Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia
| Autor: | Masafumi Taniwaki, Tomoki Naoe, Shuichi Miyawaki, Taku Seriu, Itsuro Jinnai, Tadashi Nagai, Kiyoshi Ando, Mitsune Tanimoto, Hisashi Sakamaki, K. Ishizawa, Atae Utsunomiya, Shinichiro Okamoto, Yasuo Morishima, Yasushi Miyazaki, R Ohno, Nobuhiko Uoshima, Noriko Usui, Kazunori Ohnishi, Shin Fujisawa, Masaya Okada, Toshiko Motoji, Shinsuke Iida, Kensei Tobinai |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
medicine.medical_specialty Myeloid Dasatinib Fusion Proteins bcr-abl Antineoplastic Agents Gastroenterology Asian People hemic and lymphatic diseases Internal medicine Humans Medicine Aged business.industry Myeloid leukemia Imatinib Hematology Middle Aged Precursor Cell Lymphoblastic Leukemia-Lymphoma medicine.disease Hematologic Response Thiazoles Leukemia Pyrimidines medicine.anatomical_structure Leukemia Myeloid Chronic-Phase Mutation business Complete Hematologic Response medicine.drug Chronic myelogenous leukemia |
| Zdroj: | International Journal of Hematology. 89:332-341 |
| ISSN: | 1865-3774 0925-5710 |
| Popis: | A phase 1/2 study was conducted to assess the safety and efficacy of dasatinib in Japanese patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL) resistant or intolerant to imatinib. In phase 1, 18 patients with chronic phase (CP) CML were treated with dasatinib 50, 70, or 90 mg twice daily to evaluate safety. Dasatinibor= 90 mg twice daily was well tolerated. In phase 2, dasatinib 70 mg was given twice daily to CP-CML patients for 24 weeks and to CML patients in accelerated phase (AP)/blast crisis (BC) or Ph(+) ALL for 12 weeks. In the CP-CML group (n = 30) complete hematologic response was 90% and major cytogenetic response (MCyR) 53%. In the AP/BC-CML group (n = 11) major hematologic response (MaHR) was 64% and MCyR 27%, whereas in the Ph(+) ALL group (n = 13) MaHR was 38% and MCyR 54%. Dasatinib was well tolerated and most of the nonhematologic toxicities were mild or moderate. Dasatinib therapy resulted in high rates of hematologic and cytogenetic response, suggesting that dasatinib is promising as a new treatment for Japanese CML and Ph(+) ALL patients resistant or intolerant to imatinib. |
| Databáze: | OpenAIRE |
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