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)

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 and Methods: 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 opencare 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.