Tyrosine kinase inhibitor therapy discontinuation in patients with chronic myeloid leukemia in chronic phase in the United States after clinical practice guideline updates

Abstract

A physician survey (July 2019–August 2019) and a retrospective patient medical chart review (November 2019–December 2019) were conducted to assess TKI therapy discontinuation practice in patients with Ph + CML-CP in the US after the publication of practice guidelines updated with recommendations for TKI discontinuation. After guideline updates, 90% of physicians from the survey reported attempting TKI discontinuation and 24% of their patients discontinued TKI after achieving an adequate response. Although TKI therapy discontinuation practice is increasing, particularly in community-based practice, a little more than half of physicians were aware of these updated guidelines resulting in TKI discontinuation attempted under suboptimal conditions, mainly limited to first-line TKI therapy, with more than half of physicians without access to at least MR4.5 sensitivity level of detection monitoring. Stricter response criteria per guideline recommendations were observed to relate to lower relapse rates following TKI discontinuation, emphasizing the importance of communicating these recommendations and access to adequate monitoring tools.

Keywords:

• Philadelphia positive chronic myeloid leukemia chronic phase (Ph + CML-CP)
• Tyrosine kinase inhibitor (TKI)
• TKI therapy discontinuation
• clinical practice
• physician survey
• retrospective patient medical chart review

Acknowledgements

Medical writing assistance was provided by Christine Tam, an employee of Analysis Group, Inc.

Author contributions

All authors (ELA, IS, RM, XC, DLV, IP, CR, AG, and VK) contributed to the design of the study and interpretation of the data. DLV, IP, CR, and AG contributed to the data collection and data analysis. All authors (ELA, XC, IS, RM, DLV, IP, CR, AG, and VK) critically revised the draft manuscript and approved the final content.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Data are not available due to legal restrictions. Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data is not available. Therefore, restrictions apply to the availability of these data, which are not publicly available.

Complying with ethics of experimentation

This study received an IRB exemption letter from the New England Independent Review Board (NEIRB).

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

ELA has provided paid consulting services to Bristol Myers Squibb, Novartis Pharmaceuticals Corporation, and Takeda; and has received a research grant from Takeda. VK has received honoraria from Novartis Pharmaceuticals Corporation, Pfizer, and Takeda; and has provided paid consulting services to Novartis Pharmaceuticals Corporation, Pfizer, and Takeda. XC, IS, RM are employees of Novartis Pharmaceuticals Corporation. DLV, IP, CR, and AG are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Novartis Pharmaceuticals Corporation, which funded the development and conduct of this study. This study was funded by Novartis Pharmaceuticals Corporation. The study sponsor contributed to and approved the study design, participated in the interpretation of data, and reviewed and approved the manuscript; all authors contributed to the development of the manuscript and maintained control over the final content.