225O - Impact of radiological disease progression on the health status of patients (pts) with BRCA-mutated advanced ovarian cancer (OC) treated with maintenance olaparib (OL) or placebo (PL) after first-line platinum chemotherapy

Background

In SOLO1 (NCT01844986), maintenance OL significantly improved progression-free survival vs PL (HR 0.30; 95% CI 0.23–0.41; Moore et al. NEJM 2018) following response to first-line platinum chemotherapy in pts with BRCA-mutated advanced OC. We compared pt health status pre- and post-radiological progression (RECIST) in SOLO1 using the EQ-5D-5L descriptive system and visual analogue scale (VAS).

Methods

EQ-5D-5L data were collected at baseline, day 29, every 12 weeks for 3 years, then every 24 weeks until data cut off (May 2018). Using the last EQ-5D-5L pre-progression as baseline, we assessed changes in each domain score, the proportion reporting any problem (levels 2–5) by domain, and Paretian classification of health change (PCHC) at first post-progression EQ-5D-5L. Impact of progression on VAS was assessed by mixed-effects repeated measures analysis. Data were pooled across study arms.

Results

74/100 OL pts and 81/95 PL pts with RECIST progression completed the EQ-5D-5L pre- and post-progression. Pre-progression, any problems were reported in 56%, 54%, 40%, 31% and 5% for anxiety/depression, pain/discomfort, usual activity, mobility, and self care respectively. Post-progression, proportions reporting problems with anxiety/ depression (68%), pain/discomfort (65%) and self care (15%) increased, while usual activity (43%) and mobility (30%) were unchanged. Across all levels, worsening was reported in anxiety/depression (34%), pain/discomfort (27%) and self care (13%). By PCHC, 56% reported worsening in at least one domain, with 37% reporting worse overall health status immediately post-progression. Progression was associated with a statistically significant and meaningful reduction in VAS (-0.0714, P < 0.0001).

Conclusions

Radiological progression after response to first-line platinum chemotherapy is associated with worsening health status, with anxiety/depression and pain/discomfort most affected. These results highlight the impact of progression on pts and pt-reported health benefits of delaying progression with maintenance OL.

Clinical trial identification

NCT01844986.

Editorial acknowledgement

Medical writing assistance was provided by Catherine Risebro, PhD, from Mudskipper Business Ltd, funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

M.L. Friedlander: Honoraria (self), Honoraria (institution), Advisory / Consultancy: AstraZeneca; Non-remunerated activity/ies, Consulting: AbbVie; Research grant / Funding (institution): Beigene; Advisory / Consultancy: Lilly; Advisory / Consultancy: MSD; Advisory / Consultancy: Takeda. R. Hettle: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. E. Parkhomenko: Honoraria (institution), Advisory / Consultancy, Full / Part-time employment, Employee of Parexel, which has received consultancy fees from AstraZeneca: AstraZeneca.