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International Journal of Hematology
Published in: International Journal of Hematology 2/2018

01-02-2018 | Original Article

Deeper molecular response is a predictive factor for treatment-free remission after imatinib discontinuation in patients with chronic phase chronic myeloid leukemia: the JALSG-STIM213 study

Authors: Naoto Takahashi, Tetsuzo Tauchi, Kunio Kitamura, Koichi Miyamura, Yoshio Saburi, Yoshihiro Hatta, Yasuhiko Miyata, Shinichi Kobayashi, Kensuke Usuki, Itaru Matsumura, Yosuke Minami, Noriko Usui, Tetsuya Fukuda, Satoru Takada, Maho Ishikawa, Katsumichi Fujimaki, Hiroshi Gomyo, Osamu Sasaki, Kohshi Ohishi, Takaaki Miyake, Kiyotoshi Imai, Hitoshi Suzushima, Hideki Mitsui, Kazuto Togitani, Toru Kiguchi, Yoshiko Atsuta, Shigeki Ohtake, Kazunori Ohnishi, Yukio Kobayashi, Hitoshi Kiyoi, Yasushi Miyazaki, Tomoki Naoe, The Japan Adult Leukemia Study Group

Published in: International Journal of Hematology | Issue 2/2018

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Abstract

The objective of this prospective clinical trial (JALSG-STIM213, UMIN000011971) was to evaluate treatment-free remission (TFR) rates after discontinuation of imatinib in chronic myeloid leukemia (CML). CML patients who received imatinib treatment for at least 3 years and sustained deep molecular response for at least 2 years were eligible. Molecular recurrence was defined as loss of major molecular response (MMR). Of the 68 eligible patients, 38.2% were women, the median age was 55.0 years, and the median duration of imatinib treatment was 97.5 months. The 12-month TFR rate was 67.6%. Patients who lost MMR were immediately treated with imatinib again; all re-achieved MMR. Three-year treatment-free survival (TFS) was estimated as 64.6% using the Kaplan–Meier method. Undetectable molecular residual disease (UMRD) was defined as no BCR-ABL1 in > 100,000 ABL1 control genes using international scale polymerase chain reaction. UMRD at the study baseline was found to be predictive of continuation of TFR. Our findings suggest that CML patients who meet all the eligibility criteria that have commonly been used in the TFR trials are able to discontinue imatinib use safely. TFR may thus be valuable as a new goal for CML treatment in Japan.
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Metadata
Title
Deeper molecular response is a predictive factor for treatment-free remission after imatinib discontinuation in patients with chronic phase chronic myeloid leukemia: the JALSG-STIM213 study
Authors
Naoto Takahashi
Tetsuzo Tauchi
Kunio Kitamura
Koichi Miyamura
Yoshio Saburi
Yoshihiro Hatta
Yasuhiko Miyata
Shinichi Kobayashi
Kensuke Usuki
Itaru Matsumura
Yosuke Minami
Noriko Usui
Tetsuya Fukuda
Satoru Takada
Maho Ishikawa
Katsumichi Fujimaki
Hiroshi Gomyo
Osamu Sasaki
Kohshi Ohishi
Takaaki Miyake
Kiyotoshi Imai
Hitoshi Suzushima
Hideki Mitsui
Kazuto Togitani
Toru Kiguchi
Yoshiko Atsuta
Shigeki Ohtake
Kazunori Ohnishi
Yukio Kobayashi
Hitoshi Kiyoi
Yasushi Miyazaki
Tomoki Naoe
The Japan Adult Leukemia Study Group
Publication date
01-02-2018
Publisher
Springer Japan
Published in
International Journal of Hematology / Issue 2/2018
Print ISSN: 0925-5710
Electronic ISSN: 1865-3774
DOI
https://doi.org/10.1007/s12185-017-2334-x

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