(UroToday.com) In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Smith presented an analysis of patient-reported health-related quality of life (HRQoL) based on the phase II open-label GALAHAD (NCT02854436) study of niraparib in mCRPC patients with DNA repair defects (DRD) who had progressed on prior taxane-based chemotherapy and androgen signaling inhibitor therapy.
Within the context of this trial, patients with DRD were categorized as BRCA (BRCA1 or BRCA2) or non-BRCA (ATM, FANCA, PALB2, CHEK2, BRIP1, HDAC2) mutant. HRQoL assessments were performed at Day 1 of specified cycles and metrics included the Functional Assessment of Cancer Therapy–Prostate Total Score (FACT-P TS) and Brief Pain Inventory–Short Form (BPI-SF). The authors assessed changes from baseline HRQoL patients with BRCA vs non-BRCA DRD using a mixed model for repeated measures. Patients were classified as improved/stable or worsened based on established meaningful change thresholds. Generalized estimating equations were used to calculate odds ratios of HRQoL improvement using non-BRCA as the reference category.
Among the entire ITT population (n=223), 221 patients completed the HRQoL evaluations at baseline (BRCA, n=140; non-BRCA, n=81). Within each of these cohorts, a subset patients experienced improved or stable HRQoL, pain intensity, and pain interference. these effects tended to be more pronounced among those with BRCA mutations.
While numbers are limited, in general a similar or greater proportion of patients with BRCA mutations pts had improved or stable FACT-P TS/BPI-SF scores compared to those with non-BRCA mutations. These differences were apparent and widening at earlier cycles.
By cycle 3, BRCA patients had 2.4 times greater odds of experiencing clinically meaningful improvements in overall HRQoL (FACT-P TS) than non-BRCA patients and this increased further (to 4.4 times greater odds) by cycle 5. Finally, those patients with BRCA mutations were also significantly more likely to experience meaningful reductions in pain intensity and interference.
The authors therefore conclude that treatment with niraparib in advanced mCRPC was associated with improved or maintained overall HRQoL, pain intensity, and pain interference with a greater effect among patients with BRCA mutations.
Presented by: Matthew R. Smith, MD, Ph.D., Professor of Medicine, Harvard Medical School, Assistant in Medicine, Hematology/Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.