Inflammatory Breast Cancer
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Tuesday, February 14, 2012

GENENTECH STATEMENT ON COUNTERFEIT DRUG LABELED AS AVASTIN® (BEVACIZUMAB) IN THE UNITED STATES

SOUTH SAN FRANCISCO, Calif. – February 14, 2012 – Roche and Genentech have been informed that a counterfeit product, labeled as Avastin (bevacizumab), has been distributed in the United States.

The counterfeit product is not safe or effective and should not be used. Chemical analyses of the counterfeit vials tested to date have confirmed the product does not contain the active ingredients for Avastin.

Patient safety is Roche and Genentech’s primary concern. We are working with the U.S. Food and Drug Administration (FDA) and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent its further distribution.

Important Information for Healthcare Providers to Identify Suspected Counterfeit Product
If a healthcare provider has any product in their possession that they suspect may be counterfeit, they should immediately contact the FDA’s Office of Criminal Investigations (OCI) at 1-800-551-3989 (www.fda.gov/OCI) or Genentech’s Product Quality Assurance department at 1-800-334-0290.

It is believed that some product in the United States labeled as Avastin 400 mg/16 mL with the following lot numbers on either the vials or packaging may be counterfeit:

• B86017
• B6011
• B6010

The counterfeit product does not look similar to authentic Avastin that is FDA-approved for the treatment of certain cancers in the United States. The images below show some of the differences. In addition, the following is true for all authentic Avastin that is FDA-approved for use in the United States:

• All cartons and vials approved for use in the United States have “Genentech” or “Genentech, a member of the Roche Group” printed on the labels;
• The lot number on the carton and vial should be 6 digits with no letters;
• The expiry date is formatted as a 3-letter month and 4-digit year, e.g. JUL 2014;
• The date of manufacture is not printed on the carton or vial;
• All the text on the vial labels, cartons and package inserts is English.

Authentic Avastin FDA-Approved for Use in the United States

Counterfeit Product

 

 

http://www.gene.com/gene/news/press-releases/press_statements/ps_021412.html

 

Genomic and Proteomic Pathway Mapping Reveals Signatures of Mesenchymal-Epithelial Plasticity in Inflammatory Breast Cancer
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Circulating tumor cells not linked to survival in newly diagnosed inflammatory breast cancer

Results also suggest patients who have stray tumor cells in the blood should receive aggressive treatment, even if imaging shows no metastases

SAN ANTONIO, TX — The presence of circulating tumor cells in the blood appears to have no relationship to survival in women who have just been diagnosed with inflammatory breast cancer, according to new research from Fox Chase Cancer Center. However, the research shows that these stray tumor cells may signal that the disease has spread to other parts of the body, even before imaging reveals any metastases. The results will be presented on Friday, December 9 at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium.

If a woman is diagnosed with inflammatory breast cancer, a particularly fast-growing form of the disease, doctors should consider close imaging to monitor and possibly continue aggressive treatment if she also has circulating tumor cells (CTCs), regardless of what imaging shows, recommends study author Massimo Cristofanilli, M.D., F.A.C.P., chair of the department of medical oncology at Fox Chase. “You should be carful before stopping treatment in someone who has evidence of circulating cells, particularly when dealing with a disease like inflammatory breast cancer, which can progress rapidly.”

Previous research by Cristofanilli and his colleagues found that the number of stray cancer cells circulating in the blood is the best predictor of both how long a woman with metastatic breast cancer will live and the amount of time until her cancer progresses. But the researchers have also found that the presence or lack of CTCs has little to say about prognosis in women with metastatic inflammatory breast cancer, an aggressive disease with extremely poor outcomes in spite of multidisciplinary modality treatment.

During the current study, Cristofanilli and his team reviewed the records of 84 women who had just learned they have inflammatory breast cancer, either in stage III or stage IV. A total of 64 (76.2%) women had at least 1 CTC and 29 (34.5%) had at least 5. The researchers found that women with no CTCs had comparable survival and spent the same amount of time progression-free as women with one or more CTCs. The results suggest that there is little prognostic value in measuring CTCs in women newly diagnosed with inflammatory breast cancer.

It’s not clear why CTCs appear to be linked to prognosis in some forms of cancer but not others, says Cristofanilli. Inflammatory breast cancer is already an aggressive disease, he says, so compared to other forms of breast cancer whether or not cells have broken off and entered the blood may say little more about an otherwise already aggressive disease.

Inflammatory breast tumors are typically fast-growing, and travel quickly to lymph nodes and the brain. During follow-up in the current study, which lasted more than 22 months for half of patients, more than 30% of the entire group had died.

Perhaps “the most important finding from the study,” says Cristofanilli, is that more than three-quarters of women who just learned they have inflammatory breast cancer had CTCs that can be detected in the blood. In comparison, he adds, only 15% of women with non-inflammatory breast cancer typically have CTCs. “So there is a huge difference in inflammatory breast cancer and other forms of breast cancer.” These stray tumor cells, therefore, may indicate something about inflammatory breast cancer, he reasons, perhaps serving as an early sign that it has already spread. Indeed, only approximately one-third of women with inflammatory breast cancer have detectable metastases at diagnosis, but 60% will eventually develop them.

