Effect of XELOX on functional ability among elderly patients with metastatic colorectal cancer: Results from the FNCLCC/GERICO 02 phase II study

ObjectivesThis study investigated the effect of capecitabine–oxaliplatin (XELOX) on functional independence in patients aged ≥ 70 years with histologically proven metastatic colorectal cancer (mCRC).Materials and methodsPatients received capecitabine 750 mg/m2 bid d1–14 + oxaliplatin 90 mg/m2 d1, every 3 weeks; doses were increased to 1000 and 120 mg/m2, respectively, in the absence of significant toxicity. The primary endpoint was stabilization/improvement of Katz Activities of Daily Living (ADL) scale.ResultsSixty patients were enrolled. ADL was stabilized/improved in 36/40 patients (90%) after 3 cycles, and in 25/27 patients (93%) after 6 cycles. Capecitabine and oxaliplatin doses were increased in 31% of patients. The objective response rate was 37% (1 complete and 21 partial responses). Toxicity included grade 3/4 diarrhea (13%), neurotoxicity (grade 1/2 in 68%, grade 3/4 in 2%), and grade 3/4 anemia (7%).ConclusionThis study demonstrates the feasibility of XELOX in elderly mCRC patients, with no impairment of independence among patients who remained on therapy.