Exploring the clinical outcomes and safety profile of inetetamab treatment in metastatic breast cancer patients: A multicenter assessment of a Chinese-origin recombinant Anti-HER2 monoclonal antibody
Binliang Liu,
Ning Xie,
Can Tian,
Ronghua Feng,
Zhe-Yu Hu,
Jing Li,
Liping Liu,
Huawu Xiao,
Xiaohong Yang,
Mengsi Zeng,
Hui Wu,
Jun Lu,
Jianxiang Gao,
Xuming Hu,
Min Cao,
Zhengrong Shui,
Yu Tang,
Tao Wu,
Quchang Ouyang
Affiliations
Binliang Liu
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Ning Xie
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Can Tian
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Ronghua Feng
Department of Oncology, Changde Hospital, Xiangya School of Medicine, Central South University, Changde, Hunan, 415000, China
Zhe-Yu Hu
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Jing Li
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Liping Liu
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Huawu Xiao
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Xiaohong Yang
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Mengsi Zeng
Department of Oncology, Changde Hospital, Xiangya School of Medicine, Central South University, Changde, Hunan, 415000, China
Hui Wu
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Jun Lu
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Jianxiang Gao
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Xuming Hu
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Min Cao
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Zhengrong Shui
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China
Yu Tang
Department of Gastroenterology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410013, China
Tao Wu
Department of Oncology, Changde Hospital, Xiangya School of Medicine, Central South University, Changde, Hunan, 415000, China; Corresponding author. No. 818, Renmin Road, Changde, 415000, China.
Quchang Ouyang
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China; Corresponding author. No. 283, Tongzipo Road, Yuelu District, Changsha, 410000, China.
Background: Inetetamab is a novel recombinant humanized anti-HER2 monoclonal antibody. This study aimed to evaluate the efficacy and safety of inetetamab and predictive factors for response in HER2-positive metastatic breast cancer (MBC) patients. Methods: A cohort of HER2-positive MBC patients who received inetetamab-based therapy between June 2020 and August 2021 was evaluated. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR) and disease control rate (DCR). Adverse events (AEs) were graded according to the National Cancer Institute Common Toxicity Criteria. Results: A total of 141 patients were included in the final analysis. The median PFS of the entire cohort was 7.1 months. The median number of treatment lines administered was three. The ORR was 36.9 %, and the DCR was 80.9 %. The most frequently employed treatment strategy was inetetamab + chemotherapy (49/141, 34.8 %), followed by inetetamab + HER2-tyrosine kinase inhibitors (HER2-TKIs) + chemotherapy, inetetamab + pertuzumab + chemotherapy, inetetamab + endocrine treatment and inetetamab + HER2-TKIs. Cox multivariate analysis revealed that PFS was associated with liver metastasis (hazard ratio [HR] 2.112, 95 % confidence interval [CI] 1.334–3.343, p = 0.001), previous HER2-TKI treatment (HR 2.019, 95 % CI 1.133–3.597, p = 0.017) and estrogen receptor positivity (HR 0.587, 95 % CI 0.370–0.934, p = 0.024). The toxicity was tolerable, with neutropenia being the most common treatment-related grade 3/4 AE (14.9 %). Conclusion: Inetetamab demonstrates effectiveness with a manageable safety profile, offering a promising therapeutic option for HER2-positive breast cancer patients who have shown resistance to prior anti-HER2 treatments.
