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 language | English |
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Pages (from-to) | 2204-2211 |
Number of pages | 8 |
Journal | European Journal of Cancer |
Volume | 44 |
Issue number | 15 |
DOIs | |
Publication status | Published - Oct 2008 |
Keywords
- Adjuvant treatment
- Colon cancer
- PETACC-1
- Raltitrexed
- Randomised clinical trial
ASJC Scopus subject areas
- Cancer Research
- Oncology
- Medicine(all)