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BY ELIZABETH WHITTINGTON | MAY 1, 2012
As of this posting, nearly 40,000 people have viewed Darlene Gant's plea to the FDA on Youtube. Gant has metastatic breast cancer that has spread to her liver. She is asking for the release of the investigational drug pertuzumab to her on a compassionate use basis.
She writes:
"I am stage 4 breast cancer and am in final stages. I have a beautiful son, Cameron age 11 that is watching me die little by little each day, as well as my husband. It is tearing us up and so many other families are going through this too. The most unfortunate part is that there is a very promising drug for me, Pertuzumab that the FDA is just sitting on since December and does not plan on releasing it until June 2012. I am not expected to make it to June, my liver is engulfed with tumors and I am wasting away. In this video, which we did not plan, I am reading cards that I have filled out for my son from age 12-25 for birthdays, graduation, wedding et.... I am trying to leave him pieces of me to comfort him and let him know how much I love him - he is my world. I can handle dying but not leaving my son. You see I want to finish my mission here and raise my baby to manhood. For years I have watched other women die waiting on the FDA to release a drug that has concluded all their trials and data and they would not give the drug for compassionate use then either. I do NOT qualify for any trials as my disease has progressed to much. We must stand together and not let anyone else die WAITING. Please help by passing on this video link and writing to your local congressman or senator. Support the NBCC, National Breast Cancer Coalition as they are fighting for us and with us to make compassionate use a standard. It may be too late for me but there are so many others waiting and yet to come. Blessings."
Pertuzumab, which is expected to be approved by the FDA this summer, has been shown to delay disease progression in women with HER2-positive breast cancer, but it's not known if it will work for Gant's cancer. However, after weeks of public pleas, most likely generated by her video, Genentech, the drug's manufacturer, has allowed Gant to receive it before final FDA approval. (The FDA also approved the compassionate use of the drug.)
There are a lot of questions raised by Gant's case: Why does the FDA wait on approval decisions when it is apparent some drugs are better than what's available (pertuzumab was given priority review, which means it was reviewed much faster than the traditional route)? Is the use of social media appropriate in asking for compassionate use (when typically it is the patient's physician who works with the pharmaceutical company to get access)? And can anyone fault a patient for trying each and every way to cure their disease?
What would you do?
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BY ELIZABETH WHITTINGTON | APRIL 11, 2012
I recently went to the doctor for a past due exam – all clear, but the doctor reminded me that I would need a baseline mammogram at age 35.
"Umm ... 35? I thought it was 40 or 50? Why do I need a mammogram so early?"
"That's just what we do here," she replied.
To my doctor's credit, I didn't question further about why a baseline mammogram is the norm in her practice, or what benefit it would give me. But I did want to do more research before I made a decision.
Let's be perfectly clear. This is a baseline mammogram we're talking about. A baseline mammogram is taken first to compare to future mammograms when a woman decides to begin routine screening at 40 or 50. There's no evidence that this comparison between a baseline mammogram and the first routine screening holds any benefit. In addition, the baseline mammogram isn't looking for anything at this point.
I have no family history of breast cancer. I don't have a suspicious lump or any other symptoms. I don't have dense breasts.
I checked with my insurance company and they cover mammograms, regardless of age or reason. However, I can't find a professional group that recommends a baseline mammogram. The American College of Obstetricians and Gynecologists don't recommend them unless there is a family history. The American Cancer Society recommended baseline mammograms several decades ago, but removed it back in the early 1990s.
So, why do some gynecologists still recommend them?
I talked with Dr. Len at the ACS and he gave me some important background. He said the ACS recommended baseline mammograms from 1980 to 1991 because of the belief that they could help detect cancers in the future – comparing the mammography images from baseline and those taken later. (Here's a chronological depiction of the various guidelines from the ACS over the years.)
Unfortunately, he says, baselines mammograms didn't help find cancers. Many times those baseline images weren't even available to compare with later images, and ultimately they just didn't prove to be very valuable.
Women depend on their doctors to understand these guidelines and they should be comfortable being able to discuss the pros and cons with their patients, Dr. Len says. And an answer of "That's just what we do here," isn't helpful.
This isn't to say I don't think young women should be screened for breast cancer. I know several young women who had symptoms, a family history or just a nagging concern that something was wrong but had to jump through hoops to get a mammogram or other screening test to finally diagnose breast cancer.
When I asked on my Facebook page what other women thought of baseline mammograms, it generated a great discussion.
Lisa, who was diagnosed with breast cancer at a young age only 18 months after a clean baseline mammogram, had some great advice: Any doctor should be able to give an answer to the question, "Why are you ordering this test, and why now?" If not, I'd press for better explanation for the timing. When told "that's just what we do," I'd definitely press that. "Why do you do what you do if research on screening's effectiveness contradicts your practice?"
For now, I'm going to hold off. I have a few more years before I decide whether to start routine screenings at 40 or 50--and I have a feeling that will be a much harder decision.
What do you think? Did you get a baseline mammogram?
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BY ELIZABETH WHITTINGTON | FEBRUARY 6, 2012
Today, the breast cancer talk wasn't of Komen or Planned Parenthood or pink handguns.
Feb. 6 was the day that Rachel Moro and Susan Niebur, breast cancer survivors in every sense of the word, died.
Rachel had been living with metastatic breast cancer and blogged at The Cancer Culture Chronicles as @ccchronicles. Her profile statement is especially meaningful today: "It's time to move beyond pink ribbons and messages of "breast cancer awareness," and start agitating for real and meaningful action in the fight to eradicate this disease for good."
Susan had lived with inflammatory breast cancer, her fourth bout with cancer.
