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Randomized Trial of Adjuvant Chemotherapy With Mitomycin, Fluorouracil, and Cytosine Arabinoside Followed by Oral Fluorouracil in Serosa-Negative Gastric Cancer: Japan Clinical Oncology Group 9206–1

Atsushi Nashimoto, Toshifusa Nakajima, Hiroshi Furukawa, Masatsugu Kitamura, Taira Kinoshita, Yoshitaka Yamamura, Mitsuru Sasako, Yasuo Kunii, Hisahiko Motohashi, Seiichiro Yamamoto, the Gastric Cancer Surgical Study Group in the Japan Clinical Oncology Group

From the Department of Surgery, Niigata Cancer Center Hospital, Niigata; Department of Surgery, Cancer Institute Hospital; Department of Surgery, Tokyo Komagome Metropolitan Hospital; Department of Surgery, National Cancer Center Hospital, Central; Department of Surgery, National Cancer Center, Research Institute, Tokyo; Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka; Department of Surgery, National Cancer Center Hospital, East, Tokyo; Department of Surgery, Aichi Cancer Center, Nagoya; Department of Surgery, National Sendai Hospital, Sendai; and Department of Surgery, Kanagawa Cancer Center, Yokohama, Japan.

Address reprint requests to A. Nashimoto, MD, Department of Surgery, Niigata Cancer Center Hospital, 2-15-3 Kawagishicho, Niigata 951-8566, Japan; email: nasimoto{at}niigata-cc.niigata.niigata.jp.

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated.

Patients and Methods: From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m², fluorouracil (FU) 166.7 mg/m², and cytarabine 13.3 mg/m² twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m² daily for the next 18 months for a total dose of 67 g/m². The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points.

Results: Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P = .14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P = .13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence.

Conclusion: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.

Supported by Grants-in-Aid for Cancer Research (2S-1, 5S-1, 8S-1, 11S-3, and 11S-4) from the Ministry of Health, Labor and Welfare.

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