5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) in very old patients with metastatic colorectal cancer

Abstract

3571 Background: Pts with age over 75 years are usually excluded from randomised studies. OPTIMOX trial consisted in a phase III study for pts with conventional inclusion criteria (526 pts), comparing FOLFOX4 to FOLFOX7 x 6 cycles, followed simplified LV5FU2 x 12 cycles and FOLFOX7 reintroduction; and two exploratory studies in pts > 75 yrs (37 pts) and in pts with Alk Ph level > 3-time the UNV (63 pts), treated according to the same regimens. Methods: This report concerns the tolerance and the efficacy observed for the 37 pts aged 75 years or older. 20 pts were treated with FOLFOX4 (arm A), and 17 with FOLFOX7 - sLV5FU2 - FOLFOX7 (arm B). Characteristics of these pts were : PS 0/1–2=49/51%, LDH (normal / > normal / unknown) 51%/27%/22%, metastatic site (1/ > 1) 73/27%, alk phosp (nl/elevated/unknown) 59%/35%/6%. Results: 37 pts are evaluable for safety and 35 pts for response. Grade 3–4 toxicities (% of pts, arm A / arm B) were: neutrophils 55/24, platelets 5/0, hemoglobin 5/0, nausea-vomiting 0/12, diarrhea 5/6, neurotoxicity 20/24. Maximal toxicity per patient was grade 3–4 in 80% of arm A pts, and 59% of arm B pts. Response rate (intent-to-treat) was 59.4 % (arm A 65%; arm B 53%). Median PFS was 37 weeks (arm A 33 w; arm B 41 w) and median OS was 79 weeks (arm A 65w and arm B 90w). Moreover, in OPTIMOX study, age does not appear as a prognosis factor in a multivariate analysis. Conclusion: These results indicate that efficacy is maintained with Folfox regimens in patients >75years. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi