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.