Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 3565
© 2004 American Society of Clinical Oncology

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Abstract

5-Fluorouracil, folinic acid and oxaliplatin (FOLFOX) in poor prognosis patients with metastatic colorectal cancer

Hopital Saint Antoine, Paris, France; Hopital Tenon, Paris, France; Hospital Clinico de Valencia, Valencia, Spain; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Clinique Saint Jean, Lyon, France; Hopital Drevon, Dijon, France; Hospital Xeral Calde, Lugo, Spain; Clinique de l'Orangerie, Strasbourg, France; HEGP, Paris, France; CHRU, Lille, France

3565

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 (UNV) 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 UNV (63 pts), treated according to the same regimens. Methods: This report concerns the tolerance and the efficacy observed for the 63 pts with an initial Alk Ph level over 3-time the UNV. 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 54 pts are evaluable for safety and response, respectively. 2 pts benefited from metastasis removal. 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: These safety and efficacy results incite to propose FOLFOX regimens (either FOLFOX4 or FOLFOX7) in poor prognosis pts with metastatic colorectal cancer.

No significant financial relationships to disclose.

Abstract presentation from the 2004 ASCO Annual Meeting