Impact of age and comorbidities on the efficacy and tolerability of bosutinib in previously treated patients with chronic myeloid leukemia: results from the phase 4 BYOND study
dc.contributor.author | Rosti, Gianantonio | |
dc.contributor.author | Brümmendorf, Tim H. | |
dc.contributor.author | Gjertsen, Bjørn Tore | |
dc.contributor.author | Giraldo-Castellano, Pilar | |
dc.contributor.author | Castagnetti, Fausto | |
dc.contributor.author | Gambacorti-Passerini, Carlo | |
dc.contributor.author | Ernst, Thomas | |
dc.contributor.author | Zhao, Huadong | |
dc.contributor.author | Kuttschreuter, Luke | |
dc.contributor.author | Purcell, Simon | |
dc.contributor.author | Giles, Francis J. | |
dc.contributor.author | Hochhaus, Andreas | |
dc.date.accessioned | 2024-08-05T11:44:19Z | |
dc.date.available | 2024-08-05T11:44:19Z | |
dc.date.created | 2023-12-19T14:13:41Z | |
dc.date.issued | 2024 | |
dc.identifier.issn | 0887-6924 | |
dc.identifier.uri | https://hdl.handle.net/11250/3144446 | |
dc.description.abstract | In the phase 4 BYOND trial, patients with pretreated chronic myeloid leukemia (CML) received bosutinib (starting dose: 500 mg/day). Efficacy and safety after ≥3 years of follow-up in 156 patients with Philadelphia chromosome–positive chronic phase CML by age and Charlson Comorbidity Index scores (without the age component; mCCI) is reported. Cumulative major molecular response rates at any time on treatment were 73.6%, 64.5%, and 74.1% in patients <65, 65–74, and ≥75 years of age, and 77.9%, 63.0%, and 59.3% in patients with mCCI scores 2, 3, and ≥4, respectively. Patients <65, 65–74, and ≥75 years of age experienced grade 3/4 treatment-emergent adverse events (TEAEs) at rates of 74.7%, 78.8%, and 96.4% and permanent discontinuations due to AEs at rates of 22.1%, 39.4%, and 46.4%, respectively. In patients with mCCI 2, 3, and ≥4, respective rates of grade 3/4 TEAEs were 77.8%, 77.8%, and 86.7%, and permanent discontinuations due to AEs were 25.3%, 33.3%, and 43.3%. In conclusion, a substantial proportion of patients maintained/achieved cytogenetic and molecular responses across age groups and mCCI scores. Older patients (≥75 years) and those with high comorbidity burden (mCCI ≥4) may require more careful monitoring due to the increased risk of TEAEs. Clinicaltrials.gov: NCT02228382. | en_US |
dc.language.iso | eng | en_US |
dc.publisher | Nature | en_US |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | Impact of age and comorbidities on the efficacy and tolerability of bosutinib in previously treated patients with chronic myeloid leukemia: results from the phase 4 BYOND 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 2023 The Author(s) | en_US |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 2 | |
dc.identifier.doi | 10.1038/s41375-023-02080-y | |
dc.identifier.cristin | 2215679 | |
dc.source.journal | Leukemia | en_US |
dc.source.pagenumber | 126–135 | en_US |
dc.identifier.citation | Leukemia. 2024, 38, 126–135. | en_US |
dc.source.volume | 38 | en_US |
Files in this item
This item appears in the following Collection(s)
-
Department of Clinical Science [2379]
-
Registrations from Cristin [10237]