Journal of ovarian research · 2025
A multicenter, prospective, non-interventional drug intensive monitoring study of olaparib in a large real-world Chinese patient cohort with ovarian cancer (DIM-OC).
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Wang Li, Xie Lingling, Li Qingshui, Shen Yang, Wang Huaying, Sun Li, Yang Hongying, Cao Dongyan, Li Haiying, Lin Bei, Chen Qionghua, Guo Ruixia, Lou Ge, Liu Ziling, Shen Yuanming, Feng Weiwei, Zhang Ping, Zhou Jianwei, Wang Xipeng, Wang Yue, Shen Zhen, Xue Fengxia, Ma Liguo, Tu Chunhua, Yang Yingjie, Cheng Wenjun, Zhang Yi, Kang Shan, Li Congzhu, Wen Hongwu, Wu Xin, Luo Xiping, Yin Rutie, Lin Zhongqiu
Аннотация
BACKGROUND: Ovarian cancer (OC) is a highly lethal gynecological cancer. Olaparib maintenance therapy was effective and well-tolerated in pivotal RCTs. However, nationwide real-world safety information is limited in China. This multicenter, prospective, observational drug intensive monitoring study monitored the safety of olaparib in a largest-to-date, real-world Chinese OC cohort.
METHODS: Eligible OC patients had received ≥ 1 dose of olaparib. Follow-up extended up to 30 days post-olaparib discontinuation or maximally for six months post-enrolment. Primary and secondary endpoints were adverse events (AEs) in all OC patients and in special populations (hepatically/renally impaired before olaparib treatment; aged > 65 years), respectively.
RESULTS: By Jun 30, 2023, 799 patients from 33 sites were enrolled. By data cut-off (Dec 29, 2023), 796 patients treated with olaparib were analyzed. The median age was 55 years (range, 25-85). Of 796 patients, 490 (61.6%) were newly diagnosed and 306 (38.4%) had platinum-sensitive relapsed OC. AEs occurred in 343 (43.1%) patients, and 257 (32.3%) had treatment-related AEs. Anemia (19.2%) was the most common AE. Sixty-eight (8.5%) patients experienced grade ≥ 3 AEs, and 3 had AEs of special interest (AESIs; 0.4%; 1 myelodysplastic syndrome, 1 breast cancer, 1 pneumonitis). 45.2% (19/42) patients with hepatic impairment at baseline, 38.5% (5/13) with renal impairment at baseline and 38.6% (49/127) aged > 65 years experienced any AEs, respectively. No AESIs were reported in these subgroups.
CONCLUSIONS: In this largest-to-date, first prospectively enrolled, real-world Chinese OC cohort, olaparib demonstrated a well-tolerated and manageable safety profile (including in special populations) with appropriate management, regardless of treatment lines. No new safety signals were identified.
METHODS: Eligible OC patients had received ≥ 1 dose of olaparib. Follow-up extended up to 30 days post-olaparib discontinuation or maximally for six months post-enrolment. Primary and secondary endpoints were adverse events (AEs) in all OC patients and in special populations (hepatically/renally impaired before olaparib treatment; aged > 65 years), respectively.
RESULTS: By Jun 30, 2023, 799 patients from 33 sites were enrolled. By data cut-off (Dec 29, 2023), 796 patients treated with olaparib were analyzed. The median age was 55 years (range, 25-85). Of 796 patients, 490 (61.6%) were newly diagnosed and 306 (38.4%) had platinum-sensitive relapsed OC. AEs occurred in 343 (43.1%) patients, and 257 (32.3%) had treatment-related AEs. Anemia (19.2%) was the most common AE. Sixty-eight (8.5%) patients experienced grade ≥ 3 AEs, and 3 had AEs of special interest (AESIs; 0.4%; 1 myelodysplastic syndrome, 1 breast cancer, 1 pneumonitis). 45.2% (19/42) patients with hepatic impairment at baseline, 38.5% (5/13) with renal impairment at baseline and 38.6% (49/127) aged > 65 years experienced any AEs, respectively. No AESIs were reported in these subgroups.
CONCLUSIONS: In this largest-to-date, first prospectively enrolled, real-world Chinese OC cohort, olaparib demonstrated a well-tolerated and manageable safety profile (including in special populations) with appropriate management, regardless of treatment lines. No new safety signals were identified.