HannaH Trial: Subcutaneous Versus Intravenous Trastuzumab in Early Breast Cancer
Posted: Friday, August 16, 2019
For patients with ERBB2 (HER2)-positive early breast cancer, the efficacy and safety of perioperative subcutaneous versus intravenous trastuzumab seem to be comparable. This result, which is based on the final analysis of the phase III international HannaH trial, is consistent with previous reports from this study. Christian Jackisch, MD, PhD, of the Sana Klinikum Offenbach GmbH, Germany, and colleagues published their findings in JAMA Oncology.
A total of 596 patients who received neoadjuvant chemotherapy (docetaxel, fluorouracil, epirubicin, and cyclophosphamide) were enrolled in this study. They were randomly assigned nearly evenly to receive subcutaneous trastuaumb at 600 mg or intravenous trastuzumab at a loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks in the neoadjuvant setting followed by 10 cycles of subcutaneous or intravenous adjuvant trastuzumab to complete 1 year of treatment.
At a 6-year final analysis, event-free survival was 65% and overall survival was 84% in both groups, indicating no difference in outcomes between the administration routes. Safety data compiled showed no significant differences in terms of grade 3 or higher adverse events (with both groups at about 53%) and any adverse events (more than 90% in both groups). As for cardiac toxicity, about 14% of both groups experienced cardiac events of any grade.
The investigators concluded: “This final analysis of the HannaH trial…highlights the suitability of subcutaneous trastuzumab as an alternative route of administration for patients with ERBB2 [HER2]-positive early breast cancer.”
Disclosure: The study authors’ disclosure information may be found at jamanetwork.com.