SCAN RESULTS

Dear friends and family,
My latest scan results are mixed and difficult to interpret.  Of the 7 visible tumors in my liver, 2 are slightly larger, 2 are slightly smaller, 2 are stable, and 1 is new.  We need a PET scan to really see what is going on, so I'll have a follow up scan in a couple weeks.  The glass-half-full scenario is that the increased size in the tumors is due to the chemo working, not the cancer getting worse.  Dr. Rinn said she learned this lesson long ago with liver tumors that sometimes you have to be patient.  She was not alarmed at all, just a bit disappointed that we didn't see the same response I had with Abraxane/Avastin, but she said to hold fast with Xeloda and give it a little more time to work.

I feel great, very few side effects, and I have to say this might be the easiest chemo I've had.  I'm a little bit tired and nauseated, though the latter is controlled with meds.  My hands and feet are good, just a little more dry than normal, but Udder Cream works miracles.  I'm still upbeat that Xeloda will do the trick and agree with Dr. Rinn that we just need a little more time and a little more data from the scans.  

Thanks to everyone for your continued support!!
-Nancy

Status check

Happy Holidays!
Dear friends and family,
All is going well on my new chemo regimen of Xeloda and cytoxan.  I have mild nausea, I've figured out how to control it.  I end up taking about 15 pills a day, but it is easier than having weekly chemo infusions.

I've got a CT scan on Tues this week and visit with Dr. Rinn on Thur to discuss results and get my monthly zometa infusion.  Fingers crossed, the Xeloda is working, so I hope to post good results later this week.
Thanks again to everyone for your continued support and well wishes.   We appreciate it so much!!
Love, Nancy

Team Survivor NW benefit is a success!

Nancy and Jake were surrounded by friends and family on Saturday night as Jake took the podium and shared the story of Northwest Team Survivor's impact on their lives. An amazing night of love, laughter and tears.

Team Survivor NW Benefit

Jake and Nancy want to invite you to join them for the Team Survivor Gala to be held next month. It is going to be an incredible night, and the best part is that Jake is the featured speaker!!!! Come show your support and love. Tickets are $75 and are available online.



Getting started again...

Dear family and friends,

Thanks to everyone for your well wishes with our latest health news. We met with my doctor last week and came up with a plan. I will be starting an oral chemo regimen of Xeloda and Cytoxan and continue with monthly infusions of Zometa. Dr. Rinn recommended this chemo over going back to Abraxane/Avastin because it will be much easier to keep working if I can take all my chemo from home and the side effects should be milder, though totally different than what I've had in the past. I won't lose my hair with this chemo and hopefully won't be as tired. The main side effect is hand-foot syndrome, which is peeling and blistering of the hands and feet.
We will give this a shot and then have scans again in a couple months to see how it is working. Thanks again everyone. Nancy

Time to fight again...

As some of you may already know, Nancy's cancer has "outsmarted" the treatment, so it's time to fight again. Nancy sent the following note along with a photo of her on a hike yesterday with some Team Survivor friends. Thank you for your continued prayers...

Dear family and friends,

My latest PET/CT and bone scans showed progression of the cancer in my bones, liver and pleura, so it is time to switch up treatment. We meet with Dr. Rinn on Thursday to figure out which chemo cocktail is next. She mentioned either going back to Abraxane/Avastin or trying an oral chemo called Xeloda. Lots of choices and weighing the pros and cons of each. We're disappointed at the latest news, but ready to roll up our sleeves and get going. I've had a terrific run these past two years and am incredibly thankful treatment has worked so well in spite of this latest bump in the road.


Thanks to everyone for your continued love and support. I'll continue to send updates as next steps become clear. By the way, insurance companies are continuing to pay for Avastin, so even though we lost the proverbial battle with the FDA, I think it is fair to say we won the war. If going back on Avastin is the next step, we are fairly confident (thankfully!) it will be covered by insurance.
Love, Nancy

Return from Washington

Photo taken from NPR piece.

Dear Family and Friends,


Jake and I returned from Washington DC on Thursday after giving public testimony at the Avastin hearing. It was interesting and emotionally draining all at the same time. If you want a challenge, try condensing my complex medical history into 3 minutes while convincing a panel of experts who have already made up their minds. I can't really box up the arguments into a short post, so grab a cup of coffee, this is a long read.

