Background Uncontrolled studies suggest that a combination ofchemotherapy and radiotherapy improves the survival of patientswith esophageal adenocarcinoma. We conducted a prospective,randomized trial comparing surgery alone with combined chemotherapy,radiotherapy, and surgery.
Methods Patients assigned to multimodal therapy received twocourses of chemotherapy in weeks 1 and 6 (fluorouracil, 15 mgper kilogram of body weight daily for five days, and cisplatin,75 mg per square meter of body-surface area on day 7) and acourse of radiotherapy (40 Gy, administered in 15 fractionsover a three-week period, beginning concurrently with the firstcourse of chemotherapy), followed by surgery. The patients assignedto surgery had no preoperative therapy.
Results Of the 58 patients assigned to multimodal therapy andthe 55 assigned to surgery, 10 and 1, respectively, were withdrawnfor protocol violations. At the time of surgery, 23 of 55 patients(42 percent) treated with preoperative multimodal therapy whocould be evaluated had positive nodes or metastases, as comparedwith 45 of the 55 patients (82 percent) who underwent surgeryalone (P<0.001). Thirteen of the 52 patients (25 percent)who underwent surgery after multimodal therapy had completeresponses, as determined pathologically. The median survivalof patients assigned to multimodal therapy was 16 months, ascompared with 11 months for those assigned to surgery alone(P = 0.01). At one, two, and three years, 52, 37, and 32 percent,respectively, of patients assigned to multimodal therapy werealive, as compared with 44, 26, and 6 percent of those assignedto surgery, with the survival advantage favoring multimodaltherapy reaching significance at three years (P = 0.01).
Conclusions Multimodal treatment is superior to surgery alonefor patients with resectable adenocarcinoma of the esophagus.
Source Information
From the Departments of Surgery (T.N.W., T.P.J.H.) and Gastroenterology (N.N., N.K.), St. James's Hospital; the Department of Radiotherapy, St. Luke's Hospital (D.H.); and the Departments of Community Health and Statistics, Trinity College (A.K.) all in Dublin, Ireland.
Address reprint requests to Dr. Walsh at the Department of Surgery, Beaumont Hospital, Dublin 9, Ireland.
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