Adjuvant chemotherapy

Adjuvant Chemotherapy With Fluorouracil Plus Folinic
Acid vs Gemcitabine Following Pancreatic Cancer
Resection: A Randomized Controlled Trial
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current as of September 9, 2010.

John P. Neoptolemos; Deborah D. Stocken; Claudio Bassi; et al.
JAMA. 2010;304(10):1073-1081 (doi:10.1001/jama.2010.1275)
http://jama.ama-assn.org/cgi/content/full/304/10/1073Supplementary material

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Surgery; Surgical Interventions; Surgical Oncology; Randomized Controlled Trial;
Prognosis/ Outcomes; Drug Therapy; Drug Therapy,Other; Gastroenterology;
Liver/ Biliary Tract/ Pancreatic Diseases
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Refinement of Adjuvant Therapy for Pancreatic Cancer

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ORIGINAL CONTRIBUTION

Adjuvant Chemotherapy With Fluorouracil
Plus Folinic Acid vs Gemcitabine
Following Pancreatic Cancer Resection
ARandomized Controlled Trial
John P. Neoptolemos, MD
Deborah D. Stocken, PhD
Claudio Bassi, MD
Paula Ghaneh, MD
David Cunningham, MD
David Goldstein, MD
Robert Padbury, MD
Malcolm J. Moore, MD
Steven Gallinger, MD
Christophe Mariette, MD
Moritz N. Wente, MD
Jakob R. Izbicki, MD
Helmut Friess, MD
Markus M. Lerch, MD
Christos Dervenis, MD
Attila Olah, MD
´
Giovanni Butturini, MD
RyuichiroDoi, MD
Pehr A. Lind, MD
David Smith, MD
Juan W. Valle, MD
Daniel H. Palmer, MD
John A. Buckels, MD
Joyce Thompson, MD
Colin J. McKay, MD
Charlotte L. Rawcliffe, MSc
Markus W. Büchler, MD
for the European Study Group
for Pancreatic Cancer

P

Context Adjuvant fluorouracil has been shown to be of benefit for patients with resected pancreatic cancer. Gemcitabine is known to be themost effective agent in
advanced disease as well as an effective agent in patients with resected pancreatic
cancer.
Objective To determine whether fluorouracil or gemcitabine is superior in
terms of overall survival as adjuvant treatment following resection of pancreatic
cancer.
Design, Setting, and Patients The European Study Group for Pancreatic Cancer (ESPAC)-3 trial, an open-label, phase 3,randomized controlled trial conducted
in 159 pancreatic cancer centers in Europe, Australasia, Japan, and Canada.
Included in ESPAC-3 version 2 were 1088 patients with pancreatic ductal adenocarcinoma who had undergone cancer resection; patients were randomized between
July 2000 and January 2007 and underwent at least 2 years of follow-up.
Interventions Patients received either fluorouracilplus folinic acid (folinic acid, 20
mg/m2, intravenous bolus injection, followed by fluorouracil, 425 mg/m2 intravenous bolus injection given 1-5 days every 28 days) (n = 551) or gemcitabine (1000
mg/m2 intravenous infusion once a week for 3 of every 4 weeks) (n = 537) for 6
months.
Main Outcome Measures Primary outcome measure was overall survival;
secondary measures were toxicity,progression-free survival, and quality of life.
Results Final analysis was carried out on an intention-to-treat basis after a median
of 34.2 (interquartile range, 27.1-43.4) months’ follow-up after 753 deaths (69%).
Median survival was 23.0 (95% confidence interval [CI], 21.1-25.0) months for
patients treated with fluorouracil plus folinic acid and 23.6 (95% CI, 21.4-26.4)
months for those treated...