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

doi:10.1177/17588359221122715

	A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer
	Yan, Min 4,5; Yuan, Peng 6; Ouyang, Quchang 7; Cheng, Ying 8; Han, Guohui 9; Wang, Dewei 10; Ran, Li 11; Sun, Tao 12; Zhao, Da 13; Bai, Yuju 14
刊名	THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
	2022-10-01
卷号	14
关键词	breast cancer chemotherapy efficacy lobaplatin neoplasm metastasis safety
ISSN号	1758-8340
DOI	10.1177/17588359221122715
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.
资助项目	`Twelfth Five-Year Plan' National Major New Drug Development Major Special Project[2013ZX 09104001]
WOS关键词	PLATINUM-BASED CHEMOTHERAPY ; CISPLATIN ; ANTHRACYCLINES ; MONOTHERAPY
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
内容类型	期刊论文
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.Shihezi Univ, Sch Med, Affiliated Hosp 1, Dept Oncol, Shihezi, Peoples R China 2.Guilin Med Univ, Affiliated Hosp, Dept Med Oncol, Guilin, Peoples R China 3.Chinese Acad Med Sci, Canc Hosp, Dept Med Oncol, 17 Panjiayuannanli, Beijing 100021, Peoples R China 4.Zhengzhou Univ, Affiliated Canc Hosp, Henan Breast Canc Ctr, Dept Breast Dis, Zhengzhou, Henan, Peoples R China 5.Henan Canc Hosp, Zhengzhou, Peoples R China 6.Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Dept Med Oncol,Natl Canc Ctr, Beijing, Peoples R China 7.Hunan Canc Hosp, Dept Breast Canc Med Oncol, Changsha, Peoples R China 8.Canc Hosp Jilin Prov, Dept Oncol, Changchun, Peoples R China 9.Shanxi Med Univ, Shanxi Prov Canc Hosp, Dept Breast Surg, Taiyuan, Peoples R China 10.Hainan Gen Hosp, Dept Thorac Surg, Haikou, Hainan, 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).