AbstractBACKGROUND:Irinotecan‐based chemotherapy regimens are 1 option for treatment of metastatic colorectal cancer (mCRC). The authors report the safety and efficacy of such regimens in elderly patients using a large phase III trial (bolus, infusional, or capecitabine with camptostar‐celecoxib [BICC‐C]) cohort.METHODS:In period 1, 430 previously untreated patients with mCRC were randomized in a 3‐by‐2 design to receive irinotecan plus infusional 5‐fluorouracil, and leucovorin (FOLFIRI), irinotecan plus bolus 5‐fluorouracil/leucovorin (mIFL), and irinotecan plus oral capecitabine (CapeIRI). In period 2, an additional 117 patients were randomized to receive FOLFIRI or mIFL and bevacizumab. In both periods patients were also randomized to a double‐blind treatment with celecoxib or placebo. A secondary analysis was conducted examining the safety and efficacy of these regimens in elderly (age >70 years) versus nonelderly (age ≤70 years) patients.RESULTS:In period 1, 19.5% of patients were elderly, compared with 24.8% in period 2. Rates of grade 3 and higher toxicity did not differ significantly between age groups in either period by treatment arm, with the exception of asthenia in the FOLFIRI and CapeIRI arms (P= .05 andP= .03, respectively) and dehydration in the CapeIRI arm in period 1 (P= .02). Overall progression‐free survival for FOLFIRI in both periods was not statistically different by age. Objective responses and overall survival did not differ by patient age within treatment arms and periods.CONCLUSIONS:Irinotecan/fluoropyrimidine combinations are well tolerated in the elderly population, with similar efficacy to that found in nonelderly patients in first‐line mCRC. Cancer 2009. © 2009 American Cancer Society.