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Surgery Plus Chemotherapy Compared With Surgery Alone for Localized Squamous Cell Carcinoma of the Thoracic Esophagus: A Japan Clinical Oncology Group Study—JCOG9204

Nobutoshi Ando, Toshifumi Iizuka, Hiroko Ide, Kaoru Ishida, Masayuki Shinoda, Tadashi Nishimaki, Wataru Takiyama, Hiroshi Watanabe, Kaichi Isono, Norio Aoyama, Hiroyasu Makuuchi, Otsuo Tanaka, Hideaki Yamana, Shunji Ikeuchi, Toshiyuki Kabuto, Kagami Nagai, Yutaka Shimada, Yoshihide Kinjo, Haruhiko Fukuda

From the Department of Surgery, Keio University School of Medicine; National Oji Hospital; the Department of Surgery, Tokyo Women’s Medical University; the Department of Surgery, National Cancer Center Hospital; the Department of Surgery, National Tokyo Medical Center; the Department of Surgery, Tokyo Medical and Dental University Faculty of Medicine; the Japan Clinical Oncology Group Data Center, Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo; the Department of Surgery, Iwate Medical College, Morioka; the Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya; the Department of Surgery, Niigata University Faculty of Medicine, the Department of Surgery, Niigata Cancer Center Hospital, Niigata; the Department of Surgery, National Shikoku Cancer Center Hospital, Matsuyama; the Department of Surgery, Chiba University Faculty of Medicine, Chiba; the First Division of Surgery, Kanagawa Cancer Center, Yokohama; the Department of Surgery, Tokai University Faculty of Medicine, Isehara; the Department of Surgery, Kurume University School of Medicine, Kurume; the Department of Surgery, Osaka Medical Center and Cardiovascular Diseases, Osaka; the Department of Surgery, Kyoto University Faculty of Medicine, Kyoto; the Health Information & Epidemiology, Okinawa Prefectural College of Nursing, Okinawa, Japan.

Address reprint requests to Nobutoshi Ando, MD, The Department of Surgery, Tokyo Dental College, Ichikawa General Hospital, 5-11-13 Sugano, Ichikawashi, Chiba, 272-8513 Japan; e-mail: nando{at}tdc.ac.jp.

Purpose: We performed a multicenter randomized controlled trial to determine whether postoperative adjuvant chemotherapy improves outcome in patients with esophageal squamous cell carcinoma undergoing radical surgery.

Patients and Methods: Patients undergoing transthoracic esophagectomy with lymphadenectomy between July 1992 and January 1997 at 17 institutions were randomly assigned to receive surgery alone or surgery plus chemotherapy including two courses of cisplatin (80 mg/m² of body-surface area x 1 day) and fluorouracil (800 mg/m² x 5 days) within 2 months after surgery. Adaptive stratification factors were institution and lymph node status (pN0 versus pN1). The primary end point was disease-free survival.

Results: Of the 242 patients, 122 were assigned to surgery alone, and 120 to surgery plus chemotherapy. In the surgery plus chemotherapy group, 91 patients (75%) received both full courses of chemotherapy; grade 3 or 4 hematologic or nonhematologic toxicities were limited. The 5-year disease-free survival rate was 45% with surgery alone, and 55% with surgery plus chemotherapy (one-sided log-rank, P = .037). The 5-year overall survival rate was 52% and 61%, respectively (P = .13). Risk reduction by postoperative chemotherapy was remarkable in the subgroup with lymph node metastasis.

Conclusion: Postoperative adjuvant chemotherapy with cisplatin and fluorouracil is better able to prevent relapse in patients with esophageal cancer than surgery alone.

Supported by a Grant-in-Aid for Cancer Research from the Ministry of Health, Labor, and Welfare of Japan (5S-1, 8S-1, 11S-3, 11S-4) and from the Second Term Comprehensive 10-Year Strategy for Cancer Control (H10-Gan-027, H12-Gan-012).

Presented in part at the 35^th Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15–18, 1999.

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