PMID- 37668154 OWN - NLM STAT- MEDLINE DCOM- 20231102 LR - 20231102 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 22 IP - 10 DP - 2023 Jul-Dec TI - Safety of PARP inhibitors as maintenance therapy in ovarian cancer. PG - 897-908 LID - 10.1080/14740338.2023.2254699 [doi] AB - INTRODUCTION: Antiangiogenic agents and poly(ADP-ribose) polymerase inhibitors (PARP-Is) have improved the outcome of patients suffering from ovarian cancer. However, as they are associated with many adverse events (AEs), it is important to be aware of their safety and toxicity profiles. AREAS COVERED: We reviewed PARP-I therapeutical indications, mechanism of action, metabolism, and interactions. We reported on all major and minor AEs that have emerged from clinical trials (SOLO1, PRIMA, PAOLA1, ATHENA, SOLO2, NOVA, ARIEL3, NORA), their follow-ups, meta-analyses, and real-world studies, particularly hematologic toxicities and their management, and secondary malignancies (myelodysplastic syndrome and acute myeloid leukemia). We also addressed gastrointestinal, neurological, respiratory, hepatic, and renal toxicity and the use of PARP-Is in older, pregnant, and lactating patients. No specific research strategy in terms of keywords, inclusive dates and databases was used. EXPERT OPINION: PARP-Is benefits largely outweigh the risks associated with potential AEs. Randomized controlled trials produced strong good, quality data, but they enrolled a selected population and failed to capture rare events. More pharmacovigilance data and real-life studies on a larger and more heterogeneous sample are needed to understand PARP-Is differences and to clarify the incidence of late AEs to balance the risk/benefit ratio. FAU - Cecere, Sabrina Chiara AU - Cecere SC AD - Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy. FAU - Casartelli, Chiara AU - Casartelli C AD - Medical Oncology Unit, University Hospital of Parma, Parma, Italy. FAU - Forte, Miriam AU - Forte M AD - Department of Precision Medicine, Division of Medical Oncology, University of Campania Luigi Vanvitelli, Naples, Italy. FAU - Pignata, Sandro AU - Pignata S AD - Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy. FAU - Pisano, Carmela AU - Pisano C AD - Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy. LA - eng PT - Journal Article PT - Review DEP - 20230914 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Poly(ADP-ribose) Polymerase Inhibitors) RN - 0 (Piperazines) RN - 0 (Piperidines) SB - IM MH - Humans MH - Female MH - Aged MH - *Poly(ADP-ribose) Polymerase Inhibitors/adverse effects MH - Lactation MH - *Ovarian Neoplasms/drug therapy MH - Piperazines MH - Piperidines/adverse effects OTO - NOTNLM OT - PARP inhibitor OT - acute myeloid leukemia OT - adverse events OT - myelodysplastic syndrome OT - niraparib OT - olaparib OT - ovarian cancer OT - rucaparib EDAT- 2023/09/05 12:42 MHDA- 2023/09/05 12:43 CRDT- 2023/09/05 06:53 PHST- 2023/09/05 12:43 [medline] PHST- 2023/09/05 12:42 [pubmed] PHST- 2023/09/05 06:53 [entrez] AID - 10.1080/14740338.2023.2254699 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2023 Jul-Dec;22(10):897-908. doi: 10.1080/14740338.2023.2254699. Epub 2023 Sep 14.