Neo-adjuvant and/or Adjuvant Subcutaneous Trastuzumab (Herceptin®) in Patients With Early HER2-positive Breast Cancer: Real World Data from a German Observational Study - (NIS HerSCin).
Anticancer Res
; 41(1): 485-496, 2021 Jan.
Article
em En
| MEDLINE
| ID: mdl-33419847
ABSTRACT
BACKGROUND/AIM:
Subcutaneous Herceptin (HER SC) has been shown to be equally effective and safe compared to intravenous Herceptin (HER i.v.) application in early HER2-positive breast cancer (HER2+ BC). However, real-world data from the subcutaneous application are currently limited. PATIENTS ANDMETHODS:
Based on a non-interventional study (NIS), data from routine clinical use of HER SC have been gathered between 2013 and 2018 in 135 hospitals and open-care practices throughout Germany.RESULTS:
A total of 265 patients were recruited in the neo-adjuvant and 605 patients in the adjuvant setting. Primary effectiveness endpoint in the neoadjuvant treatment setting was pathological complete response rate, which was achieved in 41.5%. Primary endpoint in the adjuvant setting was disease free survival rate after 2 years (94.9%). Safety results from the study were comparable to the well-known safety profile of HER i.v. including preferred terms, incidence, severity, including cardiac events. No new safety signals were detected.CONCLUSION:
Effectiveness and safety of HER SC were comparable to data from HER i.v. in early HER2+ BC.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
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Receptor ErbB-2
/
Trastuzumab
/
Antineoplásicos Imunológicos
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limite:
Adult
/
Aged
/
Aged80
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Female
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Humans
/
Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
Anticancer Res
Ano de publicação:
2021
Tipo de documento:
Article