Yan Min, Yuan Peng, Ouyang Quchang, Cheng Ying, Han Guohui, Wang Dewei, Ran Li, Sun Tao, Zhao Da, Bai Yuju, Yang Shun'e, Wang Xiaojia, Wu Rong, Zeng Xiaohua, Yao Herui, Ji Xuening, Jiang Jun, Hu Xiaohua, Lin Haifeng, Zheng Liping, Zhu Zhitu, Ge Wei, Yang Junlan, Cui Tongjian, Zhang Xiaozhi, Lu Fangyang, Li Wenhui, Xu Hongyan, Kang Mafei, Gong Ping, Zou Liqun, Liu Jiang, Zhang Hongliang, Yu Hao, Xu Binghe
Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.
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.
Ther Adv Med Oncol. 2022 Oct 24;14:17588359221122715. doi: 10.1177/17588359221122715. eCollection 2022.
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.
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).
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).
LBP-based chemotherapy shows favorable efficacy in patients with advanced breast cancer, with manageable safety profile.
This trial was registered with ChiCTR.org.cn, ChiCTR-ONC-13003471.
由于洛铂（LBP）在中国已被批准用于治疗转移性乳腺癌，本研究旨在评估在临床实践中基于LBP的化疗的安全性和疗效。
本试验是一项前瞻性、开放标签、多中心IV期临床试验，于2013年7月至2017年3月期间从34个地点纳入了不可切除的局部晚期或复发/转移性乳腺癌患者。患者接受LBP单药治疗或联合治疗4至6个周期。主要终点是安全性。次要终点包括无进展生存期（PFS）、客观缓解率（ORR）和疾病控制率（DCR）。
共分析了1179例患者；59例（5.0%）仅接受LBP治疗，134例（11.4%）接受LBP联合紫杉醇治疗，263例（22.3%）接受LBP联合多西他赛治疗，237例（20.1%）接受LBP联合吉西他滨治疗，403例（34.2%）接受LBP联合长春瑞滨治疗，83例（7.0%）接受其他基于LBP的方案治疗。不良事件（AE）的总体发生率为95.2%，57.9%的患者发生3级以上AE。最常见的3级以上AE是中性粒细胞减少（43.9%）、白细胞减少（39.4%）、贫血（17.8%）和血小板减少（17.7%）。LBP单药治疗的3级以上AE发生率最低（39.0%），其次是LBP联合多西他赛（52.9%）、LBP联合紫杉醇（59.0%）、LBP联合长春瑞滨（62.5%）和LBP联合吉西他滨（62.9%）。ORR和DCR分别为36.8%和77.0%。中位PFS为5.5个月（95%置信区间：5.2 - 5.9）。
基于LBP的化疗在晚期乳腺癌患者中显示出良好的疗效，且安全性可控。
本试验在中国临床试验注册中心（ChiCTR.org.cn）注册，注册号为ChiCTR - ONC - 13003471。
