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Preoperative Radiotherapy With or Without Concurrent Fluorouracil and Leucovorin in T3-4 Rectal Cancers: Results of FFCD 9203

Jean-Pierre Gérard, Thierry Conroy, Franck Bonnetain, Olivier Bouché, Olivier Chapet, Marie-Thérèse Closon-Dejardin, Michel Untereiner, Bernard Leduc, Éric Francois, Jean Maurel, Jean-François Seitz, Bruno Buecher, Rémy Mackiewicz, Michel Ducreux, Laurent Bedenne

From the Centre Antoine Lacassagne, Nice; Centre Alexis Vautrin, Vandoeuvre lès Nancy; Fédération Francophone de Cancérologie Digestive; Centre Hospitalier Universitaire de Dijon, Dijon; Centre Hospitalier Universitaire de Reims, Reims; Centre Hospitalier Universitaire de Lyon "Pierre Bénite," Lyon; Clinique Claude Bernard, Metz; Centre Hospitalier de Brive, Brive; Centre Hospitalier Universitaire Côte de Nacre, Caen; Centre Hospitalier Universitaire La Timone, Marseille; Centre Hospitalier Universitaire Hôtel Dieu Nantes, Nantes; Clinique Générale, Valence; Institut Gustave Roussy, Villejuif, France; and France University Hospital, Liège, Belgium

Address reprint requests to Jean-Pierre Gérard, MD, Centre Antoine Lacassagne, Radiotherapy Department, 33 avenue de Valombrose, 06189 Nice Cedex 02, Nice, France; e-mail: jean-pierre.gerard{at}cal.nice.fnclcc.fr

PURPOSE: In 1992, preoperative radiotherapy was considered in France as the standard treatment for T3-4 rectal cancers. The present randomized trial compares preoperative radiotherapy with chemoradiotherapy.

PATIENTS AND METHODS: Patients were eligible if they presented a resectable T3-4, Nx, M0 rectal adenocarcinoma accessible to digital rectal examination. Preoperative radiotherapy with 45 Gy in 25 fractions during 5 weeks was delivered. Concurrent chemotherapy with fluorouracil 350 mg/m²/d during 5 days, together with leucovorin, was administered during the first and fifth week in the experimental arm. Surgery was planned 3 to 10 weeks after the end of radiotherapy. All patients should receive adjuvant chemotherapy with the same fluorouracil/leucovorin regimen. The primary end point of the trial was overall survival.

RESULTS: A total of 733 patients were eligible. Grade 3 or 4 acute toxicity was more frequent with chemoradiotherapy (14.6% v 2.7%; P < .05). There was no difference in sphincter preservation. Complete sterilization of the operative specimen was more frequent with chemoradiotherapy (11.4% v 3.6%; P < .05). The 5-year incidence of local recurrence was lower with chemoradiotherapy (8.1% v 16.5%; P < .05). Overall 5-year survival in the two groups did not differ.

CONCLUSION: Preoperative chemoradiotherapy despite a moderate increase in acute toxicity and no impact on overall survival significantly improves local control and is recommended for T3-4, N0-2, M0 adenocarcinoma of the middle and distal rectum.

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

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