Olaparib Outcomes in Patients with BRCA 1-2 Mutated, Platinum-Sensitive, Recurrent Ovarian Cancer in Croatia: A Retrospective Noninterventional Study

Abstract

Our objective was to assess the safety and efficacy of olaparib in maintenance therapy of BRCA 1-2 mutated, platinum-sensitive, recurrent ovarian carcinoma after the partial or complete response to the second or further lines platinum-based chemotherapy in a real-world setting. We performed a multicenter, real-world observational population-based cohort study on the whole population of Croatian patients initiated to olaparib maintenance therapy between 2016 and 2020. The primary endpoints were progression-free survival and the discontinuation of treatment because of adverse events. We enrolled the total population of 69 patients with the median (interquartile range; IQR) age of 53 (48–59), 56 (81%) of them with BRCA1 mutation. The median (IQR) follow-up was 16 (9–25) months. Treatment had to be discontinued because of toxicity in 2 (3%) and temporarily interrupted in 14 (20%), while dose was reduced because of toxicity in 18 (26%) of patients. Toxicity of any grade was observed in 61 (88%) patients and toxicity of grade 3 or 4 in 12 (17%). Median progression-free survival was 21 (95% CI 16-not calculable) months from the introduction of olaparib, and the median overall survival was not reached. Our study confirmed efficacy and safety of olaparib as the maintenance therapy of BRCA 1-2 mutated, platinum-sensitive, recurrent ovarian carcinoma. We observed the real-world efficacy and safety comparable to those observed in the randomized controlled trials. We found the interesting observation of better efficacy of 300 mg tablets, compared to 400 mg capsules, an issue that should be addressed on much larger real-world populations.

Comprehensive Genomic Profiling in the Management of Ovarian Cancer—National Results from Croatia

“…Furthermore, one can argue that with more precise diagnostics, classical clinical trials will no longer suffice for drawing conclusions regarding treatment, and we will have to learn for and from every patient individually. Hence, importance and emphasis are placed on real-world data and clinical experience to determine the real efficacy and toxicity, for which we already have positive feedback for the use of PARP inhibitors for ovarian cancer [ 37 , 38 ].…”

Real-World Efficacy and Safety of Bevacizumab in the First-Line Treatment of Metastatic Cervical Cancer: A Cohort Study in the Total Population of Croatian Patients

“…Moreover, the organizational approach to regular work-ups and general oncological care, especially in the underserved parts of the world where the majority of cases are diagnosed, explain the difference between outcomes in real-world settings [9,10]. erefore, it is important to monitor the real-world efficacy and safety of the given drug to understand its actual use and benefits in everyday clinical practice [11,12]. Furthermore, this could be tremendously important for cervical cancer, where the burden of the disease is high in less-developed countries, since bevacizumab is a rather expensive drug.…”