PRESENT: An exercise in futility

Sometimes clinical trials go like gangbusters. Sometimes clinical trials lead to new chemotherapies, new treatments and changes the way diseases are treated. And sometimes new drugs show early promise in early trials, but when a large population is tested it is shown to have no value. 

Unfortunately, the once promising Nuevax vaccine, the vaccine used in the PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment), was found to be futile. 

Futile; incapable of producing any useful result, fruitless, ineffective, pointless. 

The study has been shut down. What happen was after the ~700 people were enrolled in the study  and 70 DFS (disease free survival) events [ok this is a little tough, DFS events are the opposite of disease free survival they are recurrence, secondary cancers, or all cause death] and Independent Data Monitoring Committee (IDMC) unblinded the study. The IDMC found that the vaccine offered no benefit and recommended that the study be stopped; mathematically they found the study to be futile 

To say that I am bummed is an understatement. I understand that this is how drug development works, and I was so hopeful that this would be the next big thing for breast cancer treatment. However, I'm thankful to not be writing about wishing my chemotherapy or surgery had been successful. I'm trying to keep it in perspective. 

The upside to the study ending is that now I have regular follow up which means a lot less tests, scans and follow up appointments. 

I will no longer need to have MUGA scans, bone scans and CT scans. I will only see my oncologist every 6 months for another year than annually after that and the only annual imaging I will need is a mammogram. I asked my oncologist about needing an MRI and she explained that I am not high risk and those who have positive genetics are those who they do MRIs with. She explained that if that had been what I needed for imaging that I would have been getting it all along with the CT scans because they are looking at different things (the CT scan was more looking for metastatic disease while MRIs are for looking specifically at the breast for new disease that wouldn't be able to be shown on a mammogram).

As the research nurse put it; I'm just a regular healthy person . (But, I'm still going to mourn the futility of being injected with an ineffective vaccine 40 times). Also, they are going to unblind the study and  I will be told what I was actually getting.

In the meantime I signed up to send my saliva (for my genes) to test if there is a genetic link between why people develop chemopause (lack of menstruation during chemotherapy).  Saliva and survey? Easy enough.

What a bummer.

Triclosan Banned!!

Since finishing my treatment in February 2013 and embarking on the cancer survivor right of passage that is known as "review all the chemicals that are in your life and try to see if they are the source of what just happened to me" I have been avoiding Triclosan. Triclosan has been in antibacterial soap and even toothpastes. Triclosan can potentially create super bacteria and is a known endocrine disruptor. As someone who just took an endocrine disruptor on purpose (my tamoxifen) I would like to put only the ones my doctor prescribes into my body.

Guess who finally got on board that Triclosan shouldn't be allowed in consumer products? The federal government. Yesterday, the FDA banned triclosan and 18 other specific ingredients because they were not any more effective than plain soap and water.

In the press release the FDA, the mention that the data when these chemicals were studied may demonstrate that the do harm. Here is a direct quote.

Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.

 Another case of more is not always better. This may have been 3 years later than most consumer protection agencies would have liked, but the FDA finally got there and it means a lot less people exposed to an endocrine disruptor. Companies have 1 year to get triclosan and the 18 other ingredients out of their products, but by 2018 antibacterial soap should be thing of the past and that makes me happy.

The Marking of the Annual Diagnosis Day

Yesterday was four years since the Nurse Practitioner called me at 3:30 pm and said "You have breast cancer". Four years. The same amount of time I spent in my undergrad. The same amount of time I spent in high school. Four years.

It seems forever ago and yesterday all at the same time.

Four years ago, I didn't believe anyone when they said this would just be a blip in the path that is my health. I didn't believe anyone, that after learning I had cancer, that I would ever spend another day not thinking about it. I didn't know what pure gratitude felt like and I had no idea how loved and supported I would feel throughout treatment and into survivorship.

I spent the day, like I have a couple before, doing what my mother and I were supposed to be doing August 8th, 2012, sitting on the dock with my Aunt in Lake Sunappee. We enjoyed the sun, peace and quite and some down time (and my hand is back to normal size!). While sitting quietly in my chair on the dock, the swell of gratitude was impossible to fight. In the four years since I was diagnosed, treated and declared cancer free I have had such a strong army of co-survivors who still would do anything for me. It's amazing to know that that support is out there. In the past four years, I have also seen many individuals who have not had the same happy outcome that cancer journey did. I think of Joanne. I think of Marisa. I think of Mary. I take comfort in knowing they are at peace.

Four years. The olympics are back and I'm watching them in prime time and not the middle of the night because my mind is too full. I may run much slower than I did 4 years ago, but my spirit, my sense of humor and my health are all in tact.

Although I still take it one day at a time, I think I shall now start to look to the future with the classic campaign slogan-4 more years (at the very least)?

Blogging with one hand

I have a long history of exaggerated reactions to bug bites. Every year from first grade through 6th grade I would get bitten by a black fly on my eye the night before class pictures. Then there would be a photo of me with my glasses barely able to make it over my swollen shut eye. Because of the over-reaction I have it is why they had to do a dose reduction in the PRESENT trial. Apparently my super, duper quad was not the goal of the trial.

On Saturday while waiting for a friend sitting on my front porch a bee decided my finger was a predator and stung it. (Side note, those injections for PRESENT really did feel like bee stings). My middle finger instantly swelled. However, knowing that swelling is just what I do, I did the regular; ice, benadryl, and NSAIDS. Well, that was fine and dandy, but the swelling didn't stop. My finger doubled in size, turned hot pink and spread into my knuckles. And then this morning my elbow was also pink. Uh oh.

By 9 am I was in to see a PA whom I hadn't seen before. He took one look at my hand and said "Well, looks like you just bought yourself some time off and some IV antibiotics". Damn. He asked my why I waited so long to come in and get checked out. I explained my history of exaggerated reactions and that I was just trying to wait it out. He asked me how well that worked out for me.

