Therapeutic Advances in Medical Oncology (Oct 2022)

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

  • Min Yan,
  • Peng Yuan,
  • Quchang Ouyang,
  • Ying Cheng,
  • Guohui Han,
  • Dewei Wang,
  • Li Ran,
  • Tao Sun,
  • Da Zhao,
  • Yuju Bai,
  • Shun’e Yang,
  • Xiaojia Wang,
  • Rong Wu,
  • Xiaohua Zeng,
  • Herui Yao,
  • Xuening Ji,
  • Jun Jiang,
  • Xiaohua Hu,
  • Haifeng Lin,
  • Liping Zheng,
  • Zhitu Zhu,
  • Wei Ge,
  • Junlan Yang,
  • Tongjian Cui,
  • Xiaozhi Zhang,
  • Fangyang Lu,
  • Wenhui Li,
  • Hongyan Xu,
  • Mafei Kang,
  • Ping Gong,
  • Liqun Zou,
  • Jiang Liu,
  • Hongliang Zhang,
  • Hao Yu,
  • Binghe Xu

DOI
https://doi.org/10.1177/17588359221122715
Journal volume & issue
Vol. 14

Abstract

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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.