599 Real-life tolerability of PARP inhibitors using specific PRO-CTCAE questionnaires: a single centre experience in ovarian cancer

Introduction/Background* Maintenance therapy with PARP inhibitors (PARPis) in Epithelial Ovarian Cancer (EOC) is associated with outstanding results in progression free survival but has to be weighted on patients’ quality of life (QoL). Objective of the analysis of specific questionnaires from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is to achieve an applicable measure of patients outcomes. Methodology Patients treated with PARPis between November 2016 and December 2020 were enrolled in this prospective study. PRO-CTCAE questionnaires were generated on the specific toxicities of PARPis using the form builder developed by the Division of Cancer Control and Population Science in the National Cancer Institute at the National Institute of Health and administered to the cohort. Patients toxicities, as recorded by physicians, were analyzed and compared with monthly PRO-CTAE questionnaires. Result(s)* Thirty-one EOC patients underwent maintenance therapy with PARPis after 1 (24%), 2 (48%) and ≥3 (28%) lines of chemotherapy. The median age was 56 (range 35-77), 83.3% of patients had an ECOG Performance Status 0 and 14 (45.2%) were BRCA mutated. 50% received olaparib, 42.9% niraparib and 7,1% rucaparib. No patient discontinued treatment due to toxicity and 38.7% delayed the treatment due to anaemia (29%) or thrombocytopenia (9,7%). Haematological toxicities and asthenia were the most frequent adverse events recorded by physicians and occurred in 42.5% and 45.2% of patients, respectively. Concordance between the toxicity reported by patients and by physicians was observed in 40% of cases. PRO-CTCAE questionnaires contributed to the toxicity evaluation revealing symptoms under-reported by physicians, in particular: 35.7% of anorexia, 79.5% of nausea, 90% of vomiting, 63.7% of constipation, 79.8% of diarrhea, 35.3% of asthenia, 87.4% of arthralgia and 100% of headache and insomnia. Conclusion* PRO-CTCAE is a toxicity assessment tool that should be required especially in the monitoring of maintenance treatments. The physician’s evaluation of toxicities, enriched by the patient reported outcomes, could allow more targeted and earlier interventions and potentially affect the adherence to the treatment. All authors have no conflict of interest