Shorter halving time of BCR‐ABL1 transcripts is a novel predictor for achievement of molecular responses in newly diagnosed chronic‐phase chronic myeloid leukemia treated with dasatinib: Results of the D‐first study of <scp>K</scp>anto CML study group
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- Noriyoshi Iriyama
- Division of Hematology and Rheumatology Department of Medicine Nihon University School of Medicine Tokyo Japan
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- Shin Fujisawa
- Department of Hematology Yokohama City University Medical Center Kanagawa Japan
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- Chikashi Yoshida
- Department of Hematology National Hospital Organization Mito Medical Center Ibaraki Japan
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- Hisashi Wakita
- Division of Hematology and Oncology Japanese Red Cross Society, Narita Red Cross Hospital Narita Japan
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- Shigeru Chiba
- Department of Hematology Faculty of Medicine University of Tsukuba Ibaraki Japan
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- Shinichiro Okamoto
- Division of Hematology Department of Internal Medicine Keio University School of Medicine Tokyo Japan
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- Kimihiro Kawakami
- Department of Hematology and Clinical Oncology Kagawa Prefectural Central Hospital Kagawa Japan
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- Naoki Takezako
- Department of Hematology National Hospital Organization Disaster Medical Center Tokyo Japan
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- Takashi Kumagai
- Department of Hematology Ohme Municipal General Hospital Tokyo Japan
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- Koiti Inokuchi
- Division of Hematology Department of Internal Medicine Nippon Medical School Tokyo Japan
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- Kazuma Ohyashiki
- Department of Hematology Tokyo Medical University Tokyo Japan
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- Jun Taguchi
- Department of Hematology Japanese Red Cross Shizuoka Hospital Shizuoka Japan
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- Shingo Yano
- Division of Clinical Oncology and Hematology Department of Internal Medicine Jikei University School of Medicine Tokyo Japan
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- Tadahiko Igarashi
- Division of Hematology and Oncology Gunma Prefectural Cancer Center Gunma Japan
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- Yasuji Kouzai
- Department of Hematology Tokyo Metropolitan Tama Synthesis Medical Center Tokyo Japan
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- Satoshi Morita
- Department of Biomedical Statistics and Bioinformatics Kyoto University Graduate School of Medicine Kyoto Japan
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- Junichi Sakamoto
- Tokai Central Hospital Gifu Japan
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- Hisashi Sakamaki
- Hematology Division Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital Tokyo Japan
抄録
<jats:p>To investigate the factors that affect molecular responses on dasatinib treatment in patients with chronic‐phase chronic myeloid leukemia (CML‐CP), we performed a clinical trial named the “D‐First study.” Fifty‐two patients with newly diagnosed CML‐CP were enrolled in this study and received 100 mg dasatinib once daily. A deep molecular response (DMR) was defined as <50 copies/μg RNA of <jats:italic>BCR‐ABL1</jats:italic> transcript value corrected by <jats:italic>GAPDH</jats:italic>, which ensures <0.01% of <jats:italic>BCR‐ABL1</jats:italic> transcript value according to International Scale (<jats:italic>BCR‐ABL1<jats:sup>IS</jats:sup></jats:italic>). The halving time for <jats:italic>BCR‐ABL1</jats:italic> transcripts was calculated using transcript levels before dasatinib treatment, transcript levels after 3 months of treatment, and the treatment time between these two points. In terms of molecular response, 38 of 51 (75%) patients reached major molecular response (MMR) by 12 months, and the rate of DMR by 18 months was 59% (30/51). While both <jats:italic>BCR‐ABL1</jats:italic> transcript levels before treatment and a shorter halving time of <jats:italic>BCR‐ABL1</jats:italic> transcripts (≤14 days) were significant factors affecting achievement of MMR by 12 months, the Sokal score at diagnosis was not associated with MMR. Importantly, the halving time was the only factor that predicted achievement of DMR by 18 months. We showed that patients with CML‐CP treated with dasatinib can be stratified according to the early treatment response as determined by the halving time of <jats:italic>BCR‐ABL1</jats:italic> transcripts. These data emphasize the significance of the early response from dasatinib treatment in achieving a DMR. (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link>; NCT01464411) Am. J. Hematol. 90:282–287, 2015. © 2014 Wiley Periodicals, Inc.</jats:p>
収録刊行物
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- American Journal of Hematology
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American Journal of Hematology 90 (4), 282-287, 2015-03-02
Wiley
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詳細情報 詳細情報について
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- CRID
- 1360846639335309824
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- ISSN
- 10968652
- 03618609
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