Currently, says Cristofanilli, doctors primarily measure CTCs in women with metastatic disease, since a decrease in CTCs can signal that treatment is working. But given that most women with inflammatory breast cancer are likely metastatic at the time of diagnosis, this test could serve another purpose – to guide doctors towards more aggressive and prolonged forms of treatment, says Cristofanilli. “If women with inflammatory breast cancer have CTCs, perhaps we should continue to treat them as if they have already established metastatic breast cancer, even if imaging does not show metastases.”

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Co-authors include Michal Mego, Antonio Giordano, Ugo De Giorgi, Limin Hsu, Anthony Lucci, Shaheenah Dawood, Wendy A. Woodward, Naoto T. Ueno, Vicente Valero, Eleni Andreopoulou, Gabriel N. Hortobagyi, and James M. Reuben.

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Research for Inflammatory Breast Cancer

November 13, 2011
AACR Press Releases

Signaling Pathway Linked to Inflammatory Breast Cancer May Drive Disease Metastasis

Findings represent first evidence of ALK activity in inflammatory breast cancer. Data emphasize importance of proteins and enzymes to define molecular biology.?Identification of ALK pathway activation could allow for more targeted treatment.
SAN FRANCISCO - Amplification of anaplastic lymphoma kinase, which has been reported in other cancers such as non-small cell lung cancers, may be a primary driver of the rapid metastasis that patients with inflammatory breast cancer experience.

If validated, the use of anaplastic lymphoma kinase (ALK) inhibitors may be a new treatment approach for patients with this lethal form of breast cancer.

These data were presented at the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, held Nov. 12-16, 2011.

“A diagnosis of inflammatory breast cancer carries with it a very low five-year survival rate of about 40 percent, clearly indicating the critical need for an understanding of the molecular basis of the disease,” said Fredika M. Robertson, Ph.D., professor in the department of experimental therapeutics at The University of Texas M.D. Anderson Cancer Center and a member of the Morgan Welch Inflammatory Breast Cancer Research Program. “However, there are few molecules that have been identified that are matched with available targeted therapies of clinical benefit in patients with inflammatory breast cancer.”

Robertson and colleagues used patient-derived tumors, tumor cell lines and animal models to evaluate protein-signaling pathways and genetic abnormalities with the goal of identifying molecules that may be associated with the increased metastases of inflammatory breast cancer. They discovered ALK amplification in 13 of 15 tumor samples taken from patients with this lethal variant of breast cancer. They then validated the presence of this abnormality in tumor cell lines and newly developed xenograft models.

Gene amplification of ALK is only found in about 2 percent of the overall breast cancer population, according to Robertson. However, results from this analysis indicate that in inflammatory breast cancer, it could be occurring in up to 86 percent of patients.

“The observation that ALK is amplified may be comparable to the observation of HER2 oncogene amplification in some cases of breast cancer, which revolutionized how the disease was treated,” Robertson said. “Our observation that ALK is amplified in inflammatory breast cancer suggests that ALK may serve as a good target for treatment.”

To test this, the researchers evaluated the effects of a drug that inhibits ALK using tumor cells isolated from patients with metastatic inflammatory breast cancer and in two animal models that recapitulate the disease. Results indicated that the use of this drug resulted in tumor cell death.

“Patients with inflammatory breast cancer are now being evaluated for ALK genetic abnormalities, and if found and eligible, may be enrolled in a phase 1, dose-escalation clinical trial of a small-molecule ALK/cMet inhibitor,” Robertson said. She added that Massimo Cristofanilli, M.D., chair of medical oncology at Fox Chase Cancer Center in Philadelphia has implemented this trial at the center’s Inflammatory Breast Cancer Clinic.

Moving forward, Robertson emphasized the importance of collaborating with a research team with expertise in using both proteomic and genomic approaches to define molecular biology of tumors, to identify therapeutic targets and, once validated, to rapidly translate these findings to the clinic.

“Our results demonstrate that, had we only been using genomic platforms, the likelihood of identifying ALK as a therapeutic target would have been significantly diminished,” she said.

The funding for these studies came from an American Airlines/Komen Race for the Cure Promise Grant KGO81287 entitled, "Novel Targets for Treatment and Detection of Inflammatory Breast Cancer." Robertson and Cristofanilli are co-principal investigators on this grant. The proteomics studies were performed in collaboration with Emanuel F. Petricoin III, Ph.D., and Lance Liotta, M.D., Ph.D., at the George Mason Center for Applied Proteomics and Molecular Medicine in Manassas, Va.

