Efficacy and safety of tyrosine kinase inhibitors for newly diagnosed chronic-phase chronic myeloid leukemia over a 5-year period

results from the Japanese registry obtained by the New TARGET system

the New TARGET investigators

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

We report the results of a multicenter observational study using the New TARGET system, in which the effectiveness and safety of tyrosine kinase inhibitors (TKIs) were evaluated in newly diagnosed chronic-phase chronic myeloid leukemia (CML) patients. A total of 506 patients were enrolled between April 2010 and March 2013. Median age was 56 (range 18–92) years; 35% of patients were females. As the first-line therapy, 139 (27.9%), 169 (33.9%) and 144 (28.9%) patients were treated with imatinib, nilotinib, and dasatinib, respectively. Five-year progression-free survival (PFS) and overall survival (OS) were 93.8% and 94.5%, respectively. The OS curve was significantly superior for patients treated with second-generation TKIs than imatinib (P = 0.0068), and an early molecular response (EMR) at 3 months (BCR-ABL1 < 10%) was detected in 328 of 377 patients evaluated for molecular response. The PFS curve was significantly superior for patients with EMR than without (P < 0.0001). Although 12 patients experienced vascular adverse events, no new safety issues were observed in patients with adverse events. The results of this observational study demonstrated that treating newly diagnosed CML-CP patients with TKI results in satisfactory and reliable outcomes.

Original languageEnglish
Pages (from-to)426-439
Number of pages14
JournalInternational journal of hematology
Volume109
Issue number4
DOIs
Publication statusPublished - 2019 Apr 5

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Leukemia, Myeloid, Chronic Phase
Protein-Tyrosine Kinases
Registries
Safety
Disease-Free Survival
Observational Studies
Survival
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Multicenter Studies
Blood Vessels

Keywords

  • BCR-ABL1
  • Chronic myeloid leukemia (CML)
  • Early molecular response (EMR)
  • Overall survival (OS)
  • Tyrosine kinase inhibitor (TKI)

ASJC Scopus subject areas

  • Hematology

Cite this

@article{4640ef432e2b432896ae9a594bf2da0c,
title = "Efficacy and safety of tyrosine kinase inhibitors for newly diagnosed chronic-phase chronic myeloid leukemia over a 5-year period: results from the Japanese registry obtained by the New TARGET system",
abstract = "We report the results of a multicenter observational study using the New TARGET system, in which the effectiveness and safety of tyrosine kinase inhibitors (TKIs) were evaluated in newly diagnosed chronic-phase chronic myeloid leukemia (CML) patients. A total of 506 patients were enrolled between April 2010 and March 2013. Median age was 56 (range 18–92) years; 35{\%} of patients were females. As the first-line therapy, 139 (27.9{\%}), 169 (33.9{\%}) and 144 (28.9{\%}) patients were treated with imatinib, nilotinib, and dasatinib, respectively. Five-year progression-free survival (PFS) and overall survival (OS) were 93.8{\%} and 94.5{\%}, respectively. The OS curve was significantly superior for patients treated with second-generation TKIs than imatinib (P = 0.0068), and an early molecular response (EMR) at 3 months (BCR-ABL1 < 10{\%}) was detected in 328 of 377 patients evaluated for molecular response. The PFS curve was significantly superior for patients with EMR than without (P < 0.0001). Although 12 patients experienced vascular adverse events, no new safety issues were observed in patients with adverse events. The results of this observational study demonstrated that treating newly diagnosed CML-CP patients with TKI results in satisfactory and reliable outcomes.",
keywords = "BCR-ABL1, Chronic myeloid leukemia (CML), Early molecular response (EMR), Overall survival (OS), Tyrosine kinase inhibitor (TKI)",
author = "{the New TARGET investigators} and Masahiro Kizaki and Naoto Takahashi and Noriyoshi Iriyama and Shinichiro Okamoto and Takaaki Ono and Noriko Usui and Koiti Inokuchi and Chiaki Nakaseko and Mineo Kurokawa and Masahiko Sumi and Fumihiko Nakamura and Tatsuya Kawaguchi and Ritsuro Suzuki and Kazuhito Yamamoto and Kazunori Ohnishi and Itaru Matsumura and Tomoki Naoe and M. Kizaki and S. Mori and T. Nemoto and M. Sagawa and T. Tabayashi and M. Tokuhira and T. Tomikawa and R. Watanabe and Y. Hatta and Y. Inoue and N. Iriyama and S. Kobayashi and Y. Kobayashi and D. Kurita and D. Karigane and H. Kasahara and Yuya Koda and Y. Miyakawa and K. Murakami and S. Okamoto and S. Watanuki and T. Ono and Y. Nagata and A. Takeshita and N. Takahashi and Y. Kameoka and T. Yoshioka and S. Takahashi and N. Usui and K. Dan and K. Inokuchi and K. Nakamura and Katsuya Suzuki",
year = "2019",
month = "4",
day = "5",
doi = "10.1007/s12185-019-02613-1",
language = "English",
volume = "109",
pages = "426--439",
journal = "International Journal of Hematology",
issn = "0925-5710",
publisher = "Springer Japan",
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TY - JOUR

