Patients with HER2-positive early breast cancer who received subcutaneous trastuzumab had safety and efficacy outcomes that were noninferior to intravenous trastuzumab, a 6-year follow-up analysis of the open-label, prospective, multicenter, phase III, randomized HannaH trial showed (ClinicalTrials.gov identifier: NCT00950300). The long-term trial results were recently published in JAMA Oncology.
The HannaH (Enhanced Treatment With Neoadjuvant Herceptin) trial included patients with HER2-positive early breast cancer who were randomly assigned neoadjuvant treatment with a subcutaneous trastuzumab (297 individuals) or intravenous trastuzumab (299 individuals) given concurrently with 8 cycles of chemotherapy every 3 weeks. In the adjuvant setting, patients continued their randomized treatment until 1 year of trastuzumab treatment was reached.
The 6-year event-free survival rate was 65% in both the subcutaneous and intravenous trastuzumab arms (hazard ratio [HR], 0.98; 95% CI, 0.74-1.29). Similarly, the 6-year overall survival rate was 84% in both arms (HR, 0.94; 95% CI, 0.61-1.45).
In addition, an association between total pathologic complete response and better event-free survival and overall survival rates was observed for both treatment groups.
Across the subcutaneous and intravenous trastuzumab arms, similar adverse event (AE) profiles were observed for the overall incidence of AEs (97.6% vs 94.6%, respectively), grade 3 or higher AEs (53.2% vs 53.7%, respectively), cardiac events (14.8% vs 14.1%, respectively), and serious AEs (21.9% vs 15.1%, respectively).
“This final analysis of the phase 3 HannaH trial further supports the long-term comparability of the efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab, consistent with previous reports from this study,” the study authors wrote in conclusion.
- Jackisch C, Stroyakovskiy D, Pivot X, et al. Subcutaneous vs intravenous trastuzumab for patients with ERBB2-positive early breast cancer: Final analysis of the HannaH phase 3 randomized clinical trial [published online April 18, 2019]. JAMA Oncol. doi: 10.1001/jamaoncol.2019.0339