Japanese Journal of Clinical Oncology 31:419-423 (2001)
© 2001 Foundation for Promotion of Cancer Research
Phase II Evaluation of Protracted Infusion of Cisplatin and 5-Fluorouracil in Advanced Squamous Cell Carcinoma of the Esophagus: a Japan Esophageal Oncology Group (JEOG) Trial (JCOG9407)
1Department of Surgery, Tokyo Women’s Medical University, Tokyo, 2Department of Surgery, School of Medicine, Keio University, Tokyo, 3Department of Surgery, National Cancer Center Hospital, Tokyo, 4First Department of Surgery, School of Medicine, Tokyo Medical and Dental University, Tokyo, 5First Division of Surgery, Kanagawa Cancer Center, Yokohama, 6Department of Surgery, National Shikoku Cancer Center Hospital, Matsuyama, 7First Department of Surgery, Iwate Medical University, Morioka, 8Second Department of Surgery, School of Medicine, Chiba University, Chiba, 9Department of Surgery, School of Medicine, Tokai University, Isehara, 10Department of Surgery and Surgical Basic Science, School of Medicine, Kyoto University, Kyoto, 11Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, 12Department of Surgery, National Tokyo Medical Center, Tokyo, 13Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, 14Department of Surgery, Faculty of Medicine, Kurume University, Kurume, 15Japan Clinical Oncology Group Data Center, Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo, Japan
Background: Surgery for advanced esophageal carcinoma has its limits as regards aggressiveness and therapeutic effect, therefore effective multimodality treatment is required to obtain better survival. The objective of this study was to evaluate whether daily continuous infusion of CDDP could achieve a higher clinical response rate with less toxicity than its drip infusion in the previous phase II study that we had conducted.
Methods: Patients with primary extensive or relapsed esophageal carcinoma after esophagectomy, which had distant organ metastasis and histologically proven SCC, were eligible for this study. A dose of 20 mg/m2 of cisplatin and 800 mg/m2 of 5-fluorouracil was given by continuous infusion for 24 h on days 1–5. This treatment was repeated every 4 weeks for up to four cycles. A total of 36 men and six women with a median age of 64 (range 39–75) years were registered and 36 patients were eligible.
Results: The overall response rate of the registered patients was 33.3% (12/36) and the median response duration was 175 days. Median survival time was 201.5 days and the 1-year survival rate was 27.8%. Change from bolus to continuous infusion of cisplatin affected neither the type nor the degree of toxicity.
Conclusion: Daily continuous infusion of cisplatin was not associated with higher response or lower toxicity than those seen with the high-dose bolus or multibolus treatment regimens. We conclude that this regimen in this setting is not worthy of further phase III trials. JEOG is now evaluating other drug combination regimens.
+ For reprints and all correspondence: Kazuhiko Hayashi, Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University, 8–1, Kawada-cho, Shinjuku-ku, Tokyo,162-8666, Japan. E-mail: hayashi@hosp.net
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