Abstract 395P
Background
International pivotal RCTs established olaparib as maintenance therapy in the first line (1L) and platinum-sensitive recurrent (PSR) settings for OC. However, real-world data of safety profile of olaparib in Chinese OC patients (pts) are limited. This study assessed such data in the largest Chinese OC cohort from the nationwide National Cancer Information Database (NCID).
Methods
This retrospective, observational study analyzed electronic medical records from 53 hospitals in NCID from 1 Jan 2013 to 30 Jun 2023 in China. Adult pts with newly diagnosed advanced or PSR OC who had ≥1 olaparib prescription from 1 Aug 2018 to 30 Jun 2023 were included. Primary endpoints were incidences of adverse events (AE), including AEs of special interest (AESIs) in all pts. Secondary endpoints were AEs in subgroups.
Results
Among 2,506 pts included, the mean age was 56±9 years at baseline. Olaparib was mostly used per label in clinical practice (1L monotherapy, 1L with bevacizumab, PSR monotherapy and other therapy classifications in 1,165 [46.49%], 27 [1.08%], 995 [39.70%] and 319 [12.73%] pts, respectively). In all pts, 1,560 (62.25%) had ≥1 AE, and 1,138 (45.41%) had ≥1 treatment related AE (TRAE). Most common TRAEs included anemia (n=716, 28.57%), neutrophil count decrease (n=351, 14.01%) and myelosuppression (n=248, 9.9%). 550 (21.95%) pts had grade ≥3 AEs, 380 (15.16%) had grade ≥3 TRAEs, and 185 (7.38%) had serious AEs. 1 (0.04%) pt had treatment related AESI (interstitial lung disease). Due to TRAEs, 51 (2.04%) pts discontinued study treatment, and 2 (0.08%) died. Pts in subgroups who received more lines of chemotherapy prior to olaparib, 1L olaparib plus bevacizumab, and longer olaparib treatment duration had numerically higher AE incidences than the respective comparator subgroups (Table). Table: 395P
Summary of AEs by relationship to treatment
| N (%) | Any AEs | Grade ≥3 AEs |
| Lines of chemotherapy prior to olaparib | ||
| 1 (N=1280) | 755 (58.98) | 235 (18.36) |
| 2 (N=837) | 545 (65.11) | 204 (24.37) |
| 3 (N=241) | 160 (66.39) | 66 (27.39) |
| ≥4 (N=148) | 100 (67.57) | 45 (30.41) |
| Olaparib treatment status | ||
| 1L monotherapy (N=1165) | 677 (58.11) | 202 (17.34) |
| 1L with bevacizumab (N=27) | 21 (77.78) | 11 (40.74) |
| PSR monotherapy (N=995) | 629 (63.22) | 236 (23.72) |
| Others (N=319) | 233 (73.04) | 101 (31.66) |
| Duration of olaparib treatment | ||
| ≤3 months (N=540) | 241 (44.63) | 71 (13.15) |
| (3–6] months (N=385) | 227 (58.96) | 65 (16.88) |
| (6–12] months (N=532) | 347 (65.23) | 126 (23.68) |
| (12–24] months (N=681) | 476 (69.90) | 180 (26.43) |
| >24 months (N=368) | 269 (73.10) | 108 (29.35) |
Conclusions
This largest to date, database study showed the well-tolerated and manageable safety profile of olaparib in actual clinical practice in China. No new safety signal was detected.
Clinical trial identification
NCT06324734.
Editorial acknowledgement
Medical writing support for the development of the abstract, under the input and direction of the authors, was provided by Xiaowei Ning from Costello Medical Singapore.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca China.
Disclosure
J. Deng, S. Zhang, F. Ye: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. All other authors have declared no conflicts of interest.