机构：[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河南省肿瘤医院[3]Henan Canc Hosp, Zhengzhou, Peoples R China河南省肿瘤医院[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浙江省肿瘤医院[15]Chinese Acad Sci, Inst Canc & Basic Med IBMC, Hangzhou, Peoples R China浙江省肿瘤医院[16]China Med Univ, Shengjing Hosp, Dept Oncol, Shenyang, Peoples R China中国医科大学附属盛京医院中国医科大学盛京医院[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中山大学附属第二医院[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四川大学华西医院[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
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.
基金：
`Twelfth Five-Year Plan' National Major New Drug Development Major Special Project [2013ZX 09104001]
第一作者机构：[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
通讯作者：
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:doi:10.1177/17588359221122715.
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)
