Bosutinib is an Src/Abl tyrosine kinase inhibitor (TKI) indicated for adults with Ph+ chronic myeloid leukemia (CML) resistant/intolerant to prior TKIs. This long-term update of an ongoing phase 1/2 study evaluated the efficacy and safety of third-/fourth-line bosutinib in adults with chronic phase (CP) CML. Median durations of treatment and follow-up were 8.6 (range, 0.2–87.7) months and 32.7 (0.3–93.3) months, respectively. Cumulative confirmed complete hematologic response (cCHR) and major cytogenetic response (MCyR) rates were 74% (95% CI, 65–81%) and 40% (31–50%), respectively; Kaplan–Meier (K–M) probability of maintaining cCHR or MCyR at 4 years was 63% (95% CI, 50–73%) and 69% (52–81%). Cumulative incidence of on-treatment disease progression (PD)/death at 4 years was 24% (95% CI, 17–33%); K–M 4-year overall survival was 78% (68–85%). Baseline Ph+ cells ≤35 vs. ≥95% was prognostic of MCyR and CCyR by 3 and 6 months, increased baseline basophils was prognostic of PD/death, and no prior response to second-line TKI was prognostic of death. Common adverse events included diarrhea (83%), nausea (48%), vomiting (38%), and thrombocytopenia (39%). Bosutinib demonstrates durable efficacy and a toxicity profile similar to previous bosutinib studies in CP CML patients resistant/intolerant to multiple TKIs, representing an important treatment option for patients in this setting. This trial is registered at www.clinicaltrials.gov (NCT00261846). Am. J. Hematol. 91:1206–1214, 2016. © 2016 Wiley Periodicals, Inc.
Cortes J.E., Khoury H.J., Kantarjian H.M., Lipton J.H., Kim D.-W., Schafhausen P., et al. (2016). Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. AMERICAN JOURNAL OF HEMATOLOGY, 91(12), 1206-1214 [10.1002/ajh.24536].
|Citazione:||Cortes J.E., Khoury H.J., Kantarjian H.M., Lipton J.H., Kim D.-W., Schafhausen P., et al. (2016). Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. AMERICAN JOURNAL OF HEMATOLOGY, 91(12), 1206-1214 [10.1002/ajh.24536].|
|Tipo:||Articolo in rivista - Articolo scientifico|
|Carattere della pubblicazione:||Scientifica|
|Presenza di un coautore afferente ad Istituzioni straniere:||Si|
|Titolo:||Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib|
|Autori:||Cortes J.E.; Khoury H.J.; Kantarjian H.M.; Lipton J.H.; Kim D.-W.; Schafhausen P.; Matczak E.; Leip E.; Noonan K.; Brummendorf T.H.; Gambacorti-Passerini C.|
GAMBACORTI PASSERINI, CARLO (Ultimo)
|Data di pubblicazione:||2016|
|Rivista:||AMERICAN JOURNAL OF HEMATOLOGY|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1002/ajh.24536|
|Appare nelle tipologie:||01 - Articolo su rivista|