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Phase III Trial of Protracted Compared With Split-Course Chemoradiation for Esophageal Carcinoma: Fédération Francophone de Cancérologie Digestive 9102

Gilles Crehange, Philippe Maingon, Karine Peignaux, Tan Dat N'guyen, Xavier Mirabel, Christian Marchal, Pierre Verrelle, Bernard Roullet, Franck Bonnetain, Laurent Bedenne

From the Department of Radiation Oncology, Centre Georges François Leclerc; Department of Biostatistics, Fédération Francophone de Cancérologie Digestive; Dijon University Hospital, Department of Gastroenterology, Dijon; Department of Radiation Oncology, Centre Henri Becquerel, Rouen; Department of Radiation Oncology, Institut Jean Godinot, Reims; Department of Radiation Oncology, Centre Oscar Lambret, Lille; Department of Radiation Oncology, Centre Alexis Vautrin, Vandoeuvre-Les-Nancy; Department of Radiation Oncology, Centre Jean Perrin, Clermont Ferrand; and Department of Radiation Oncology, University Hospital Dupuytren, Limoges, France

Address reprint requests to Gilles Crehange, MD, Department of Radiation Oncology, Centre G-F Leclerc, 1 rue du Professeur Marion, 21079 Dijon Cedex, France; e-mail: gcrehange{at}dijon.fnclcc.fr

Purpose Chemoradiotherapy (CRT) is an alternative to surgery for resectable locally advanced esophageal carcinoma (RLA-EC). We investigated the heterogeneity of the treatment benefits across subgroups of patients, defined according to the radiation scheme.

Patients and Methods Between February 1993 and December 2000, 451 patients were enrolled. The following two schemes were allowed: protracted radiotherapy (P-RT), which scheduled 46 Gy over 4.5 weeks or split-course radiotherapy (SC-RT) with two 1-week courses of 15 Gy. Two courses of cisplatin and fluorouracil were delivered concomitantly. In case of exclusive CRT, a further course of 20 Gy over 2 weeks in the P-RT group and one 1-week course of 15 Gy in the SC-RT group were delivered with three courses of chemotherapy. SC-RT and P-RT were administered to 285 patients (64%) and 161 patients (36%), respectively.

Results For P-RT versus SC-RT, the response rate to induction CRT was 67% v 68%, respectively (P = .09), and 2-year local relapse-free survival rate was 76.7% v 56.8%, respectively (P = .002). Shorter tumor length and P-RT were associated with better local control in multivariate analysis (P = .002 for both). After a median follow-up time of 47.4 months, 2-year overall survival rate was 37.1% for P-RT compared with 30.5% for SC-RT (P = .25). Independent prognostic factors on survival were tumor diameter (P = .02), weight loss of 10% or less (P = .05), and response to induction CRT (P = .002).

Conclusion Patients with RLA-EC treated with P-RT had better local control than patients treated with SC-RT. Response to induction CRT is a determinant prognostic factor on survival.

Supported by grants from the Ligue Nationale Contre le Cancer, the Fonds de Recherche de la Société Nationale Française de Gastroentérologie, the Programme Hospitalier pour la Recherche Clinique, and the Association pour la Recherche Contre le Cancer.

Presented orally in part at the 25th Annual Meeting of the European Society for Therapeutic Radiology and Oncology, October 8-12, 2006, Leipzig, Germany; the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, November 5-9, 2006, Philadelphia, PA; and the 31st Journées Francophones de Pathologie Digestive, March 17-21, 2007, Lyon, France.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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