Safety and tolerability
anaemia, nausea, vomiting
ADVERSE EVENTS, DISEASE, ANAEMIA
In terms of treatment exposure, four patients came off the study whilst receiving olaparib alone and did not commence durvalumab: two due to progressive disease and two due to adverse events. The median relative dose intensity (the ratio of administered doses to planned doses) was 100% (range 70–100%). The dose of olaparib was reduced in 8 patients (17%), with six of these patients also requiring treatment delays. These dose reductions were mainly due to anaemia, nausea and vomiting, or elevated creatinine. An additional 14 patients (29%) required delays in olaparib without dose reductions and four patients required a delay of durvalumab. At the time of study analysis, there were two patients in each group still receiving olaparib.The most common AEs across grades were nausea (Compared to visit 1, no change was observed in mean on-study global health status based on the QLQ-C30, +1.3 (95% CI: −5.3 to +7.9) across all study participants. Importantly, no change was observed in mean global health status amongst 16 patients progressing before 6 months, +0.7 (95% CI: −9.7 to +11.1), while the 17 patients who remained progression-free at 6 months experienced a modest increase in mean global health status of +1.9 (95% CI: −7.4 to +11.2). Overall, none of these changes in global health status met thresholds for clinically meaningful differences [