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.

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.

• 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, Japan Adult Leukemia Study Group
• Journal: International journal of hematology (Int J Hematol) Vol. 107 Issue 2 Pg. 185-193 (Feb 2018) ISSN: 1865-3774 [Electronic] Japan
• PMID: 28929332 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• BCR-ABL1 fusion protein, human
• Imatinib Mesylate
• Fusion Proteins, bcr-abl

Topics

• Disease-Free Survival
• Female
• Fusion Proteins, bcr-abl (genetics)
• Humans
• Imatinib Mesylate (therapeutic use)
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy, genetics, mortality)
• Leukemia, Myeloid, Chronic-Phase (drug therapy, genetics, mortality)
• Male
• Middle Aged
• Prospective Studies
• Remission Induction
• Treatment Outcome