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Final Analysis of the HannaH Trial: Perioperative Subcutaneous vs Intravenous Trastuzumab in HER2-Positive Early Breast Cancer

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Key Points

  • SC and IV trastuzumab were associated with similar efficacy.
  • Safety profiles for SC and IV trastuzumab were similar.

As reported in JAMA Oncology by Jackisch et al, the final analysis of the phase III HannaH trial indicated comparable efficacy and safety of perioperative subcutaneous (SC) vs intravenous (IV) trastuzumab in ERBB2 (HER2)-positive early breast cancer. Earlier reports from the trial showed similar pathologic complete response rates—a primary endpoint of the trial—and 2-year event-free survival with SC vs IV treatment.

The international open-label trial enrolled 596 patients between October 2009 and December 2010. Patients received neoadjuvant chemotherapy (docetaxel, fluorouracil, epirubicin, and cyclophosphamide) and were randomly assigned to receive SC trastuzumab at 600 mg (n = 294) or IV trastuzumab at a loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks in the neoadjuvant setting (n = 297) followed by 10 cycles of SC or IV adjuvant trastuzumab to complete 1 year of treatment. The current report describes outcomes after approximately 6 years of follow-up.

Long-Term Outcomes and Adverse Events

At 6 years, event-free survival was 65% in the SC group vs 65% in the IV group (hazard ratio [HR] = 0.98, 95% confidence interval [CI] = 0.74–1.29), and overall survival was 84% vs 84% (HR = 0.94, 95% CI = 0.61­–1.45). Patients with pathologic complete response had improved event-free survival and overall survival vs those with residual disease.

For the SC vs IV groups, adverse events of any grade occurred in 97.6% vs 94.6% of patients, grade ≥ 3 adverse events occurred in 53.2% vs 53.7%, cardiac events of any grade occurred in 14.8% vs 14.1%, and serious adverse events occurred in 21.9% vs 15.1%.

The investigators concluded, “This final analysis of the HannaH trial further confirms the comparable efficacy and safety of subcutaneous and intravenous trastuzumab and highlights the suitability of subcutaneous trastuzumab as an alternative route of administration for patients with ERBB2 [HER2]-positive early breast cancer.”

Christian Jackisch, MD, PhD, of the Department of Obstetrics and Gynecology, Sana Klinikum Offenbach GmbH, is the corresponding author for the JAMA Oncology article.

Disclosure: This study was sponsored by F. Hoffmann–La Roche Ltd. For full disclosures of the study authors, visit jamanetwork.com.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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