Lack of efficacy of high-dose leucovorin and fluorouracil in patients with advanced pancreatic adenocarcinoma Journal Article


Authors: Crown, J.; Casper, E. S.; Botet, J.; Murray, P.; Kelsen, D. P.
Article Title: Lack of efficacy of high-dose leucovorin and fluorouracil in patients with advanced pancreatic adenocarcinoma
Abstract: Leucovorin potentiates the cytotoxicity of fluorouracil (5-FU) in experimental tumor systems and appears to enhance the effectiveness of 5-FU in patients with colon cancer. Twenty-two eligible patients (18 previously untreated) with advanced pancreatic adenocarcinoma were treated in a phase II trial of leucovorin 500 mg/m2/d for 6 days by continuous intravenous infusion with 5-FU 370 mg/m2/d by rapid intravenous injection on 5 consecutive days, beginning 24 hours after initiation of leucovorin infusion. Among the 20 assessable patients, there were no complete or partial regressions, although there was one minor response lasting 4 months. Three patients had stable disease for 5, 20, and 21 months, respectively. Median survival was 10 weeks. Toxicity was predominantly mucosal; stomatitis grade 2 or worse was seen in five patients, and diarrhea grade 2 or worse was seen in four. Hospitalization for toxicity was necessary in four previously untreated patients and three previously treated patients. The median WBC nadir was 4.6 (range, 1.4 to 9.6) × 103/μL, and the median platelet nadir was 147.0 (range, 69.0 to 240.0) × 103/μL. This combination of leucovorin and 5-FU did not demonstrate meaningful therapeutic activity in patients with adenocarcinoma of the pancreas and was associated with moderate to severe toxicity. It should not be considered a standard treatment for patients with this disease. © 1991 by American Society of Clinical Oncology.
Keywords: survival; adult; controlled study; aged; major clinical study; fluorouracil; advanced cancer; pancreatic neoplasms; prospective studies; adenocarcinoma; phase 2 clinical trial; leukopenia; mucosa inflammation; antineoplastic combined chemotherapy protocols; drug administration schedule; folinic acid; pancreas adenocarcinoma; toxicity; leucovorin; intravenous drug administration; middle age; drug evaluation; human; male; female; priority journal; article; support, non-u.s. gov't; support, u.s. gov't, p.h.s.
Journal Title: Journal of Clinical Oncology
Volume: 9
Issue: 9
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1991-09-01
Start Page: 1682
End Page: 1686
Language: English
DOI: 10.1200/jco.1991.9.9.1682
PUBMED: 1875224
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 27 September 2019 -- Source: Scopus
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MSK Authors
  1. David P Kelsen
    537 Kelsen
  2. Ephraim S Casper
    108 Casper
  3. John Crown
    47 Crown
  4. José F. Botet
    60 Botet