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)

Ivan Popov, Alfredo Carrato, Alberto Sobrero, Mark Vincent, David Kerr, Roberto Labianca, Angelo Raffaele Bianco, Mostafa El-Serafi, Laurent Bedenne, Bernard Paillot, Enrico Mini, Evaristo Sanches, John Welch, Laurence Collette, Michel Praet, Jacques Wils

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)2204-2211
Number of pages8
JournalEuropean Journal of Cancer
Volume44
Issue number15
DOIs
Publication statusPublished - Oct 2008

Keywords

  • Adjuvant treatment
  • Colon cancer
  • PETACC-1
  • Raltitrexed
  • Randomised clinical trial

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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