Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up

• Published in: International journal of hematology Vol. 99; no. 2; pp. 141 - 153
• Main Authors: Fujisawa, Shin, Nakamae, Hirohisa, Ogura, Michinori, Ishizawa, Ken-ichi, Taniwaki, Masafumi, Utsunomiya, Atae, Matsue, Kosei, Takamatsu, Yasushi, Usuki, Kensuke, Tanimoto, Mitsune, Ishida, Yoji, Akiyama, Hideki, Onishi, Shintaro
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-02-2014; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Benzamides - adverse effects; Benzamides - therapeutic use; Biological and medical sciences; Dasatinib; Drug Resistance, Neoplasm; Female; Follow-Up Studies; Fusion Proteins, bcr-abl - antagonists & inhibitors; Fusion Proteins, bcr-abl - blood; Fusion Proteins, bcr-abl - genetics; Fusion Proteins, bcr-abl - metabolism; Hematologic and hematopoietic diseases; Hematology; Humans; Imatinib Mesylate; Japan; Leukemia, Myeloid, Chronic-Phase - blood; Leukemia, Myeloid, Chronic-Phase - drug therapy; Leukemia, Myeloid, Chronic-Phase - genetics; Leukemia, Myeloid, Chronic-Phase - metabolism; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Mutation; Oncology; Original Article; Piperazines - adverse effects; Piperazines - therapeutic use; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - therapeutic use; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Survival Analysis; Thiazoles - adverse effects; Thiazoles - therapeutic use; Young Adult; Asia; Japan; Dasatinib; First-line; Japanese; CML-CP; Newly diagnosed; Antineoplastic agent; Early stage; Myeloproliferative syndrome; Clinical trial; Protein-tyrosine kinase; Human; Imatinib; Hematology; Enzyme; Tyrosine kinase inhibitor; Transferases; Treatment efficiency; Enzyme inhibitor; Chronic myelogenous leukemia; Malignant hemopathy; First line treatment; Follow up study; Multikinase inhibitor; Comparative study; Cancer
• ISSN: 0925-5710; 1865-3774
• DOI: 10.1007/s12185-013-1470-1

Dasatinib is a highly potent BCR-ABL kinase inhibitor with established efficacy and safety in imatinib-resistant or -intolerant patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia. In the global phase III DASISION trial in patients with newly diagnosed chronic phase CML (CML-CP), dasatinib was found to have an acceptable safety profile and demonstrated significantly faster and higher rates of complete cytogenetic response (CCyR) and major molecular response (MMR) compared with imatinib. Here, we report the results of a subset analysis of Japanese patients enrolled in the DASISION trial, showing safety and efficacy profiles generally consistent with patients enrolled worldwide, including higher response rates (CCyR, MMR) with dasatinib compared with imatinib and similar high rates of progression-free and overall survival with both therapies. However, the small sample size of the present study limits the strength of these conclusions, and further exploration is needed to confirm any differences observed in Japanese patients compared with the total treated population. These findings support the use of dasatinib 100 mg QD as a first-line treatment in Japanese patients with newly diagnosed CML-CP.