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

Author:

Yan Min1,Yuan Peng2,Ouyang Quchang3,Cheng Ying4,Han Guohui5,Wang Dewei6,Ran Li7,Sun Tao8,Zhao Da9,Bai Yuju10,Yang Shun’e11,Wang Xiaojia12,Wu Rong13,Zeng Xiaohua14,Yao Herui15,Ji Xuening16,Jiang Jun17,Hu Xiaohua18,Lin Haifeng19,Zheng Liping20,Zhu Zhitu21,Ge Wei22,Yang Junlan23,Cui Tongjian24,Zhang Xiaozhi25,Lu Fangyang26,Li Wenhui27,Xu Hongyan28,Kang Mafei29,Gong Ping30,Zou Liqun31,Liu Jiang32,Zhang Hongliang33,Yu Hao34,Xu Binghe35

Affiliation:

1. Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China

2. 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

3. Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha, China

4. Department of Oncology, Cancer Hospital of Jilin Province, Changchun, China

5. Department of Breast Surgery, Shanxi Provincial Cancer Hospital, Shanxi Medical University, Taiyuan, China

6. Department of Thoracic Surgery, Hainan General Hospital, Haikou, China

7. Department of Oncology, The Affiliated Hospital of Guizhou Medical University/Guizhou Cancer Hospital, Guiyang, China

8. Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China

9. Department of Internal Medicine-Oncology, The First Hospital of Lanzhou University, Lanzhou, China

10. Department of Oncology, The Affiliated Hospital of Zunyi Medical University, Zunyi, China

11. Department of Breast Cancer and Lymphoma, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China

12. 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

13. Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China

14. Breast Center, Chongqing Cancer Hospital, Chongqing University, Chongqing, China

15. Department of Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China

16. Department of Oncology, Affiliated Zhongshan Hospital of Dalian University, Dalian, China

17. Department of Surgical Oncology, General Hospital of Mining Industry Group Fuxin, Fuxin, China

18. Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China

19. Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical University, Haikou, China

20. Department of Breast-Thoracic Tumor Surgery, Affiliated Hospital of Hainan Medical University, Haikou, China

21. Cancer Center, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, China

22. Center of Oncology, Renmin Hospital of Wuhan University, Wuhan, China

23. Department of Medical Oncology, People’s Liberation Army General Hospital, Beijing, China

24. Department of Oncology, Fujian Provincial Hospital, Fuzhou, China

25. Department of Radiotherapy and Oncology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China

26. Department of Oncology, The Second Affiliated Hospital of Guiyang Medical University, Guiyang, China

27. Department of Radiotherapy, Tumor Hospital of Yunnan Province, The Third Affiliated Hospital of Kunming Medical College, Kunming, China

28. Department of Oncology, Jilin Second People’s Hospital, Jilin, China

29. Department of Medical Oncology, The Affiliated Hospital of Guilin Medical University, Guilin, China

30. Department of Oncology, The First Affiliated Hospital, Shihezi University School of Medicine, Shihezi, China

31. Department of Oncology, West China Hospital, Sichuan University, Chengdu, China

32. Department of Oncology, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China

33. Department of Oncology, Xinjiang Uygur Autonomous Region Chinese Medicine Hospital, Urumqi, China

34. School of Public Health, Nanjing Medical University, Nanjing, China

35. Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, No.17 Panjiayuannanli, Chaoyang District, Beijing 100021, China

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. Trial registration: This trial was registered with ChiCTR.org.cn, ChiCTR-ONC-13003471.

Funder

“Twelfth Five-Year Plan” National Major New Drug Development Major Special Project

Publisher

SAGE Publications

Subject

Oncology

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