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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Raltitrexed (Tomudex
®
) versus standard leucovorin-modulated bolus 5-fluorouracil: Results from the randomised phase III Pan-European Trial in Adjuvant Colon Cancer 01 (PETACC-1)
European Journal of Cancer, Volume 44, No. 15, Year 2008
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Description
Objectives: PETACC-1 assessed if raltitrexed is non-inferior to 5-fluorouracil and leucovorin for relapse-free survival (RFS) and overall survival (OS) in adjuvant stage III colon cancer. Methods: Non-inferiority required both HR for RFS and OS < 1.25 at 1-sided α = 0.05. Patients (1921) were randomised to six cycles of 5-FU/LV (n = 969) or eight cycles of raltitrexed (n = 952). We report the final results in 993 eligible patients who started and completed the allocated treatment (489 5-FU/LV and n = 504 Raltitrexed) of whom respectively 146 and 148 died, respectively. Results: The trial closed prematurely when 17 (1.9%) raltitrexed-related deaths were reported. Haematological and gastrointestinal toxicities were more frequent with 5-FU/LV, liver toxicities with raltitrexed. Raltitrexed was stopped for toxicity in 13.2% and 5-FU/LV in 8.5%. Sixty-day mortality was 9% versus 7%. With 4.1 years median follow-up, the HR for RFS was 1.16 (90% CI 0.99-1.37) and that for OS was 1.01 (90% CI 0.84-1.23). Conclusion: The trial failed to demonstrate non-inferiority of raltitrexed. Funding: Free drugs and financial support from AstraZeneca. © 2008 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Popov, Ivan
Serbia, Belgrade
Institute of Oncology and Radiology of Serbia
Carrato, Alfredo
Spain, Elche
Hospital General Universitario de Elche
Sobrero, A.
Italy, Genoa
Irccs San Martino Polyclinic Hospital
Vincent, Mark David
Canada, London
London Regional Cancer Program
Kerr, David James
United Kingdom, Oxford
Radcliffe Infirmary
Labianca, R.
Italy, Bergamo
Ospedali Riuniti Di Bergamo
Raffaele Bianco, Angelo
Italy, Naples
Università Degli Studi Di Napoli Federico Ii, Facoltà Di Medicina e Chirurgia
El-Serafi, Moustafa M.
Egypt, Giza
National Cancer Institute
Bedenne, Laurent
France, Dijon
Fédération Francophone de Cancérologie Digestive Ffcd
Paillot, Bernard
France, Rouen
Hopital Charles Nicolle
Mini, Enrico
Italy, Florence
Università Degli Studi Di Firenze
Sanches, Evaristo
Portugal, Porto
Centro Hospitalar do Porto
Welch, John J.
Belgium, Brussels
European Organisation for Research and Treatment of Cancer
Collette, Laurence
Belgium, Brussels
European Organisation for Research and Treatment of Cancer
Praet, Michel
Belgium, Brussels
European Organisation for Research and Treatment of Cancer
Belgium, Brussels
Petacc Coordinating Unit
Wils, Jacques
Unknown Affiliation
Statistics
Citations: 45
Authors: 16
Affiliations: 14
Identifiers
Doi:
10.1016/j.ejca.2008.07.002
ISSN:
09598049
Research Areas
Cancer
Study Design
Cohort Study