Background We conducted a multicenter, randomized trial to comparepreoperative chemoradiotherapy followed by surgery with surgeryalone in patients with stage I and II squamous-cell cancer ofthe esophagus.
Methods The preoperative combined therapy consisted of two one-weekcourses; each involved radiotherapy, in a dose of 18.5 Gy deliveredin five fractions of 3.7 Gy each, and 80 mg of cisplatin persquare meter of body-surface area, administered 0 to 2 daysbefore the first day of radiotherapy. The surgical plan includedone-stage en bloc esophagectomy and proximal gastrectomy bythe abdominal and right thoracic routes, to be performed immediatelyafter randomization in the group assigned to surgery alone andtwo to four weeks after the completion of preoperative chemoradiotherapyin the group assigned to combined therapy.
Results A total of 297 patients entered the study; 11 were foundto be ineligible, and 4 were lost to follow-up. Of the remaining282, 139 were assigned to surgery alone and 143 to combinedtherapy. After a median follow-up of 55.2 months, no significantdifference in overall survival was observed; the median survivalwas 18.6 months for both groups. As compared with the grouptreated with surgery alone, the group treated preoperativelyhad longer disease-free survival (P = 0.003), a longer intervalfree of local disease (P = 0.01), a lower rate of cancer-relateddeaths (P = 0.002), and a higher frequency of curative resection(P = 0.017). However, there were more postoperative deaths (P= 0.012) in the group treated preoperatively with chemoradiotherapy.Three prognostic factors were found to influence survival ina multivariate analysis: the disease stage, based on computedtomography; the location of the tumor; and whether the surgicalresection was curative.
Conclusions In patients with squamous-cell esophageal cancer,preoperative chemoradiotherapy did not improve overall survival,but it did prolong disease-free survival and survival free oflocal disease.
Source Information
From University Hospital J. Minjoz, Besançon (J.-F.B., G.M., J.-J.P., M.M.); University Hospital Côte de Nacre, Caen (M.G.); University Hospital C. Hurriez, Lille (J.-P.T.); University Hospital St. Antoine, Paris (E.T.); Institut Gustave Roussy, Villejuif (D.E.); University Hospital A. Morvan, Brest (P.L.); and University Hospital, Schiltigheim (J.-C.O.) — all in France, and the European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium (T.S.). Other authors were Philippe Ségol (University Hospital Côte de Nacre, Caen), Jean-Bernard Flamant (University Hospital E. Debré, Reims), Jean-Pierre Arnaud (University Hospital, Angers), Jean-Pierre Plachot (University Hospital, Amiens), Anne-Marie Mandard (Centre F. Baclesse, Caen), and Gaelle Chaillard (University Hospital J. Minjoz, Besançon).Presented in part at the 30th Annual Meeting of the American Society of Clinical Oncology, Dallas, May 14–17, 1994.
Address reprint requests to Dr. Bosset at the Radiation Oncology Department, University Hospital J. Minjoz, 25030 Besançon, CEDEX, France.
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