Real-world treatment patterns and clinical outcomes in patients with AML unfit for first-line intensive chemotherapy^*

Abstract

Acute myeloid leukemia (AML) predominantly affects the elderly, and prognosis declines with age. Induction chemotherapy plus consolidation therapy is standard of care for fit patients; options for unfit patients include hypomethylating agents (HMA), low-dose cytarabine (LDAC), targeted therapies, and best supportive care (BSC). This retrospective chart review evaluated clinical outcomes in unfit patients with AML who initiated first-line treatment or BSC 01/01/2015–12/31/2018. Overall survival (OS), progression-free survival (PFS), time-to-treatment failure (TTF), and response rates were assessed. Of 1762 patients, 1310 received systemic therapies: 809 HMA, 199 LDAC, and 302 other therapies; 452 received BSC. Median OS was 9.9, 7.9, 5.4, and 2.5 months for HMA, LDAC, other, and BSC, respectively. Median PFS was 7.5, 5.3, 4.1, and 2.1 months for HMA, LDAC, other, and BSC, respectively; median TTF was 4.9, 2.1, 2.2, and 2.1 months, respectively. Our findings highlight the unmet need for novel therapies for unfit patients.

Keywords:

• Acute myeloid leukemia
• hypomethylating agents
• low-dose cytarabine
• best supportive care
• unfit patients

Acknowledgments

AbbVie and authors thank the team who contributed to data collection and input, and to ICON for the data analysis. Medical writing support was provided by Hayley Ellis, PhD, of Fishawack Health, and funded by AbbVie.

AbbVie participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.

Author contributions

All authors had access to relevant data, and participated in the writing, review, and approval of the manuscript. T. Miyamoto, D. Sanford, C. Tomuleasa, H.-H. Hsiao, L. J. Enciso Olivera, A. K. Enjeti, A. Gimenez Conca, T. Bernal del Castillo, L. Girshova, M. P. Martelli, B. Guvenc, A. Delgado, Y. Duan, B. Garbayo Guijarro, C. Llamas, and J.-H. Lee: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content.

Disclosure statement

T. Miyamoto: Speaker honoraria for AbbVie, Amgen, Astellas, Daiichi-Sankyo, MSD, Bristol Myers Squibb.

D. Sanford: Advisory role for AbbVie, Astellas, Novartis, Pfizer.

C. Tomuleasa: No potential conflicts of interest are reported.

H.-H. Hsiao: Advisory role for AbbVie, Amgen, Janssen, Novartis, Pfizer.

L. J. Enciso Olivera: No potential conflicts of interest are reported.

A. K. Enjeti: Advisory role for AbbVie, Astellas, Novartis, Alexion and Jazz Pharmaceuticals. Speaker for Alexion, Bayer, Sanofi A.

A. Gimenez Conca: Lecture honoraria for AbbVie and Novartis.

T. Bernal del Castillo: No potential conflicts of interest are reported.

L. Girshova: No potential conflicts of interest are reported.

M. P. Martelli: Advisory role for AbbVie, Amgen, Celgene, Janssen, Jazz Pharmaceuticals, Novartis, Pfizer. Speaker honoraria for Amgen, Celgene, Janssen, Novartis.

B. Guvenc: Advisory role for AbbVie, Amgen, Novartis.

A. Delgado, Y. Duan, B. Garbayo Guijarro, C. Llamas: Employees of AbbVie and may hold stock or options.

J.-H. Lee: Advisory role for AbbVie, Astellas, Celgene, Janssen, Novartis.

Data availability statement

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g. protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

Additional information

Funding

AbbVie funded this study.