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.

Autor: Rosti G; IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy. gianantonio.rosti@unibo.it., Brümmendorf TH; Universitätsklinikum RWTH Aachen, Aachen, Germany.; Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), Aachen, Germany., Gjertsen BT; Haukeland University Hospital, Department of Medicine, Hematology Section, Helse Bergen, and Centre for Cancer Biomarkers CCBIO, Department of Clinical Science, University of Bergen, Bergen, Norway., Giraldo-Castellano P; CIBER Enfermedades Raras (CIBERER), Miguel Servet University Hospital, Zaragoza, Spain., Castagnetti F; Institute of Hematology 'Seràgnoli', IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy., Gambacorti-Passerini C; University of Milano-Bicocca, Monza, Italy., Ernst T; Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany., Zhao H; Pfizer (China) R&D Co., Ltd., Shanghai, China., Kuttschreuter L; Pfizer Ltd, Oxford, UK., Purcell S; Pfizer Ltd, London, UK., Giles FJ; Developmental Therapeutics Consortium, Chicago, IL, USA., Hochhaus A; Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.
Jazyk: angličtina
Zdroj: Leukemia [Leukemia] 2024 Jan; Vol. 38 (1), pp. 126-135. Date of Electronic Publication: 2023 Nov 25.
DOI: 10.1038/s41375-023-02080-y
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
Externí odkaz: