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OPTIMOX1 Study: Folfox in old patients with metastatic colorectal cancer.A GERCOR study
A. Figer A, N. Perez, E. Carola, T. Andre, A Cervantes, G. Lledo, M. Flesch, M. Rivera, P. Colin, A. de Gramont. GERCOR, Paris, France.
Background: Pts with age over 75 years are usually excluded from metastatic colorectal cancer randomized 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 and in pts with Alk Ph level > 3-time the UNL, treated according to the same regimens. This report concerns the tolerance and the efficacy observed for the 37 pts aged over 75 years.
Methods: 37 patients were studied, 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%, alkaline phosphatases (normal/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 70% 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 39 weeks (arm A 34 w; arm B 41 w) and median OS was 90 weeks (arm A 65w and arm B 109w). In the 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 >75 years and that tolerance is good despite a high incidence of non febrile neutropenia, especially with FOLFOX4. Elderly patients in good performance status can receive combination chemotherapy for advanced colorectal cancer.
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