Next up comes an IV in my hand for at least the next 2 days. The IV RN who puts my IV has put in a couple of them for my MUGA scans and we chat about my bee sting. Then in comes in an RN to give me the IV antibiotics. She is befuddled as to why the IV RN put the IV in the same arm as where I had the bug bite. I explain to her that I am a "left arm only" and she asked if I had a mastectomy or lumpectomy, "Lumpectomy with sentinel node removal". She looks and me again and says "unbelievable". She asks me my date of birth again and tells me I look 22. I told her today I will take it (I had slept for maybe 3 hrs because of pain and itching in my hand) and was not looking my best.

So I'll go back to the hospital I'll go tomorrow for more IV antibiotics and until then this how I'm hanging out at home until then

Thoughts on the Moonshot

Back in October, Vice President Joe Biden announced his Cancer Moonshot; how he was going to meet with researchers and encourage collaboration in order to accelerate findings of cancer cures. Biden has been spurred on since the death of his son, Beau, to a brain tumor. Part of this initiative is to attempt to get a decade’s worth of research development within a 5 year period. Many people have taken exception to VP Biden calling for a Moonshot as they feel this conveys a false pretext as research results don’t result in large leaps in knowledge, but often small increments.

As a cancer survivor, I love that Biden called it a Cancer Moonshot.  The word moonshot conjures the image of President John F. Kennedy standing at Rice University inspiring the country with the importance of space exploration. When I heard Biden call it a Cancer Moonshot, I could hear JFK in his Boston accent say

“We choose to go to the moon in this decade and do the other things, not because they are easy, but because they are hard”

Curing cancer would be incredibly hard. Doing 10 years of research development in 5 years would be hard. But, these are initiatives that we must take on, that we must work towards and needs collaborative effort. That is why I love that VP Biden called it a moonshot.

As a cancer survivor, I feel that my role in the cancer moonshot is to continue to enroll in trials, send my blood and tumor out for study and support the research effort by continuing for follow up with the PRESENT trial.

Part of the biggest initiative in the cancer moonshot is the development of immunotherapy-using the body’s own immune system to fight cancer. This is part the reason why I was so drawn to the PRESENT trial.My friends at The Mesothelioma + Asbestos Awareness Center sent along a great infographic that explains the moonshot and immunotherapy beautifully. If you want to learn more about the rare cancer they raise awareness for, head on over to their mesothelioma page here.

Thank you Mr. Vice President for starting the Cancer Moonshot. Thank you for choosing to do what is hard. I am one inspired American and will continue to participate in the PRESENT trial and hope that vaccines and the use of immunotherapy will become the standard in the fight against cancer.

Lahey Health 5K Cancer Walk and Run 2016

Yesterday was a perfect summer day. The temperature was in the high 60's, low 70's around race time and the turnout was phenomenal. Team NED has never been so large in numbers or in spirit. And yet somehow I came home without a photo of the team...team captain fail.

 The race itself was great, it is much easier to run without a belly full of buttercream frosting! I ran better than I thought (can still get under 8 min/mile for a 5K). But, what was so great was all the people out there in the Team NED tshirts. My parents, my boyfriend, my good friend from elementary school, her sisters and their children, my good friend from middle school, my track teammate from college, her husband and their children, and a couple of great Lahey Dietitians and Speech Language Pathologist thrown in for good measure.

My sister in law and brother organized an amazing turnout of virtual runners online. I got to spend the rest of day with a constant stream of updates from folks supporting Team NED and going for runs from Arizona, Colorado, Ohio, Texas, South Carolina, and Pennsylvania (a strong presence in PA).

 How great is that? Support from around the country and lots of people going for a run!

Because of all the Team NED participants, our bake sale, and generous donations from family, friends, and the Kelly Care's Foundation Team NED raised over $3,600 for the Lahey Cancer Centers. This, I think is the most money the team has every raised.

I am grateful for everyone who came and out, those who virtually ran and all those who donated.
Thank you for making yesterday such a great day and having an excellent celebration of all things NED.

Naked Toe Nails

I have painted my toe nails since I started running competitively (since I was a freshman in high school). I have some pretty ugly runner's feet and have long had weird or missing toe nails. Sometimes when a toe nail would fall off, I would paint one on with multiple layers of nail polish and no one would be wiser. I would occasionally go the winter months without polish on my nails, but for at least 9 months out of the year there would be some color on there.

Post chemo, I sill had black spots in my fingernails even a year after treatment; for almost an entire year I painted my finger nails too. During this year, I was investigating all of my food sources looking for potential causes of harm, looking at sunscreens and lotions, handwashes and toothpaste. It never occurred to me to look down at my nails.

Last October, the Environmental Working Group (EWG) in collaboration with Duke University released a study using 26 women (small number, would have like to see more than 30) on chemicals in nail polish. In particular, the study was looking at Triphenyl Phosphate (TPHP). TPHP is suspected to be an endocrine disruptor. This study tested the urine of the 26 woman after they painted their nails and found an increase in the TPHP levels within half a day. That is a pretty short turn around to be able to find it in the human body. TPHP is also the same chemical used as a fire retardant and is used more in polishes that are chip resistant.

The EWG compiled a list of all the nail polishes that contain TPHP here. Knowing that there are possible endocrine disruptors in cosmetics does give me further pause before I put anything on (which is a very rare occasion anyways). Knowing that I was spending a week on vacation where I spend most of my time in bare feet, I let my feet stay ugly. I threw out all 24 bottles of nail polish prior to vacation. It freed up a whole drawer. Maybe busted runner's feet will become the next big thing for summer? A girl can dream. But, for now they will stay unpainted.