PMID- 36330235 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221105 IS - 1758-8340 (Print) IS - 1758-8359 (Electronic) IS - 1758-8340 (Linking) VI - 14 DP - 2022 TI - A prospective, open-label, multicenter phase IV clinical trial on the safety and efficacy of lobaplatin-based chemotherapy in advanced breast cancer. PG - 17588359221122715 LID - 10.1177/17588359221122715 [doi] LID - 17588359221122715 AB - 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. TRIAL REGISTRATION: This trial was registered with ChiCTR.org.cn, ChiCTR-ONC-13003471. CI - (c) The Author(s), 2022. FAU - Yan, Min AU - Yan M AD - Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China. FAU - Yuan, Peng AU - Yuan P AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Ouyang, Quchang AU - Ouyang Q AD - Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha, China. FAU - Cheng, Ying AU - Cheng Y AD - Department of Oncology, Cancer Hospital of Jilin Province, Changchun, China. FAU - Han, Guohui AU - Han G AD - Department of Breast Surgery, Shanxi Provincial Cancer Hospital, Shanxi Medical University, Taiyuan, China. FAU - Wang, Dewei AU - Wang D AD - Department of Thoracic Surgery, Hainan General Hospital, Haikou, China. FAU - Ran, Li AU - Ran L AD - Department of Oncology, The Affiliated Hospital of Guizhou Medical University/Guizhou Cancer Hospital, Guiyang, China. FAU - Sun, Tao AU - Sun T AD - Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China. FAU - Zhao, Da AU - Zhao D AD - Department of Internal Medicine-Oncology, The First Hospital of Lanzhou University, Lanzhou, China. FAU - Bai, Yuju AU - Bai Y AD - Department of Oncology, The Affiliated Hospital of Zunyi Medical University, Zunyi, China. FAU - Yang, Shun'e AU - Yang S AD - Department of Breast Cancer and Lymphoma, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China. FAU - Wang, Xiaojia AU - Wang X AD - Department of Breast Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital and Institute of Cancer and Basic Medicine (IBMC), Chinese Academy of Sciences, Hangzhou, China. FAU - Wu, Rong AU - Wu R AD - Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China. FAU - Zeng, Xiaohua AU - Zeng X AD - Breast Center, Chongqing Cancer Hospital, Chongqing University, Chongqing, China. FAU - Yao, Herui AU - Yao H AD - Department of Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China. FAU - Ji, Xuening AU - Ji X AD - Department of Oncology, Affiliated Zhongshan Hospital of Dalian University, Dalian, China. FAU - Jiang, Jun AU - Jiang J AD - Department of Surgical Oncology, General Hospital of Mining Industry Group Fuxin, Fuxin, China. FAU - Hu, Xiaohua AU - Hu X AD - Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. FAU - Lin, Haifeng AU - Lin H AD - Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical University, Haikou, China. FAU - Zheng, Liping AU - Zheng L AD - Department of Breast-Thoracic Tumor Surgery, Affiliated Hospital of Hainan Medical University, Haikou, China. FAU - Zhu, Zhitu AU - Zhu Z AD - Cancer Center, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, China. FAU - Ge, Wei AU - Ge W AD - Center of Oncology, Renmin Hospital of Wuhan University, Wuhan, China. FAU - Yang, Junlan AU - Yang J AD - Department of Medical Oncology, People's Liberation Army General Hospital, Beijing, China. FAU - Cui, Tongjian AU - Cui T AD - Department of Oncology, Fujian Provincial Hospital, Fuzhou, China. FAU - Zhang, Xiaozhi AU - Zhang X AD - Department of Radiotherapy and Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. FAU - Lu, Fangyang AU - Lu F AD - Department of Oncology, The Second Affiliated Hospital of Guiyang Medical University, Guiyang, China. FAU - Li, Wenhui AU - Li W AD - Department of Radiotherapy, Tumor Hospital of Yunnan Province, The Third Affiliated Hospital of Kunming Medical College, Kunming, China. FAU - Xu, Hongyan AU - Xu H AD - Department of Oncology, Jilin Second People's Hospital, Jilin, China. FAU - Kang, Mafei AU - Kang M AD - Department of Medical Oncology, The Affiliated Hospital of Guilin Medical University, Guilin, China. FAU - Gong, Ping AU - Gong P AD - Department of Oncology, The First Affiliated Hospital, Shihezi University School of Medicine, Shihezi, China. FAU - Zou, Liqun AU - Zou L AD - Department of Oncology, West China Hospital, Sichuan University, Chengdu, China. FAU - Liu, Jiang AU - Liu J AD - Department of Oncology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China. FAU - Zhang, Hongliang AU - Zhang H AD - Department of Oncology, Xinjiang Uygur Autonomous Region Chinese Medicine Hospital, Urumqi, China. FAU - Yu, Hao AU - Yu H AD - School of Public Health, Nanjing Medical University, Nanjing, China. FAU - Xu, Binghe AU - Xu B AD - Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, No.17 Panjiayuannanli, Chaoyang District, Beijing 100021, China. LA - eng PT - Journal Article DEP - 20221024 PL - England TA - Ther Adv Med Oncol JT - Therapeutic advances in medical oncology JID - 101510808 PMC - PMC9623367 OTO - NOTNLM OT - breast cancer OT - chemotherapy OT - efficacy OT - lobaplatin OT - neoplasm metastasis OT - safety COIS- The authors declare that there is no conflict of interest. EDAT- 2022/11/05 06:00 MHDA- 2022/11/05 06:01 PMCR- 2022/10/24 CRDT- 2022/11/04 02:30 PHST- 2021/12/21 00:00 [received] PHST- 2022/08/10 00:00 [accepted] PHST- 2022/11/04 02:30 [entrez] PHST- 2022/11/05 06:00 [pubmed] PHST- 2022/11/05 06:01 [medline] PHST- 2022/10/24 00:00 [pmc-release] AID - 10.1177_17588359221122715 [pii] AID - 10.1177/17588359221122715 [doi] PST - epublish SO - Ther Adv Med Oncol. 2022 Oct 24;14:17588359221122715. doi: 10.1177/17588359221122715. eCollection 2022.