Continuation of fluoropyrimidine treatment with S-1 after cardiotoxicity on capecitabine- or 5-fluorouracil-based therapy in patients with solid tumours: a multicentre retrospective observational cohort study
dc.contributor.author | Osterlund, P. | |
dc.contributor.author | Kinos, S. | |
dc.contributor.author | Pfeiffer, P. | |
dc.contributor.author | Salminen, T. | |
dc.contributor.author | Kwakman, J.J.M. | |
dc.contributor.author | Frödin, J.-E. | |
dc.contributor.author | Shah, C.H. | |
dc.contributor.author | Sorbye, Halfdan | |
dc.contributor.author | Ristamäki, R. | |
dc.contributor.author | Halonen, P. | |
dc.contributor.author | Soveri, L.M. | |
dc.contributor.author | Heervä, E. | |
dc.contributor.author | Ålgars, A. | |
dc.contributor.author | Bärlund, M. | |
dc.contributor.author | Hagman, H. | |
dc.contributor.author | McDermott, R. | |
dc.contributor.author | O'Reilly, M. | |
dc.contributor.author | Röckert, R. | |
dc.contributor.author | Liposits, G. | |
dc.contributor.author | Kallio, R. | |
dc.contributor.author | Flygare, P. | |
dc.contributor.author | Teske, A.J. | |
dc.contributor.author | van Werkhoven, Werkhoven | |
dc.contributor.author | Punt, C.J.A. | |
dc.contributor.author | Glimelius, B. | |
dc.date.accessioned | 2022-11-09T13:41:17Z | |
dc.date.available | 2022-11-09T13:41:17Z | |
dc.date.created | 2022-06-10T14:47:03Z | |
dc.date.issued | 2022 | |
dc.identifier.issn | 2059-7029 | |
dc.identifier.uri | https://hdl.handle.net/11250/3030975 | |
dc.description.abstract | Background Capecitabine- or 5-fluorouracil (5-FU)-based chemotherapy is widely used in many solid tumours, but is associated with cardiotoxicity. S-1 is a fluoropyrimidine with low rates of cardiotoxicity, but evidence regarding the safety of switching to S-1 after 5-FU- or capecitabine-associated cardiotoxicity is scarce. Patients and methods This retrospective study (NCT04260269) was conducted at 13 centres in 6 countries. The primary endpoint was recurrence of cardiotoxicity after switch to S-1-based treatment due to 5-FU- or capecitabine-related cardiotoxicity: clinically meaningful if the upper boundary of the 95% confidence interval (CI; by competing risk) is not including 15%. Secondary endpoints included cardiac risk factors, diagnostic work-up, treatments, outcomes, and timelines of cardiotoxicity. Results Per protocol, 200 patients, treated between 2011 and 2020 [median age 66 years (range 19-86); 118 (59%) males], were included. Treatment intent was curative in 145 (73%). Initial cardiotoxicity was due to capecitabine (n = 170), continuous infusion 5-FU (n = 22), or bolus 5-FU (n = 8), which was administered in combination with other chemotherapy, targeted agents, or radiotherapy in 133 patients. Previous cardiovascular comorbidities were present in 99 (50%) patients. Cardiotoxic events (n = 228/200) included chest pain (n = 125), coronary syndrome/infarction (n = 69), arrhythmia (n = 22), heart failure/cardiomyopathy (n = 7), cardiac arrest (n = 4), and malignant hypertension (n = 1). Cardiotoxicity was severe or life-threatening in 112 (56%) patients and led to permanent capecitabine/5-FU discontinuation in 192 (96%). After switch to S-1, recurrent cardiotoxicity was observed in eight (4%) patients (95% CI 2.02-7.89, primary endpoint met). Events were limited to grade 1-2 and occurred at a median of 16 days (interquartile range 7-67) from therapy switch. Baseline ischemic heart disease was a risk factor for recurrent cardiotoxicity (odds ratio 6.18, 95% CI 1.36-28.11). Conclusion Switching to S-1-based therapy is safe and feasible after development of cardiotoxicity on 5-FU- or capecitabine-based therapy and allows patients to continue their pivotal fluoropyrimidine-based treatment. | en_US |
dc.language.iso | eng | en_US |
dc.publisher | Elsevier | en_US |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | Continuation of fluoropyrimidine treatment with S-1 after cardiotoxicity on capecitabine- or 5-fluorouracil-based therapy in patients with solid tumours: a multicentre retrospective observational cohort study | en_US |
dc.type | Journal article | en_US |
dc.type | Peer reviewed | en_US |
dc.description.version | publishedVersion | en_US |
dc.rights.holder | Copyright 2022 The Author(s) | en_US |
dc.source.articlenumber | 100427 | en_US |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 | |
dc.identifier.doi | 10.1016/j.esmoop.2022.100427 | |
dc.identifier.cristin | 2030870 | |
dc.source.journal | ESMO Open | en_US |
dc.identifier.citation | ESMO Open. 2022, 7 (3), 100427. | en_US |
dc.source.volume | 7 | en_US |
dc.source.issue | 3 | en_US |
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