Tn. Walsh et al., A COMPARISON OF MULTIMODAL THERAPY AND SURGERY FOR ESOPHAGEAL ADENOCARCINOMA, The New England journal of medicine, 335(7), 1996, pp. 462-467
Background Uncontrolled studies suggest that a combination of chemothe
rapy and radiotherapy improves the survival of patients with esophagea
l adenocarcinoma. We conducted a prospective, randomized trial compari
ng surgery alone with combined chemotherapy, radiotherapy, and surgery
. Methods Patients assigned to multimodal therapy received two courses
of chemotherapy in weeks 1 and 6 (fluorouracil, 15 mg per kilogram of
body weight daily for five days, and cisplatin, 75 mg per square mete
r of body-surface area on day 7) and a course of radiotherapy (40 Gy,
administered in 15 fractions over a three-week period, beginning concu
rrently with the first course of chemotherapy), followed by surgery. T
he patients assigned to surgery had no preoperative therapy. Results O
f the 58 patients assigned to multimodal therapy and the 55 assigned t
o surgery, 10 and 1, respectively, were withdrawn for protocol violati
ons. At the time of surgery, 23 of 55 patients (42 percent) treated wi
th preoperative multimodal therapy who could be evaluated had positive
nodes or metastases, as compared with 45 of the 55 patients (82 perce
nt) who underwent surgery alone (P<0.001). Thirteen of the 52 patients
(25 percent) who underwent surgery after multimodal therapy had compl
ete responses, as determined pathologically. The median survival of pa
tients assigned to multimodal therapy was 16 months, as compared with
11 months for those assigned to surgery alone (P=0.01). At one, two, a
nd three years, 52, 37, and 32 percent, respectively, of patients assi
gned to multimodal therapy were alive, as compared with 44, 26, and 6
percent of those assigned to surgery, with the survival advantage favo
ring multimodal therapy reaching significance at three years (P=0.01).
Conclusions Multimodal treatment is superior to surgery alone for pat
ients with resectable adenocarcinoma of the esophagus. (C) 1996, Massa
chusetts Medical Society.