BACKGROUND: 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 aged > or =70 years.
PATIENTS AND METHODS: Patients aged > or =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).
RESULTS: 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).
CONCLUSION: CAPOX and CAPIRI had similar efficacy in elderly patients, although 
CAPOX seemed to be better tolerated.