Japanese Journal of Clinical Oncology Advance Access originally published online on February 20, 2006
Japanese Journal of Clinical Oncology 2006 36(3):159-165; doi:10.1093/jjco/hyi234
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© 2006 Foundation for Promotion of Cancer Research
A Multicenter Randomized Controlled Trial to Evaluate the Effect of Adjuvant Cisplatin and 5-Fluorouracil Therapy after Curative Resection in Cases of Pancreatic Cancer
1 Division of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, Tokyo, 2 University Hospital Medical Information Network Center, the University of Tokyo Hospital, Tokyo, 3 Department of Diagnostic Pathology, Tokyo Medical University, Tokyo and 4 National Cancer Center, Tokyo, Japan
For reprints and all correspondence: Tomoo Kosuge, Division of HBP Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: tkosuge{at}ncc.go.jp
Received October 8, 2005; accepted December 19, 2005
Background: There have been few randomized controlled clinical trials until now to determine the effectiveness of adjuvant treatments for pancreatic cancer, and the results reported so far are inconsistent.
Methods: Patients with invasive ductal pancreatic cancer who underwent radical surgery with clear histological margins at 11 Japanese institutions were enrolled and randomly assigned to one of two groups: surgery-alone group (no further treatment after surgery) and the surgery + chemotherapy group [two courses of postoperative adjuvant systemic chemotherapy with cisplatin (80 mg/m2, Day 1) and 5-fluorouracil (500 mg/m2/day, Days 1–5)]. Patients with a positive resectional margin or with resected distant metastases were excluded from the trial in order to minimize the influence of residual cancer.
Results: Between 1992 and 2000, 89 patients were randomized into the two arms of the trial (45 patients to the surgery + chemotherapy arm and 44 patients to the surgery-alone arm). Four patients in total were found to be ineligible (three in the surgery + chemotherapy group and one in the surgery-alone group). The baseline characteristics were comparable between the two groups. In the surgery + chemotherapy group, four patients did not receive the adjuvant treatment because of patient refusal. Toxicity was minor and acceptable among the eligible patients in the surgery + chemotherapy group. The estimated 5-year survival rates were 26.4% in the surgery + chemotherapy group and 14.9% in the surgery-alone group, and the median duration of survival was 12.5 months and 15.8 months, respectively. The recurrence rates at 5 years were 73.6 and 80.8%, respectively, in the surgery + chemotherapy and the surgery-alone groups. The differences in the survival and recurrence rates between the two groups were not statistically significant.
Conclusions: Postoperative adjuvant chemotherapy using cisplatin and 5-fluorouracil was safe and well tolerated; however, no clear survival benefit could be demonstrated.
Key Words: adjuvant • chemotherapy • clinical trials • pancreatic neoplasms
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