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.
Highlights
Ovarian cancer is the most lethal gynecologic cancer, responsible for approximately 140,000 deaths in the world annually [1]
Inhibitors, as maintenance therapy after response to a platinum-based therapy significantly changed the progression-free survival, increased response rate, and induced the long-term responses never seen before, especially in patients with BRCA mutated tumors [2,3,4,5,6,7,8]. e approval of three PARP inhibitors in rapid succession has resulted in a paradigm shift in the management of recurrent ovarian cancer
We found that patients with significantly higher odds for dose reduction were those with ECOG status 1 before olaparib
Summary
Ovarian cancer is the most lethal gynecologic cancer, responsible for approximately 140,000 deaths in the world annually [1]. There were no significant breakthroughs regarding overall survival in the therapy of ovarian cancer since introduction of platinum and paclitaxel as a standard treatment regimen. The incorporation of olaparib, niraparib, and rucaparib, PARP inhibitors, as maintenance therapy after response to a platinum-based therapy significantly changed the progression-free survival, increased response rate, and induced the long-term responses never seen before, especially in patients with BRCA mutated tumors [2,3,4,5,6,7,8]. E approval of three PARP inhibitors in rapid succession has resulted in a paradigm shift in the management of recurrent ovarian cancer. Previously required for proportion of patients demanding 16 capsules per day, was switched recently to a more manageable dosing regimen of 4 tablets per day [2, 3]. The capsules are not interchangeable with tablets
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