Knowledge Management System of Hefei Institute of Physical Science，CAS
| A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer | |
Yan, Min2,3; Yuan, Peng4; Ouyang, Quchang5; Cheng, Ying6; Han, Guohui7; Wang, Dewei8; Ran, Li9; Sun, Tao10; Zhao, Da11; Bai, Yuju12; Yang, Shun'e13; Wang, Xiaojia14,15; Wu, Rong16; Zeng, Xiaohua17; Yao, Herui18; Ji, Xuening19; Jiang, Jun20; Hu, Xiaohua21; Lin, Haifeng22; Zheng, Liping23; Zhu, Zhitu24; Ge, Wei25; Yang, Junlan26; Cui, Tongjian27; Zhang, Xiaozhi28; Lu, Fangyang29; Li, Wenhui30; Xu, Hongyan31; Kang, Mafei32; Gong, Ping33 ; Zou, Liqun34; Liu, Jiang35; Zhang, Hongliang36; Yu, Hao37; Xu, Binghe1
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| 2022-10-01 | |
| Source Publication | THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
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| ISSN | 1758-8340 |
| Corresponding Author | Xu, Binghe(xbh1202@126.com) |
| Abstract | 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. |
| Keyword | breast cancer chemotherapy efficacy lobaplatin neoplasm metastasis safety |
| DOI | 10.1177/17588359221122715 |
| WOS Keyword | PLATINUM-BASED CHEMOTHERAPY ; CISPLATIN ; ANTHRACYCLINES ; MONOTHERAPY |
| Indexed By | SCI |
| Language | 英语 |
| Funding Project | `Twelfth Five-Year Plan' National Major New Drug Development Major Special Project[2013ZX 09104001] |
| Funding Organization | `Twelfth Five-Year Plan' National Major New Drug Development Major Special Project |
| WOS Research Area | Oncology |
| WOS Subject | Oncology |
| WOS ID | WOS:000873458700001 |
| Publisher | SAGE PUBLICATIONS LTD |
| Citation statistics | |
| Document Type | 期刊论文 |
| Identifier | http://ir.hfcas.ac.cn:8080/handle/334002/130000 |
| Collection | 中国科学院合肥物质科学研究院 |
| Corresponding Author | Xu, Binghe |
| Affiliation | 1.Chinese Acad Med Sci, Canc Hosp, Dept Med Oncol, 17 Panjiayuannanli, Beijing 100021, Peoples R China 2.Zhengzhou Univ, Affiliated Canc Hosp, Henan Breast Canc Ctr, Dept Breast Dis, Zhengzhou, Henan, Peoples R China 3.Henan Canc Hosp, Zhengzhou, Peoples R China 4.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 5.Hunan Canc Hosp, Dept Breast Canc Med Oncol, Changsha, Peoples R China 6.Canc Hosp Jilin Prov, Dept Oncol, Changchun, Peoples R China 7.Shanxi Med Univ, Shanxi Prov Canc Hosp, Dept Breast Surg, Taiyuan, Peoples R China 8.Hainan Gen Hosp, Dept Thorac Surg, Haikou, Hainan, Peoples R China 9.Guizhou Med Univ, Guizhou Canc Hosp, Affiliated Hosp, Dept Oncol, Guiyang, Peoples R China 10.China Med Univ, Liaoning Canc Hosp & Inst, Canc Hosp, Dept Med Oncol, Shenyang, Peoples R China 11.Lanzhou Univ, Hosp 1, Dept Internal Med Oncol, Lanzhou, Peoples R China 12.Zunyi Med Univ, Affiliated Hosp, Dept Oncol, Zunyi, Guizhou, Peoples R China 13.Xinjiang Med Univ, Affiliated Tumor Hosp, Dept Breast Canc & Lymphoma, Urumqi, Peoples R China 14.Chinese Acad Sci, Univ Chinese Acad Sci, Zhejiang Canc Hosp, Dept Breast Med Oncol,Canc Hosp, Hangzhou, Peoples R China 15.Chinese Acad Sci, Inst Canc & Basic Med IBMC, Hangzhou, Peoples R China 16.China Med Univ, Shengjing Hosp, Dept Oncol, Shenyang, Peoples R China 17.Chongqing Univ, Chongqing Canc Hosp, Breast Ctr, Chongqing, Peoples R China 18.Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Oncol, Guangzhou, Peoples R China 19.Dalian Univ, Affiliated Zhongshan Hosp, Dept Oncol, Dalian, Peoples R China 20.Gen Hosp Min Ind Grp Fuxin, Dept Surg Oncol, Fuxing, Peoples R China 21.Guangxi Med Univ, Affiliated Hosp 1, Dept Med Oncol, Nanning, Peoples R China 22.Hainan Med Univ, Affiliated Hosp 2, Dept Med Oncol, Haikou, Hainan, Peoples R China 23.Hainan Med Univ, Affiliated Hosp, Dept Breast Thorac Tumor Surg, Haikou, Hainan, Peoples R China 24.Jinzhou Med Univ, Affiliated Hosp 1, Canc Ctr, Jinzhou, Peoples R China 25.Wuhan Univ, Renmin Hosp, Ctr Oncol, Wuhan, Peoples R China 26.Peoples Liberat Army Gen Hosp, Dept Med Oncol, Beijing, Peoples R China 27.Fujian Prov Hosp, Dept Oncol, Fuzhou, Peoples R China 28.Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Radiotherapy & Oncol, Xian, Peoples R China 29.Guiyang Med Univ, Affiliated Hosp 2, Dept Oncol, Guiyang, Peoples R China 30.Kunming Med Coll, Affiliated Hosp 3, Tumor Hosp Yunnan Prov, Dept Radiotherapy, Kunming, Yunnan, Peoples R China 31.Jilin Second Peoples Hosp, Dept Oncol, Jilin, Jilin, Peoples R China 32.Guilin Med Univ, Affiliated Hosp, Dept Med Oncol, Guilin, Peoples R China 33.Shihezi Univ, Sch Med, Affiliated Hosp 1, Dept Oncol, Shihezi, Peoples R China 34.Sichuan Univ, West China Hosp, Dept Oncol, Chengdu, Peoples R China 35.Peoples Hosp Xinjiang Uygur Autonomous Reg, Dept Oncol, Urumqi, Peoples R China 36.Xinjiang Uygur Autonomous Reg Chinese Med Hosp, Dept Oncol, Urumqi, Peoples R China 37.Nanjing Med Univ, Sch Publ Hlth, Nanjing, Peoples R China |
| Recommended Citation 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). |
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