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A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer

文献类型：期刊论文

作者Yan, Min10,11; Yuan, Peng12; Ouyang, Quchang13; Cheng, Ying14; Han, Guohui15; Wang, Dewei16; Ran, Li17; Sun, Tao18; Zhao, Da19; Bai, Yuju20
刊名THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
出版日期2022-10-01
卷号14
ISSN号1758-8340
关键词breast cancer chemotherapy efficacy lobaplatin neoplasm metastasis safety
DOI10.1177/17588359221122715
通讯作者Xu, Binghe(xbh1202@126.com)
英文摘要Background: Since lobaplatin (LBP) has been approved to treat metastatic breast cancer in China, this study aimed to evaluate the safety and efficacy of LBP-based chemotherapy in clinical practice. Methods: This trial was a prospective, open-label, multicenter phase IV clinical trial that enrolled patients with unresectable locally advanced or recurrent/metastatic breast cancer from 34 sites between July 2013 and March 2017. Patients were treated with LBP monotherapy or in combination for four to six cycles. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Results: A total of 1179 patients were analyzed; 59 (5.0%) were treated with LBP alone, 134 (11.4%) with LBP plus paclitaxel, 263 (22.3%) with LBP plus docetaxel, 237 (20.1%) with LBP plus gemcitabine, 403 (34.2%) with LBP plus vinorelbine, and 83 (7.0%) with other LBP-based regimens. The overall incidence of adverse events (AEs) was 95.2%, and 57.9% of patients had grade >3 AEs. The most common grade >3 AEs were neutropenia (43.9%), leukopenia (39.4%), anemia (17.8%), and thrombopenia (17.7%). LBP monotherapy showed the lowest incidence of grade >3 AEs (39.0%), followed by LBP plus docetaxel (52.9%), LBP plus paclitaxel (59.0%), LBP plus vinorelbine (62.5%), and LBP plus gemcitabine (62.9%). The ORR and DCR were 36.8 and 77.0%, respectively. The median PFS was 5.5 months (95% confidence interval: 5.2-5.9). Conclusion: LBP-based chemotherapy shows favorable efficacy in patients with advanced breast cancer, with manageable safety profile.
WOS关键词PLATINUM-BASED CHEMOTHERAPY ; CISPLATIN ; ANTHRACYCLINES ; MONOTHERAPY
资助项目`Twelfth Five-Year Plan' National Major New Drug Development Major Special Project[2013ZX 09104001]
WOS研究方向Oncology
语种英语
出版者SAGE PUBLICATIONS LTD
WOS记录号WOS:000873458700001
资助机构`Twelfth Five-Year Plan' National Major New Drug Development Major Special Project
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/129999]  
专题中国科学院合肥物质科学研究院
通讯作者Xu, Binghe
作者单位1.Jilin Second Peoples Hosp, Dept Oncol, Jilin, Jilin, Peoples R China
2.Guiyang Med Univ, Affiliated Hosp 2, Dept Oncol, Guiyang, Peoples R China
3.Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Radiotherapy & Oncol, Xian, Peoples R China
4.Fujian Prov Hosp, Dept Oncol, Fuzhou, Peoples R China
5.Peoples Hosp Xinjiang Uygur Autonomous Reg, Dept Oncol, Urumqi, Peoples R China
6.Shihezi Univ, Sch Med, Affiliated Hosp 1, Dept Oncol, Shihezi, Peoples R China
7.Guilin Med Univ, Affiliated Hosp, Dept Med Oncol, Guilin, Peoples R China
8.Kunming Med Coll, Affiliated Hosp 3, Tumor Hosp Yunnan Prov, Dept Radiotherapy, Kunming, Yunnan, Peoples R China
9.Chinese Acad Med Sci, Canc Hosp, Dept Med Oncol, 17 Panjiayuannanli, Beijing 100021, Peoples R China
10.Zhengzhou Univ, Affiliated Canc Hosp, Henan Breast Canc Ctr, Dept Breast Dis, Zhengzhou, Henan, Peoples R China
推荐引用方式
GB/T 7714		 Yan, Min,Yuan, Peng,Ouyang, Quchang,et al. A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer[J]. THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY,2022,14.
APA Yan, Min.,Yuan, Peng.,Ouyang, Quchang.,Cheng, Ying.,Han, Guohui.,...&Xu, Binghe.(2022).A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer.THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY,14.
MLA Yan, Min,et al."A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer".THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY 14(2022).

入库方式： OAI收割

来源：合肥物质科学研究院

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