Niraparib Maintenance Therapy Extends Quality-Adjusted Survival by 8 Months in Advanced Ovarian Cancer
Key Insights
Niraparib significantly improved quality-adjusted progression-free survival by approximately 8 months compared to placebo in women with newly diagnosed advanced ovarian cancer (search) who responded to first-line platinum-based chemotherapy.
The PRIMA trial demonstrated that niraparib extended quality-adjusted time without symptoms of disease or toxicity by 9 months in the overall cohort, with even greater benefits observed in patients with homologous-recombination-deficient tumors.
Disease progression was associated with marked deterioration in health-related quality of life across multiple functional scales, supporting progression-free survival as a clinically relevant endpoint in advanced ovarian cancer (search) treatment.
Women with newly diagnosed advanced ovarian cancer (search) who received niraparib as first-line maintenance therapy experienced significant quality-adjusted progression-free survival benefits compared to placebo, according to updated results from the PRIMA/ENGOT-OV26/GOG-3012 trial presented at ESMO Congress.
The analysis, led by Hannelore Denys, MD, PhD, medical oncologist at UZ Gent in Belgium, showed that niraparib extended quality-adjusted progression-free survival (QA-PFS) by approximately 8 months compared to placebo after 6.2 years of follow-up. Among the overall cohort, niraparib extended mean duration of QA-PFS to 24.3 months versus 16.4 months with placebo, representing a mean difference of 7.9 months (95% CI, 4.7-11.4).
Enhanced Benefits in Homologous Recombination-Deficient Patients
The benefits were particularly pronounced in patients with homologous-recombination-deficient tumors, where niraparib extended QA-PFS by more than 14 months (33.3 months vs. 19.2 months; mean difference = 14.1 months; 95% CI, 8.5-19.2). This subgroup also experienced nearly 16 months of extended quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) compared to placebo (38 months vs. 22.1 months; mean difference = 15.9 months; 95% CI, 9.3-21.6).
Quality of Life Impact of Disease Progression
Complementary research from the same trial, presented by Mark S. Shahin, MD, of Sidney Kimmel Medical College of Thomas Jefferson University, revealed the significant impact of disease progression on health-related quality of life. Using the European Organisation for Research and Treatment of Cancer QOL Core Questionnaire (EORTC QLQ-C30) and the EORTC QLQ Ovarian Cancer (search) Module (EORTC QLQ-OV28), researchers found that patients experiencing disease progression had significantly worse overall health-related quality of life, regardless of treatment assignment.
The study showed "marked decreases from the last on-treatment visit for global health status/QOL that never recovered to LOTV levels." Disease progression was associated with deterioration across all five functional scales of the EORTC QLQ-C30, as well as decreased scores for body image, sexuality, and attitude toward disease/treatment functional scales, along with worsening abdominal/gastrointestinal symptoms.
Trial Design and Patient Population
The PRIMA trial randomly assigned 733 participants in a 2:1 ratio to receive niraparib (n = 487; median age, 62 years; range, 32-85) or placebo (n = 246; median age 62 years; range, 33-88) as first-line maintenance therapy. All patients had responded to first-line platinum-based therapy. Survey completion rates exceeded 80% across both quality of life instruments at the end of treatment.
Sustained Treatment Benefits Over Time
The extended follow-up analysis revealed that treatment gains for both QA-PFS and Q-TWiST were sustained and even enhanced from the primary analysis. Niraparib extended QA-PFS 3.8 months more from the primary analysis, and Q-TWiST an additional 5.5 months in the overall population.
"Niraparib treatment gains for restricted mean duration of QA-PFS and Q-TWiST were extended from the primary to final analysis, likely because PFS gains were sustained with longer follow-up while the majority of treatment-emergent adverse events occur within the first 3 months of niraparib treatment," Denys explained.
The researchers concluded that these results support progression-free survival as a clinically relevant endpoint in patients with advanced ovarian cancer (search), as delays in disease progression help preserve health-related quality of life. "By integrating the quantity and quality of progression-free time, these findings further support the clinical benefit of niraparib vs. placebo for the maintenance treatment of patients with newly diagnosed advanced ovarian cancer that responded to first-line platinum-based chemotherapy," Denys stated.