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Olaparib Maintenance Monotherapy in Asian Patients with Platinum-Sensitive Relapsed Ovarian Cancer: Phase III Trial (L-MOCA)

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单位: [1]Huazhong Univ Sci & Technol,Tongji Hosp,Dept Gynecol Oncol,Tongji Med Coll,Wuhan,Peoples R China [2]Univ Chinese Acad Sci, Canc Hosp, Dept Gynecol Oncol, Zhejiang Canc Hosp, Hangzhou, Peoples R China [3]Anhui Prov Canc Hosp, Dept Gynecol Oncol, Hefei, Peoples R China [4]Hubei Canc Hosp, Dept Gynecol Oncol, Wuhan, Peoples R China [5]Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Obstet & Gynecol, Xian, Peoples R China [6]Beijing Canc Hosp, Minist Educ, Dept Gynecol, Key Lab Carcinogenesis & Translat Res, Beijing, Peoples R China [7]Tianjin Cent Hosp Gynecol Obstet, Dept Gynecol Oncol, Tianjin, Peoples R China [8]Zhengzhou Univ, Canc Hosp, Dept Gynecol Oncol, Henan Canc Hosp, Zhengzhou, Peoples R China [9]Chongqing Univ Canc Hosp, Dept Gynecol Oncol, Chongqing, Peoples R China [10]Liaoning Canc Hosp, Dept Gynecol Oncol, Shenyang, Peoples R China [11]Harbin Med Univ, Canc Hosp, Dept Gynecol Oncol, Harbin, Peoples R China [12]Hunan Canc Hosp, Dept Gynecol Oncol, Changsha, Peoples R China [13]Tianjin Med Univ, Dept Gynecol Oncol, Canc Inst & Hosp, Tianjin, Peoples R China [14]Pantai Hosp Kuala Lumpur, Canc Ctr PHKL, Kuala Lumpur, Malaysia [15]Shandong Univ, Dept Obstet & Gynecol, Qilu Hosp, Jinan, Peoples R China [16]Univ Malaya, Fac Med, Clin Oncol Unit, Kuala Lumpur, Malaysia [17]Hosp Sultan Ismail, Oncol Dept, Johor Baharu, Malaysia [18]West China Second Univ Hosp, Dept Obstet & Gynecol, Chengdu, Peoples R China [19]Zhejiang Univ, Womens Hosp, Dept Gynecol Oncol, Sch Med, Hangzhou, Peoples R China [20]Sun Yat Sen Univ, Dept Gynecol Oncol, Ctr Canc, Guangzhou, Peoples R China [21]AstraZeneca, Dept Med Affairs, Shanghai, Peoples R China [22]Fudan Univ, Zhongshan Hosp, Dept Gynaecol Oncol, Shanghai, Peoples R China [23]UTSC, Anhui Prov Hosp, Dept Obstet & Gynecol, Affiliated Hosp 1, Hefei, Peoples R China
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Purpose: In patients with platinum-sensitive relapsed (PSR) ovarian cancer, olaparib maintenance monotherapy significantly improves progression-free survival (PFS) versus placebo. However, evidence in the Asian population is lacking. This is the first study to evaluate olaparib efficacy and tolerability exclusively in Asian patients with PSR ovarian cancer. Patients and Methods: Considering the limited placebo effect and significant clinical benefit of olaparib in previous trials, and the rapid approval of olaparib in China, this phase III study was designed as an open-label, single-arm trial. Patients with highgrade epithelial PSR ovarian cancer were enrolled from countrywide clinical centers across China and Malaysia. Patients received oral olaparib (300 mg) twice daily until disease progression or unacceptable toxicity. Primary endpoint was median PFS (mPFS). Primary analysis of PFS using the Kaplan-Meier method was performed when data reached 60% maturity (clinicaltrials.gov NCT03534453). Results: Between 2018 and 2020, 225 patients were enrolled, and 224 received olaparib; 35.7% had received >= 3 lines of chemotherapy, 35.3% had achieved complete response to their last line of platinum based chemotherapy, and 41.1% had a platinum-free interval <= 12 months. At primary data cut-off (December 25, 2020), overall mPFS was 16.1 months; mPFS was 21.2 and 11.0 months in BRCAmutated and wild-type BRCA subgroups, respectively. Adverse events (AE) occurred in 99.1% of patients (grade >= 3, 48.7%); 9.4% discontinued therapy due to treatment-related AEs. Conclusions: Olaparib maintenance therapy was highly effective and well tolerated in Asian patients with PSR ovarian cancer, regardless of BRCA status. This study highlights the promising efficacy of olaparib in this Asian population.

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大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2025]版:
大类 | 1 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY
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Q1 ONCOLOGY

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第一作者单位: [1]Huazhong Univ Sci & Technol,Tongji Hosp,Dept Gynecol Oncol,Tongji Med Coll,Wuhan,Peoples R China
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通讯机构: [1]Huazhong Univ Sci & Technol,Tongji Hosp,Dept Gynecol Oncol,Tongji Med Coll,Wuhan,Peoples R China [22]Fudan Univ, Zhongshan Hosp, Dept Gynaecol Oncol, Shanghai, Peoples R China [*1]Tongji Hosp,Dept Gynecol Oncol,1095 Jie Fang Ave,Wuhan 430030,Peoples R China [*2]Fudan Univ, Zhongshan Hosp, Dept Gynaecol Oncol, 180 Fenglin Rd, Shanghai 200032, Peoples R China
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