Olaparib is well tolerated in most patients but has a number of potential side effects. With the exception of anaemia, adverse events were generally mild to moderate in severity and did not result in dose modification or treatment discontinuation. The most common grade 3 to 4 adverse events in the olaparib group were anaemia (19%), neutropenia (5%), fatigue (4%), nausea (3%) and vomiting (3%). Abdominal pain was similar in both arms (3%), as was the incidence of acute myeloid leukaemia (AML) (1%).
Dose interruptions, reductions and discontinuation occurred in 45%, 25% and 11% of the patients in the olaparib group compared to 18%, 3% and 2% respectively in the placebo group. The most common adverse events leading to discontinuation in the olaparib group were anaemia and neutropenia.
One patient (1%) in the olaparib group died from a treatment-related complication of AML. No other deaths were considered to be treatment-related.r
©Lancet Oncol 2017