Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance

Autor: Sarit Assouline, Dong-Wook Kim, Vikram Mathews, Jie Jin, Zhi Xiang Shen, Edo Vellenga, H. Jean Khoury, Ricardo Pasquini, Andrey Zaritskey, Hagop M. Kantarjian, Simon Durrant, Tim H. Brümmendorf, Jorge E. Cortes, Anna G. Turkina, Francisco Cervantes, Carlo Gambacorti-Passerini, Kathleen Turnbull, Eric Leip, Tamas Masszi, Virginia Kelly, Nadine Besson
Přispěvatelé: Guided Treatment in Optimal Selected Cancer Patients (GUTS), Stem Cell Aging Leukemia and Lymphoma (SALL), GAMBACORTI PASSERINI, C, Brümmendorf, T, Kim, D, Turkina, A, Masszi, T, Assouline, S, Durrant, S, Kantarjian, H, Khoury, H, Zaritskey, A, Shen, Z, Jin, J, Vellenga, E, Pasquini, R, Mathews, V, Cervantes, F, Besson, N, Turnbull, K, Leip, E, Kelly, V, Cortes, J
Jazyk: angličtina
Rok vydání: 2014
Předmět:
Male
DIAGNOSED CHRONIC-PHASE
NILOTINIB
DURABLE CYTOGENETIC RESPONSES
Gastroenterology
Piperazines
hemic and lymphatic diseases
Aged
80 and over
DASATINIB
Hematology
Aniline Compounds
CHRONIC MYELOGENOUS LEUKEMIA
Myeloid leukemia
Middle Aged
Dasatinib
Treatment Outcome
Benzamides
Leukemia
Myeloid
Chronic-Phase
Imatinib Mesylate
Quinolines
Female
TRIAL
Bosutinib
Complete Hematologic Response
medicine.drug
Adult
medicine.medical_specialty
Adolescent
ABL
INHIBITION
Antineoplastic Agents
chronic myeloid leukemia CML
Disease-Free Survival
Young Adult
Internal medicine
Nitriles
medicine
Humans
Protein Kinase Inhibitors
Aged
Dose-Response Relationship
Drug
business.industry
Imatinib
Original Articles
medicine.disease
THERAPY FAILURE
Surgery
Pyrimidines
Nilotinib
Drug Resistance
Neoplasm
SKI-606
business
Chronic myelogenous leukemia
Follow-Up Studies
Zdroj: American Journal of Hematology, 89(7), 732-742. Wiley
American Journal of Hematology
ISSN: 0361-8609
Popis: Bosutinib is an orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy. Here, we report the data from the 2-year follow-up of a phase 1/2 open-label study evaluating the efficacy and safety of bosutinib as second-line therapy in 288 patients with chronic phase CML resistant (n = 200) or intolerant (n = 88) to imatinib. The cumulative response rates to bosutinib were as follows: 85% achieved/maintained complete hematologic response, 59% achieved/maintained major cytogenetic response (including 48% with complete cytogenetic response), and 35% achieved major molecular response. Responses were durable, with 2-year estimates of retaining response >70%. Two-year probabilities of progression-free survival and overall survival were 81% and 91%, respectively. The most common toxicities were primarily gastrointestinal adverse events (diarrhea [84%], nausea [45%], vomiting [37%]), which were primarily mild to moderate, typically transient, and first occurred early during treatment. Thrombocytopenia was the most common grade 3/4 hematologic laboratory abnormality (24%). Outcomes were generally similar among imatinib-resistant and imatinib-intolerant patients and did not differ with age. The longer-term results of the present analysis confirm that bosutinib is an effective and tolerable second-line therapy for patients with imatinib-resistant or imatinib-intolerant chronic phase CML. http://ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT00261846","term_id":"NCT00261846"}}NCT00261846. Am. J. Hematol. 89:732–742, 2014. © 2014 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc.
Databáze: OpenAIRE
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