Real-world treatment patterns and clinical outcomes in Korean patients with AML ineligible for first-line intensive chemotherapy: A subanalysis of the CURRENT study, a non-interventional, retrospective chart review

Abstract

Background Although most elderly patients with acute myeloid leukemia are ineligible for intensive chemotherapy, treatment options remain limited. CURRENT (UMIN000037786), a real-world, non-interventional, retrospective chart review, evaluated clinical outcomes, clinicopathologic characteristics, and treatment patterns in these patients. We present results from a subanalysis of Korean patients in this study. Methods Patients were aged >=18 years with primary or secondary acute myeloid leukemia ineligible for intensive chemotherapy who initiated first-line systemic therapy or best supportive care between 2015 and 2018 across four centers in Korea. Primary endpoint was overall survival from diagnosis. Secondary endpoints included progression-free survival, time to treatment failure, and response rates. Data analyses were primarily descriptive, with time-to-event outcomes estimated using the Kaplan-Meier method, and Cox regression used to determine prognostic factors for survival. Results Among 194 patients enrolled, 84.0% received systemic therapy and 16.0% received best supportive care. Median age at diagnosis was 74 and 78 years, and Eastern Cooperative Oncology Group performance status 0 or 1 was reported in 73.0% and 48.4% of patients, respectively; poor cytogenetic risk was reported in 30.1% and 16.1% of patients. Median overall survival was 7.83 versus 4.50 months, and median progression-free survival was 6.73 versus 4.50 months in the systemic therapy versus best supportive care groups. Prognostic factors (all P <0.05) affecting overall survival included secondary acute myeloid leukemia (hazard ratio, 1.67 [95% CI: 1.13–2.45]), Eastern Cooperative Oncology Group performance status >=2 (2.41 [1.51–3.83]), poor cytogenetic risk (2.10 [1.36–3.24]), and Charlson comorbidity index >=1 (2.26 [1.43–3.58]). Conclusion Clinical outcomes are poor in Korean patients with acute myeloid leukemia ineligible for intensive chemotherapy who are prescribed current systemic therapies or best supportive care. There is a substantial unmet need for novel agents (monotherapy or in combination) to improve clinical outcomes in this patient population.

Competing Interest Statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: This study received funding from AbbVie. The funder had the following involvement with the study: funding for study design, data collection, analysis, interpretation, and medical writing for the manuscript. AD, CL, YD and JYJ are employees of AbbVie, and JHL had advisory roles for AbbVie, Astellas, Celgene, Janssen, and Novartis. All other authors (SMB, KWK, and ICS) declare no competing interests.

Funding Statement

This research was funded by AbbVie Corp. AbbVie (https://www.abbvie.com/) provided funding for study design, data collection, analysis, interpretation, and medical writing for the manuscript. AD, CL, YD and JYJ received salary as employees of AbbVie. Editorial and writing support was provided by Liting Hang BSc (Hons), PhD, and Alice Carruthers BSc (Hons), PhD, (Nucleus Global Shanghai, Shanghai, China) and was funded by AbbVie Korea.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Notification was made to the responsible ethics committees, health institutions, and/or competent authorities as required by local laws and regulations. Ethics committee approval was obtained for this study (IRB no. for Seoul National University Bundang Hospital: B-1908/559-102 IRB no. for Korea University College of Medicine: K2019-1535-001 IRB no. for Chungnan National University School of Medicine: 2019-09-027 IRB no. for Asan Medical Center: S2019-1692-0001). Data collection was carried out anonymously.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

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Data Availability

All relevant data are within the manuscript. The data presented in this study are available from AbbVie Inc., North Chicago, IL, USA (contact via cynthia.llamas@abbvie.com or yinghui.duan@abbvie.com). Authors share the “minimal data set” for their submission. The minimal data set to consist of the data required to replicate all study findings reported in the article, as well as related metadata and methods. Additionally, authors comply with field-specific standards for preparation, recording, and deposition of data when applicable.

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