For starters, the FDA is convinced there is no benefit from Avastin and that it's a dangerous treatment. This did not sit well with patients in the audience, especially the ones who have been living on Avastin alone for years. If patients' anecdotal evidence is not enough, consider that the National Comprehensive Cancer Network (NCCN), an alliance of the world's leading cancer centers, has unanimously affirmed the use of Avastin for metastatic breast cancer looking at the same clinical data. The NCCN is comprised of breast cancer experts, quite a contrast to the FDA panel, who had no breast cancer expertise. Thankfully for us, the NCCN, not the FDA, sets the reimbursement guidelines, so Avastin will continue to be covered by insurance at least for now. Still not convinced? Consider that the European equivalent to the FDA not only affirms the use Avastin, they just expanded their clinical guidelines to use it with additional chemotherapy partners, again using the same clinical research data.

The FDA argued that Avastin does not improve overall survival (we agree) but, importantly, does not improve progression-free-survival to a statistically significant degree (we disagree). Genentech argued that the progression-free-survival benefit is demonstrated by the data, statistically significant, and, more importantly, clinically meaningful. Jake and I could not agree more.

So what is progression-free-survival (PFS)? It is the time it takes for the disease to get worse. Stated another way, it is the amount of time it takes for the cancer to outsmart treatment and start growing again. I have yet to experience my first progression since being diagnosed 21 months ago, which is far longer than the median statistics, particularly given my situation (heavily tumor burdened, aggressive disease including multiple large tumors in my liver, considered the most deadly). I am nearly symptom-free from my cancer, which is amazing considering the round-the-clock pain I was in when I was diagnosed and the broad extent of my recurrence. Progression-free-disease translates into quality of life. To drive home this point during my 3 minute testimony, I put up a photo of me standing on top of Mt. Adams. Experts might argue over the extent of progression free survival benefit, but all of the studies have concluded their IS a PFS benefit with Avastin.

Regarding safety, the FDA was relentless in talking about the dangers of Avastin, which was so frustrating for the patients and breast oncologists in the audience. Avastin does cause a rise in blood pressure (easily managed) and causes bleeding (i.e. nosebleeds). Avastin has fewer, less toxic side effects than most of the chemos I've received over the years. A very small number of patients may have serious side effects such as pulmonary embolism, but that goes with the territory of cancer treatment. All cancer drugs are poison. You just have to hope the poison is more effective at killing the cancer than it is at killing you. As many of us joked during the trial, we prefer the side effects of Avastin to the side effect of death.

My cancer is incurable and very few if any treatments have proven, statistically significant survival benefit. The best we can hope for is to increase time between progressions.

Here's a quote from MD Anderson that sums it up..

The woman whose breast cancer has metastasized or who has been diagnosed initially at Stage IV must live with the reality that her breast cancer can no longer be cured, and that the disease is very likely to take her life. Consequently, the length of the remaining time she has to live, and the quality of that time, become issues of paramount concern. For her, access to the best care can make a significant difference, both in length of survival and in quality of life. With luck, excellent care, family support, personal motivation, and a skillful oncologist, her disease is likely to respond to a number of lines of treatment that can serve to extend her life-many of which may be quite costly. She may join a clinical trial, or try to get compassionate access to experimental drugs prior to their approval through single-patient INDs or expanded access programs.
Whatever path she chooses, she will be in treatment for the rest of her life, and she will require close follow-up, which will include costly scans and other tests. As her disease progresses, she will need pain-management and control of her other symptoms, and she is likely to undergo several hospitalizations to deal with particular crises in the course of the illness. Eventually, she will need hospice care.

The hearing was really frustrating in that the FDA was indifferent to our pleas. Several of the folks on the panel were so rude during the hearing they were literally reading their blackberries during the public testimony. As Jake commented, "I would have appreciated being patronized because at least we would have been acknowledged." So true! We were completely ignored on the first day and treated like we were wasting their time.
Much has been made about the cost of Avastin. Like other treatments, it is expensive, but certainly not outside the norm for oncologic therapies. When I was receiving Avastin, it was about the same price as paclitaxel (Abraxane) on a monthly basis. Cancer treatment is expensive, but we are thankful that it is available since the benefits in terms of quality of life are easily justified.
http://www.foxnews.com/on-air/journal-editorial-report/index.html#/v/1035619

TESTIMONY TODAY

Those of you who have registered for the FDA hearing, Nancy is #4 and will provide testimony at approximately 8:15 AM EST this morning. The links are provided in the post below.

