A multicenter, prospective, non-interventional drug intensive monitoring study of olaparib in a large real-world Chinese patient cohort with ovarian cancer (DIM-OC)
Year: 2025
Type: article
Study design: Observational Study
Abstract: 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.
Source: Journal of Ovarian Research
Authors: Li Wang, Lingling Xie, Qingshui Li, Yang Shen, Huaying Wang, Li Sun, Hongying Yang, Dongyan Cao, Haiying Li, Bei Lin, Qionghua Chen, Ruixia Guo, Ge Lou, Ziling Liu, Yuanming Shen, Weiwei Feng, Ping Zhang, Jianwei Zhou, Xipeng Wang, Yue Wang, Zhen Shen, Fengxia Xue, Liguo Ma, Chunhua Tu, Yingjie Yang, Wenjun Cheng, Yi Zhang, Shan Kang, Congzhu Li, Hongwu Wen, Xin Wu, Xiping Luo, Rutie Yin, Zhongqiu Lin
Institutions: Zhengzhou University, Henan Cancer Hospital, Sun Yat-sen University, Sun Yat-sen Memorial Hospital, Shandong Tumor Hospital, Zhongda Hospital Southeast University, Women's Hospital, School of Medicine, Zhejiang University, Zhejiang University, Southeast University, Fudan University Shanghai Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming Medical University, Peking Union Medical College Hospital, Sheng Jing Hospital, China Medical University, Xiamen University, First Affiliated Hospital of Xiamen University, First Affiliated Hospital of Zhengzhou University, Harbin Medical University, Third Affiliated Hospital of Harbin Medical University, First Hospital of Jilin University, Shanghai Jiao Tong University, Ruijin Hospital, Zhangjiagang First People's Hospital, Second Affiliated Hospital of Zhejiang University, XinHua Hospital, Henan University, Henan Provincial People's Hospital, University of Science and Technology of China, CAS Key Laboratory of Quantum Information, USTC, Tianjin Medical University General Hospital, Tianjin Medical University, Jinan University, Southern University of Science and Technology, ShenZhen People’s Hospital, First Affiliated Hospital of Nanchang University, Guiyang Medical University, Guizhou Cancer Hospital, Jiangsu Province Hospital, Nanjing Medical University, First Hospital of China Medical University, Hebei Medical University, Fourth Hospital of Hebei Medical University, Cancer Hospital of Shantou University Medical College, Peking University First Hospital, Shanghai Medical College of Fudan University, Fudan University, Obstetrics and Gynecology Hospital of Fudan University, Guangdong Province Women and Children Hospital, Sichuan University, West China Second University Hospital of Sichuan University
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,290
OpenAlex ID: W4417415648