{"id":329073,"date":"2021-05-10T09:33:11","date_gmt":"2021-05-10T07:33:11","guid":{"rendered":"https:\/\/medizinonline.com\/new-option-in-first-line-maintenance-therapy\/"},"modified":"2021-05-10T09:33:11","modified_gmt":"2021-05-10T07:33:11","slug":"new-option-in-first-line-maintenance-therapy","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/new-option-in-first-line-maintenance-therapy\/","title":{"rendered":"New option in first-line maintenance therapy"},"content":{"rendered":"

Ovarian cancer is still the most lethal gynecologic tumor and, especially in advanced stages, the risk of progression remains high even with optimal therapy [1, 2]. Thus, effective treatments that reduce the risk of progression or death after first-line chemotherapy are needed [1]. For patients with homologous recombination deficiency (HRD), a new option became available in April 2021 [3].<\/p>\n

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The randomized, double-blind phase III PRIMA trial demonstrated the efficacy of maintenance therapy with niraparib (Zejula) in patients with newly diagnosed advanced ovarian cancer. The patients had prior response to platinum-based chemotherapy and were at high risk of progression. Approximately half of the 733 patients included had HRD, of whom approximately 60% had a BRCA mutation and 40% did not [1]. In Switzerland, niraparib is approved in patients with BRCA mutation or other HRD [3].<\/p>\n

Vedopplication of median PFS in patients with HRD [1].<\/strong><\/p>\n

After a median follow-up of 13.8 months, median progression-free survival (PFS) was more than twice as long with niraparib as with placebo in patients with HRD (21.9 versus 10.4 months, Figure). This corresponds to a 57% reduction in the risk of progression or death (HR: 0.43; 95% CI: 0.31-0.59; P<0.001) [1]. The PFS benefit of niraparib was observed regardless of BRCA status. Thus, in a prespecified exploratory analysis, a substantial risk reduction was observed in both HRD-positive patients with (HR: 0.40; 95% CI: 0.265-0.618; P<0.0001) and without BRCA mutation (HR: 0.50; 95% CI: 0.305-0.831; P=0.0064) [4].<\/p>\n

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Figure:<\/strong> Median progression-free survival with niraparib versus placebo in patients with HRD in the randomized, double-blind phase III PRIMA trial (adapted from [1]). Censored persons are shown as circles.<\/p>\n

Established <\/strong>Tolerance profile [3, 4]<\/strong><\/p>\n

The most common adverse events (\u226530%) with niraparib in the PRIMA trial were anemia, nausea, thrombocytopenia, constipation, and fatigue. Anemia, thrombocytopenia, and neutropenia were observed as the most common serious adverse events (grade \u22653) [1]. Adverse effects could be managed by treatment interruptions or dose reductions, and only 12% of patients in the overall population discontinued treatment due to adverse effects [1]. Overall quality of life was maintained with niraparib [1].<\/p>\n

Conclusion<\/strong><\/p>\n

With the April 2021 indication expansion, niraparib provides first-line maintenance therapy for advanced ovarian cancer that can be used in all patients with HRD regardless of BRCA status [3]. As shown by data from the PRIMA trial, niraparib significantly reduces the risk of progression or death compared to placebo while maintaining quality of life [1]. With its once-daily oral administration independent of meals, PARP inhibitor is a patient-friendly option that has a manageable tolerability profile [1, 3].<\/p>\n

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Individualized starting dosage [3]<\/strong><\/p>\n

Niraparib was also approved in the first line with an individualized starting dose:<\/div>\n