Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome

Abstract

Olaparib as maintenance therapy in patients with BRCA 1-2 mutated recurrent platinum sensitive ovarian cancer. A real world experience from the MITO group.

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

“…Analyzing the total population of patients initiated on olaparib maintenance therapy in Croatia between April 18, 2016, and January 4, 2020, we observed the real-world olaparib maintenance therapy efficacy and safety comparable to the ones observed in the randomized controlled trials [2,3,13]. e progression-free survival (21 months) was longer than in the comparable Italian analysis of 234 BRCA 1-2 mutated patients who received olaparib in 13 Italian centers between September 1 2015 and May 31 2019 (14.7 months) [14], but almost the same as in the SOLO2 multicenter, double-blind, randomized, placebo-controlled, phase 3 trial (19.1 months) [3]. Italian authors explained this lower progression-free survival in their study by its realworld design and the more selected patients, highly experienced therapy providers with more strict rules and schedules in SOLO2.…”

“…Discontinuation of olaparib maintenance therapy was low in our study (3%) and completely comparable to the results of other studies. It was almost the same as in Study 19 (2%) [2], the real-world study conducted in France and Switzerland (4%) [18], Italy (5%) [14], and Korea (4%) [17]. Somewhat larger number of patients whose therapy with olaparib was discontinued because of adverse events in SOLO2 (11%) was already plausibly explained with the relatively longer follow-up (21 months) [3].…”

“…Somewhat larger number of patients whose therapy with olaparib was discontinued because of adverse events in SOLO2 (11%) was already plausibly explained with the relatively longer follow-up (21 months) [3]. Percentage of patients whose olaparib dose was reduced to control the adverse events has been very similar across different studies as well, ranging from 14% in Swedish registry real-world study [19], over 21%, 23%, 25%, and 26% in Italian study [14], Study 19 [2], SOLO2 [3], and our study, respectively, to 36% in Korean study [17]. It seems that the incidence of adverse events is somewhat higher in randomized controlled trials (35% and 36% in Study 19 and SOLO2, respectively) than in real-world data studies (17% in our study and 17% in Chinese study [20]).…”

First-line PARP inhibitors in ovarian cancer: summary of an ESMO Open - Cancer Horizons round-table discussion

“…39 More recent real-world experience suggests a reduced efficacy of platinum in patients recurring after treatment with PARP inhibitors, which perhaps is not surprising when considering that one of the identified mechanisms of PARP resistance is the occurrence of BRCA reversion mutation, which also impacts on platinum sensitivity. 40 The efficacy of subsequent chemotherapy lines after PARP inhibitor progression needs to be better addressed and additional data need to be collected in ongoing and recently closed trials as well as real-world experience to inform the optimal treatment after a PARP inhibitor.…”

Real-world evidence of poly ADP-ribose polymerase inhibitors in the treatment of ovarian cancer: A systematic literature review

“…41 The median time to treatment discontinuation was 11.6 months and dose adjustments were required in 20.9% (n ¼ 49) of patients due to toxicity. 41 The median PFS was 14.7 months (95% CI: 12.6-18.0) while median OS was not reached. 41 A retrospective study from eight hospitals in Europe was conducted in patients with EOC with germline or somatic mutations of BRCA1/BRCA2 genes.…”