New FDA Approved Breast Cancer Treatment

Studies reveal a new formulation of Herceptin is similar to previous IV form
Kathryn E. Vinson, MS, CCRC

Cancer treatment is never easy.  Its frightening.  It can make you sick.  It can consume your daily schedules for weeks, months, or even years on end. For some patients with HER2 positive breast cancers though, some of the time issues may be alleviated following the FDA approval of subcutaneous Herceptin injections, which were previously approved in an IV form.  But before we get to the newly approved dosing method, let’s take some time today to talk about what all these positives and negatives mean when we discuss breast cancer, and how those differentiations affect treatment decisions.

Positives and negatives

It seems like every time we turn on the TV, we hear an ad for new prescription medication.  When they talk about breast cancer treatments, they almost always include some combination of HER positive or negative and HR-positive or negative, and sometimes they will say “triple positive” or “triple-negative.” I have found myself wondering what all those mean, so I thought I’d share with you what I found.

HER2 refers to a protein that is found on the surface of all breast cells – be they normal cells or cancerous.  This protein promotes growth, so it is easy to discern that HER2 positive breast cancers may grow and spread faster than other types.

HR status tells us how hormones affect cancer growth.  HR stands for hormone receptor and is further broken down into ER (estrogen receptor) and PR (progesterone receptor).  Both can be positive, both can be negative, or only one of the two can be positive.

The reason that understanding the receptor status of breast cancer matters is it gives treatment teams insight into how aggressive the disease will be, as well as how it will respond to various treatments.  Certain drugs target these receptors or the hormones that attach to them.  If you have ER+ disease, for instance, estrogen blockers (known as selective estrogen receptor modulators or SERMs) or aromatase inhibitors can help in your treatment and in the prevention of recurrences by lowering the levels of estrogens circulating in your body.  Similarly, HER2 positive cancers can be treated with drugs that target the HER2 receptor.

HER2 receptor status is graded on a scale of 0, 1+, 2+, and 3+.  Those whose cancers score a 0 or 1+ are considered to have HER2 negative disease, while a 3+ is considered positive.  A grade of 2+ is called “equivocal” and needs further study.

The following image gives a good visual of how this works:

Image credit: http://www.aboutcancer.com/herceptin_0211.htm

Triple positive cancers – those that are HER2 positive, ER-positive, and PR positive can be treated with drugs that target both hormone receptors and the HER2 protein, whereas triple-negative cancers can be treated with none of these regimens.  Despite being HER2 negative, triple-negative cancers are considered to be faster growing and more aggressive than triple positive.  These cancers are also found more frequently in younger women, as well as in African-American women.

The new research

Herceptin has been on the market for around 20 years, as a drug that targets the HER2 protein.  Previously, the drug has been administered in an IV form, which takes from 30-90 minutes per infusion.  Just last week, the FDA approved the subcutaneous injection formulations of Herceptin and Herceptin Hylecta.  This approval was based on the results of the HannaH, SafeHER, and PrefHER studies.  These studies showed that the injections were “not inferior” to the already approved IV formulation.  Ladies also showed that they preferred the injection over the IV infusion by an overwhelming majority (86%).  Out of the 231 ladies surveyed, 179 stated that their preference was due to the time savings involved.

While it goes without saying that time savings may be last among our considerations when making decisions about cancer treatment, it is remarkable to find out that a new formulation of a life-saving drug can be utilized with at least the same efficacy as the older format.

As always, much love, many prayers, and abundant blessings to all of the warriors out there!

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