Posted by: bcconnections | October 11, 2012

Injectable Herceptin: Improving the Patient Experience

Contributed by Rebecca Olson, Life Science Research Assistant, Stanford Cancer Institute and BCC Volunteer

One in five breast cancers are characterized as HER2-positive (HER2+), meaning that the cancer cells overproduce the HER2 protein. Overexpression of HER2 stimulates uncontrolled cell growth and aggressive tumor formation and is generally associated with worse prognosis.

Herceptin (trastuzumab) was the first targeted therapy approved by the FDA to treat HER2+ breast cancer and has since helped many women live longer worldwide. Herceptin is an antibody that binds and neutralizes the HER2 protein on the surface of cancer cells. The antibody interrupts HER2 signaling to arrest tumor cell growth, and recruits the body’s immune system to destroy tumor cells.

For women with early-stage, HER2+ breast cancer, the current Herceptin treatment regimen involves an initial ninety minute IV infusion, and subsequently, a thirty minute infusion is given every three weeks for one year.  Soon, however, Herceptin treatment may be achieved by a subcutaneous injection lasting only five minutes. Many cancer treatments can only be delivered intravenously because of the large volume of drug required for one dose. The new injectable Herceptin formulation uses the Enhanze Technology developed by Halozyme Therapeutics, which enables injection of large volumes of drug under the skin. Herceptin is injected with hyaluronidase, an enzyme that breaks down the gel-like barriers (formed of hyaluronan) between tissue cells, allowing for a large dose of the drug to be given subcutaneously without increased pain.

Injectable Herceptin was compared to the standard intravenous delivery method in the HannaH Phase III study published last month in The Lancet Oncology In short, 596 women diagnosed with early-stage, HER2+ breast cancer participated in this study.  Prior to surgery, all of the women received chemotherapy, and half of them received a 600mg fixed dose of injectable Herceptin, while the other half received intravenous Herceptin based on their body weight (6mg/kg).  After chemotherapy, but before surgery, the concentration of Herceptin in the blood was measured in both groups.  The concentration was similar across groups, indicating that both methods were effective in delivering the drug.  Following surgery, the breast tissue was tested to determine whether cancer cells remained.  If the tissue was cancer free, the woman was said to have had a “pathological complete response.”  Both groups of women demonstrated similar rates of pathologic complete response (injectable – 45.4%; IV – 40.7%).  Side effects were similar in the two groups, with no additional major side effects associated with subcutaneous delivery. The rate of serious infection was slightly higher in groups receiving injectable versus IV therapy (8% and 4%, respectively), but was not associated with the site of subcutaneous injection.

The implications of a safe and effective injectable Herceptin are great: improving patient comfort and experience, while substantially reducing the time commitment and treatment expense for patients, physicians, and nursing staff.  A pre-packaged, fixed dose injection of Herceptin requires no pharmacy prep and takes only five minutes. In the HannaH study, subcutaneous injections of Herceptin were administered by nursing teams. While this new delivery method may become available at clinics soon, the possibility of self-administration at home is still under investigation.  Still, patients will have the option to receive a short injection of Herceptin at a satellite clinic rather than spending hours at a hospital.

This new technology will open the door for many other cancer treatments. It is the first trial that evaluates a subcutaneous formulation of a monoclonal antibody and represents a great step toward creating a better patient experience.

Additional information and references:

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Responses

  1. Not quite sure how to reply but new post was excellent!    Jill

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