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Sea Sponges Provide Good News for Metastatic Breast Cancer Patients | |
Last month, the Food and Drug Administration (FDA) granted approval for eribulin mesylate (Halaven Injection, made by Eisai Inc.) for the treatment of patients with metastatic breast cancer who have been previously treated with an anthracycline and a taxane in either the adjuvant or metastatic setting. Patients must have also received two chemotherapy regimens for treatment of their metastatic disease. This compound was approved for use in a heavily pre-treated population of breast cancer patients yet showed surprising results as a single agent.
Halichondrin B is a product isolated from the marine sponge Halichondria okadai. Halaven, a synthetic analogue of halichondrin B, is a non-taxane microtubule dynamics inhibitor. This compound has a similar mechanism of action to the taxane's Taxol and Taxotere, targeting the scaffolding protecting cells, stalling cell division and causing cells to die off.
Halaven's approval is based on results from a 762 metastatic breast cancer patient phase III international multicenter open-label randomized clinical trial. Trial participants were a mix of estrogen receptor positive and negative; Her2/neu normal and over-expressors; and progesterone receptor positive and negative tumor types. The trial demonstrated a statistically significant improvement in overall survival (OS) in the patients who received eribulin compared to those receiving other single agent treatment chosen by their physician. Notably, those on eribulin lived 75 days (13 months vs. 10 ½ months) longer than those on the non-eribulin containing arm of the study. The most common side effects associated with eribulin were neutropenia (reduction of white blood cells), anemia, asthenia/fatigue, alopecia (hair loss), peripheral neuropathy, nausea and constipation.
With the FDA approval, this compound will now be available for the treatment of metastatic breast cancer patients and more safety and efficacy data will be compiled.
For more details on this compound and the trials associated with the approval, go to: www.cancer.gov |
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Review of
DR. SUSAN LOVE'S BREAST BOOK
FIFTH EDITION
Gayla Little, ibcRF Volunteer | |
As a frequent user of Dr. Susan Love's Breast Book, Fourth Edition, which has become the source of information most of us turn to for definitive information on all things breast related, I was thrilled to be asked to review the highly anticipated FIFTH EDITION of this resource.
Two years ago, at the San Antonio Breast Cancer Symposium, Dr. Love announced to a group of advocates that the following year was to be spent revising the book; and any new information that we thought should be included should be sent to her through her website or even handed to her at the conference.
Knowing this, I was eager to find out what new information she had included on inflammatory breast cancer. I am disappointed to tell you that the answer is hardly any. Most of the four paragraph section that is IBC specific is taken directly from the fourth edition. She does mention that Herceptin may be used to treat women whose tumors overexpress HER2; but, she does not include a caution against taking Herceptin along side or shortly after being treated with an anthracycline.
I was disappointed that this new edition failed to mention that IBC has been identified as a distinct type of breast cancer by the National Comprehensive Cancer Network. I was also hoping that Dr. Love would mention the importance of banking cancerous tissue in order for research to continue to increase in the fight against inflammatory breast cancer. No mention is made of BioBanking in the IBC section (which is in the Special Situations and Populations chapter of the book.) However, she does have a short paragraph on BioBanking in the Introduction to Breast Cancer chapter.
The FIFTH EDITION of DR. SUSAN LOVE'S BREAST BOOK is easier to read, because the print is larger and there is still tons of good information to be found within the pages. My suggestion, for the breast cancer patient and/or advocate, is to take a good look at it at your local library before you go out and buy a new one. I am glad to have the updated version of this book, because I spend a good amount of time answering questions from people who write to the Inflammatory Breast Cancer Research Foundation. For the inflammatory breast cancer patient who is looking for answers, rather than answering questions, the FOURTH EDITION that is already on your shelf will probably contain the information that you want to learn. |
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Upcoming Events |
Dec. 19 - Kaleidoscope: A Celebration of Survivorship, Song, and Skating; airs on FOX at 4:30 pm EST (Survivors at SABCS attended this live event.) Click here.
