A randomized trial of surgery with and without chemotherapy for localized squamous carcinoma of the thoracic esophagus: The Japan clinical oncology group study,☆☆,,★★

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Abstract

Objective: To determine whether postoperative adjuvant chemotherapy confers a survival benefit on patients with esophageal squamous cell carcinoma undergoing radical surgery, we undertook a cooperative, prospective randomized controlled trial. Methods: A total of 205 patients underwent transthoracic esophagectomy with lymphadenectomy at eleven institutions between December 1988 and July 1991. These patients were prospectively randomized into two groups (100 patients underwent surgery alone and 105 patients had additional two courses of combination chemotherapy with cisplatin (70 mg/m2) and vindesine (3 mg/m2). 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 chemotherapy group. The relative risk was estimated to be 0.89 (95% confidence interval, 0.61 to 1.31) in the surgery plus chemotherapy group compared with the surgery alone group. No significant differences in survival were detected between the two groups, even with lymph node stratification. Conclusion: Postoperative adjuvant chemotherapy with cisplatin and vindesine has no additive effect on survival in patients with esophageal cancer compared with surgery alone. J Thorac Cardiovasc Surg 1997;114:205-9

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From the Department of Surgery, School of Medicine, Keio University, Tokyoa; National Oji Hospital, Tokyob; Department of Surgery, Faculty of Medicine, Kurume University, Kurumec; Department of Surgery, Faculty of Medicine, Chiba University, Chibad; Department of Surgery, National Cancer Center Hospital, Tokyoe; Department of Surgery, Tokyo Women's Medical College, Tokyof; Department of Surgery, Faculty of Medicine, Niigata University, Niigatag; Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoyah; Department of Surgery, National Shikoku Cancer Center Hospital, Matsuyamai; Department of Surgery, National Tokyo Second Hospital, Tokyoj; Department of Surgery, Iwate Medical College, Moriokak; Epidemiology and Biostatistics Division, National Cancer Center Research Institute, East, Chiba, Japan.l

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Supported by a Grant-in-Aid for Cancer Research from the Ministry of Health and Welfare of Japan.

Address for reprints: Nobutoshi Ando, MD, Department of Surgery, School of Medicine, Keio University, 35, Shinanomachi, Shinjukuku, Tokyo, 160 Japan.

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