Postmenopausal women who have been diagnosed with HER2 positive, estrogen receptor sensitive breast cancer can now take advantage of a drug combination just approved by the FDA. Tykerb (lapatinib) and Femara (letrozole) are not new drugs for breast cancer, but using the combination of these to treat advanced breast cancer has just been studied. Results of the study showed that women with HER2, ER positive metastatic breast cancer had almost triple the survival without progression compared to women treated with only Femara. When combined, Tykerb and Femara extended the time without disease progression by 35 weeks, as compared to 13 weeks on Femara alone.
When you think about Femara, you may consider it mostly as the drug that postmenopausal women can take after primary treatment for breast cancer. Femara blocks aromatase, preventing estrogen production and lowering your hormone levels. For women with estrogen receptor positive breast cancer, taking an aromatase inhibitor is important for preventing a recurrence. Tykerb is a targeted biological therapy which seeks out HER2 positive cancer cells, and blocks their ability to respond to growth signals from the HER2 protein. Tykerb works by inhibiting the tyrosine kinase enzyme. In 2007, the FDA approved the combination of Tykerb with Xeloda for breast cancer patients who had HER2 positive tumors that had resisted previous treatment.
Both drugs are taken as pills, and each has a variety of side effects. The study, a Phase 3 clinical trial, also showed that patients maintained their quality of life - which was better than side effects of standard chemotherapy and Femara. Results of this study were presented at the 2009 ASCO Breast Cancer Symposium by lead researcher Beth Sherrill, and sponsored by GlaxoSmithKline.
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There is a serious error in your article about the FDA accelerated approval for the combination of Tykerb (lapatinib) + Femara (letrozole) in first-line HER2+ ER+ metastatic breast cancer.
You wrote: “Results of the study showed that women with HER2, ER positive metastatic breast cancer had almost triple the survival rates of women treated with only Femara. When combined, Tykerb and Femara extended the lives of patients by 35 weeks, as compared to 13 weeks on Femara alone.”
This is NOT TRUE! The endpoint of this study is PFS (progression-free survival) not OS (overall survival). These patients did not live longer, but had a longer time to disease progression with the combination of drugs, which may or may not be beneficial, depending upon quality of life, subsequent therapy use and other factors. It is often possible to secure increased PFS by combining cancer treatments, but the studies that have compared combining treatments with giving the same drugs sequentially have shown no additional benefit in length of survival for combinations. IMO, the proper comparison for a randomized trial like this would have compared Herceptin to Tykerb in combination with Femara. Several studies say that initial treatment with Herceptin (in combination with chemo) confers longer overall survival for HER2+ metastatic patients.
As a patient advocate concerned with getting good, accurate information to patients for treatment decision-making, this kind of misstatement is really a problem.
Musa Mayer
http://AdvancedBC.org
http://BrainMetsBC.org
Musa (and readers) – I was not specific enough in the original version of this blog post, but since Musa was kind enough to point out my error, the post has been revised.
Our reviewing oncologist, Dr. VK Gadi, agreed, saying, “The data in my mind confirm that in HER2 positive disease, it is critical to address the HER2 somehow in all scenarios. it is nice to have an option that doesn’t necessarily require chemo. In breast cancer, few trials in the metastatic disease setting focus on overall survival. For now, the FDA is quite satisfied with solid PFS (progression free survival) data instead.”
- Pam Stephan
Hi, Pam I would like to find out more about a Triple negative Tumor.Thats what I had was all nodes were clear.Tumor was only 1.5 cm.Braca test Negative.No history of breast cancer in my family I am 39 years old.where does this cancer come from and what does it feeds off.no one can ansawer that question.I have changed the way I eat, I also work out 3 to 4 days a week.
I began my drug journey in Jan. 2009 ,my first drug for my anti-cancer was Arimidex and I took it for over a month. The problem with that, no over the counter med would help with the migrains. I just had to wait until it wore off. My next cancer drug was Femara and it has been very easy to take but the only problem is that is give me slight headaches. I usually take Tylenol but they recalled it,so now it’s a coated asprin.In between times I may feel a twinge so I put on my makeup-massage mask that I leave in the fridge.That usually does the trick.