CHEMORADIOTHERAPY FOLLOWED BY SURGERY COMPARED WITH SURGERY ALONE IN SQUAMOUS-CELL CANCER OF THE ESOPHAGUS

Background We conducted a multicenter, randomized trial to compare pre operative chemoradiotherapy followed by surgery with surgery alone in patients with stage I and II squamous-cell cancer of the esophagus. Me thods The preoperative combined therapy consisted of two one-week cour ses; each involved radio therapy, in a dose of 18.5 Gy delivered in fi ve fractions of 3.7 Gy each, and 80 mg of cisplatin per square meter o f body-surface area, administered 0 to 2 days before the first day of radiotherapy. The surgical plan included one-stage en bloc esophagecto my and proximal gastrectomy by the abdominal and right thoracic routes , to be performed immediately after randomization in the group assigne d to surgery alone and two to four weeks after the completion of preop erative chemoradiotherapy in the group assigned to combined therapy. R esults A total of 297 patients entered the study; 11 were found to be ineligible, and 4 were lost to fol low-up. Of the remaining 282, 139 w ere assigned to surgery alone and 143 to combined therapy. After a med ian follow-up of 55.2 months, no significant difference in overall sur vival was observed; the median survival was 18.6 months for both group s. As compared with the group treated with surgery alone, the group tr eated preoperatively had longer disease-free survival (P=0.003), a lon ger interval free of local disease (P=0.01), a lower rate of cancer-re lated deaths (P=0.002), and a higher frequency of curative resection ( P=0.017). However, there were more postoperative deaths (P=0.012) in t he group treated preoperatively with chemoradiotherapy. Three prognost ic factors were found to influence survival in a multivariate analysis : the disease stage, based on computed tomography; the location of the tumor; and whether the surgical resection was curative. Conclusions I n patients with squamous-cell esophageal cancer, preoperative chemorad iotherapy did not improve overall survival, but it did prolong disease -free survival and survival free of local disease. (C)1997, Massachuse tts Medical Society.