title: 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.
abstract: 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.
authors.affiliation: Department of Hematology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan, shin-fji@urahp.yokohama-cu.ac.jp.
authors.forename: Shin
authors.initials: S
authors.lastname: Fujisawa
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Nakamae
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Ishizawa
authors.forename: Masafumi
authors.initials: M
authors.lastname: Taniwaki
authors.forename: Atae
authors.initials: A
authors.lastname: Utsunomiya
authors.forename: Kosei
authors.initials: K
authors.lastname: Matsue
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Takamatsu
authors.forename: Kensuke
authors.initials: K
authors.lastname: Usuki
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
authors.forename: Yoji
authors.initials: Y
authors.lastname: Ishida
authors.forename: Hideki
authors.initials: H
authors.lastname: Akiyama
authors.forename: Shintaro
authors.initials: S
authors.lastname: Onishi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D000069439:Dasatinib; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D016044:Fusion Proteins, bcr-abl / Q000037:antagonists & inhibitors* / Q000097:blood / Q000235:genetics / Q000378:metabolism; D006801:Humans; D000068877:Imatinib Mesylate; D007564:Japan; D015466:Leukemia, Myeloid, Chronic-Phase / Q000097:blood / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009154:Mutation; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D013844:Thiazoles; D000068877:Imatinib Mesylate; D016044:Fusion Proteins, bcr-abl; D000069439:Dasatinib