A propensity score matching analysis of dasatinib and nilotinib as a frontline therapy for patients with chronic myeloid leukemia in chronic phase.

Abstract

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.

• Authors: Koichi Takahashi, Hagop M Kantarjian, Yulong Yang, Koji Sasaki, Preetesh Jain, Sara DellaSala, Farhad Ravandi, Tapan Kadia, Naveen Pemmaraju, Naval Daver, Gautam Borthakur, Guillermo Garcia-Manero, Elias Jabbour, Jorge E Cortes
• Journal: Cancer (Cancer) Vol. 122 Issue 21 Pg. 3336-3343 (Nov 15 2016) ISSN: 1097-0142 [Electronic] United States
• PMID: 27509035 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article)
• Copyright: © 2016 American Cancer Society.

Chemical References

• Pyrimidines
• nilotinib
• Dasatinib

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Dasatinib (administration & dosage)
• Female
• Follow-Up Studies
• Humans
• Leukemia, Myeloid, Chronic-Phase (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Staging
• Prognosis
• Propensity Score
• Pyrimidines (administration & dosage)
• Survival Rate
• Young Adult