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P115 Quality-of-life analysis in the randomized phase II CLIO trial comparing olaparib with standard chemotherapy in platinum-resistant recurrent ovarian cancer
  1. T Callewaert1,
  2. A Vanderstichele1,
  3. E Van Nieuwenhuysen1,
  4. S Han1,
  5. N Concin1,
  6. T Van Gorp1,
  7. P Berteloot1,
  8. P Neven1,
  9. P Busschaert1,
  10. D Lambrechts2,3 and
  11. I Vergote1
  1. 1BGOG and Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven Cancer Institute, Leuven, European Union
  2. 2Center for Cancer Biology, VIB
  3. 3Laboratory for Translational Genetics, Department of Oncology, KU Leuven, Leuven, Belgium


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.

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