T1 - Efficacy and safety of tyrosine kinase inhibitors for newly diagnosed chronic-phase chronic myeloid leukemia over a 5-year period

T2 - results from the Japanese registry obtained by the New TARGET system

AU - the New TARGET investigators

AU - Kizaki, Masahiro

AU - Takahashi, Naoto

AU - Iriyama, Noriyoshi

AU - Okamoto, Shinichiro

AU - Ono, Takaaki

AU - Usui, Noriko

AU - Inokuchi, Koiti

AU - Nakaseko, Chiaki

AU - Kurokawa, Mineo

AU - Sumi, Masahiko

AU - Nakamura, Fumihiko

AU - Kawaguchi, Tatsuya

AU - Suzuki, Ritsuro

AU - Yamamoto, Kazuhito

AU - Ohnishi, Kazunori

AU - Matsumura, Itaru

AU - Naoe, Tomoki

AU - Kizaki, M.

AU - Mori, S.

AU - Nemoto, T.

AU - Sagawa, M.

AU - Tabayashi, T.

AU - Tokuhira, M.

AU - Tomikawa, T.

AU - Watanabe, R.

AU - Hatta, Y.

AU - Inoue, Y.

AU - Iriyama, N.

AU - Kobayashi, S.

AU - Kobayashi, Y.

AU - Kurita, D.

AU - Karigane, D.

AU - Kasahara, H.

AU - Koda, Yuya

AU - Miyakawa, Y.

AU - Murakami, K.

AU - Okamoto, S.

AU - Watanuki, S.

AU - Ono, T.

AU - Nagata, Y.

AU - Takeshita, A.

AU - Takahashi, N.

AU - Kameoka, Y.

AU - Yoshioka, T.

AU - Takahashi, S.

AU - Usui, N.

AU - Dan, K.

AU - Inokuchi, K.

AU - Nakamura, K.

AU - Suzuki, Katsuya

PY - 2019/4/5

Y1 - 2019/4/5

N2 - We report the results of a multicenter observational study using the New TARGET system, in which the effectiveness and safety of tyrosine kinase inhibitors (TKIs) were evaluated in newly diagnosed chronic-phase chronic myeloid leukemia (CML) patients. A total of 506 patients were enrolled between April 2010 and March 2013. Median age was 56 (range 18–92) years; 35% of patients were females. As the first-line therapy, 139 (27.9%), 169 (33.9%) and 144 (28.9%) patients were treated with imatinib, nilotinib, and dasatinib, respectively. Five-year progression-free survival (PFS) and overall survival (OS) were 93.8% and 94.5%, respectively. The OS curve was significantly superior for patients treated with second-generation TKIs than imatinib (P = 0.0068), and an early molecular response (EMR) at 3 months (BCR-ABL1 < 10%) was detected in 328 of 377 patients evaluated for molecular response. The PFS curve was significantly superior for patients with EMR than without (P < 0.0001). Although 12 patients experienced vascular adverse events, no new safety issues were observed in patients with adverse events. The results of this observational study demonstrated that treating newly diagnosed CML-CP patients with TKI results in satisfactory and reliable outcomes.

AB - We report the results of a multicenter observational study using the New TARGET system, in which the effectiveness and safety of tyrosine kinase inhibitors (TKIs) were evaluated in newly diagnosed chronic-phase chronic myeloid leukemia (CML) patients. A total of 506 patients were enrolled between April 2010 and March 2013. Median age was 56 (range 18–92) years; 35% of patients were females. As the first-line therapy, 139 (27.9%), 169 (33.9%) and 144 (28.9%) patients were treated with imatinib, nilotinib, and dasatinib, respectively. Five-year progression-free survival (PFS) and overall survival (OS) were 93.8% and 94.5%, respectively. The OS curve was significantly superior for patients treated with second-generation TKIs than imatinib (P = 0.0068), and an early molecular response (EMR) at 3 months (BCR-ABL1 < 10%) was detected in 328 of 377 patients evaluated for molecular response. The PFS curve was significantly superior for patients with EMR than without (P < 0.0001). Although 12 patients experienced vascular adverse events, no new safety issues were observed in patients with adverse events. The results of this observational study demonstrated that treating newly diagnosed CML-CP patients with TKI results in satisfactory and reliable outcomes.

KW - BCR-ABL1

KW - Chronic myeloid leukemia (CML)

KW - Early molecular response (EMR)

KW - Overall survival (OS)

KW - Tyrosine kinase inhibitor (TKI)

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U2 - 10.1007/s12185-019-02613-1

DO - 10.1007/s12185-019-02613-1

M3 - Article

VL - 109

SP - 426

EP - 439

JO - International Journal of Hematology

JF - International Journal of Hematology

SN - 0925-5710

IS - 4

ER -