TY - JOUR
T1 - Treatment outcomes of chronic-phase chronic myeloid leukemia with resistance and/or intolerance to a 1st-line tyrosine kinase inhibitor in Japan
T2 - the results of the New TARGET study 2nd-line
AU - the New TARGET investigators
AU - Sakurai, Masatoshi
AU - Okamoto, Shinichiro
AU - Matsumura, Itaru
AU - Murakami, Satsuki
AU - Takizawa, Makiko
AU - Waki, Masato
AU - Hirano, Daiki
AU - Watanabe-Nakaseko, Reiko
AU - Kobayashi, Naoki
AU - Iino, Masaki
AU - Mitsui, Hideki
AU - Ishikawa, Yuichi
AU - Takahashi, Naoto
AU - Kawaguchi, Tatsuya
AU - Suzuki, Ritsuro
AU - Yamamoto, Kazuhito
AU - Kizaki, Masahiro
AU - Ohnishi, Kazunori
AU - Naoe, Tomoki
AU - Akashi, Koichi
N1 - Funding Information:
This study was supported by research funding from Novartis Pharmaceuticals and Bristol-Myers Squibb to JSH. The authors would like to thank all study participants and their families, and the study investigators at participating study sites. We also thank the New TARGET data center (EPS Co.) for managing and monitoring the study. Finally, we would like to thank the following institutes participating in this study: Chugoku Central Hospital, Ehime Prefectural Central Hospital, Fukuoka University Hospital, Hamamatsu University Hospital, Hirosaki National Hospital, Hyogo Cancer Center, Japanese Red Cross Kyoto Daini Hospital, Japanese Red Cross Shizuoka Hospital, JCHO Kobe Central Hospital, Kanazawa Medical University Hospital, Kumamoto Shinto General Hospital, Kumamoto University Hospital, Kyoto City Hospital, Kyoto Kuramaguchi Medical Center, Mie University Hospital, Nagasaki University Hospital, Nagoya City East Medical Center, National Hospital Organization Kyushu Cancer Center, National Hospital Organization Tokyo Medical Center, Nippon Medical School Hospital, NTT Medical Center Tokyo, Oita Prefectural Hospital, Osaka City University Hospital, Osaka University Hospital, Saiseikai Noe Hospital, Sanraku Hospital, Sapporo Hokushin Hospital, Shinshu University Hospital, Tenshi Hospital, The Jikei University Hospital, Tohoku University Hospital, Tosei General Hospital, Toyama Red Cross Hospital, Tsukuba University Hospital, University Hospital Kyoto Prefectural University of Medicine, Yokohama Minami Kyousai Hospital.
Funding Information:
This study was supported by research funding from Novartis Pharmaceuticals and Bristol-Myers Squibb to JSH. The authors would like to thank all study participants and their families, and the study investigators at participating study sites. We also thank the New TARGET data center (EPS Co.) for managing and monitoring the study. Finally, we would like to thank the following institutes participating in this study: Chugoku Central Hospital, Ehime Prefectural Central Hospital, Fukuoka University Hospital, Hamamatsu University Hospital, Hirosaki National Hospital, Hyogo Cancer Center, Japanese Red Cross Kyoto Daini Hospital, Japanese Red Cross Shizuoka Hospital, JCHO Kobe Central Hospital, Kanazawa Medical University Hospital, Kumamoto Shinto General Hospital, Kumamoto University Hospital, Kyoto City Hospital, Kyoto Kuramaguchi Medical Center, Mie University Hospital, Nagasaki University Hospital, Nagoya City East Medical Center, National Hospital Organization Kyushu Cancer Center, National Hospital Organization Tokyo Medical Center, Nippon Medical School Hospital, NTT Medical Center Tokyo, Oita Prefectural Hospital, Osaka City University Hospital, Osaka University Hospital, Saiseikai Noe Hospital, Sanraku Hospital, Sapporo Hokushin Hospital, Shinshu University Hospital, Tenshi Hospital, The Jikei University Hospital, Tohoku University Hospital, Tosei General Hospital, Toyama Red Cross Hospital, Tsukuba University Hospital, University Hospital Kyoto Prefectural University of Medicine, Yokohama Minami Kyousai Hospital.
Publisher Copyright:
© 2020, Japanese Society of Hematology.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - We herein report the results of the New TARGET study 2nd-line, which collected data on patients with chronic-phase (CP) chronic myeloid leukemia (CML) who received a 2nd-line tyrosine kinase inhibitor (TKI) because of resistance and/or to a 1st-line TKI. A total of 98 patients were enrolled intolerance between April 2010 and March 2013, and 82 patients were analyzed. The median age was 54 years (range 22–88 years). Seventy-six patients (93%) received imatinib as the 1st-line TKI. Forty-five (55%) and 37 (45%) patients began nilotinib and dasatinib treatments at entry, respectively. First-line TKI treatment achieved complete hematological response in 79 patients (96%) and complete cytogenetic response (CCyR) in 49 patients (60%), respectively. Nine patients (11%) had BCR-ABL1 kinase domain point mutations at enrollment. The estimated 3-year progression-free-survival rate after enrollment was 98.7% (95% CI 91.1–99.8%). Overall, the probabilities of achieving CCyR and a major molecular response were 89.3% (95% CI 81.4–94.8%) and 87.2% (95% CI 78.1–93.8%), respectively. There were no new safety issues. This study demonstrated that CML-CP patients in Japan who are resistant and/or intolerant to a 1st-line TKI can achieve an extremely good outcome by 2nd-line TKI treatment.
AB - We herein report the results of the New TARGET study 2nd-line, which collected data on patients with chronic-phase (CP) chronic myeloid leukemia (CML) who received a 2nd-line tyrosine kinase inhibitor (TKI) because of resistance and/or to a 1st-line TKI. A total of 98 patients were enrolled intolerance between April 2010 and March 2013, and 82 patients were analyzed. The median age was 54 years (range 22–88 years). Seventy-six patients (93%) received imatinib as the 1st-line TKI. Forty-five (55%) and 37 (45%) patients began nilotinib and dasatinib treatments at entry, respectively. First-line TKI treatment achieved complete hematological response in 79 patients (96%) and complete cytogenetic response (CCyR) in 49 patients (60%), respectively. Nine patients (11%) had BCR-ABL1 kinase domain point mutations at enrollment. The estimated 3-year progression-free-survival rate after enrollment was 98.7% (95% CI 91.1–99.8%). Overall, the probabilities of achieving CCyR and a major molecular response were 89.3% (95% CI 81.4–94.8%) and 87.2% (95% CI 78.1–93.8%), respectively. There were no new safety issues. This study demonstrated that CML-CP patients in Japan who are resistant and/or intolerant to a 1st-line TKI can achieve an extremely good outcome by 2nd-line TKI treatment.
KW - Chronic myeloid leukemia
KW - Japan
KW - Observational study
KW - Resistance or intolerance
KW - Tyrosine kinase inhibitors
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UR - http://www.scopus.com/inward/citedby.url?scp=85081231576&partnerID=8YFLogxK
U2 - 10.1007/s12185-020-02843-8
DO - 10.1007/s12185-020-02843-8
M3 - Article
C2 - 32152876
AN - SCOPUS:85081231576
SN - 0925-5710
VL - 111
SP - 812
EP - 825
JO - International Journal of Hematology
JF - International Journal of Hematology
IS - 6
ER -