Nancy to give testimony at FDA hearing on Avastin

We are all so proud of Nancy and are thinking of her and Jake as they travel to Washington DC this morning because Nancy will provide testimony at the FDA hearing on Avastin. The hearing will take place tomorrow, and Nancy will have three minutes to tell her story. There will be a live webcast of the testimony for us to watch, but in order to gain access, you need to pre-register.

We are all with you in spirit and are confident you will be remarkable because you ARE remarkable, Nancy!Her acceptance to participate in this important event was based on the following letter:

Hello Ms. Williams,



I am living with stage 4 breast cancer and was successfully treated with Avastin and Abraxane (paclitaxel). I am interested in publically testifying in June and am trying to understand whether I would be assured a time slot. I will be flying from Seattle at my own expense and don’t want to book flights/hotel unless I’m certain that I’ll have a chance to speak.


I’m 41 years old and have extensive metastatic disease, with multiple tumors in my liver, lungs and spine. At the time of my stage 4 breast cancer diagnosis in September 2009, I was in agonizing pain, had 42 tumors in my lungs, 14 tumors in my liver, and 2 in my spine. After 8 months on Avastin/Abraxane, my tumors were reduced significantly, my pain was nearly eliminated and my quality of life is excellent. I tolerated Avastin extremely well, with very minimal side effects. Even while on this treatment, I actively participated in vigorous hiking with a group of cancer survivors and even climbed to the top of Mt. Adams, elevation 12,276 feet.


I would welcome the opportunity to share more about my experience as I believe I may need to use this treatment again when my cancer progresses and I run out of other treatments. I’m also concerned for the woman diagnosed tomorrow who won’t have this powerful treatment available.


As you know, most cancer therapies have dangerous side effects and can be extremely expensive. I’ve had many chemotherapies and treatments over the past 9 years since my original stage 2 diagnosis in 2002 including Adriamycin, Cytoxan, Taxol, Methotrexate, 5-FU, Zometa, and radiation. All of these treatments have had dangerous side effects and required additional medications and medical monitoring to ensure the treatments themselves didn’t cause my death rather than the cancer. I’ve had the usual list of side effects, neutropenia, nausea, hair loss, fatigue, peripheral neuropathy, and so forth. Damage from the Adriamycin and radiation treatment is still visible on my scans today. When my oncologist had me sign the consent form for Avastin, it frankly seemed pretty mild compared to other therapies. My blood pressure did go up a couple points and I did have a few bloody noses, very trivial side effects compared to what I have experienced from other drugs. From a cost perspective, Avastin was about the same price as these other treatments and was thankfully covered by my insurance. I estimate that I’ve had close to $2M in treatment, surgical, and diagnostic expenses over the past 9 years, the cost of Avasin was perhaps 1 - 2% of the total (rough estimate).


Thank you for your consideration. I am happy to provide more details if needed.


Sincerely,
Nancy Haunty

Jake's Speech

Hello family and friends,


As some of you know, I have participated in the past in a fashion show for a local breast cancer organization, but this year, Jake took the stage and gave a beautiful speech. The video company that recorded the event was kind enough to post it to YouTube for us. Here's the link. http://www.youtube.com/watch?v=F1SKlbQOaUE

National Breast Cancer Coalition NBCC - Washington DC

The trip to DC was energizing, educational, but also discouraging and frustrating. I met lots of amazing women and I was able to network with scientists, doctors, and public policy makers, not the least of whom was Susan Love, MD. ALL women should sign up at Dr. Love's website The Army of Women, regardless of whether you have breast cancer. The goal of her organization is to enroll large numbers of women into research studies, so if you enroll there is a chance you'll be called upon to participate in a study.


