TP53 and Decitabine in Acute Myeloid Leukemia and Myelodysplastic Syndromes
Open accessAbstract
BACKGROUND: The molecular determinants of clinical responses to decitabine therapy in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) are unclear. METHODS: We enrolled 84 adult patients with AML or MDS in a single-institution trial of decitabine to identify somatic mutations and their relationships to clinical responses. Decitabine was administered at a dose of 20 mg per square meter of body-surface area per day for 10 consecutive days in monthly cycles. We performed enhanced exome or gene-panel sequencing in 67 of these patients and serial sequencing at multiple time points to evaluate patterns of mutation clearance in 54 patients. An extension cohort included 32 additional patients who received decitabine in different protocols. RESULTS: Of the 116 patients, 53 (46%) had bone marrow blast clearance (<5% blasts). Response rates were higher among patients with an unfavorable-risk cytogenetic profile than among patients with an intermediate-risk or favorable-risk cytogenetic profile (29 of 43 patients [67%] vs. 24 of 71 patients [34%], P<0.001) and among patients with TP53 mutations than among patients with wild-type TP53 (21 of 21 [100%] vs. 32 of 78 [41%], P<0.001). Previous studies have consistently shown that patients with an unfavorable-risk cytogenetic profile and TP53 mutations who receive conventional chemotherapy have poor outcomes. However, in this study of 10-day courses of decitabine, neither of these risk factors was associated with a lower rate of overall survival than the rate of survival among study patients with intermediate-risk cytogenetic profiles. CONCLUSIONS: Patients with AML and MDS who had cytogenetic abnormalities associated with unfavorable risk, TP53 mutations, or both had favorable clinical responses and robust (but incomplete) mutation clearance after receiving serial 10-day courses of decitabine. Although these responses were not durable, they resulted in rates of overall survival that were similar to those among patients with AML who had an intermediate-risk cytogenetic profile and who also received serial 10-day courses of decitabine. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT01687400 .).
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Increased HMA duration, such as 10-day decitabine, initially suggested improved outcomes in a limited number of patients with TP53-mutant myeloid malignancies, but there was no improvement in CR or OS in a prospective randomized study comparing 10-day versus 5-day decitabine in AML.
“Increased HMA duration, such as 10-day decitabine, initially suggested improved outcomes in a limited number of patients with TP53-mutant myeloid malignancies (patients with MDS; n = 9),18 but there was no improvement in CR or OS in a prospective randomized study comparing 10-day versus 5-day decitabine in AML, and this treatment schedule has not been widely adopted.19,20”
From Eprenetapopt (APR-246) and Azacitidine in <i>TP53</i> -Mutant Myelodysplastic Syndromes (2021) · cites this paper as [18]
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- Authors
- Welch, J. S., Petti, A. A., Miller, C. A., Fronick, C. C., O’Laughlin, M., Fulton, R. S., Wilson, R. K., Baty, J. D., Duncavage, E. J., Tandon, B., Lee, Y.-S., Wartman, L. D., Uy, G. L., Ghobadi, A., Tomasson, M. H., Pusic, I., Romee, R., Fehniger, T. A., Stockerl-Goldstein, K. E., Vij, R., Oh, S. T., Abboud, C. N., Cashen, A. F., Schroeder, M. A., Jacoby, M. A., Heath, S. E., Luber, K., Janke, M. R., Hantel, A., Khan, N., Sukhanova, M. J., Knoebel, R. W., Stock, W., Graubert, T. A., Walter, M. J., Westervelt, P., Link, D. C., DiPersio, J. F., & Ley, T. J.
- Affiliations
- Washington University in St. Louis (US)
- ORCID
- Welch, John S.
- Petti, Allegra A.
- Miller, Christopher A.
- Fronick, Catrina C.
- O’Laughlin, Michelle
- Fulton, Robert S.
- Wilson, Richard K.
- Tandon, Bevan
- Lee, Yi-Shan
- Wartman, Lukas D.
- Uy, Geoffrey L.
- Ghobadi, Armin
- Tomasson, Michael H.
- Pusic, Iskra
- Romee, Rizwan
- Fehniger, Todd A.
- Stockerl-Goldstein, Keith E.
- Vij, Ravi
- Oh, Stephen T.
- Abboud, Camille N.
- Schroeder, Mark A.
- Heath, Sharon E.
- Hantel, Andrew
- Khan, Niloufer
- Sukhanova, Madina J.
- Knoebel, Randall W.
- Stock, Wendy
- Graubert, Timothy A.
- Walter, Matthew J.
- Link, Daniel C.
- DiPersio, John F.
- Ley, Timothy J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-11-24
- Volume
- 375
- Issue
- 21
- Pages
- 2023-2036
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5217532
- OpenAlex
- W2549790759
- Cited by
- 796
- References
- 37
- Citations by year
- 2026: 39 · 2025: 50 · 2024: 58 · 2023: 80 · 2022: 82 · 2021: 96 · 2020: 103 · 2019: 105 · 2018: 93 · 2017: 85 · 2016: 5
- FWCI
- 91.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
- Funders
- Washington University in St. Louis
- Sunesis
- Agios Pharmaceuticals
- National Heart, Lung, and Blood Institute (R01HL128447)
- National Cancer Institute (CA101937, K08CA166229, P01CA101937, R35CA197561, P50CA171963, K12CA167540)
- Topics
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinoids in leukemia and cellular processes
- Health Sciences › Medicine › Hematology › Chronic Myeloid Leukemia Treatments
- Keywords
- decitabine, acute myeloid leukemia, myelodysplastic syndrome, TP53 mutation, overall survival, hypomethylating agents, somatic mutations
- MeSH terms
- Decitabine, Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, Azacitidine, Bone Marrow, Female, Humans, Male, Middle Aged, Mutation, Myelodysplastic Syndromes, Prospective Studies, Risk Factors, Biomarkers, Tumor, Leukemia, Myeloid, Acute, Survival Rate, Tumor Suppressor Protein p53, 5-Methylcytosine, Exome
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