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Previous Volume 339:1979-1984 December 31, 1998 Number 27 Next

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ABSTRACT

Background We performed a multi-institutional randomized trial comparing preoperative chemotherapy followed by surgery with surgery alone for patients with local and operable esophageal cancer.

Methods Preoperative chemotherapy for patients randomly assigned to the chemotherapy group included three cycles of cisplatin and fluorouracil. Surgery was performed two to four weeks after the completion of the third cycle; patients also received two additional cycles of chemotherapy after the operation. 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 significant differences between the two groups in median survival: 14.9 months for the patients who received preoperative chemotherapy and 16.1 months for those who underwent immediate surgery (P=0.53). At one year, the survival rate was 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 addition of chemotherapy did not appear to increase the morbidity or mortality associated with surgery. There were no differences in survival between patients with squamous-cell carcinoma and those with adenocarcinoma. Weight loss was a significant predictor of poor outcome (P=0.03). With the addition of chemotherapy, there was no change in the rate of recurrence at locoregional or distant sites.

Conclusions Preoperative chemotherapy with a combination of cisplatin and fluorouracil did not improve overall survival among patients with epidermoid cancer or adenocarcinoma of the esophagus.

Source Information

From Memorial Sloan-Kettering Cancer Center, New York (D.P.K., R.G., B.D.M.); the Radiation Therapy Oncology Group Statistical Office, Philadelphia (T.F.P.); the University of Pittsburgh, Pittsburgh (D.G.S.); the Mayo Clinic, Rochester, Minn. (L.G.); Washington University, St. Louis (J.M.); the University of Kansas, Lawrence (N.E.); the University of Pennsylvania, Philadelphia (D.G.H.); M.D. Anderson Cancer Center, Houston (J.A., J.A.R.); and the University of Western Ontario, London, Canada (W.K.). Presented in part at the 1997 Meeting of the American Society of Clinical Oncology, Denver, May 17–20, 1997.

Address reprint requests to Dr. Kelsen at the Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021.

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