Jan. 6 - Teleconference: News from the San Antonio Breast Cancer Symposium; 12:00-1:15 pm EST Click here.
Jan. 13-14 - 3rd Breast-Gynecology International Cancer Conference BGICC; Cairo, Egypt Click here.
Jan. 15 - Current Trends in Breast Cancer: Updates from the 2010 SABCS; Dallas TX Click here.
Jan. 19 - Mindfulness Meditation for Women Living with Metastatic Breast Cancer; 6:00-8:00 pm EST; Loews Philadelphia Hotel Click here.
Feb. 25-27 - Annual Conference for Young Women Affected by Breast Cancer (C4YW); Peabody Orlando Hotel Click here. |
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 Quick Links for IBC Patients and Caregivers
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1-877-STOP-IBC
1-877-786-7422
email:
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2nd International IBC Conference
By, Ginny Mason, RN, BSN
Executive Director, ibcRF
In December 2008, the First International Inflammatory Breast Cancer Conference was held at M. D. Anderson Cancer Center in Houston, TX. A wide variety of speakers gave presentations on the basic science of inflammatory breast cancer, epidemiology of the disease, treatment and the role of the media and advocacy in inflammatory breast cancer. The conference attracted a wide variety of participants that included scientists, clinicians, media as well as a significant number of patients/advocates. At the close of the conference the decision was made to meet again in 2010 in Europe. October 6 and 7, 2010 the Second International Inflammatory Breast Cancer Conference convened in Marseille, France. While held at the Villa Massalia hotel, the local group providing support for the meeting was the Institut Paoli-Calmettes Comprehensive Cancer Center, Marseille, France. The conference organizing committee did an excellent job of bringing a variety of speakers to Marseille. After a welcome from Dr. Patrice Viens, from our host city, the opening session was devoted to 'Epidemiology of IBC" with speakers from the U.S. and Tunisia. The next section focused on the challenges associated with diagnosis and how bench research can distinguish between IBC and other breast cancer. Speakers in this section represented the U.S., Egypt, and Belgium. An interesting session on 'Imaging of IBC' included a wide variety of presentations that included ways to monitor response to therapy, gene expression data, and genome profiling. A research group from Spain gave an intriguing presentation on canine inflammatory mammary carcinoma. Many of us were not aware that canine inflammatory mammary carcinoma is a naturally occurring phenomenon that closely resembles the disease in humans. Most research takes place in special cells lines or in mice that have been injected with cancerous cells. It was fascinating to learn about a naturally occurring animal model that would allow study of this disease. The U.S., France, Belgium and Spain were represented during this session of speakers. The final presentations for the day were listed under 'Biology of IBC' with genome-wide profiling, tumor stem cells, gene signatures, and Akt1 involvement as topics. It was early evening by the time the final presenter completed her presentation. Some conference participants stayed on at the hotel for dinner together while others, headed out for dinner or home. It was a long, full day and while our minds were racing with information, most of us were exhausted due to the time changes and overnight travel the day before. It was a bit smaller group that gathered the next morning for the final sessions of the conference. While it was difficult to get a good count of attendees, someone said attendance averaged about 50-60 the first day and dropped the second. An interesting basic science presentation opened day two of the conference addressing the epithelial to mesenchymal transition in inflammatory breast cancer, shared by the IBC research group at New York University. The remainder of the conference focused on therapeutics, medical treatment and local-regional treatment/survival. Unfortunately there were no presentations that will lead immediately to practice changing treatment, which is what patients are anxious to hear. Instead, there were many good and interesting presentations that will hopefully lead to better understanding of this complex disease and its treatment. After officially closing the conference participants were invited to stay for a discussion of how this international collaborative group might identify ways to enhance and facilitate research of inflammatory breast cancer. Reports of collaborative efforts already underway were shared but it was clear that while individuals might be interested in collaborative projects, their respective institutions might have policies that prohibit sharing resources. It is unfortunate that our current system doesn't reward collaborative efforts. To move ahead as a researcher/clinician you must guard your work carefully so you'll be the first to publish on a specific topic. And if your work might lead to a treatment or other product with monetary value, the intellectual property (or the ability to patent your