Elderly patients with advanced colorectal cancer derive similar benefit without excessive toxicity after first-line chemotherapy with oxaliplatin-based combinations: Comparative outcomes from the 03-TTD-01 phase III study

Abstract Purpose Healthy elderly patients with metastatic colorectal cancer may benefit from chemotherapy as much as the younger population. This analysis compares the outcomes of first-line oxaliplatin plus fluoropyrimidines in elderly versus young patients. Patients and methods 348 patients were randomized to capecitabine 1000 mg/(m 2  12 h), days 1–14 plus oxaliplatin 130 mg/m 2 day 1, every 3 weeks or weekly infusional 5-FU 2250 mg/m 2 over 48 h plus bimonthly oxaliplatin 85 mg/m 2 . We evaluated response rate, time to progression, overall survival and toxicity according to age. Results ORR for elderly and young patients were 34.9% and 44.7%, respectively ( p  = 0.081). Median TTP did not differ between the two groups: 8.3 months for patients ≥70 years and 9.6 months for those p  = 0.114). Median OS was 16.8 months and 20.5 months for the ≥70 and p  = 0.74). With XELOX, mild paresthesia and an increase in transaminase levels were more frequent for young patients, whereas grade 3/4 diarrhea was higher in those ≥70 years (25% vs. 8%, p  = 0.005). For FUOX, only paresthesia was significantly lower in patients ≥70 years (53% vs. 71%, p  = 0.032). Conclusion Elderly patients with MCRC benefit from first-line oxaliplatin–fluoropyrimidine combinations as much as younger patients, without increased toxicity.