675PDPOLO: Health-related quality of life (HRQoL) of olaparib maintenance treatment versus placebo in patients with a germline BRCA mutation and metastatic pancreatic cancer (mPC)

Abstract Background In the Phase III POLO trial (NCT02184195) patients (pts) with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and mPC derived a statistically significant and clinically meaningful progression-free survival benefit from maintenance olaparib compared with placebo. HRQoL assessment was a predefined secondary objective. Methods Pts with a gBRCAm and mPC whose disease had not progressed during first-line platinum-based chemotherapy were randomized to receive maintenance olaparib tablets (300 mg bid) or placebo. Pts completed the EORTC QLQ-C30 questionnaire at baseline and every 4 wks until discontinuation, with calculated scores ranging from 1–100. A change of ≥ 10 points was predefined as clinically meaningful improvement (increase) or deterioration (decrease) for global HRQoL and physical function score. Overall adjusted mean change from baseline was analysed using a mixed model for repeated measures. Time to sustained clinically meaningful deterioration (TCMD) was analysed using a log-rank test. Results Analyses were conducted in 89/92 olaparib pts and 58/62 placebo pts with evaluable baseline forms (overall compliance was 96.6% and 94.8%). There was no difference between arms for global HRQoL score (Table). The adjusted mean difference for physical function scale did not reach the threshold considered to be clinically meaningful. Global HRQoL and physical function remained relatively stable over time. There was no difference in TCMD for olaparib versus placebo for global HRQoL (median 21.2 vs 6.0 mo, respectively; hazard ratio 0.72 [95% CI 0.41–1.27]) or physical function (medians not reached, 1.38 [0.73–2.63]). Table:675PDGlobal HRQoLPhysical functionMaintenance olaparibPlaceboMaintenance olaparibPlaceboAbsolute score, mean (n)Baseline70.4 (89)74.3 (58)83.3 (89)84.9 (58)Week 1273.6 (66)74.1 (36)84.4 (67)85.4 (36)Week 2473.4 (41)NC87.4 (43)NCWeek 4879.0 (23)NC89.6 (23)NCOverall change from baseline*Adjusted mean ± SE (n)−1.2±1.4 (84)1.3±1.9 (54)−2.1±1.3 (84)2.4± 1.7 (54)Between group difference (95% CI)−2.5 (−7.3, 2.3)−4.5 (−8.7, −0.2)P value0.310.04*Pts had to have baseline and ≥1 post-baseline assessmentNC, not calculated due to insufficient numbers of values; SE, standard error Conclusions HRQoL was preserved during maintenance olaparib treatment with no meaningful difference versus placebo. Findings support the observed clinical benefit of maintenance olaparib in pts with a gBRCAm and mPC. Clinical trial identification NCT02184195. E