Thursday, June 30, 2011

FDA Panel Upholds Ban on Avastin, Even for Metastatic TNBC

The story, from an Internal Medicine News article by Elizabeth Mechcatie:

SILVER SPRING, MD. – In a series of three unanimous votes, a Food and Drug Administration advisory panel supported the agency’s decision to withdraw approval of bevacizumab for metastatic breast cancer.

Panelists voted 6-0 on June 29 that the available evidence does not show bevacizumab (Avastin) to be safe or effective for the first-line treatment of women with metastatic HER2-negative breast cancer, in combination with paclitaxe


The company said that no new safety signals were seen in the studies, that the drug’s adverse event profile is well-known, and that effects like proteinuria and hypertension are generally manageable. It contended that bevacizumab combined with paclitaxel had a favorable risk-benefit profile as a first-line treatment of metastatic breast cancer –and that its safety profile was in line with other first-line metastatic breast cancer treatments.

The company also said that access to the treatment should be maintained for women with triple-negative metastatic breast cancer, as they have few treatment options.

But FDA officials explained that based on the overall data, the agency decided that the benefits do not outweigh serious and potentially life-threatening risks, which can include intestinal perforations, impaired wound healing, and hemorrhages. MORE

Monday, June 27, 2011

Yale Scientists Say 10-20 Percent of TNBC Cases May Be Misdiagnosed

A news release from Yale University:

A team of Yale Cancer Center researchers has confirmed that between 10-20% of breast cancers classified as Estrogen Receptor (ER) negative are really positive. Understanding when and why breast cancers may be misclassified has important implications for treatment and outcomes for women diagnosed with breast cancer. Its findings are published online in the June 28 Journal of Clinical Oncology.

A woman diagnosed with breast cancer can be tested by immunohistochemistry (IHC), a process that detects the presence of specific proteins in cancer tissue. Those who test positive for ER are prescribed an endocrine therapy, like Tamoxifen, Letrazol or a similar drug. The 10-20% of cancer patients who are incorrectly classified as ER negative may be treated with less effective therapies.

Led by David Rimm, M.D., professor of pathology at Yale School of Medicine, the research team highlighted the limitations of IHC in the assessment of Estrogen Receptor in breast cancer and defined a new method for standardizing ER measurement. It used a novel method to detect the estrogen receptor that uses fluorescent detection in conjunction with a series of standard controls. The team reported that this more sensitive and reproducible method finds cases initially called "negative" that behave as "positive."

"Our research shows that the conventional methods of measurement of Estrogen Receptor may result in a 10-20% false negative rate," said Rimm. "This may be leading to under-treatment of breast cancer patients and we may be missing the opportunity to use one of our best drugs (Tamoxifen) due to inadequate testing."

The assay has been licensed to HistoRx Inc. of Branford, Conn. The test will soon be available to patients in Clinical Laboratory Improvement Amendments-certified labs. The first lab to release the test will be Genoptix Inc. based in Carlsbad, California.

Friday, June 17, 2011

TNBC News from ASCO 2011

The Triple Negative Foundation has an excellent overview of research presented at the annual meeting of the American Society for Clinical Oncology (ASCO) June 2 through 7, 2011. While several studies dealt with TNBC, none was groundbreaking. According to the Foundation:

This year, according to TNBCF Medical Advisory Board Member, Eric Winer, MD, there was no study presented on TNBC that represents a major step forward or will have a significant immediate impact on clinical practice. That statement is true for the meeting as a whole in which the majority of studies were focused on incremental advances, especially in the area of targeted therapies.

Thursday, June 16, 2011

Finishing a Triathlon Three Years after TNBC

This is one of the short profiles from the book I am writing on TNBC:

Here’s one way to get over the worries about cancer treatment and the fears of its return: Run a triathlon or two. That’s the approach Julie Desloge took—she completed her first sprint triathlon in June 2010, a little more than two years after she was diagnosed with triple-negative. She did two additional races that summer—and her radiation oncologist was her teammate on the final one.

On that race, her doctor swam 1.5 kilometers, another friend ran 10 kilometers, and Julie biked 40 kilometers. That translates to slightly less than a mile swim, a 24.8-mile bike ride, and a 6.2-mile run.


And a year later, in June 2011, just one week shy of her third cancerversary, Julie finished another race, this time the entire sprint triathlon: Swimming. Biking. And running.

Julie is thoroughly enjoying her healthy new pursuit and enjoying life, period. It took some doing and a serious commitment—eight months of training that was far from easy. Running, she writes on her wonderful blog, is the most difficult for her—she has trouble getting enough air. But she keeps at it and each time it is a little easier.

Julie was diagnosed with a 2.6-centimeter triple-negative tumor in February 2008 when she was 41. She had neoadjuvant chemotherapy—four rounds of Taxotere and Cytoxan—that got rid of all but .3 centimeters of the tumor, a nearly 90 percent reduction.

Easily speaking the jargon on cancer, she says, “No pathologically complete response for me.” And, while her response was only partial, it nevertheless was significant, offering her a positive prognosis that she is making the most of.

A lumpectomy followed chemo, with radiation after that.

Risk factors? She’s negative for the BRCA mutation, but wonders about her reproductive history—she started her periods young, at age 11. And she’s the mother of three children, who were 11, 9, and 6 at the time of diagnosis, although she breastfed all three for nine to ten months.

She was about 15 pounds overweight when she was diagnosed; Taxol added another 8 pounds or so. Her weight continues to be a challenge, even with her high level of exercise. She now weighs more than she did at diagnosis, although much of that is probably muscle, which weighs more than fat. I haven't really found the key to unlocking much weight loss,” she says. Still, we’re talking about being only slightly beyond her ideal—Julie says her BMI is a healthy 24.8.

She had been exercising regularly before cancer, doing cardio and resistance exercises four to five days a week. But she upped the ante after treatment and hit the triathlon circuit with her husband Denis near their Portland, Oregon home.

Cancer, she says, not only gave her motivation to maintain a healthy lifestlye, but it provided a chance to look outside herself at what others are going through. She’s bothered when friends protest that they should not complain about any problems they encounter, given what she faced in cancer treatment. “Pain is pain,” she says.

The one effect she could do without is the constant anxiety that comes from follow-up doctor visits. “While my doctors are incredible people and I enjoy them personally, I still don't like the reason I have to see them,” she says.

By making her radiation oncologist her racing partner, she’s turning at least one medical relationship into a fun one, helping her move on with her life at a pretty good clip.

Wednesday, June 15, 2011

Chondroitin sulfate may fight breast cancer

I take a combination of glucosamine and chondroitin for my achy bones; I am pretty sold on it, as I notice that I have more bone pain when I forget to take my daily doses. Now, I am pleased to find that on ingredient of this concoction, chondroitin sulfate glycosaminoglycans, may help fight breast cancer. The research, published in the journal Breast Cancer Research, is available online and in a downloadable PDF.