Niraparib is a well-tolerated maintenance therapy that provides longer progression free-survival (PFS) than placebo in patients with recurrent, platinum-sensitive ovarian cancer, who also maintain their quality of life (QoL) for the duration of niraparib maintenance, researchers reported during the ESMO 2017, the Annual Congress of the European Society for Medical Oncology in Madrid, Spain.
Amit M. Oza, Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network in Toronto, Canada, presented QoL findings on behalf of the ENGOT-OV16/NOVA investigators.
In this randomised double-blind phase III trial, patients receiving niraparib as maintenance therapy after achieving complete or partial response on platinum-based chemotherapy demonstrated significantly prolonged PFS as compared to placebo.
Improved PFS was observed regardless of the patients’ germline BRCA (gBRCA) mutation or homologous recombination deficiency (HRD) status. Patients in the niraparib group had a significantly longer median duration of PFS compared to patients in the placebo group; the overall non-mutated gBRCA showed PFS of 9.3 months versus 3.9 months (hazard ratio [HR] 0.45; 95% confidence interval [CI] 0.34, 0.61), PFS was 21.0 versus 5.5 months in the gBRCA cohort (HR 0.27; 95% CI 0.17, 0.41), and PFS was 12.9 months versus 3.8 months in the non-gBRCA cohort of patients with HRD tumours (HR 0.38; 95% CI 0.24, 0.59; p < 0.001 for all three comparisons).1
QoL with niriparib was comparable to that observed with placebo
The investigators then determined the effect of niraparib compared to placebo on QoL in patients in the ENGOT-OV16/NOVA trial using the Functional Assessment of Cancer Therapy-Ovarian Symptoms Index (FOSI) and European Quality of Life Scale 5-Dimensions (EQ-5D-5L).
Item-specific FOSI data suggest a trend for niraparib treatment improve levels pain and fatigue over time.
Individual FOSI measures show a trend for niraparib treatment to improve fatigue and pain over time.
© Amit M. Oza.
FOSI data suggest that treatment with niraparib improves their QoL in certain aspects
They further constructed a mixed-effects growth-curve model, which adjusted for baseline demographic values and 3 stratification factors to model the relationship between treatment and the patient reported outcome (PRO) score for each measure. The relationship between health status and PROs was evaluated through a cross-sectional analysis of adjusted EQ-5D-5L health utility index (HUI) scores. A disutility analysis of haematologic adverse events was conducted at different time points.
The investigators found no significant difference in mean PRO scores between patients in the niraparib and placebo arms.
According to the model, adjusted HUI scores were similar in both arms at baseline. However, the average adjusted HUI pre-progression scores trended to be higher in the niraparib arm versus the placebo arm at 0.812 versus 0.803 in patients with germline BRCA mutation compared to 0.845 versus 0.828 in non-germline BRCAmutation cohort, respectively.
They further observed that haematologic toxicities had no detrimental effect on the patients overall health-related QoL.
Conclusions
The authors noted that QoL measures are important to determine the benefit of drug therapy in this population. Data from this evaluation of PRO associated with QoL and individual patient-reported symptoms suggest that patients with recurrent ovarian cancer receiving niraparib as maintenance therapy following complete or partial response to platinum-based chemotherapy can continuously maintain their QoL while on treatment.
Disclosure
This study received funding from TESARO Inc.
Citation
- Mirza M, et al. N Engl J Med 2016;375:2154-2164.
Reference
930O - Oza AM, at al. Quality of Life in Patients with Recurrent Ovarian Cancer (OC) Treated with Niraparib: Results from the ENGOT-OV16/NOVA Trial.