News Release

New Herceptin® delivery method could vastly simplify breast cancer treatment

Peer-Reviewed Publication

The Lancet_DELETED

A new method of delivering a commonly used breast cancer drug could result in considerably less time spent in hospital for some women undergoing breast cancer treatment, according to the results of a Phase 3 trial published Online First in The Lancet Oncology.

Women who develop breast cancer characterised as HER2-positive – approximately 1 in 5 of all breast cancers – are often treated with a drug called trastuzumab, commonly known by its brand name Herceptin®, alongside standard chemotherapy drugs. Trastuzumab is currently delivered intravenously, requiring the patient to be connected to a drip for 90 minutes when they receive their initial dose. If the drug is well tolerated, the patient then needs to travel to hospital to receive subsequent doses, spending 30 minutes connected to a drip, usually once every 3 weeks.

The new study examines whether a newly developed form of trastuzumab which can be delivered via a standard injection (known to doctors as subcutaneous delivery) is as effective as the traditional method of intravenous delivery. In contrast to time-consuming intravenous preparations, subcutaneous injections take less than five minutes to deliver, and also have the potential to be self-administered from home with appropriate patient training and support.

The researchers found that the subcutaneous formulation of the drug appears to be as effective as the traditional intravenous formulation, with the drug being used by the body in the same way for both delivery methods, and resulting in similar levels of what scientists call pathologic complete response (pCR), defined as the disappearance of all clinical evidence of the disease.

While it is too soon to say whether the subcutaneous formulation of trastuzumab results in comparable survival times and mortality reduction as for the intravenous delivery method, previous studies suggest that pCR rates correlate with survival times and mortality reduction. The authors note that the subcutaneous formulation of the drug also has a safety profile comparable to the existing delivery method, raising hopes that in future, treatment for women taking trastuzumab for breast cancer could become considerably less time-consuming.

According to one of the study's authors, Dr Gustavo Ismael of the Amaral Carvalho Hospital in Brazil, "Our study shows that subcutaneously delivered trastuzumab offers a valid alternative to existing intravenously delivered treatments. The shortened duration of administration with subcutaneous trastuzumab has the potential to save time for patients, physicians and nursing staff."*

In a linked Comment, Javier Cortes of the Vall d´Hebron Institute of Oncology in Spain, highlights the potential advantages of delivering trastuzumab subcutaneously: "The ability to deliver the drug in about 5 minutes without the need to secure intravenous access makes subcutaneous treatment more convenient. 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. This treatment will also save resources in terms of nurses and cleaning in already crowded hospitals."*

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Dr Gustavo Ismael, Hospital Amaral Carvalho, Jaú, Brazil T) +55 14 36021399 E) gismael@uol.com.br

and

Professor Dr Christian Jackisch, Klinikum Offenbach, Offenbach, Germany T) +49 698 405 3850 E) christian.jackisch@klinikum-offenbach.de

Javier Cortes, Vall d´Hebron Institute of Oncology, Barcelona, Spain T) +34 629 550 361 E) jacortes@vhebron.net

Notes to Editors:

*Quotes direct from authors and cannot be found in text of Article / Comment.


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