients with a good PS and those who have responded to first‐line chemotherapy. Cancer 2008. © 2008 American Cancer Society.

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