Real-World Experience of Olaparib Maintenance in High-Grade Serous Recurrent Ovarian Cancer Patients with BRCA1/2 Mutation: A Korean Multicenter Study

Abstract

Background: Olaparib maintenance therapy has shown efficacy and tolerability in patients with platinum-sensitive, high-grade serous recurrent ovarian cancer (HSROC) with BRCA1/2 mutation (BRCAm). Our aim was to present real-world experience with olaparib in Korea. Method: We included HSROC patients with BRCAm treated with olaparib maintenance at four institutions in Korea between 2016 and 2018. Medical records were reviewed for clinico-pathologic characteristics, objective response, survival outcomes, and safety. Results: One hundred HSROC patients with BRCAm were included. BRCA1 mutation was present in 71 patients (71.0%), and BRCA2 mutation was present in 23 patients (23.0%). In terms of the best objective response with olaparib maintenance in 53 patients with partial remission from most recent chemotherapy, complete remission occurred in 12 (22.6%) and partial remission in four (7.5%), while 33 patients (62.3%) had stable disease. The 24 month progression-free survival was 42.4%, and 24 month overall survival was 82.1%. Grade 3 or more adverse events were as follows: anemia in 14 patients (14.0%), neutropenia in seven patients (7.0%), thrombocytopenia in two patients (2.0%), oral mucositis in one patient (1.0%), and soft tissue infection in one patient (1.0%). Conclusions: The safety and effectiveness of olaparib maintenance treatment in a real-world study were consistent with those reported in previous clinical trials.

What predicts the clinical benefits of PARP inhibitors in platinum-sensitive recurrent ovarian cancer: A real-world single-center retrospective cohort study from China

“…The percentage of grade 3–4 hematological AEs, dose reduction (15.3%) and treatment discontinuation (4.2%) in the olaparib maintenance therapy group in our study was very similar to that of different studies ( 4 , 9 , 10 , 26 ). The rates of grade 3–4 hematological AEs, dose reduction (23.5%), dose interruption (23.5%) and treatment discontinuation in patients receiving niraparib were generally lower than those reported in the phase 3 NORA trial ( 7 ), and were comparable to those observed in a real-world study in China ( 27 ).…”

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

“…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]).…”

“…Tablets instead of capsules are probably part of the explanation for markedly longer progression-free survival in SOLO2 [3] and our study compared to Study 19 (11.2 months in patients with BRCA 1-2 mutation) [13]. Progression-free survival in the Italian study was almost the same as in the real-world data study performed in Korea in 2016-2018 [17]. Our previous explanation for somewhat shorter progression-free survival in the case of Italian study which postulated the effect of 16% of patients with no objective response to the previous chemotherapy does not hold for the Korean study as they enrolled only the patients with complete or partial response to the last platinum-based treatment before initiation of olaparib, as we and SOLO2 did.…”

“…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].…”

Comparisons of survival outcomes between bevacizumab and olaparib inBRCA-mutated, platinum-sensitive relapsed ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG 3052)

“…In terms of effectiveness, the OLA users in the current study showed better PFS (median, 23.8 vs. 19.1 vs. 14.6 months), compared to those in SOLO2 [ 11 ] and a previous real-world Korean study [ 17 ]. This may be because our study only included patients who relapsed for the first time, whereas SOLO2 also included patients with multiple recurrences.…”