The National Breast Cancer Coalition (NBCC), the group who put on the conference and organized lobby day on Tuesday, is an influential, albeit controversial group. They are trying to change the conversation away from pink ribbons, awareness, and early detection to prevention and ending the disease once and for all. I was surprised to learn their position on several issues including Avastin (they applaud the FDA's decision), they are opposed to screening mammograms on women under the age of 50 (yes, 50), and they even oppose breast self exams. Pretty shocking, right? Conventional wisdom about early detection is not the answer, women are dying from breast cancer at the same rate they were 20 years ago. I found myself going back and forth in throughout the conference, trying to decide if I can get behind this group or not. In the end, I am throwing my support behind them and, in fact, am trying to wiggle my way into a position of being able to provide leadership and influence.

During one of the workshops led by Dr. Love, I was able to ask my question, "I have metastatic disease with liver, lung and bone mets. I am a super responder to Avastin, help me understand the FDA's decision." She handled the question well, citing cost (I appreciated her honesty) and said public policy cannot support a very expensive, potentially lethal drug that shows no benefit in overall survival. I argued back that a small number of patients do seem to benefit from the drug, including me. I later learned just how political the Avastin debate really is. The Avastin decision is a shot in the wheel house of Genetech/Roche. The FDA is trying to send a message to Big Pharma to encourage them to figure out who will respond. Too bad individuals like me are getting caught in the crossfire.

There was a lot of bashing of the pharmaceutical industry and our current broken healthcare system. As we all know, there is plenty of blame to go around. The universities and academic medical centers are part of the problem since researchers' incentive is to publish papers, not help patients. Likewise, government funding of research discourages innovative ideas and encourages safe research with predictable results. Biotech and drug companies have an incentive to produce treatments that are profitable, not necessarily those that will end the disease. The only party at the table interested in ending breast cancer is the advocacy community, so I plan to do what I can.

Lobby day was especially disappointing and I left feeling that our government is completely impenetrable. I don't think I'd bother to do that again and don't even feel compelled to send letters or emails to lawmakers because I think it is a waste of time. It was interesting to be on Capitol Hill and walk the halls of the Senate and House office buildings, but that was about it.

I'll end on a brighter note. The highlight of the conference was the Emerging Leaders program of the NBCC, a group of young, articulate women who are future leaders of health policy. It was refreshing to see gals in their 20's using their talents and energy to support the mission of NBCC. Next steps for me will be to connect further with these young women and encourage them to continue fighting. I also might go back to DC in June for the hearing on Avastin. Even the most staunch Avastin opponents at the conference encouraged me to do this, saying that there has been a precedent of the FDA overturning their decisions based on patient feedback, so we'll see.

Long post, sorry about that, my brain is just so full of new ideas I had to share.

Update and a Face on the Avastin Debate

Dear friends and family,

Sorry it has been so long since I've posted an update, we've been busy! Lots of good things to report. For starters, my health is great. I had another PET/CT scan last week and the results were positive, no changes in the tumors and everything is stable and "quiet" according to Dr. Rinn. I will meet with her on Wed and have my monthly Zometa infusion, so she'll go over the results in detail then. I went back to work in October and things couldn't be better, I even managed to get myself promoted. My energy level is great and I'm having a lot of fun being back in the swing of things work-wise. I went snow-shoeing a couple weeks ago with my friends from Team Survivor, which was great fun (photo attached - I'm in front wearing the bright red jacket).

In other news, I attended a symposium at the UW Law School a couple weeks ago called, "Regulating the Treatment of Cancer: Who Decides and How." It was an amazing opportunity to hear from experts in the field, including one of the four decision makers from the FDA on the use of Avastin. The format for the day was a series of lectures and panel discussions with time for questions from the audience. About midway through the conference I overcame my fears and decided to ask a question to the panel. My question was along the lines of "I have advanced breast cancer and I'm alive/healthy as a result of taking Avastin for 7+ months, help me understand why the FDA is taking it away as a weapon in my oncologist's arsenal?" I wanted to put a face on the Avastin debate and hopefully was successful. It was a fascinating day from a public policy perspective - I wish it wasn't so personal - but am excited to get involved in the fight. I was so fired up after the conference I decided I want to do more and am headed to Washington DC in early May for a conference and session on Capitol Hill. Stay tuned for more!


