Publication: Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL1 tyrosine kinase inhibitors
1
Issued Date
2014-07-01
Resource Type
ISSN
15928721
03906078
03906078
Other identifier(s)
2-s2.0-84903650301
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Mahidol University
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SCOPUS
Bibliographic Citation
Haematologica. Vol.99, No.7 (2014), 1191-1196
Suggested Citation
Sung Hyun Kim, Hari Menon, Saengsuree Jootar, Tapan Saikia, Jae Yong Kwak, Sang Kyun Sohn, Joon Seong Park, Seong Hyun Jeong, Hyeoung Joon Kim, Yeo Kyeoung Kim, Suk Joong Oh, Hawk Kim, Dae Young Zang, Joo Seop Chung, Ho Jin Shin, Young Rok Do, Jeong A. Kim, Dae Young Kim, Chul Won Choi, Sahee Park, Hye Lin Park, Gong Yeal Lee, Dae Jin Cho, Jae Soo Shin, Dong Wook Kim Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL1 tyrosine kinase inhibitors. Haematologica. Vol.99, No.7 (2014), 1191-1196. doi:10.3324/haematol.2013.096776 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/34232
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Title
Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL1 tyrosine kinase inhibitors
Author(s)
Sung Hyun Kim
Hari Menon
Saengsuree Jootar
Tapan Saikia
Jae Yong Kwak
Sang Kyun Sohn
Joon Seong Park
Seong Hyun Jeong
Hyeoung Joon Kim
Yeo Kyeoung Kim
Suk Joong Oh
Hawk Kim
Dae Young Zang
Joo Seop Chung
Ho Jin Shin
Young Rok Do
Jeong A. Kim
Dae Young Kim
Chul Won Choi
Sahee Park
Hye Lin Park
Gong Yeal Lee
Dae Jin Cho
Jae Soo Shin
Dong Wook Kim
Hari Menon
Saengsuree Jootar
Tapan Saikia
Jae Yong Kwak
Sang Kyun Sohn
Joon Seong Park
Seong Hyun Jeong
Hyeoung Joon Kim
Yeo Kyeoung Kim
Suk Joong Oh
Hawk Kim
Dae Young Zang
Joo Seop Chung
Ho Jin Shin
Young Rok Do
Jeong A. Kim
Dae Young Kim
Chul Won Choi
Sahee Park
Hye Lin Park
Gong Yeal Lee
Dae Jin Cho
Jae Soo Shin
Dong Wook Kim
Other Contributor(s)
Dong-A University
Tata Memorial Hospital
Mahidol University
Prince Aly Khan Hospital
Chonbuk National University, School of Medicine
Kyungpook National University Hospital
Ajou University
Chonnam National University
SungKyunKwan University, School of Medicine
University of Ulsan, College of Medicine
Hallym University
Pusan National University, College of Medicine
Keimyung University, Dongsan Medical Center
The Catholic University of Korea
Korea University
IL-YANG Pharmaceutical Co., Ltd.
Tata Memorial Hospital
Mahidol University
Prince Aly Khan Hospital
Chonbuk National University, School of Medicine
Kyungpook National University Hospital
Ajou University
Chonnam National University
SungKyunKwan University, School of Medicine
University of Ulsan, College of Medicine
Hallym University
Pusan National University, College of Medicine
Keimyung University, Dongsan Medical Center
The Catholic University of Korea
Korea University
IL-YANG Pharmaceutical Co., Ltd.
Abstract
Radotinib (IY5511HCL), a novel and selective BCR-ABL1 tyrosine kinase inhibitor, has shown pre-clinical and phase I activity and safety in chronic myeloid leukemia. This phase II study investigated the efficacy and safety of radotinib in Philadelphia chromosome-positive chronic phase-chronic myeloid leukemia patients with resistance and/or intolerance to BCR-ABL1 tyrosine kinase inhibitors. Patients received radotinib 400 mg twice daily for 12 cycles based on results from the phase I trial. The primary end point was rate of major cytogenetic response by 12 months. A total of 77 patients were enrolled. Major cytogenetic response was achieved in 50 (65%; cumulative 75%) patients, including 36 (47%) patients with complete cytogenetic response by 12 months. Median time to major cytogenetic response and complete cytogenetic response were 85 days and 256 days, respectively. Major cytogenetic response and complete cytogenetic response rates were similar between imatinib-resistant and imatinib- intolerant patients, but were higher in patients without BCR-ABL1 mutations. Overall and progression-free survival rates at 12 months were 96.1% and 86.3%, respectively. All newly-occurring or worsening grade 3/4 hematologic abnormalities included thrombocytopenia (24.7%) and anemia (5.2%); grade 3/4 drug-related nonhematologic adverse events included fatigue (3.9%), asthenia (3.9%), and nausea (2.6%). The most common biochemistry abnormality was hyperbilirubinemia (grade 3/4 23.4%), and 12 of 18 cases were managed with dose modification. Study findings suggest radotinib is effective and well tolerated in chronic phase-chronic myeloid leukemia patients with resistance and/or intolerance to BCR-ABL1 tyrosine kinase inhibitors and may represent a promising alternative for these patients. (clinicaltrials.gov identifier: 01602952). © 2014 Ferrata Storti Foundation.