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BY ELIZABETH WHITTINGTON | DECEMBER 8, 2011
One of the most highly anticipated presentations at this year's SABCS is BOLERO-2 (Breast Cancer Trials of Oral Everolimus-2), a phase 3 study examining whether adding Afinitor (everolimus) to Aromasin (exemestane) in postmenopausal women with advanced estrogen-positive breast cancer would delay disease progression.
The study followed 724 patients with progressing breast cancer who have responded to previous hormone therapy for their cancer.
The BOLERO-2 trial was halted in February when it became apparent the Afinitor combination was better than Aromasin alone, much sooner than expected, said investigator Gabriel N. Hortobagyi, MD, director of the Breast Cancer Research Program at the University of Texas M.D. Anderson Cancer Center in Houston. Preliminary data were announced at a European meeting in September showing that with the addition of Afinitor, progression-free survival (PFS) improved from 2.8 months to 6.9 months.
Researchers announced updated results at the San Antonio Breast Cancer Symposium, and after a year follow-up PFS had improved from 3.2 months in the Aromasin arm to 7.4 months in the Aromasin and Afinitor arm, an improvement of about 57 percent. Response rates also doubled from 25.5 to 50.5 percent, which included complete and partial responses, as well as stable disease lasting at least six months. Side effects in the combination arm included oral mucositis, rash, diarrhea and fatigue.
Data also suggest a survival benefit, but researchers were quick to caution that survival results arenot expected for another year. Hortobagyi says it may be another year before survival data is available.
Afinitor inhibits mTOR, a protein that helps regulate the growth of cancer cells and blood vessels. Aromasin is a commonly used drug in hormone-positive cancers that inhibits the enzyme aromatase, blocking its conversion to estrogen, the hormone that drives tumor growth in certain breast cancers. It's believed that some cancers that are resistant to hormonal therapy have an over-activation of the mTOR pathway. By using an aromatase inhibitor in combination with Afinitor, researchers hope to overcome that resistance.
At last year's symposium, results of a study suggested that women with metastatic disease taking Afinitor and tamoxifen live longer. Two other BOLERO studies are looking at whether Afinitor benefits women when combined with Herceptin (trastuzumab) and Taxol (paclitaxel) or vinorelbine. Afinitor is currently approved to treat advanced kidney cancer.
Novartis, the drug's maker, is expected to submit Afinitor to the FDA for use in advanced breast cancer within the next few weeks in light of the positive results.
You can read about the study in the New England Journal of Medicine.
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BY ELIZABETH WHITTINGTON | DECEMBER 7, 2011
It's hard to follow all the great stories and commentaries coming out of SABCS while also taking in the sessions. I started keeping up with a list of bloggers I wanted to go back and read for later and thought I would share it with you, too. Some are advocates, some are survivors, some are doctors, but all have the same goal of sharing what they learn here.
Kathi Apostolidis
Alamo Breast Cancer Foundation
Breast cancer and patient rights advocate blogging for the Alamo Breast Cancer Foundation
Sally Church
Pharma Strategy Blog
More scientific, but her joy in learning about what drives drug resistance and new therapies is infectious
Karuna Jaggar
Breast Cancer Action
Karuna is the executive director of Breast Cancer Action
Jody Schoger
Women with Cancer
http://womenwcancer.blogspot.com/
Breast cancer survivor and advocate, health blogger, her husband is a melanoma survivor
Dr. Debu Tripathy
Dr. Debu's CURE blog
Editor-in-chief at CURE, Co-Leader of the Women's Cancer Program at Norris Comprehensive Cancer Center and Professor of Medicine at the Keck School of Medicine at the University of Southern California (what a mouthful!)
Let me know if you're blogging from San Antonio (or remotely!) and I'll include your blog.
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BY ELIZABETH WHITTINGTON | DECEMBER 7, 2011
The release of the Institute of Medicine's Breast Cancer and the Environment: A Life Course Approach report has generated quite a bit of interest. Many are expecting information on BPA, pollution and cosmetics; what we get is that there needs to be more research.
The committee defined "environmental" as most non-hereditary causes of cancer. Many of the environment factors it discusses that are preventable are those that can be changed by lifestyle. In addition to exercising more, drinking less alcohol and avoiding tobacco use, the report did mention some other notable topics:
Forego hormone therapy replacement – when the WHI study results were published in 2002 linking HRT to breast cancer, many women taking HRT for menopausal symptoms stopped taking the drug, and the rate of breast cancer significantly dropped.
Reduce radiation exposure – this doesn't mean not going through the X-ray machine at the airport when you travel for the holidays nor does it mean cutting back on screening mammograms. But if you don't need a full body CT scan every year, it's probably not a good idea to get one.
Some things the report didn't include as environmental carcinogens are probably noteworthy in itself, such as cosmetics and BPA (Bisphenol A).
