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To determine the efficacy and tolerability of capecitabine combined with oxaliplatin (CAPOX) or irinotecan (CAPIRI) as first-line treatment in patients with advanced/metastatic colorectal cancer agedor =70 years.Patients agedor =70 years were randomly assigned to receive CAPOX [oxaliplatin 65 mg/m(2) intravenously (i.v.) days 1 and 8 and capecitabine 1000 mg/m(2) orally b.i.d. days 1-14; q21d] or CAPIRI (irinotecan 80 mg/m(2) i.v. days 1 and 8 and capecitabine 1000 mg/m(2) orally b.i.d. days 1-14; q21d). The primary study end point was overall response rate (ORR).Ninety-four patients were enrolled. In an intent-to-treat analysis, 2 complete responses (CRs) and 16 partial responses (PRs) were reported with CAPOX (ORR 38%), and 2 CRs and 15 PRs with CAPIRI (ORR 36%; P = 0.831). Median time to progression was 8 months for CAPOX and 7 months for CAPIRI (P = 0.195), with median survival times of 19.3 months and 14.0 months (P = 0.165), respectively. Global health status was improved in 45% and in 21% of patients in the CAPOX and CAPIRI arms, respectively. The most common treatment-related grade 3-4 adverse events in CAPIRI versus CAPOX patients were diarrhea (32% versus 15%; P = 0.052) and neutropenia (23% versus 6%; P = 0.021).CAPOX and CAPIRI had similar efficacy in elderly patients, although CAPOX seemed to be better tolerated.

Introduction The addition of bevacizumab to oxaliplatin-based chemotherapy significantly improved progression-free survival (PFS) in patients with metastatic colorectal cancer (MCRC). However, clinical trials have been conducted primarily in younger patients with only a small proportion of elderly patients. Moreover, an increased risk of arterial thromboembolic events has been observed in some trials in older patients. This phase II study was designed to evaluate the efficacy and safety of XELOX (capecitabine plus oxaliplatin) plus bevacizumab in fit patients over 70 years of age with MCRC. Methods Treatment consisted of bevacizumab 7.5mg/Kg and oxaliplatin 130mg/m2 on day 1, plus capecitabine 1000mg/m2 twice daily on days 1-14, every 3 weeks up to a maximum of 8 cycles. Patients with a clinical response or stable disease could be maintained on bevacizumab monotherapy up to progressive disease. The primary study end-points were safety and response rate. Results A total of 44 patients were recruited. In an intention-to-treat analysis, the overall response rate was 52% [95% confidence interval (CI): 37% to 68%], with 86% of patients achieving disease control. Median PFS and overall survival were 11.5 months (95% CI: 10.0-12.9 months) and 19.3 months (95% CI: 16.5-22.1 months), respectively. Four patients (9%) underwent liver metastasectomy with curative intent. In all, 10 patients (23%) had grade 3/4 adverse events (AEs), the most common being peripheral neuropathy (7%), stomatitis (7%), diarrhoea (7%). No patients died because of treatment-related AEs. The low incidence of bevacizumab-associated AEs (hypertension, thromboembolic events and gastrointestinal perforation) was not consistent with that of previous reports in elderly patients. Conclusion XELOX plus bevacizumab is effective and has a manageable tolerability profile when administered to fit elderly patients with MCRC.