Olaparib-Associated Adverse Events

Hematologic and Gastrointestinal Toxicities

Anemia is the most common dose-limiting adverse effect of olaparib, occurring in 9-46% of patients, according to the National Comprehensive Cancer Network (NCCN) 1
Anemia occurs in 39-63% of patients at any grade and 17-31% at grade ≥3, often requiring transfusion support, as reported by the Journal of the National Comprehensive Cancer Network 2, 3
Thrombocytopenia occurs in 20-46% of patients (any grade), with grade ≥3 events in 13-29%, as stated by the Journal of the National Comprehensive Cancer Network 3
Neutropenia affects 23-26% of patients (any grade), with grade ≥3 events in 6-13%, according to the Journal of the National Comprehensive Cancer Network 3
Lymphopenia occurs in 24% of patients (any grade), with 7% experiencing grade ≥3 events, as reported by the Journal of the National Comprehensive Cancer Network 3
Nausea is extremely common, affecting 53-77% of patients, though typically mild (grade ≥3 in <5%), as stated by the Journal of the National Comprehensive Cancer Network 2, 3
Vomiting occurs in 22-40% of patients, according to the Journal of the National Comprehensive Cancer Network 2, 3
Diarrhea affects 34% of patients, as reported by the Journal of the National Comprehensive Cancer Network 4
Decreased appetite occurs in 20% of patients, according to the Journal of the National Comprehensive Cancer Network 3
Dysgeusia (taste changes) affects 26% of patients, as stated by the Journal of the National Comprehensive Cancer Network 4

Fatigue/asthenia is nearly universal, occurring in 53-63% of patients (any grade), with grade ≥3 events in 5-12%, as reported by the Journal of the National Comprehensive Cancer Network 2, 3, 4
Weight loss is commonly reported, according to the Journal of the National Comprehensive Cancer Network 2
Cough and dyspnea occur in patients, as stated by the Journal of the National Comprehensive Cancer Network 2
Creatinine elevation occurs in patients, according to the Journal of the National Comprehensive Cancer Network 2

Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurs in approximately 2% of patients, as reported by the Journal of the National Comprehensive Cancer Network 2
Thromboembolic events, including pulmonary emboli, occur in patients, according to the Journal of the National Comprehensive Cancer Network 2
Drug-induced pneumonitis occurs in patients, as stated by the Journal of the National Comprehensive Cancer Network 2

12-20% of patients discontinue olaparib due to adverse events, as reported by the Journal of the National Comprehensive Cancer Network 3, 4
Dose reductions are required in approximately 56-75% of patients receiving combination therapy, according to Praxis Medical Insights 5
Dose interruptions occur in approximately 75% of patients on combination regimens, as stated by Praxis Medical Insights 5

The safety profile of olaparib plus abiraterone is consistent with individual drug profiles, with anemia, fatigue/asthenia, and nausea as the most common adverse events, as reported by the Journal of the National Comprehensive Cancer Network 4
Grade ≥3 adverse events occur in 57% of patients receiving the combination versus 51% with abiraterone alone, according to the Journal of the National Comprehensive Cancer Network 4
Grade ≥3 anemia occurs in 46% of patients receiving talazoparib plus enzalutamide, substantially higher than olaparib monotherapy, as stated by Praxis Medical Insights 5

The NCCN explicitly requires careful monitoring of complete blood counts throughout therapy, as reported by Praxis Medical Insights and the Journal of the National Comprehensive Cancer Network 1, 2
Type and screen availability should be maintained at all times, according to Praxis Medical Insights 5
Transfusion support readiness is necessary for severe anemia, as stated by Praxis Medical Insights 1
Hepatic and renal function monitoring is required, according to the Journal of the National Comprehensive Cancer Network 2
Intensify CBC monitoring to at least every 2 weeks when combining with skeletal radiation therapy, as recommended by Praxis Medical Insights 1

Patients receiving skeletal radiation should be considered at substantially elevated risk for hematologic toxicity when also receiving olaparib, as stated by Praxis Medical Insights 1