A RANDOMIZED TRIAL OF SURGERY WITH AND WITHOUT CHEMOTHERAPY FOR LOCALIZED SQUAMOUS CARCINOMA OF THE THORACIC ESOPHAGUS - THE JAPAN CLINICALONCOLOGY GROUP-STUDY

Objective: To determine whether postoperative adjuvant chemotherapy co nfers a survival benefit on patients with esophageal squamous cell car cinoma undergoing radical surgery, we undertook a cooperative, prospec tive randomized controlled trial. Methods: A total of 205 patients und erwent transthoracic esophagectomy with lymphadenectomy at eleven inst itutions between December 1988 and July 1991. These patients were pros pectively randomized into two groups (100 patients underwent surgery a lone and 105 patients had additional two courses of combination chemot herapy with cisplatin (70 mg/m(2)) and vindesine (3 mg/m(2)). The two groups did not differ with respect to sex, age, location of tumor, and distributions of pT, pN, pM, or p stage, Results: The 5-year survival was 44.9% in the surgery alone group and 48.1% in the surgery plus ch emotherapy group. The relative risk was estimated to be 0.89 (95% conf idence interval, 0.61 to 1.31) in the surgery plus chemotherapy group compared with the surgery alone group. No significant differences in s urvival were detected between the two groups, even with lymph node str atification. Conclusion: Postoperative adjuvant chemotherapy with cisp latin and vindesine has no additive effect on survival in patients wit h esophageal cancer compared with surgery alone.