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
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:72 |
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| Enthalten in: |
Breast (Edinburgh, Scotland) - 72(2023) vom: 01. Dez., Seite 103597 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Liu, Binliang [VerfasserIn] |
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| Links: |
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| Themen: |
Adverse events |
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| Anmerkungen: |
Date Completed 11.01.2024 Date Revised 11.01.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.breast.2023.103597 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Liu, Binliang |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Exploring the clinical outcomes and safety profile of inetetamab treatment in metastatic breast cancer patients |b A multicenter assessment of a Chinese-origin recombinant Anti-HER2 monoclonal antibody |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 %) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Feng, Ronghua |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Zhe-Yu |e verfasserin |4 aut | |
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| 700 | 1 | |a Wu, Hui |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Jianxiang |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Xuming |e verfasserin |4 aut | |
| 700 | 1 | |a Cao, Min |e verfasserin |4 aut | |
| 700 | 1 | |a Shui, Zhengrong |e verfasserin |4 aut | |
| 700 | 1 | |a Tang, Yu |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Tao |e verfasserin |4 aut | |
| 700 | 1 | |a Ouyang, Quchang |e verfasserin |4 aut | |
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