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A propensity score matching analysis of dasatinib and nilotinib as a frontline therapy for patients with chronic myeloid leukemia in chronic phase
Author(s) -
Takahashi Koichi,
Kantarjian Hagop M.,
Yang Yulong,
Sasaki Koji,
Jain Preetesh,
DellaSala Sara,
Ravandi Farhad,
Kadia Tapan,
Pemmaraju Naveen,
Daver Naval,
Borthakur Gautam,
GarciaManero Guillermo,
Jabbour Elias,
Cortes Jorge E.
Publication year - 2016
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.30197
Subject(s) - nilotinib , medicine , dasatinib , myeloid leukemia , propensity score matching , oncology , tyrosine kinase inhibitor , imatinib , cancer
BACKGROUND Both dasatinib and nilotinib are approved frontline therapy for chronic myeloid leukemia in chronic phase (CML‐CP) based on randomized trials compared with imatinib. However, no head‐to‐head comparison of dasatinib and nilotinib has been conducted in patients with newly diagnosed CML‐CP. METHODS The authors conducted a propensity score (PS) matched comparison of patients with CML‐CP who received frontline therapy with either dasatinib (N = 102) or nilotinib (N = 104) under the respective phase 2 trials conducted in parallel. RESULTS PS matching resulted in 87 patients from each trial being matched for pretreatment characteristics. The 3‐month BCR‐ABL1/ABL1 ratio <10% rate was 93% with dasatinib and 94% with nilotinib ( P = .25); the rates of major molecular response at 12 months were 77% and 85%, respectively ( P = .13); and the rates of molecular response with 4.5‐log reduction in the ratio at 36 months were 66% and 64%, respectively ( P = .96). All other clinically relevant responses were similar between the 2 treatment cohorts. The 3‐year probability of event‐free survival was 89% among the patients who received dasatinib and 87% among those who received nilotinib ( P = .99), and the corresponding 3‐year overall survival probabilities were 99% and 93%, respectively ( P = .95). No statistical difference was observed between the dasatinib and nilotinib groups in any of the other survival endpoints. The treatment discontinuation rate also was similar between the 2 cohorts (dasatinib group, 18%; nilotinib group, 19%; P = .82). CONCLUSIONS In a PS‐matched cohort of patients with newly diagnosed CML‐CP, dasatinib and nilotinib offer similar response and survival outcomes. Both drugs can be considered reasonable standard‐of‐care options as first‐line therapy for patients with CML‐CP. Cancer 2016;122:3336–3343 . © 2016 American Cancer Society .