Faster Injectable Trastuzumab Matches Intravenous in Response Rates

A rapid, subcutaneous delivery of trastuzumab could come with several big advantages, Dr. Jose Perez-Garcia and Dr. Javier Cortes wrote in an accompanying editorial (Lancet Onc. 2012 Aug. 9 [doi.org/10.1016/S1470-2045(12)70367-4]).

"First, the ability to deliver the drug in about 5 minutes without the need to secure intravenous access makes subcutaneous treatment more convenient," wrote Dr. Perez-Garcia and Dr. Cortes of Vall d’Hebron Institute of Oncology, Barcelona. "Second, in addition to time savings, once the drug can be administered at home, patients will be able to continue their lives with less hospital dependence, which is an important psychological aspect."

The study didn’t address which drug delivery method patients preferred, or how an at-home subcutaneous administration might affect their quality of life. But another randomized study, PrefHer, aims to explore that, they wrote. PrefHer will evaluate patients' preference and healthcare satisfaction with subcutaneous vs. intravenous trastuzumab.

They also noted that the HannaH study could set a precedent for rapid approval of neoadjuvant drugs based on the pathological complete response (pCR) – but that pCR as an end point has not yet been fully vetted. "This approach appears to have at least two major limitations. First, we do not know what improvement in pCR would be necessary to translate into disease-free survival or overall survival benefit. Second, we also do not know what proportion of patients achieving a pCR would be needed to establish noninferiority between two drugs or between two methods of administering the same drug."

Finally, they wrote. "Third, the method of categorizing long-term adverse effects might be insufficient because many adverse events might appear after pCR, so if pCR is enough for regulatory purposes, the consequences of these long-term events might not be taken into account."

Dr. Perez-Garcia is an oncologist in the breast cancer program at Vall d’Hebron Institute of Oncology, Barcelona. He had no financial disclosures. Dr. Cortes, of the same institution, disclosed relationships with Roche and other companies.