Randomized Phase II Study of Capecitabine With or Without Oxaliplatin as First-line Treatment for Elderly or Fragile Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter Trial of the Korean Cancer Study Group CO06-01.

BACKGROUND: To compare 2 different strategies of chemotherapy for elderly metastatic colorectal cancer patients.

METHODS: This randomized, multicenter phase II study involved 80 metastatic colorectal cancer patients aged 70 years and above (performance status [PS] 0-2) or 65 years and above (PS 2), randomly assigned to arm A (capecitabine 1250 mg/m twice daily on days 1-14) or arm B (capecitabine 1000 mg/m twice daily on days 1-14, oxaliplatin 100 mg/m on day 1 initially, 130 mg/m for subsequent cycles). Primary endpoint was response rate, and secondary endpoints were toxicity, progression-free survival, overall survival, and quality of life (QoL), which was assessed with the EORTC QLQ-C30 questionnaire.

RESULTS: Confirmed response rates were 22.5% and 35.0% (P=0.217), progression-free survival were 4.4 and 6.6 months (P=0.335), and overall survival were 14.2 and 11.0 months (P=0.106). Hematologic toxicities were frequently observed in arm B, but grade ≥3 toxicities were not different. Patients in arm A tended to present more favorable preservation of QoL in global health status, physical and role functioning, fatigue, and appetite loss.

CONCLUSIONS: Initial aggressive treatment strategy would not be recommended for this patient population because QoL appeared more preserved, treatments were better tolerated, and survivals did not differ in patients treated with initial capecitabine monotherapy.