Title |
Phase I study of panobinostat and 5-azacitidine in Japanese patients with myelodysplastic syndrome or chronic myelomonocytic leukemia
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Published in |
International Journal of Hematology, September 2017
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DOI | 10.1007/s12185-017-2327-9 |
Pubmed ID | |
Authors |
Yukio Kobayashi, Wataru Munakata, Michinori Ogura, Toshiki Uchida, Masafumi Taniwaki, Tsutomu Kobayashi, Fumika Shimada, Masataka Yonemura, Fumiko Matsuoka, Takeshi Tajima, Kimikazu Yakushijin, Hironobu Minami |
Abstract |
The current therapy for high-risk myelodysplastic syndrome (MDS) involves repeated cycles of the DNA demethylating agent 5-azacitidine (5-Aza), but combination treatments have been proposed to improve patient outcomes. We performed a phase Ib study to investigate the safety and tolerability of 5-Aza (75 mg/m(2)) combined with the histone deacetylase inhibitor panobinostat (PAN) in adult Japanese patients with MDS or chronic myelomonocytic leukemia (CMML). Eleven patients were enrolled; five received 20 mg PAN + 5-Aza and six received 30 mg PAN + 5-Aza. All patients in the 20 mg PAN cohort had MDS, while two in the 30 mg PAN cohort had MDS and three had CMML. All patients experienced ≥1 adverse event (AE) related to the study treatment, and five discontinued the study treatment because of AEs. One patient in each group exhibited dose-limiting toxicities: lung infection (PAN 20 mg + 5-Aza) and cellulitis (PAN 30 mg + 5-Aza). PAN exposure increased with ascending doses, and combination therapy did not affect PAN plasma trough concentrations. In summary, 20 or 30 mg PAN combined with 5-Aza was safe and tolerable in adult Japanese patients with CMML or MDS. Study registration ClinicalTrials.gov Identifier: NCT01613976. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 17 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Bachelor | 3 | 18% |
Researcher | 2 | 12% |
Lecturer | 1 | 6% |
Unspecified | 1 | 6% |
Student > Ph. D. Student | 1 | 6% |
Other | 3 | 18% |
Unknown | 6 | 35% |
Readers by discipline | Count | As % |
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Biochemistry, Genetics and Molecular Biology | 3 | 18% |
Unspecified | 1 | 6% |
Agricultural and Biological Sciences | 1 | 6% |
Nursing and Health Professions | 1 | 6% |
Other | 0 | 0% |
Unknown | 6 | 35% |