Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 812-825 |
| Number of pages | 14 |
| Journal | International journal of hematology |
| Volume | 111 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jun 1 2020 |
All Science Journal Classification (ASJC) codes
- Hematology
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In: International journal of hematology, Vol. 111, No. 6, 01.06.2020, p. 812-825.
Research output: Contribution to journal › Article › peer-review
}
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. Funding Information: M. Sakurai reports personal fees from Bristol-Myers Squibb, Takeda Pharmaceutical, Eisai Pharmaceuticals and Nippon Shinyaku, outside the submitted work; S. Okamoto reports grants and personal fees from Otsuka Pharmaceutical, Novartis Pharmaceuticals, Bristol-Myers Squibb, Astellas Pharma, Kyowa Hakko Kirin and Chugai Pharmaceutical, and personal fees from Pfizer, outside the submitted work; I. Matsumura reports grants and personal fees from Bristol-Myers Squibb, Novartis Pharmaceuticals and Otsuka Pharmaceutical, and personal fees from Pfizer, during the conduct of the study; grants and personal fees from Nippon Shinyaku, Celgene, Pfizer, Ono Pharmaceutical, Shionogi and Takeda Pharmaceutical, grants from Kyowa Hakko Kirin, Sumitomo Dainippon Pharma, Teijin Pharma, Boehringer Ingelheim, Sanofi, Chugai Pharmaceutical, Eisai Pharmaceuticals, MSD, Asahi Kasei Pharma, Astellas Pharma, Japan Blood Products Organization, Nihon Pharmaceutical, Daiichi Sankyo, and personal fees from AbbVie GK, outside the submitted work;. N. Takahashi reports grants and personal fees from Novartis Pharmaceuticals, Pfizer and Otsuka Pharmaceutical, grants from Kyowa Hakko Kirin, Astellas Pharma, Chugai Pharmaceutical, Asahi Kasei Pharma, Ono Pharmaceutical and Eisai Pharmaceuticals, and personal fees from Bristol-Myers Squibb, outside the submitted work; T. Kawaguchi reports grants and personal fees from MSD, and personal fees from Pfizer, Alexion Pharma and Novartis Pharmaceuticals, outside the submitted work; R. Suzuki reports personal fees from Bristol-Meyer Squib, Novartis Pharmaceuticals, Kyowa Hakko Kirin, Chugai Pharmaceutical, Shionogi, Takeda Pharmaceutical, Meiji Seika Pharma, MSD, Otsuka Pharmaceutical, Sawai, Celgene, Sumitomo Dainippon Pharma, Eisai Pharmaceuticals, Alexion Pharma, Sanofi, Gilead Sciences, Abbvie Inc., Mundi Pharma, Jazz Pharma, Ono Pharmaceutical and Janssen Pharmaceuticals, outside the submitted work; K. Yamamoto reports grants and personal fees from Astra-Zeneca, Celgene, Chugai Pharmaceutical, Eisai Pharmaceuticals, MSD, Novartis Pharmaceuticals, Ono Pharmaceutical, Takeda Pharmaceutical, Zenyaku, Abbvie Inc., Mundi Pharma and Nippon Shinyaku, grants from ARIAD, Bayer, Gilead Sciences, Solasia Pharma, SymBio and Incyte, and personal fees from Bristol-Myers Squibb, Kyowa Hakko Kirin, Meiji Seika Pharma, Mochida, Otsuka Pharmaceutical, Pfizer, Sumitomo Dainippon Pharma, Boehringer Ingelheim, HUYA/IQVIA Services Japan, Janssen and Stemline Therapeutics, outside the submitted work; M. Kizaki reports grants from Kyowa Hakko Kirin, Chugai Pharmaceutical and Pfizer, and personal fees from Bristol-Myers Squibb, Celgene, Nippon Shinyaku, Takeda Pharmaceutical and Ono Pharmaceutical, outside the submitted work; T. Naoe reports personal fees from Astellas Pharma, Nippon Shinyaku, Bristol-Myers Squibb, Pfizer, Otsuka Pharmaceutical, FujiFilm and Eisai Pharmaceuticals, outside the submitted work; K. Akashi reports grants and personal fees from Bristol-Myers Squibb, Astellas Pharma, Janssen Pharmaceuticals and Kyowa Hakko Kirin, grants from Canon and Otsuka Pharmaceutical, and personal fees from Novartis Pharmaceuticals, Abbvie Inc., Eisai Pharmaceuticals, Celgene and Chugai Pharmaceutical, outside the submitted work; the other authors have nothing to disclose. 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.
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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 -