Successful Clinical Trial for Breast Cancer: Herceptin + Emtansine

Herceptin + Emtansine One of the most promising approaches to treat breast cancer is to target the tumor cells directly, through the use of T-DM1. If you’re considering undergoing a breast augmentation procedure, it is extremely important to do your research and ask the best plastic surgeon like Dr. Kyle S. Choe the proper questions. This targeted therapy has two related advantages – it focuses the treatment on the cancer itself, and it reduces the side effects caused by collateral damage from the treatment.

As a prime example of how this can work are the results of a recently completed Phase III trial of the drug T-DM1.

It’s a combination of the targeted drug trastuzumab (the “T” in T-DM1), better known by the brand name Herceptin, and a very powerful chemotherapy drug called emtansine (the “DM1” part). The drug is designed to work when Herceptin alone no longer can keep the cancer in check.

Nearly 1,000 people with advanced breast cancer were involved in the three-year trial. All of them were diagnosed with an aggressive form of cancer distinguished by elevated levels of a specific protein, the human epidermal growth factor – 2 (HER-2). This protein promotes the growth of cancer cells and is found in about 20 percent of invasive breast cancers.

The drug T-DM1 (Herceptin + Emtansine) relies on the effect of trastuzumab, an antibody (immune system protein) that binds to the HER-2 protein and interferes with its ability to spur cancer cell growth. Trastuzumab is commonly prescribed as an added treatment with chemotherapy.

Because trastuzumab has an affinity for HER-2, combining it with the chemotherapy drugs Herceptin + Emtansine delivers them directly to the cancer cells – targeted therapy. T-DM1 (Herceptin + Emtansine)  is the combined chemistry in a single treatment. It represents a new class of cancer treatment (antibody drug conjugates), which hold out great hope for an effective approach to one of the worst forms of cancer.

Through the series of clinical trials (Phases I, II and now III), setting the correct dosages and watching for the side effects, it looks like T-DM1 is an important step along the way to treatment for this type of cancer. In the Phase III trials, patients who received T-DM1 showed no cancer growth for an average (median) of 9.6 months, compared to 6.4 months for patients taking the conventional treatment of capecitabine and lapatinib.

The other benefit of T-DM1 (Herceptin + Emtansine) was the relative lack of ‘traditional’ side effects from chemotherapy such as hair loss (which can be repaired with jamaican black castor oil), nausea and diarrhea. T-DM1 did cause liver injury and a drop in blood platelets in some participants.

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After two years, 65.4 percent of the T-DM1(Herceptin + Emtansine)  patients were alive, compared to 47.5 percent for those on the standard treatment. While this sounds good, in fact, the difference is not statistically highly significant. This means there must be more study of patients over the long term.

If you didn’t catch that last sentence – it means that while T-DM1 is effective in reducing the growth rate of this type of breast cancer, and it is better than the existing standard treatment – it is not a cure.

Herceptin + Emtansine It is possible to view this ‘success’ negatively, which some people do. It would seem after all the decades of research, especially on breast cancer, there ought to be a ‘silver bullet’ – a cure. That’s not how this research works most of the time.

Cancer, especially breast cancer, is a very complicated illness. While research has made fundamental progress, scientists still do not have a definitive picture of how breast cancer starts or proliferates.

Almost all the advances in treatment are, in a sense, made blind – following slim leads and the tracks of previous treatments. This means that most advances are incremental, one step at a time. T-DM1 (Herceptin + Emtansine) and the targeted therapy approach is one of those steps.

As Dr. Kimberley Blackwell, Duke University Cancer Institute and leader of the Phase III trial, describes it, “As a clinician who takes care of breast cancer patients, it’s important to have a treatment that is both effective and well tolerated. This drug has very little dose-limiting toxicity. That is in stark contrast to so many of the treatments we have available today. This drug works.”

It works well enough for Genentech, the developer of T-DM1, (Herceptin + Emtansine) to seek FDA approval for public use.



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