Both were prominent bloggers. Rachel's death was sudden. Susan had been sick for a while. Both chronicling their journey and supporting others in their online communities of women dealing with breast cancer, either as newly diagnosed, survivors or those living with metastases.
As I was reading reactions of others on Twitter about their deaths, a colleague noted that Susan had been interviewed for a story in the Spring issue--one that focused on how to help children cope with a parent's diagnosis. This was a perfect fit for Susan, who blogged under the name @WhyMommy at Toddler Planet: The joy of life after cancer. My hope is that the article will be just one more piece of a lasting legacy of helping others cope with this horrible disease.
Susan's family noted her passing on her blog today and wrote: "In lieu of flowers, please consider furthering Susan's legacy through a contribution to the Inflammatory Breast Cancer Research Foundation. Or please choose to make a difference somewhere, anywhere, to anyone."
Make a difference.
These women did. Unfortunately, sadly, there will be other women who will fill the void left by Rachel and Susan...women with cancer, or those who will be diagnosed, who will become a voice for others to draw strength and inspiration from. We need them. Just like we need Rachel and Susan.
Those wanting to remember Rachel and Susan tonight can join the #bcsm Twitter chat tonight at 9 pm ET/6 pm PT.
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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 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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BY ELIZABETH WHITTINGTON | NOVEMBER 16, 2011
Another cancer-related smart phone application launched in late October – this one specifically for colon cancer and breast cancer patients.
The free app was created by Genomic Health, which markets Oncotype DX, tests that provide genetic information to physicians to help determine treatment options for breast cancer and colorectal cancer patients. Two non-profit organizations, Breastcancer.org and Fight Colorectal Cancer, partnered with Genomic Health to provide information for the app.
Newly diagnosed patients would need to download the app and choose to follow the breast cancer or colorectal cancer tool. It begins by informing the patient what information they will need to fully utilize the app, including their pathology report or simple information about their diagnosis (such as if their colorectal tumor tested positive for the KRAS mutation). Patients would then need to fill out a brief questionnaire to receive a summary of treatment options and information.
The tool offers good information and offers to save the report, which includes questions to ask your doctor and an option to email the report to yourself to print off and take to your next oncology appointment.
The other features of the tool include Questions to Ask – including suggested questions and an option to record your own. You can input your questions and answers by text or voice recorder, which I thought was incredibly helpful. I can see this being useful for caregivers who may want to know exactly what the doctor said during an appointment if they weren't able to make it or for keeping track of questions before meeting with your medical team and then recording the answers immediately.
The Journal feature offers users a way to track appointments, take notes (by text or voice recorder) and even take and save photos. A glossary is also included, as well as a list of resources, including the web version of the tool.
You can download the Cancer Coach app on iTunes or Android Market. And if you'd rather not take your coaching from a cell phone, the app is based on the online tools found at My Breast Cancer Coach and My Colon Cancer Coach.
Do you use the Cancer Coach? What do you think of the app or online tool?
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BY ELIZABETH WHITTINGTON | OCTOBER 31, 2011
This past weekend, I participated in the Tupelo Komen 5K. I woke up at 5 a.m. to drive an hour and half to get there for the 8 a.m. start. And it was so cold. But it was all worth it. I finished with new friends and found some old friends, too.
I met Randy, the husband of Lauren Groover, whom we featured in "Friends in Need" in the spring of 2010.
She was diagnosed with metastatic breast cancer in 2006 in Tupelo, a small town in Mississippi. She connected with other patients and survivors all over the country through Facebook and became the face for the story. Sadly, she died in 2010 (Saying goodbye to someone I've never met).
Imagine my surprise when I saw the Live for Lauren booth at the 5K. Randy was giving out pink cups and telling everyone about the new foundation they had started in her memory - Live for Lauren.
And he tells me people are still writing on Lauren's Facebook page.
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BY ELIZABETH WHITTINGTON | OCTOBER 28, 2011
Jeanie recently posted a comment to Susan's blog (Finally good news for triple negative breast cancer patients), which was posted several years ago. I'm not sure if many other TNBC survivors will see her message on the older blog, so I wanted to repost it. Hopefully someone out there can help Jeanie and give her some advice on living with the fear of recurrence.
I was diagnosed in 2/2011 with triple negative invasive ductal carconoma. In May I opted for a bilateral mastectomy because I also had some abnormalities on my right breast opposite from the left that had a tumor the size of 3.6 cm who seemed to have appeared over night. I am 36 years old, divorced with two children and having a dificult time with all this. I have become severely depressed and self conscience, leading to rarely leaving my house beacuse of the way I look. I have no hair and only have one expander in due to the other becoming infected and replacement was not an option at the time.
I have never been much to crave any type of attention nor pity and I don't handle it well. I am about to get my last chemo tomorrow. TC is my regimen ... But I am sooo scared I dread a recurrence. How can I go on with my life if no one can tell me it's gone because they checked and don't see any. How do they know 4 cycles was enough? I know about how they base it on studies and all but I am not a study. I am an individual. We all are. And I think since no one can tell me where it came from or if it will be back for sure, they should at least be able to give me a clear answer now as to what we have done so far to me, the individual, is working or worked. Something that says there are currently no cancer cells present after chemotherapy... something, anything. I am tired of all the suprises and I don't want to live the next three to five years of my life thinking "is today the day?" because my head hurts or my hair is falling out, I'm starting to feel sluggish and fatigued again...
I'm really scared, and I can't seem to overcome this fear, I got no warning signs the first time, and I know if there was to be a second there won't be any either. I wish everyone the best health and healing. And I pray that the lost find their way again and the one who have found their way to show us the way. God bless us all.
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