A comparison of low‐dose cytarabine and hydroxyurea with or without all‐trans retinoic acid for acute myeloid leukemia and high‐risk myelodysplastic syndrome in patients not considered fit for intensive treatment
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BACKGROUND: The survival of older patients with acute myeloid leukemia has not improved. Few clinical trials have been available for older patients who are not considered fit for an intensive chemotherapy approach. METHODS: Between December 1998 and November 2003, as part of National Cancer Research Institute Acute Myeloid Leukemia 14 Trial, 217 patients, who were deemed unfit for intensive chemotherapy were randomized to receive low‐dose cytarabine (Ara‐C) (20 mg twice daily for 10 days) or hydroxyurea with or without all‐trans retinoic acid (ATRA). RESULTS: Low‐dose ara‐C produced a better remission rate (18% vs 1%; odds ratio [OR], 0.15; 95% confidence interval [95% CI], 0.06–0.37; P = .00006) and better overall survival (OR, 0.60; 95% CI, 0.44–0.81; P = .0009), which was accounted for by the achievement of complete remission (CR) (duration of CR: 80 weeks vs 10 weeks for patients with no CR). Patients who had adverse cytogenetics did not benefit. ATRA had no effect. Toxicity scores or supportive care requirements did not differ between the treatment arms. CONCLUSIONS: Older, less fit patients have a poor outcome, and few trials have been conducted in this patient group. Low‐dose ara‐C treatment was superior to best supportive care and hydroxyurea because it had greater success in achieving CR, and it could represent standard care against which new treatments may be compared in this patient group. [See editorial on pages 000–000, this issue.] Cancer 2007 © 2007 American Cancer Society.
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The efficacy of ATRA to treat other acute myeloid leukaemia (AML) subtypes and solid tumours remains poor.
“After decades of studies, the efficacy of ATRA to treat other acute myeloid leukaemia (AML) subtypes and solid tumours remains poor.”
From Unlocking the potential of retinoic acid in anticancer therapy (2014) · cites this paper as Burnett et al, 2007
Other phase 2 studies showed no or non-significant effects of ATRA in non-APL AML.
“However, other phase 2 studies showed no or non-significant effects (Milligan et al, 2006; Burnett et al, 2007).”
From Unlocking the potential of retinoic acid in anticancer therapy (2014) · cites this paper as Burnett et al, 2007
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- Authors
- Burnett, A. K., Milligan, D., Prentice, A. G., Goldstone, A. H., McMullin, M. F., Hills, R. K., & Wheatley, K.
- Affiliations
- Cardiff University (GB)
- Heartlands Hospital (GB)
- Derriford Hospital (GB)
- University College Hospital (GB)
- Belfast City Hospital (GB)
- Cancer Research UK Clinical Trials Unit (GB)
- Corresponding author
- Burnett, Alan K.
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2007-02-21
- Volume
- 109
- Issue
- 6
- Pages
- 1114-1124
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- OpenAlex
- W2068556430
- Cited by
- 619
- References
- 26
- Citations by year
- 2026: 5 · 2025: 14 · 2024: 13 · 2023: 23 · 2022: 28 · 2021: 43 · 2020: 45 · 2019: 40 · 2018: 29 · 2017: 37 · 2016: 36 · 2015: 54 · 2014: 48 · 2013: 42 · 2012: 36
- FWCI
- 18.95
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- ORCA Online Research @Cardiff (Cardiff University) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Research Portal (Queen's University Belfast) (submittedVersion)
- 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 › Hematopoietic Stem Cell Transplantation
- Keywords
- acute myeloid leukemia, high-risk myelodysplastic syndrome, low-dose cytarabine, hydroxyurea, all-trans retinoic acid, elderly patients, complete remission, overall survival, adverse cytogenetics, best supportive care
- MeSH terms
- Acute Disease, Aged, Antineoplastic Combined Chemotherapy Protocols, Cytarabine, Female, Humans, Hydroxyurea, Leukemia, Myeloid, Male, Middle Aged, Myelodysplastic Syndromes, Risk, Survival, Tretinoin, Treatment Outcome
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