The C-PATROL study is a single-arm, prospective, noninterventional study in Germany of 278 patients who have BRCA-mutated platinum-sensitive relapsed (PSR) ovarian cancer and are undergoing maintenance treatment with the poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib. One of the outcome measures of the study is the assessment of health-related quality of life (HRQOL) in patients participating in the study. This analysis collects both clinical and patient-reported data utilizing 2 HRQOL questionnaires (ie, Functional Assessment of Cancer Therapy for Patients with Ovarian Cancer [FACT-O] and Functional Assessment of Chronic Illness - Fatigue [FACIT-F]) to obtain general cancer-related information and ovarian cancer–specific data.
The hard-capsule form of olaparib was the first PARP inhibitor approved in the European Union in 2014 as monotherapy for the maintenance treatment of patients with PSR BRCA-mutated ovarian cancer who are responding to platinum-based chemotherapy (PBC). Film-coated tablets were approved in the European Union in 2018 for PSR ovarian cancer with or without BRCA mutations, and in 2019 for patients with BRCA-mutated ovarian cancer who are responding to first-line PBC. Prior to this study, limited data were available surrounding the real-world quality-of-life impact on patients undergoing olaparib treatment. This interim analysis generated real-world data on patient characteristics, dosing, adverse events, and safety for the use of olaparib as maintenance therapy.
The patients included in the study had PSR ovarian cancer and were in partial or complete response to the chemotherapy treatment immediately prior to study enrollment. In addition, the cancers were documented as BRCA1 and/or BRCA2 mutated. This fourth interim analysis in 278 patients focused on HRQOL during the first year of olaparib maintenance treatment. The participants in the study had a median age of 60 years (range, 36-85 years), 93.3% of participants had Eastern Cooperative Oncology Group scores of ≤1, and 32% of patients had ≥2 prior platinum chemotherapies while 33.9% had ≥3 prior platinum chemotherapies. Patients started with a median daily dose of 800 mg of olaparib. At data cutoff, median therapy duration was 11 months (range, 0-49 months), and 34% of patients were still receiving olaparib maintenance. Adverse events were reported in 92% of patients; however, serious adverse events only occurred in 22% of patients.
The HRQOL questionnaires were administered to more than 80% of patients at baseline and at the third month of treatment, and more than 60% of participants provided questionnaires after 6 months of treatment, 55% at 9 months of treatment, and 45% at 1 year of treatment.
The results of the study reveal the mean scores of the FACT-O total score, FACT-O trial outcome index (TOI), and the FACIT-F score remained stable throughout the 12-month assessment period. The FACT-O total and TOI mean scores (± SD) at baseline were 111.1 ± 19.2 and 71.8 ± 13.6, with mean changes at month 12 of –0.50 ± 15.65 and 0.13 ± 11.96, respectively. The FACIT-F mean score (± SD) was 34.7 ± 10.9 at baseline, and the mean change from baseline at 12 months was 0.09 ± 9.09.
The data analyzed from the C-PATROL noninterventional study reveals that maintenance treatment with olaparib for patients with BRCA-mutated PSR ovarian cancer is well tolerated and does not negatively impact HRQOL.
Abstract and Poster 825P. ESMO 2020. September 19-21, 2020. Olaparib maintenance therapy in routine clinical practice: quality of life interim results of the non interventional C-PATROL study in ovarian cancer patients in Germany.