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Chemoradiation Followed by Surgery Compared With Chemoradiation Alone in Squamous Cancer of the Esophagus: FFCD 9102

Laurent Bedenne, Pierre Michel, Olivier Bouché, Chantal Milan, Christophe Mariette, Thierry Conroy, Denis Pezet, Bernard Roullet, Jean-François Seitz, Jean-Philippe Herr, Bernard Paillot, Patrick Arveux, Franck Bonnetain, Christine Binquet

From the University Hospital Le Bocage; Anticancer Center Georges-François Leclerc, Dijon; University Hospital Charles-Nicolle, Rouen; University Hospital Robert-Debré, Reims; University Hospital Claude-Huriez, Lille; Anticancer Center Alexis Vautrin, Vandoeuvre; University Hospital Hôtel-Dieu, Clermont-Ferrand; University Hospital Dupuytren, Limoges; Université de la Méditerranée, Marseille; and Clinique Sainte-Marie, Chalon, France

Address reprint requests to Laurent Bedenne, MD, Fédération Francophone de Cancérologie Digestive, Faculté de Médecine, BP 87900, 21079 Dijon-Cedex, France; e-mail: lbedenne{at}u-bourgogne.fr

Purpose Uncontrolled studies suggest that chemoradiation has similar efficacy as surgery for esophageal cancer. Therefore, a randomized trial was carried out to compare, in responders only, chemoradiation alone with chemoradiation followed by surgery in patients with locally advanced tumors.

Patients and Methods Eligible patients had operable T3N0-1M0 thoracic esophageal cancer. Patients received two cycles of fluorouracil (FU) and cisplatin (days 1 to 5 and 22 to 26) and either conventional (46 Gy in 4.5 weeks) or split-course (15 Gy, days 1 to 5 and 22 to 26) concomitant radiotherapy. Patients with response and no contraindication to either treatment were randomly assigned to surgery (arm A) or continuation of chemoradiation (arm B; three cycles of FU/cisplatin and either conventional [20 Gy] or split-course [15 Gy] radiotherapy). Chemoradiation was considered equivalent to surgery if the difference in 2-year survival rate was less than 10%.

Results Of 444 eligible patients, 259 were randomly assigned; 230 patients (88.8%) had epidermoid cancer, and 29 (11.2%) had glandular carcinoma. Two-year survival rate was 34% in arm A versus 40% in arm B (hazard ratio for arm B v arm A = 0.90; adjusted P = .44). Median survival time was 17.7 months in arm A compared with 19.3 months in arm B. Two-year local control rate was 66.4% in arm A compared with 57.0% in arm B, and stents were less required in the surgery arm (5% in arm A v 32% in arm B; P < .001). The 3-month mortality rate was 9.3% in arm A compared with 0.8% in arm B (P = .002). Cumulative hospital stay was 68 days in arm A compared with 52 days in arm B (P = .02).

Conclusion Our data suggest that, in patients with locally advanced thoracic esophageal cancers, especially epidermoid, who respond to chemoradiation, there is no benefit for the addition of surgery after chemoradiation compared with the continuation of additional chemoradiation.

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 in part at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, 2002, Orlando, FL, and the 27th Annual Journées Francophones de Pathologie Digestive, March 31-April 2, 2003, Paris, France.

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

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• Surgery After Primary Chemoradiotherapy in Squamous Cancer of the Esophagus: Is the Photon Mightier Than the Sword?
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