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Gercor > news > Communications ASCO > OPTIMOX1 Study...

OPTIMOX1 study:5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) in poor prognosis patients with metastatic colorectal cancer. A GERCOR study.

C Tournigand, T André, I Chirivella, A Figer, G Lledo, M Flesch, JR Mel Lorenzo, E Achille, B Landi, M Hebbar, A de Gramont. GERCOR, Paris, France.

Background: High alkaline phosphatases (Alk Ph) level is an adverse prognostic factor in patients (pts) with metastatic colo-rectal cancer (CRC). Pts with Alk Ph level over 3-time the upper normal value (UNL) were excluded from previous 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 UNL (63 pts), treated according to the same regimens. This report concerns the 63 pts with an initial Alk Ph level over 3-time the UNV.

Methods: 33 pts were treated with FOLFOX4 (arm A), and 30 with FOLFOX7 - sLV5FU2 - FOLFOX7 (arm B). Characteristics of these pts were: PS 0/1-2=26/74%, median age 63 yrs; LDH (normal / > normal) 6%/94%, metastatic site (1/ > 1) 70/30%.

Results : 60 pts (766 cycles) and 53 pts are evaluable for safety and response, respectively. Liver surgery was performed in 2 pts. Grade 3-4 toxicities (% of pts, arm A / arm B) were: neutrophils 15.2/10.0, platelets 9.1/3.3, hemoglobin 9.1/3.3, nausea-vomiting 0/10.0, diarrhea 6.1/6.7, neurotoxicity 9.1/10.0. Maximal toxicity per patient was grade 3-4 in 42.4% of arm A pts, and 33.4% of arm B pts. Response rate (intent-to-treat) was 55.6 % (arm A 48.5%; arm B 63.3%). Median PFS was 28 weeks (arm A 29 w ; arm B 28 w) and median OS was 50 weeks (arm A 61w and arm B 48 w).

Conclusion: Based on these safety and efficacy results, FOLFOX regimens (either FOLFOX4 or FOLFOX7) can be administered in poor prognosis pts with metastatic colorectal cancer.  

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