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Definition of an IBC Clinic, by Dr. Naoto Ueno, MD Anderson Morgan Welch IBC clinic

Defining the critical components of an inflammatory breast cancer clinic
There are many places in the world that refer to themselves as inflammatory breast cancer (IBC) clinics, but what defines an inflammatory breast cancer clinic? The University of Texas MD Anderson Cancer Center Morgan Welch Inflammatory Breast Cancer Research Program and Clinic was established based on our commitment to provide patient-centered team care incorporating all of the critical clinical team members from each discipline into one IBC team. We propose that this multi-disciplinary, team medicine approach combined with the broad experience and expertise that only come from seeing and treating hundreds of patients with this rare disease are critical ingredients to establish a true IBC clinic. Research in every area of medicine has shown that experience measured in number of patients seen and treated leads to measurably better results. In addition to our long history treating IBC at MD Anderson Cancer Center, our clinic has treated hundreds more IBC patients in just the last 5 years. Our IBC clinic is supported by world-class dedicated researchers who work together (team science) to bring new therapies to patients and to solve the mystery of this deadly disease.

Our Board Certified clinical team consists of three breast medical oncologists, two radiation oncologists, two surgical oncologists, three pathologists, and two breast imaging radiologists. We are not only dedicated to research and treatment of inflammatory breast cancer, we specialize in it. We work together to provide the best care to our patients and excel in providing the best experience for our patients.
Our mission is to mitigate the suffering of IBC patients through translational research–driven, clinical medicine.
Our vision is to be a world premier IBC research group in disease prevention, in developing innovative molecular biomarkers and targeted therapy based on hypothesis-driven translational/clinical research, and in nurturing a new generation of oncology investigators.
We hope and expect that accomplishment of this vision will provide the best care for our patients with the highest level of satisfaction. We will not compromise the care we offer our patients and we pledge always to do our best to provide the highest quality in clinical care.
What are the three most important questions that our program will be answering in the field of IBC?
A recent survey of program members identified three important questions in the field of IBC:
1. How can differences between IBC from non-IBC at the molecular level be exploited to establish universal criteria for the diagnosis of IBC?
2. What are the IBC unique etiologies that can be developed as IBC-specific targets?
3. What are the risk factors associated with the development of IBC?

What does this mean for the IBC patient?
A mission-driven IBC program supported through a team medicine approach is what you need if you are an IBC patient. This ensures that you are getting the best and most current treatment options available and you are treated by a team of physicians dedicated to your unique needs. Our clinic can provide this personalized care.
Morgan Welch Inflammatory Breast Cancer Clinic is located at Mays Clinic Building

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PET Scans Confirm Effectiveness of Estrogen-Blocking Drugs in Breast Cancer Patients

ScienceDaily (Aug. 18, 2011) — For the first time, researchers at Seattle Cancer Care Alliance have demonstrated the feasibility of using serial positron emission tomography (PET) scans, using a special estrogen-containing isotope, to confirm the relative effectiveness of estrogen-blocking and estrogen-depleting therapy in patients with metastatic breast cancer.

The results of the research are published online in Clinical Cancer Research.

The PET scans, taken before, during and after hormonal therapy, confirmed the superior effectiveness of estrogen-receptor-blocking drugs such as tamoxifen and fulvestrant over estrogen-depleting therapies such as aromatase inhibitors in blocking the estrogen receptor in cancer cells. The study also confirmed that tamoxifen is superior to fulvestrant in blocking estrogen.

While the results were expected they had never before been proven, according to corresponding author Hannah Linden, M.D., a breast oncologist at SCCA and an associate professor of Medicine at the University of Washington School of Medicine.

Linden and colleagues measured regional estrogen-receptor blocking and binding by using PET scans with 18F-flouroestradiol (FES), a trace amount of estrogen in isotope form, prior to and during treatment with aromatase inhibitors, tamoxifen and fulvestrant in a series of 30 patients whose breast cancer had spread to the bones. Tumor FES uptake declined more markedly in patients who took estrogen-receptor blockers compared to those who took estrogen-depleting aromatase inhibitors (an average decline of 54 percent versus 15 percent, respectively). Among the two estrogen-blocking drugs studied, the rate of complete tumor blockade was highest following use of tamoxifen versus fulvestrant.

“What we’re suggesting in the paper — that we couldn’t fully test for before — is if estrogen is incompletely blocked you’re not getting a good outcome for the patient,” Linden said.

“Our findings support the ability of FES PET to visualize the in vivo activity of endocrine therapy,” the authors concluded. “This technology could be used early in drug development to measure effectiveness at the intended therapeutic targets, and to help refine selection and dosing for agents to move forward in drug development.”

Additionally, pharmacodynamic imaging could provide clinicians with a promising tool for therapeutic selection and for predicting and evaluating response to estrogen-receptor-targeted therapy, Linden said.

The isotope was manufactured by the chemistry group at the UW as part of the UW Nuclear medicine program project grant. Key collaborators in the study include David Mankoff, M.D., Jeanne Link, M.D., and Kenneth Krohn, M.D., at the SCCA, and UW, and Brenda Kurland, a statistician at Fred Hutchinson Cancer Research Center. .

Grants to Linden, Mankoff and Krohn from The National Institutes of Health and the Mary Kay Ash Foundation funded the study.

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Our friend at KOMO TV, Michelle Esteban, is still helping educate the public.  Here is the latest piece she did.  CLICK the LINK to watch KOMO TV in Seattle.

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Dr. Cristofanilli and President Patti Bradfield at the opening of the new Fox Chase IBC clinic.

Click picture to link to clinic.