ESMO 2020: Maintenance Niraparib in Older Patients With Advanced Ovarian Cancer
Posted: Tuesday, October 13, 2020
An analysis of data from the phase III PRIMA/ENGOT-OV26/GOG-3012 trial concluded that age did not appear to impact the efficacy and safety profile of maintenance therapy with niraparib in patients with newly diagnosed advanced ovarian cancer who responded to first-line platinum-based chemotherapy. Previously, the study showed that niraparib significantly reduced the risk of disease progression by 38% overall compared with placebo. Giorgio Valabrega, MD, of the University of Torino, Italy, and colleagues shared their findings at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 819P).
In the double-blind, placebo-controlled trial, 733 patients were randomly assigned 2:1 to receive either a fixed starting dose of 300 mg of niraparib or placebo daily. A protocol amendment introduced an individualized starting dose of 200 mg daily for patients either weighing up to 77 kg or with a platelet count up to 150,000/μL; all other patients continued to receive a starting dose of 300 mg daily.
In this analysis, patients were divided into two age groups: 444 patients were younger than age 65 (297 niraparib, 147 placeboes), and 289 patients were at least 65 years old (190 niraparib, 99 placeboes). The efficacy of niraparib was similar in the younger patients (hazard ratio = 0.61) and older patients (hazard ratio = 0.53) compared with those who received a placebo.
As for safety, the rates of any-grade and grade ≥ 3 treatment-emergent adverse events were similar across age groups. Grade ≥ 3 thrombocytopenia events in the younger patients were reported in 43% receiving a fixed starting dose and in 18% receiving an individualized starting dose; in the older patients, the rates were 57% and 26%, respectively. “Implementation of an individualized starting dose regimen improved rates of grade ≥ 3 thrombocytopenia events in older patients,” noted the authors.
Disclosure: For a full list of author disclosures, visit oncologypro.esmo.org.