P115 Quality-of-life analysis in the randomized phase II CLIO trial comparing olaparib with standard chemotherapy in platinum-resistant recurrent ovarian cancer. (1st November 2019) - Callewaert, T
Abstract : Introduction/Background: Patients with relapsed ovarian cancer receive multiple lines of chemotherapy, each negatively affecting their health-related quality of life (HRQOL). The CLIO trial randomized patients with platinum-resistant relapsed ovarian cancer (PROC) to treatment with olaparib versus standard chemotherapy (paclitaxel weekly, or pegylated liposomal doxorubicin, or gemcitabine or topotecan). Olaparib showed a favorable response rate compared with chemotherapy (Vanderstichele A et al., ASCO 2019). We aimed to assess HRQOL and quality-adjusted survival measures including Q-TWIST (quality-adjusted time without symptoms and toxicities of treatment) and QAPFS (quality-adjusted progression free survival). Methodology: EORTC questionnaires QLQ-C30 and QLQ-OV28 were administered at baseline and every three months until end of treatment. Scoring of HRQOL focused on abdominal/gastrointestinal symptoms. Overall survival was partitioned into three health states to calculate Q-TWIST: time with grade ≥2 nausea, vomiting and fatigue (toxicity), time without toxicities (twist) and relapse. Each health state was adjusted by a utility weight derived from the QLQ-C30 global health status. QAPFS calculation was based on Q-TWIST, but excluded relapse status. Results: In CLIO, we randomized 100 PROC patients 2:1 towards olaparib (n=67) and chemotherapy (n=33). Baseline compliance rate of questionnaires was 83% (88% olaparib vs. 73% chemotherapy). There was no significant difference in abdominal/gastrointestinal symptoms between both arms (p=0.4). In the olaparib-arm, significant differences were observed between responders and non-responders (p=0.001). Adverse events (AEs) of grade ≥3 occurred in 60% and 52% of patients in the olaparib and chemotherapy arm respectively (p=0.521). The difference in Q-TWIST was 35.6 days (95%CI: -121.5–27.8) in favour of chemotherapy. The difference in QAPFS was 23.8 days (95% CI: -42.2–63.5) in favour of olaparib. Conclusion: In PROC patients, olaparib monotherapy showed similar HRQOL compared to standard chemotherapy. There were no significant differences in abdominal/gastrointestinal symptoms, Q-TWIST and QAPFS between the two treatment arms. Disclosure: The presenting author, T. Callewaert, has no conflict of interest.