دورية أكاديمية
Efficacy and Safety of Trastuzumab Biosimilar (CT-P6) Compared With Reference Trastuzumab in Patients With HER2-positive Advanced Gastric Cancer: A Retrospective Analysis.
| العنوان: | Efficacy and Safety of Trastuzumab Biosimilar (CT-P6) Compared With Reference Trastuzumab in Patients With HER2-positive Advanced Gastric Cancer: A Retrospective Analysis. |
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| المؤلفون: | Park JH; Division of Medical Oncology, Departments of Internal Medicine., Yeo JH; Division of Medical Oncology, Departments of Internal Medicine., Kim YS; Division of Medical Oncology, Departments of Internal Medicine., Park I; Division of Medical Oncology, Departments of Internal Medicine., Ahn HK; Division of Medical Oncology, Departments of Internal Medicine., Cho EK; Division of Medical Oncology, Departments of Internal Medicine., Shin DB; Division of Medical Oncology, Departments of Internal Medicine., Yang JY; Surgery., Kim HS; Radiology, Gachon University Gil Medical Center, Incheon, Republic of Korea., Lee WK; Surgery., Sym SJ; Division of Medical Oncology, Departments of Internal Medicine. |
| المصدر: | American journal of clinical oncology [Am J Clin Oncol] 2022 Feb 01; Vol. 45 (2), pp. 61-65. |
| نوع المنشور: | Comparative Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 8207754 Publication Model: Print Cited Medium: Internet ISSN: 1537-453X (Electronic) Linking ISSN: 02773732 NLM ISO Abbreviation: Am J Clin Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: New York, N.Y. : Masson Pub. USA, c1982- |
| مواضيع طبية MeSH: | Antineoplastic Agents, Immunological/*therapeutic use , Biosimilar Pharmaceuticals/*therapeutic use , Stomach Neoplasms/*drug therapy , Trastuzumab/*therapeutic use, Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Immunological/adverse effects ; Biosimilar Pharmaceuticals/adverse effects ; Female ; Humans ; Male ; Middle Aged ; Progression-Free Survival ; Receptor, ErbB-2/metabolism ; Retrospective Studies ; Stomach Neoplasms/mortality ; Stomach Neoplasms/pathology ; Trastuzumab/adverse effects ; Treatment Outcome |
| مستخلص: | Objectives: Treatment with trastuzumab and chemotherapy significantly improves the outcome in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). CT-P6 (trastuzumab-pkrb; Herzuma) is a trastuzumab biosimilar approved for the treatment of HER2-positive gastric cancer. In this study, we aimed to compare the efficacy and safety of CT-P6 and reference trastuzumab as first-line treatment for HER2-positive AGC. Materials and Methods: The medical records of 102 patients with HER2-positive AGC treated with first-line trastuzumab-based chemotherapy were retrospectively reviewed. These patients were treated with either reference trastuzumab (n=72) or a biosimilar (n=30). Treatment outcomes, such as objective response rate, progression-free survival (PFS), and overall survival (OS), were compared between the reference and biosimilar groups. Results: The objective response rate of both groups (52.8% and 56.8% in the reference and biosimilar groups, respectively) were comparable (P=0.72). No statistically significant difference was observed with the reference versus biosimilar trastuzumab for PFS (median PFS, 6.9 vs. 5.4 mo; P=0.98) or OS (median OS, 12.3 mo vs. not reached; P=0.42). Safety profiles were similar between the 2 groups. Conclusions: Biosimilar trastuzumab showed equivalent outcome to reference trastuzumab, with similar adverse events. Biosimilar trastuzumab can suitably and safely replace trastuzumab as a reference for the treatment of HER2-positive AGC. Competing Interests: The authors declare no conflicts of interest. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.) |
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| المشرفين على المادة: | 0 (Antineoplastic Agents, Immunological) 0 (Biosimilar Pharmaceuticals) EC 2.7.10.1 (ERBB2 protein, human) EC 2.7.10.1 (Receptor, ErbB-2) P188ANX8CK (Trastuzumab) |
| تواريخ الأحداث: | Date Created: 20220106 Date Completed: 20220214 Latest Revision: 20230902 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC8781232 |
| DOI: | 10.1097/COC.0000000000000887 |
| PMID: | 34991106 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1537-453X |
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| DOI: | 10.1097/COC.0000000000000887 |