FOLFOX in patients aged between 76 and 80 years with metastatic colorectal cancer

BACKGROUND. Patients older than 75 years of age are usually excluded from metastatic colorectal cancer randomized studies. The OPTIMOX1 study evaluated FOLFOX7, a simplified (s) leucovorin (LV) and 5‐fluorouracil (5FU) regimen (sLV5FU2) with high‐dose oxaliplatin, in a new oxaliplatin stop‐and‐go strategy. An exploratory cohort of patients aged 76 to 80 years was included in the study. METHODS. In all, 620 previously untreated patients were randomized between FOLFOX4 until progression (arm A), or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 (arm B). RESULTS. A total of 37 patients aged 76 to 80 years were included, 20 in arm A and 17 in arm B. The overall response rate (ORR) was 59.4%, comparable to younger patients (59%). Median progression‐free survival (PFS) was 9.0 months and median overall survival (OS) was 20.7 months. These results did not differ from that in younger patients ≤75 years in the OPTIMOX1 study with PFS 9.0 months (P = .63) and OS 20.2 months (P = .57). They experienced slightly more grade 3 of 4 toxicity than younger patients: 65% versus 48% (P = .06), mainly with more neutropenia (41% vs 24%, P = .03) and neurotoxicity (22% vs 11%, P = .06). Tolerability, however, was manageable and no toxic death occurred in this elderly population. CONCLUSIONS. The efficacy of FOLFOX‐based treatment was maintained in patients >75 years with both FOLFOX regimens. The oxaliplatin stop‐and‐go management strategy performed well in this population. Cancer 2007. © 2007 American Cancer Society. In the OPTIMOX1 study the efficacy of FOLFOX‐based treatment was maintained in patients between 76 and 80 years as for younger patients with slightly more grade 3/4 toxicity than patients ≤75 years, but manageable and with no toxic death. This study supports the belief that FOLFOX treatment can be offered to these elderly patients with appropriate motivation and performance status.