Authors
Carlo Gambacorti-Passerini, Tim H Brümmendorf, Dong-Wook Kim, Yeow Tee Goh, Iryna Dyagil, Katia Pagnano, Arpad Batai, Anna G Turkina, Eric Leip, Simon Purcell, Jocelyn Leone, Andrea Viqueira, Jorge E Cortes
Published in
Haematologica. Jun 18, 2026. Epub Jun 18, 2026.
Abstract
This is the final ≥10-year report of a phase I/II study and its extension study of second-line bosutinib for chronic phase chronic myeloid leukemia (CP-CML), representing the longest follow-up to date of any tyrosine kinase inhibitor after imatinib failure (n=284). Median (range) follow-up and treatment duration were 53.7 (0.5-171.6) and 25.6 (0.2-170.5) months, respectively. At the start of year 11, 19.4% of patients were receiving bosutinib; 13.4% were receiving bosutinib at study completion. The most common reasons for treatment discontinuation were lack of efficacy (disease progression/unsatisfactory response; 26.8%) and adverse events (26.1%). Cumulative rates of complete cytogenetic response, major molecular response, and MR4 were 49.6%, 42.1%, and 37.1%, respectively. Kaplan-Meier probabilities of maintaining response at year 11 were 58.3%, 56.1%, and 55.7%, respectively. At year 11, cumulative incidence of on-treatment disease progression/death was 24.6%; 15 (5.3%) patients had ontreatment transformations to accelerated/blast phase (one after year 5). The Kaplan-Meier overall survival rate was 70.5%; 55 (19.4%) patients died on study (15 after year 5). At the start of year 11, 29/55 (52.7%) patients still on bosutinib were receiving ≥500 mg once daily. Thirteen patients had adverse events leading to discontinuation in year 6 or later. No new safety signals emerged. After ≥10 years, bosutinib demonstrated durable efficacy and acceptable safety as second-line treatment for CP-CML.
PMID:
42312395
Bibliographic data and abstract were imported from PubMed on 18 Jun 2026.
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