Instead the report outlined future methods to studying environmental causes, suggesting that the way most studies are conducted isn't adequate. This we know because of the back-and-forth, contradictory studies on everything from cell phones to supplements. The committee recommends looking into exposures over the course of a lifetime (hence the report's title), including in utero, while also taking into account the combination and mixture of chemicals, interplay between genetics and environmental toxins, and length of exposure and age when exposed. These are difficult topics to study and will take a lot of time and money before we have anything meaningful.
"We know that breast cancer is influenced by hormones, and estrogen exposure is a risk factor," said Irva Hertz-Picciotto, PhD, chair of the committee. "A number of compounds are active estrogenically - those are opportunities for potentially reducing risk. BPA is one of those compounds," and therefore, she says, deserves more research attention. Currently, there is little to no epidemiological research on BPA and cancer risk. Other possible breast carcinogens that need more research are benzene and night-shift work. Some expressed disappointment that the report didn't turn up more definitive answers and prevention strategies.
"What we found was that the evidence base wasn't there to say these (other factors) contribute to breast cancer. I think we were all disappointed to not be able to recommend more," said Herz-Picciotto during the presentation's question-and-answer Wednesday afternoon.
The report was funded by Susan G. Komen for the Cure. If you'd like to download the free pdf of the report, go to iom.edu/breastcancerenvironment.
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BY ELIZABETH WHITTINGTON | DECEMBER 7, 2011
One of the last educational sessions on Tuesday night went into detail about oncofertility. I was expecting a talk I've heard before: doctors should inform patients of fertility options and what those options are. Instead, Teresa Woodruff, PhD, of the Oncofertility Consortium at Northwestern University went into so much more.
On top of the obvious – not being able to have children - Woodruff mentioned some of the psychosocial issues involving treatment-related sterility, including depression and increased anxiety in adult survivors of childhood cancer, which doesn't just include hopeful parents, but survivors who are entering the dating field – because who wants to start out on a first date with the bombshell of "I can't have kids."
While men are able to bank sperm before the start of cancer treatment, women have it a bit more complicated. Freezing embryos often requires a partner (or at least an anonymous donor) and harvesting eggs may not be an option for some patients. Two investigational methods are cryopreservation of ovarian tissue and oocytes, which include removing tissue before initiating cancer therapy and freezing it with the idea that it can be later transplanted back into the patient once they are cancer-free; however, the threat of re-introducing cancer cells is worrisome and it doesn't have a high success rate so far.
The Consortium is looking into a technique that grows follicles isolated from ovarian tissue. They're attempting to develop an artificial ovary derived from brown algae to cultivate the follicles. The follicles have been shown (in the lab) to produce hormones, contain oocytes and, in mice models, have produced live births.
They've been able to use the method in mice, but humans are much more complex, she acknowledges. There are also a bevy of questions in this field regarding legality, ethics and costs (CURE touches on these topics in "What to Expect When You're Not Expecting – Yet"). These are not simple questions to answer.
The first step, though, is knowing that "practice guidelines exist and recommend that the fertility threat associated with cancer treatment be discussed with all young patients," she says, and that "options do exist for men, women and children ... that's right for the patient and time of life."
No matter how serious the cancer or how young the patient, the conversation should be approached. And while it may seem like patients should know to ask by now, I still think it's the oncology team to start the conversation and offer options and referrals, if needed.
You can find more information on oncofertility on the Oncofertility Consortium's website at myoncfertility.org. It also offers a hotline (866-708-3378) for patients and survivors. There is also a smart phone app to download the patient guide and navigation tool.
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BY ELIZABETH WHITTINGTON | DECEMBER 6, 2011
After a long flight from Memphis to San Antonio by way of Atlanta, I arrived at the San Antonio Convention Center near the Riverwalk. This year is shaping up to be an exciting program regarding breast cancer research, with about 8,000 attendees expected from around the world.
On my flight, I explained to an unsuspecting traveler that he would be arriving in the southern Texas town at a very exciting time; that this large breast cancer conference is always held in San Antonio in December. Unlike other oncology conferences that may change location every year, SABCS originated here 34 years ago and has stayed ever since.
The first presentations are scheduled for tomorrow morning, but there are a series of educational seminars that explore hot topics in treatment and biologic research, including sessions on reconstruction, biomarkers, new targeted pathways, treating early-stage disease and metastasis, as well as how to treat special populations - namely the very young and the elderly. Dr. Debu Tripathy, CURE's editor-in-chief and a practicing breast oncologist, will be blogging about how this year's presented research will translate to the clinical setting. (You can read his first post on what to expect this year here.) Our publisher, and two-time breast cancer survivor, Susan McClure, will be finding those patient advocates that SABCS is known for to report on how they are interpreting the information. I'll be doing a little bit of both.
To get the full recap of SABCS, follow our blogs (tagged SABCS2011) and sign up for our breast cancer newsletter at curetoday.com/newsletters. You can also follow along with the discussion on our Facebook fan page and on Twitter using the hashtag #sabcs.
Let us know what you'd like to hear about and if you have any questions for Dr. Debu. And if you're at SABCS blogging, advocating or just soaking it all in, let us know. We'll start a blogroll and post them here for those who are watching from near and far.
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