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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Myelodysplastic Syndrome |
| Drug: | azacitidine (DNMT inhibitor) |
| Direction: | Resistant |
Evidence:
Source:
Title:
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Excerpt:
...Is willing to undergo malignancy genotyping for TP53 mutation, insertion, or deletion at screening....
Trial ID:
Source:
Title:
Prospective clinical study of prophylactic low-dose azacytidine after transplantation in patients with high risk of recurrence of MDS, CMML and AML
Excerpt:
...(1) Mds-eb2 diagnosis was confirmed; (2) Karyotype with poor prognosis; (3) Ipss-r score was very high risk; (4) TP53 mutation was positive. ...
Trial ID:
More C2 evidence
Source:
Title:
A randomized controlled multi-center clinical study of Sanzi Huangshi No. 3 pills combined with azacitidine in the treatment of high-risk MDS
Excerpt:
...Do not meet the indications for transplantation (transplant indications include: age < 65 years old, high-risk group MDS patients; age < 65 years old, with severe cytopenia, ineffective after other treatments, or with genetic abnormalities with poor prognosis i.e. -7, 3q26 rearrangement, TP53 gene mutation, complex karyotype, monosomy karyotype lower-risk group patients.) or patients who refused to accept transplantation; 5. ...
Trial ID:
Less C2 evidence
Source:
Title:
APR 246 plus Azacitidine (AZA) in TP53 mutated (M) MDS and AML. Long term follow up of phase 2 study by the GFM
Published date:
07/29/2021
Excerpt:
CONTRADICTING EVIDENCE: ...Median response duration was 16.6 months (5.1-30.3+) OS was higher in patients reaching MRD negativity (5% sensitivity): median 16.6 vs 4.1 months, p<0.0001....results suggest an OS improvement in TP53 mutated MDS/AML patients treated by AZA + APR 246...
Secondary therapy:
APR-246
Source:
Title:
Prognostic value of TP53 gene mutations in myelodysplastic syndromes and acute myeloid leukemia treated with azacitidine
Excerpt:
We analyzed TP53 mutations in 62 patients with high risk MDS or AML treated with AZA...TP53 mutations strongly correlated with poorer survival in higher risk MDS and AML treated with AZA.
DOI:
10.1016/j.leukres.2014.03.012
Source:
Title:
Long-Term Follow up of a Randomized Phase 2 Study of Low-Dose Decitabine Versus Low-Dose Azacitidine in Lower-Risk Myelodysplastic Syndromes
Excerpt:
A total of 113 pts were treated: 73 with decitabine and 40 with azacitidine…On multivariate analysis, age, U2AF1, TP53, and DNMT3A mutations all correlate with poor OS…Mutations had similar effects on OS regardless of HMA used….Low-doses of HMA in pts with lower-risk MDS are safe and can improve outcomes compared to historical data in pts with intermediate or high risk features by the MDA-LRPSS.
DOI:
10.1182/blood-2019-129141
