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).
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 alpha=0.05. Patients (1921) wer...
| Auteurs principaux: | , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Langue: | English |
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2008
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| _version_ | 1826275597299482624 |
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| author | Popov, I Carrato, A Sobrero, A Vincent, M Kerr, D Labianca, R Raffaele Bianco, A El-Serafi, M Bedenne, L Paillot, B Mini, E Sanches, E Welch, J Collette, L Praet, M Wils, J |
| author_facet | Popov, I Carrato, A Sobrero, A Vincent, M Kerr, D Labianca, R Raffaele Bianco, A El-Serafi, M Bedenne, L Paillot, B Mini, E Sanches, E Welch, J Collette, L Praet, M Wils, J |
| author_sort | Popov, I |
| collection | OXFORD |
| 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 alpha=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. |
| first_indexed | 2024-03-06T23:01:10Z |
| format | Journal article |
| id | oxford-uuid:622d6222-6f1c-4ae4-a303-1022cfdc829b |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T23:01:10Z |
| publishDate | 2008 |
| record_format | dspace |
| spelling | oxford-uuid:622d6222-6f1c-4ae4-a303-1022cfdc829b2022-03-26T18:04:33ZRaltitrexed (Tomudex) versus standard leucovorin-modulated bolus 5-fluorouracil: Results from the randomised phase III Pan-European Trial in Adjuvant Colon Cancer 01 (PETACC-1).Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:622d6222-6f1c-4ae4-a303-1022cfdc829bEnglishSymplectic Elements at Oxford2008Popov, ICarrato, ASobrero, AVincent, MKerr, DLabianca, RRaffaele Bianco, AEl-Serafi, MBedenne, LPaillot, BMini, ESanches, EWelch, JCollette, LPraet, MWils, J 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 alpha=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. |
| spellingShingle | Popov, I Carrato, A Sobrero, A Vincent, M Kerr, D Labianca, R Raffaele Bianco, A El-Serafi, M Bedenne, L Paillot, B Mini, E Sanches, E Welch, J Collette, L Praet, M Wils, J 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). |
| title | 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). |
| title_full | 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). |
| title_fullStr | 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). |
| title_full_unstemmed | 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). |
| title_short | 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). |
| title_sort | 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 |
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