Real-World Experience Differs from Trial Results for Niraparib in Recurrent Ovarian Cancer
Patients in the real world setting were initiated at a lower dose and experienced fewer side effects than trial participants.
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Real-world experience of adverse events with the oral PARP inhibitor niraparib in patients with platinum-sensitive recurrent ovarian cancer at a 200 mg daily dose differed from those most commonly seen in the phase 3 clinical trial at a 300 mg daily, according to data that will be presented at the 2018 ESMO Congress in Munich, Germany.
In a phase 3 clinical trial of niraparib, patients initiated therapy at a 300 mg daily dose of the drug. Nausea, thrombocytopenia, and fatigue were the most commonly reported adverse events and more than 60% of patients reported experiencing these 3 events in the study. After dose adjustment in the trial, 200 mg per day was the most commonly administered dose.
In this retrospective analysis, researchers wanted to describe adverse events among patients in a real-world setting given a 200 mg starting dose of niraparib. For the study 53 study-qualified physicians were randomly selected from a national database and were requested to extract data from the medical charts of 153 qualified patients who had received 200 mg per day niraparib for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. All patients were in complete or partial response to platinum-based chemotherapy.
In contrast to the 60% of patients in the phase 3 clinical trial, a little more than one-third (37%) of the real-world patients included experienced at least 1 of the 3 most common adverse events within the first 3 months of treatment initiation; 32% experienced only grade 1/2 events.
Overall, fatigue was reported in 24% of patients, nausea in 16% or patients, and thrombocytopenia in 14% of patients. Only 2% of patients experienced grade 3 or worse thrombocytopenia.
Very few patients had a dose interruption (4%) or had to discontinue niraparib altogether due to adverse events (2%). However, about 1 in 10 patients (11%) had to reduce their dose.
The researchers wrote that more real-world research would help to understand the effect of niraparib dosing on adverse events.
Disclosure: This study was funded by Tesaro.
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- Gallagher JR. Real world occurrence of top three clinical-trial reported adverse events of PARP inhibitor niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer, a national retrospective observational study of a 200 mg/day starting-dose cohort. Abstract presented at the ESMO 2018 Congress; Munich, Germany: October 20, 2018. Abstract 986P.