discovery) is carefully guarded as well. Until we are able to find ways to address these issues, true collaboration will be difficult to obtain. Unlike the First International Inflammatory Breast Cancer Conference, where there were many patients/advocates in attendance, I was the only patient in attendance and there was one other advocate. It is essential that the patient/advocate voice be heard in settings like this. We were there to address the needs of those facing a diagnosis of inflammatory breast cancer, and patient/advocates help keep the focus where it needs to be. It was an honor to attend the Second International Inflammatory Breast Cancer Conference and represent all those who have had or are dealing with this dreadful disease. I had the opportunity to talk with many of the presenters and participants, exchange business cards, and even see a little of the city of Marseille. The conference organizers hope to hold the Third International Inflammatory Breast Cancer Conference in the U.S. The location has yet to be decided. Visit the conference website (www.2ibc-conference.com) for more information about the presenters and look forward to publications coming from this conference. |
FDA begins process to remove breast cancer indication from Avastin label Drug not shown to be safe and effective in breast cancer patients
The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.
The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or "holes") in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.
In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin's label.
"After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug."
Removing the breast cancer indication from the Avastin label will be a process. This is the first step. The drug itself is not being removed from the market and today's action will not have any immediate impact on its use in treating breast cancer. Today's action will not affect the approvals for colon, kidney, brain, and lung cancers.
Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.
The agency has informed Genentech, Avastin's manufacturer, of its proposal to withdraw marketing approval of the drug for breast cancer. Genentech has not agreed to remove the breast cancer indication voluntarily, so the agency has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency's determination. The company has 15 days to request a hearing; if it does not do so, the hearing will be waived, and FDA will begin proceedings to remove the breast cancer indication.
Avastin, in combination with chemotherapy (paclitaxel), was approved in February 2008 under the FDA's accelerated approval program, based on the results of a clinical trial known as "E2100," which evaluated the drug in patients who had not received chemotherapy for their metastatic HER2-negative breast cancer. Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this. The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.
After the accelerated approval of Avastin for breast cancer, Genentech completed additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on "progression-free survival" without evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. The small increase in "progression-free survival" reflects a small, temporary effect in slowing tumor growth.
Avastin has also been associated with several other serious and potentially life-threatening side effects including the risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.
On the basis of all available data relating to the use of Avastin to treat metastatic breast cancer, the agency has determined that the risks of the drug outweigh the benefits for this use.
FDA is open to working with Genentech on any proposals to conduct additional studies of Avastin in patients with metastatic breast cancer designed to identify a population of patients in which the drug's benefits exceed the risks.
For more information:
FDA: Bevacizumab (marketed as Avastin) Information Click here.
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Thanks, and remember us with your year-end giving!
This time of year we are all busy purchasing holiday gifts, many of the public radio and television stations are running pledge drives, and our mailboxes are full of appeals for assistance. It can be daunting.
As you evaluate how and who you'll support with your year-end giving, we hope you'll consider a donation to the Inflammatory Breast Cancer Research Foundation. As an IRS designated 501 (c) 3 non-profit, your donations are tax deductible and if you'd like to make your donation in honor or memory of someone, we'll be happy to notify them of the donation if you'll provide the contact information. An IMO (in memory of) or IHO (in honor of) donation makes a great gift, always fits, and won't be returned after the holidays!
We appreciate the continued support and volunteer time we receive from the Inflammatory Breast Cancer Research Foundation community. While it remains an uphill climb, we ARE making progress. Thanks for being on this journey with us!
To donate online go to: www.ibcresearch.org
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