Monday, September 19, 2016

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.

Saturday, September 3, 2016

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.