Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 4532
© 2007 American Society of Clinical Oncology

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Abstract

Definitive chemo-radiotherapy (CRT) with folfox 4 or 5FU-cisplatin as first line treatment for patients (pts) with inoperable esophageal cancer (IEC): Final results of a randomized phase II study

Centre Alexis Vautrin, Nancy, France; Sanofi-Aventis, Paris, France; Clinique Armoricaine, Saint Brieuc, France; University Hospital, Rouen, France; Centre Rene Gauducheau, Nantes, France; Centre Eugene Marquis, Rennes, France; Clinique Sainte Catherine, Avignon, France; Centre Claudius Regaud, Toulouse, France; Centre Oscar Lambret, Lille, France

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Background: The RTOG regimen of concurrent CRT with 5FU/CDDP represents the standard treatment of pts with IEC (Al- Sarraf JCO, 1997). As new combinations are required to improve survival, we launched a multicenter randomized phase II study to assess the feasibility and endoscopic complete response rate (ECRR) of combination CRT with Folfox 4 (arm A) or 5FU/CDDP (arm B) in pts with IEC. Methods: Radiotherapy (RT) was in both arms 50 Gy (2Gy/fraction) 5 days/ week for 5 weeks. In Arm A, pts received 6 biweekly cycles (cy): Oxaliplatin 85mg/m2 d1 and Leucovorin 200mg/m2 followed by 5-FU 400mg/m2 bolus and 600mg/m2 22h continuous infusion (C.I.) d1–2 ; the first 3 cy were delivered during RT, the 3 other after. Arm B: 4 cy were delivered: CDDP 75mg/m2 d1 followed by 5FU 1,000 mg/m2/d C.I. d1–4, the first two cy during RT and 2 other after RT. To be evaluable pts must have completed the concurrent CRT. Response evaluation (esophagoscopy + CT-scan) was done on week 15; ECRR was reviewed by an independent expert committee. Results: 97 pts (A/B= 53/44) were included and 95 treated: 19% adenocarcinoma, 81% squamous cell carcinoma; median age 59 [39–81] and PS 0–1: 98%. In arms A/B, 89/91% of pts completed the concurrent CRT and 75/70% the full treatment. Main NCI-CTC grade (G) 3–4 toxicities (% per pt) were in arms A/B: neutropenia 19/19, febrile neutropenia 12/5, neutropenic infection 2/7, esophagitis 8/14. Neurotoxicity: in arms A/B, 13%/ 2% of pts had G 2 and 46%/13% G 1 neuropathy, no G 3 neuropathy occurred. 47/40 pts (90%) were evaluable for response. In the ITT population, the ECRR was 44.7% and 30.0%, median TTP was 15.0 [9.9–18.9] / 9.5 [7.6- not reached (NR)] months (mos), median Event Free Survival was 11.6 [8.6–17.2]/ 7.8 [5.1–9.9] mos and the median overall survival was 22.7 [16.7-NR]/ 14.7 [9.2–17.2] mos, in arms A and B respectively. Conclusions: The new concurrent CRT with Folfox4 is a well tolerated and convenient combination with promising efficacy associated with very good survival results. Final data will be presented at the meeting. The study continues as a phase III trial.

No significant financial relationships to disclose.

Abstract presentation from the 2007 ASCO Annual Meeting