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)

• Published in: Anticancer research 2021-01, Vol.41 (1), p.485-496
• Main Authors: Schmidt, Marcus, KÜmmel, Sherko, Ruf-Doerdelmann, Antonia, Distelrath, Andrea, Wacker, JÜrgen, Schmatloch, Sabine, Busch-Liles, Saskia, LÜdtke-Heckenkamp, Kerstin
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Immunological - administration & dosage; Antineoplastic Agents, Immunological - adverse effects; Biomarkers, Tumor; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - genetics; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Chemotherapy, Adjuvant; Duration of Therapy; ErbB-2 protein; Female; Germany; Humans; Immunotherapy; Injections, Subcutaneous; Intravenous administration; Middle Aged; Molecular Targeted Therapy; Monoclonal antibodies; Neoadjuvant Therapy; Neoplasm Grading; Neoplasm Staging; Observational studies; Patients; Polymerase Chain Reaction; Prognosis; Quality of Life; Receptor, ErbB-2 - antagonists & inhibitors; Receptor, ErbB-2 - genetics; Retreatment; Safety; Survival; Targeted cancer therapy; Trastuzumab; Trastuzumab - administration & dosage; Trastuzumab - adverse effects; Treatment Outcome; Young Adult
• ISSN: 0250-7005; 1791-7530
• DOI: 10.21873/anticanres.14799

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. 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. 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. Effectiveness and safety of HER SC were comparable to data from HER i.v. in early HER2+ BC.