One of the speakers at the symposium (probably my favorite panelists from the day) was Robert Erwin, who is president of Canceractionnow.org, an advocacy group who keeps a careful eye on the FDA and was founded in honor of his late wife, Marti Nelson, MD. Mr. Erwin shared a letter with me, sent to the FDA, regarding Avastin (text from the letter is below). I urge all of you to read up on the issue and let me know if you have any questions or want to get involved. The Avastin issue is complex and certainly controversial, but I truly believe it is worth fighting for. Mr. Erwin's letter articulates this well. The Avastin appeal is scheduled for June and I'm hoping to get more involved.-Nancy

Marti Nelson Cancer Foundation
1520 East Covell Blvd. B5#103
Davis, California 95616

February 14, 2011

Re: Comments on FDA Docket No. 2010-N-0621

Dear Dr. Hamburg,

We encourage the FDA to hold a public hearing on its proposal to withdraw approval of the metastatic breast cancer indication for bevacizumab. We believe there are at least two issues of relevance that are best considered or debated at greater length in a public forum.

First, we would like further consideration of an apparent lack of data directly contradicting the results of the E2100 clinical trial, the primary basis for the accelerated approval of bevacizumab for metastatic breast cancer. The results of subsequently published clinical trials testing bevacizumab in combination with other chemotherapeutic agents have certainly been disappointing, and they suggest that bevacizumab is not as valuable a clinical tool for the treatment of breast cancer as many of us had hoped it would be. However, the specific combination of bevacizumab with paclitaxel has clearly been of benefit to some patients with metastatic breast cancer and may offer benefit to many more in the future. We are concerned that fully withdrawing the breast cancer indication at this time will deprive some future patients of meaningful clinical benefit and believe this is an issue worth further public consideration.

We are disappointed that despite substantial resources committed to various bevacizumab clinical studies, Genentech and Roche have not obtained sufficient data to definitively replicate or invalidate the results of the E2100 study of bevacizumab specifically in combination with paclitaxel. However, we do not think this failure alone, at this time, is adequate reason to deny the possibility of clinical benefit from this drug combination to breast cancer patients who cannot afford to obtain it off-label and unreimbursed while we wait for the results of planned clinical trials.

It is clear that many patients treated with bevacizumab may suffer its side effects without receiving benefit, while a minority may receive significant benefit. Unfortunately, no one can predict which patient is which prior to initiating treatment. Ultimately, we believe these difficult regulatory decisions need to be made with the individual patient in mind, both the person who is harmed and the person who is helped. Legal arguments and procedural arguments should take a distant back seat to issues of science, medicine and patient well-being. In the face of substantial uncertainty, each patient, as a valued individual, must make an treatment irreversible decision in consultation with one or more individual physicians. Under these circumstances, more information is always better; thus, our exhortations to the FDA to conduct thorough and even redundant public analysis prior to taking final action and to Genentech and Roche to deploy the necessary resources to answer open and critical clinical questions about bevacizumab as rapidly and unambiguously as possible.

A second issue of broad public health and public policy importance we believe justifies a public hearing is the need to further consider, and more objectively define, clinical significance versus statistical significance in the context of the use of progression free survival versus overall survival as clinical trial endpoints to support drug approval applications. Although such a broad issue would not be the primary purpose of a public hearing, and the issue has been, and will continue to be, debated in other venues, we believe a public hearing on the immediate bevacizumab issue may contribute important understanding to this important technical policy issue.

We believe that a clinically meaningful and statistically significant improvement in progression free survival provides an important clinical benefit to patients, even in the absence of a demonstrated statistically significant improvement in overall survival. Many intelligent and well-informed people disagree with our view on this issue. The bases for agreement and disagreement on this topic are complex and beyond the scope of this letter, but we believe those who disagree with our view would agree that more extensive public discourse on this topic could be valuable.

We understand that the decisions the FDA makes are not easy and are made carefully. We do not have access to all the expertise or data available to the FDA, nor does the public at large, nor does the individual patient or physician in the exam room or hospital room. We believe a public hearing will enhance public understanding of the difficult work performed by the FDA and also provide this specific issue with the careful, complete and public analysis its importance warrants.

Very truly yours,
Robert Erwin

President

Marti Nelson Cancer Foundation