Chemotherapy followed by surgery compared with surgery alone for localizedesophageal cancer

Background We performed a multi-institutional randomized trial comparing pr eoperative chemotherapy followed by surgery with surgery alone for patients with local and operable esophageal cancer. Methods Preoperative chemotherapy for patients randomly assigned to the che motherapy group included three cycles of cisplatin and fluorouracil. Surger y was performed two to four weeks after the completion of the third cycle; patients also received two additional cycles of chemotherapy after the oper ation. Patients randomly assigned to the immediate-surgery group underwent the same surgical procedure. The main end point was overall survival. Results Of the 440 eligible patients with adequate data, 213 were assigned to receive preoperative chemotherapy and 227 to undergo immediate surgery. After a median possible study time of 55.4 months, there were no significan t differences between the two groups in median survival: 14.9 months for th e patients who received preoperative chemotherapy and 16.1 months for those who underwent immediate surgery (P=0.53). At one year, the survival rate w as 59 percent for those who received chemotherapy and 60 percent for those who had surgery alone; at two years, survival was 35 percent and 37 percent , respectively. The toxic effects of chemotherapy were tolerable, and the a ddition of chemotherapy did not appear to increase the morbidity or mortali ty associated with surgery. There were no differences in survival between p atients with squamous-cell carcinoma and those with adenocarcinoma. Weight loss was a significant predictor of poor outcome (P=0.03). With the additio n of chemotherapy, there was no change in the rate of recurrence at locoreg ional or distant sites. Conclusions Preoperative chemotherapy with a combination of cisplatin and f luorouracil did not improve overall survival among patients with epidermoid cancer or adenocarcinoma of the esophagus. (N Engl J Med 1998;339:1979-84. ) (C) 1998, Massachusetts Medical Society.