Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study.
Expert Opin Biol Ther
; 24(4): 305-312, 2024 Apr.
Article
en En
| MEDLINE
| ID: mdl-38664937
ABSTRACT
BACKGROUND:
The trastuzumab biosimilar CT-P6 is approved for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC). The objective of this post-marketing surveillance (PMS) study was to evaluate the real-world safety and effectiveness of CT-P6 in patients with HER2-positive cancers. RESEARCH DESIGN ANDMETHODS:
This open-label, observational, prospective, PMS study collected data via investigator surveys from 35 centers in the Republic of Korea (5 October 2018-4 October 2022). Eligible patients with HER2-positive EBC, MBC, or MGC started CT-P6 treatment during routine clinical practice, followed by 1-year observation. Evaluations included adverse events (AEs), adverse drug reactions (ADRs), and effectiveness.RESULTS:
Safety was analyzed in 642 patients (494 EBC, 94 MBC, 54 MGC). Overall, 325 (50.6%) patients experienced 1316 AEs, and 550 ADRs occurred in 199 (31.0%) patients. Unexpected ADRs occurred in 62 (9.7%) patients. Unexpected ADRs and ADRs of special interest did not raise any new safety signals. Among trastuzumab-naïve patients, 34/106 (32.1%) with EBC achieved pathological complete response; 30/74 (40.5%) MBC and 24/49 (49.0%) MGC patients achieved complete or partial response.CONCLUSIONS:
In a real-world setting, CT-P6 demonstrated safety and efficacy findings consistent with previous CT-P6 studies.Palabras clave
Texto completo:
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Bases de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
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Neoplasias Gástricas
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Neoplasias de la Mama
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Biosimilares Farmacéuticos
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Trastuzumab
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Antineoplásicos Inmunológicos
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Asia
Idioma:
En
Revista:
Expert Opin Biol Ther
Asunto de la revista:
BIOLOGIA
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TERAPEUTICA
Año:
2024
Tipo del documento:
Article