Document Detail

A multicenter randomized controlled trial to evaluate the effect of adjuvant cisplatin and 5-fluorouracil therapy after curative resection in cases of pancreatic cancer.
MedLine Citation:
PMID:  16490736     Owner:  NLM     Status:  MEDLINE    
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/m(2), Day 1) and 5-fluorouracil (500 mg/m(2)/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.
Tomoo Kosuge; Takahiro Kiuchi; Kiyoshi Mukai; Tadao Kakizoe;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-02-20
Journal Detail:
Title:  Japanese journal of clinical oncology     Volume:  36     ISSN:  0368-2811     ISO Abbreviation:  Jpn. J. Clin. Oncol.     Publication Date:  2006 Mar 
Date Detail:
Created Date:  2006-04-06     Completed Date:  2006-06-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0313225     Medline TA:  Jpn J Clin Oncol     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  159-65     Citation Subset:  IM    
Division of HBP Surgery, National Cancer Center Hospital, Chuo-ku, Tokyo 104-0045, Japan.
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / administration & dosage,  therapeutic use*
Carcinoma, Pancreatic Ductal / drug therapy*,  mortality,  secondary,  surgery
Chemotherapy, Adjuvant
Cisplatin / administration & dosage
Drug Administration Schedule
Fluorouracil / administration & dosage
Liver Neoplasms / secondary
Middle Aged
Multivariate Analysis
Neoplasm Recurrence, Local
Pancreatic Neoplasms / drug therapy*,  mortality,  pathology,  surgery
Survival Rate
Reg. No./Substance:
0/CF regimen; 15663-27-1/Cisplatin; 51-21-8/Fluorouracil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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