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Efficacy and safety of chronomodulated irinotecan, oxaliplatin, 5‐fluorouracil and leucovorin combination as first‐ or second‐line treatment against metastatic colorectal cancer : results from the International EORTC 05011 Trial
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Innominato, Pasquale F., Karaboué, Abdoulaye, Focan, Christian, Chollet, Philippe, Giacchetti, Sylvie, Bouchahda, Mohamed, Ulusakarya, Ayhan, Torsello, Angela, Adam, René, Lévi, Francis A. and Garufi, Carlo (2021) Efficacy and safety of chronomodulated irinotecan, oxaliplatin, 5‐fluorouracil and leucovorin combination as first‐ or second‐line treatment against metastatic colorectal cancer : results from the International EORTC 05011 Trial. International Journal of Cancer, 148 (10). pp. 2512-2521. doi:10.1002/ijc.33422 ISSN 0020-7136.
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Official URL: http://dx.doi.org/10.1002/ijc.33422
Abstract
The triplet combination of irinotecan, oxaliplatin and fluorouracil is an active frontline regimen in metastatic colorectal cancer, but scarce data exist on its use as salvage treatment. We aimed at assessing its safety and efficacy profiles with its circadian‐based administration (chronoIFLO5) as either first‐ or second‐line treatment, within the time‐finding EORTC 05011 trial. Five‐day chronoIFLO5 was administered every 3 weeks in patients with PS 0, 1 or 2. It consisted of chronomodulated irinotecan (180 mg/sqm), oxaliplatin (80 mg/sqm) and fluorouracil‐leucovorin (2800 and 1200 mg/sqm, respectively). For our study, toxicity and antitumour activity were evaluated separately in first‐ and second‐line settings. Primary endpoints included Grade 3‐4 toxicity rates, best objective response rate (ORR), progression‐free survival (PFS) and overall survival (OS). One‐hundred forty‐nine and 44 patients were treated in first‐line and second‐line settings, respectively, with a total of 1138 cycles with median relative dose intensities of about 90%. Demographics were comparable in the two groups. Thirty‐six (24.7%) and 10 (22.2%) patients experienced at least one episode of severe toxicity in first line and second line, respectively. Frontline chronoIFLO5 yielded an ORR of 62.3% [95% CI: 54.2‐70.4] and resulted in median PFS and OS of 8.7 months [7.5‐9.9] and 19.9 months [15.4‐24.5]. Corresponding figures in second line were 37.5% [22.5‐52.5], 6.7 months [4.8‐8.9] and 16.3 months [11.8‐20.8]. International and prospective evaluation revealed the favourable safety and efficacy profiles of chronoIFLO5, both as frontline and as salvage treatment against metastatic colorectal cancer. In particular, encouraging activity in second line was observed, with limited haematological toxicity.
Item Type: | Journal Article | ||||||||
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Subjects: | R Medicine > RC Internal medicine R Medicine > RM Therapeutics. Pharmacology |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Biomedical Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Colon (Anatomy) -- Cancer , Colon (Anatomy) -- Cancer -- Treatment, Rectum -- Cancer , Rectum -- Cancer -- Treatment, Chemotherapy, Combination , Colon (Anatomy) -- Cancer -- Chemotherapy, Rectum -- Cancer -- Treatment | ||||||||
Journal or Publication Title: | International Journal of Cancer | ||||||||
Publisher: | John Wiley & Sons, Inc. | ||||||||
ISSN: | 0020-7136 | ||||||||
Official Date: | 15 May 2021 | ||||||||
Dates: |
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Volume: | 148 | ||||||||
Number: | 10 | ||||||||
Page Range: | pp. 2512-2521 | ||||||||
DOI: | 10.1002/ijc.33422 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 15 December 2020 | ||||||||
Date of first compliant Open Access: | 16 December 2020 | ||||||||
RIOXX Funder/Project Grant: |
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