Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 3549
© 2004 American Society of Clinical Oncology

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Abstract

5FU-leucovorin (5FU/LV) with or without irinotecan (CPT-11) in stages II-III rectal cancers: Preliminary safety analysis of the French Intergroup R98 phase III trial

Henri Mondor Hospital, Creteil, France; Tenon Hospital, Paris, France; Gauducheau Center, Nantes, France; Ambroise Paré Hospital, Boulogne, France; La Roche Sur Yon Hospital, La Roche Sur Yon, France; Val d Aurelle Center, Montpellier, France; Polyclinique Beaulieu, Saint Etienne, France; Strasbourg Oncology, Strasbourg, France; IDDI, Brussels, Belgium; Aventis, Paris, France

3549

Background:The optimal adjuvant treatment of stages II-III rectal cancers is still debatable. When administered, postoperative chemotherapy is usually a 5FU-leucovorin (5FU/LV) regimen. CPT-11 + 5FU/LV has been shown to improve the outcome of patients (Pts) with metastatic disease. Methods: R98 trial compares postoperative 5FU/LV (control arm) to 5FU/LV + CPT-11. Primary endpoint is DFS. The trial, designed to include 600 Pts, was initiated in February 1999 by AERO, joined by three French groups (GERCOR in June 2000, FFCD and FNCLCC in December 2003). RT was recommended preoperatively. Centers were asked to choose the control arm, as either Mayo-Clinic regimen (A: LV 20 mg/m², 5FU 425 mg/m² bolus days 1–5, repeated at d29, d57, d92, d127 and d162) or LV5FU2 regimen (A': LV 200 mg/m² over 2-hour, 5FU 400 mg/m² bolus and 600 mg/m² 22-hour infusion, d1–2, Q2W for 12 cycles). Experimental arm (B) consisted of LV5FU2 + CPT-11 180 mg/m² d1 of every cycle. Data were reviewed by an IDMC, which approved release of the present analyses. Results: Toxicity data from the first 154 Pts entered by 53 centers before 01/01/02 is analyzed. Pretreatment characteristics were well balanced between the groups; median age 64 years, stage II in 32% of Pts. 69% of Pts received RT, and 79% had sphincter conservation. 95% arm A and A', and 75% arm B Pts received more than 75% of planned chemotherapy dose. No toxic deaths were reported. G3–4 toxicity per Pt was as follows (A, A', B): neutropenia 28%, 0%, 34%; diarrhea 8%, 11%, 15%; nausea-vomiting 0%, 0%, 5%; mucositis: 8%, 0%, 0%; infection: 8%, 0%, 1%; other G3–4 toxicities <5%. Statistically significant differences in G3–4 toxicity profiles between the control and experimental arms indicated a higher incidence of mucositis in arm A (P=0.01), and a lower incidence of neutropenia in arm A' (P<0.0001). RT was not associated with a higher risk of diarrhea. Conclusions:5FU/LV + CPT-11 has an acceptable safety profile in Pts with resected rectal cancer compared to 5FU/LV. No major, unexpected toxicities were observed. Pt accrual is still ongoing. Study supported by Aventis Oncology, France

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis Aventis

Abstract presentation from the 2004 ASCO Annual Meeting