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Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (MDS) and/or acute myeloid leukaemia (AML). Today, data about MDS/AML are scarce.
The objective was to investigate reports of MDS/AML adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib and veliparib using the World Health Organization (WHO) and the French pharmacovigilance databases.
Here, investigators use the World Health Organization (WHO) and the French database of individual safety case reports, to identify cases of MDS/AML related to PARPi.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARP Inhibitors | Drug | olaparib, rucaparib, niraparib, talazoparib, veliparib |
| Measure | Description | Time Frame |
|---|---|---|
| MDS/AML reports related to PARPi (from WHO database). | Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the World Health Organization (WHO) database of individual safety case reports. | From inception to May 3, 2020 |
| MDS/AML reports related to PARPi (from French database). | Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the French pharmacovigilance database of individual safety case reports. The aim is to describe clinical features of these rare adverse events, including bone marrow analyzes, cytogenetic and molecular abnormalities, blasts immunophenotyping anonymously reported in this database. | From inception to May 1, 2021 |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the median time to onset since first PARPi exposure. | From inception to May 3, 2020 | |
| Description of the fatality rate. | From inception to May 3, 2020 | |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients treated with PARPi and experiencing MDS/AML.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandre Joachim | Caen | Basse Normandie | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33347814 | Derived | Morice PM, Leary A, Dolladille C, Chretien B, Poulain L, Gonzalez-Martin A, Moore K, O'Reilly EM, Ray-Coquard I, Alexandre J. Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: a safety meta-analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database. Lancet Haematol. 2021 Feb;8(2):e122-e134. doi: 10.1016/S2352-3026(20)30360-4. Epub 2020 Dec 18. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000067856 | Poly(ADP-ribose) Polymerase Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Description of patients who experienced co-reported adverse events. |
| From inception to May 3, 2020 |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |