Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQuali study

Purpose: To evaluate the efficacy, safety and quality of life of a short course of oxaliplatin plus capecitabine (XELOX) followed by single-agent capecitabine in patients with previously untreated, inoperable, metastatic colorectal cancer. Methods: Patients received intravenous oxaliplatin 130 mg/m2 on d1 plus oral capecitabine 1,000 mg/m2 twice daily (bid) on d1-14 every 21 days for four cycles. Patients achieving stable disease (SD) or better than received capecitabine 1,250 mg/m2 bid on d1-14 every 21 days until disease progression. The primary endpoint was progression-free survival (PFS). Results: Overall, 21/45 (47%) of patients responded to the initial XELOX chemotherapy whilst SD or better was documented in 76%. Median PFS was 6.7 (95% CI 5.7-9.6) months, and median overall survival (OS) was 20.5 (95% CI 13.1-28.1) months. In the 34 patients who then received capecitabine maintenance therapy, the median PFS was 8.1 (95% CI 6.2-11.8) months and median OS was 23.1 (95% CI 17.8-28.5) months. A marked reduction in the vast majority of all grades of adverse event occurred on switching from initial XELOX to maintenance capecitabine chemotherapy including grades 1-2 (77 vs. 47%) and grade 3 (7 vs. 3%) neuropathy, diarrhoea and lethargy. Conclusions: Short-course XELOX followed by capecitabine maintenance therapy provides an active and well-tolerated treatment option for patients with previously untreated metastatic colorectal cancer. A median OS of more than 20 months is promising and by limiting the number of oxaliplatin infusions, this approach minimises the risk of unwanted cumulative neurotoxicity, is cheaper and more convenient for both patients and healthcare providers. © 2010 Springer-Verlag.