Oxaliplatin in Combination With Infusional 5-Fluorouracil as First-Line Chemotherapy for Elderly Patients With Metastatic Colorectal Cancer: A Phase II Study of the Spanish Cooperative Group for the Treatment of Digestive Tumors

Observed efficacy and safety of oxaliplatin plus 5-fluorouracil (5-FU) continuous infusion (TTD [Spanish Cooperative Group for Digestive Tumour Therapy] schedule) in this large prospective phase II study that included patients >= 72 years with metastatic colorectal cancer and relevant concomitant diseases compare favorably with efficacy and safety results reported for this population, including regimens with biologic therapies. Background: We previously reported a 35% overall response rate (ORR) with biweekly 5-fluorouracil (5-FU) continuous infusion (TTD [Spanish Cooperative Group for Digestive Tumour Therapy] schedule) plus irinotecan as first-line therapy in elderly patients with metastatic colorectal cancer (mCRC). The present study also was carried out in elderly patients to determine the efficacy and safety of the same 5-FU schedule plus oxaliplatin. Patients and Methods: Patients (aged >= 72 years old) with mCRC, measurable disease, ECOG (Eastern Cooperative Oncology Group) <= 2 and no prior treatment were treated with oxaliplatin 85 mg/m(2) plus 5-FU 3000 mg/m(2) as a 48-hour infusion every 2 weeks. Results: The study included 134 patients, of whom, 129 were eligible. The main comorbidities were hypertension (44%), diabetes (17%), and chronic obstructive pulmonary disease (11%). The OAR and disease control rate (ORR plus stable disease) were 52% and 80%, respectively. With a median follow-up of 14 months, the median progression-free survival and overall survival were 9.1 and 16.3 months, respectively. The most frequent grade 3/4 adverse events included neutropenia (16%), diarrhea (11%), and grade 3 neurotoxicity (18%). No correlation was found between efficacy or safety and comorbidities. Conclusions: To our knowledge, this is the largest phase II prospective study in elderly patients with mCRC. The observed efficacy and safety of this schedule compared favorably with those reported in this population, including regimens with monoclonal antibodies.