Backstrokin’

 

It’s been kind of a crazy week. I had a virtual visit with my oncologist, who said he would actually prefer if I *do* enter the clinical trial, which was a bit of a surprise! I also finally learned why I’m not on Verzenio. There are a number of factors involved for someone to qualify- tumor size, high grade, a larger number of involved lymph nodes, and/or high ki67 score. My tumor was too small, it was moderate grade, I only had “1 1/2” lymph nodes involved, and my ki67 was never tested. Some oncologists do it, but none of mine find it particularly valuable. However, my oncologist felt that it’s possible I could benefit from Verzenio (about a 5-7% improvement in overall recurrence risk if I qualify) so he ran the ki67.

In order to do the clinical trial, I cannot take Verzenio, and for 2 of the 3 places I might land in the trial, I would not have any changes to my current medication. So, if eligible for Verzenio, I would have to decide if I want to do that OR the trial. Also, the side effects tend to be pretty bad for most people, with diarrhea being quite common, so I am apprehensive about taking it. I would be on it for 2 years. 

Luckily, (or not?) my Ki67 score came back today at 10-12%. 5% or less is considered a low score. 30% or more is a high score. 20% is required for Verzenio eligibility. So, for better or worse, I do not have to make the decision about whether to take it. It is not an option for me. The data does not support that it would be beneficial for my cancer and it costs more than $14,000 per month…Verzenio is off the table.

I have been in contact with the clinical trial coordinator and the breast cancer center at Ohio State. I have my first appointment (to become an established patient) on 3/10. I have to be an established patient to get into the trial. They will do Signatera testing. If my test is positive, they will do scans. If the scans are clear, they will randomize me into one of the “positive arms” of the trial. One arm would change my medications to Fulvestrant + Palbociclib. Palbociclib is a similar type of drug as Verzenio. The Fulvestrant is a different hormone suppressing med. If I test positive, but they find something on the scans, then I will be metastatic and not eligible for the trial. In that case, my oncologist will resume the lead and I will start whatever first line MBC drug is appropriate (maybe Verzenio? 😆),

The other positive arm follows current standard of care. If I am randomized to that arm I will just continue on my regular meds, but they will monitor me more closely than my oncologist typically would. 

Both of these arms would involve repeated Signatera testing, however, neither I nor the researchers would be informed of the results after the initial test.

If I test negative, I can probably remain in the trial, and I will just continue my regular meds. They would also continue to test. They would still follow me, but not that closely. If I do that, but eventually have a positive test, I think I may be able to switch to the positive side of the trial?? But I’m not clear on that, yet.

So far, Ohio State has not had any positives. (The guy at Yale said the study needs a total of 100 positive cases from their 15 trial locations and they’ve only found THREE in more than 2 years!!!) So, either the required 6 months of hormone suppression (before you can be eligible for the trial) causes most people to turn negative, or, I’m a goddamn unicorn…I haven’t tested since I hit that 6 month mark, so let’s hope mine just “turns”negative, too. 🤞

Signatera got Medicare coverage approval across all breast cancer subtypes last week. This seems to lend credibility to their claims, but I’m still extremely skeptical of their claims, and especially their practices. I’ve found some curious discrepancies in my own testing and who knows who profits from this company… I could go on for days about how shady these assholes are but it’s not important. The company is a mixed bag of good scientists and greedy board members and a bunch of stuff in-between. Ultimately, I hope someone finds that they’ve actually broken laws and takes them down, but for now they are just getting bigger, so I hope that something positive comes out of all of this, at least. If I join the trial, maybe I can help make that happen. Unfortunately, it is going to be expensive. Some stuff is covered by the trial, but some will be billed through insurance and it’s not clear how much they will cover. We will also have monthly- sometimes bi-monthly travel expenses. It’s frustrating to have to spend more money to participate, but it seems like it’s the best option. If I do happen to test negative, then it would be much less of a burden and I can still participate in advancing the science, so that is the best case scenario, across the board! 

Today, someone reached out to me on social media who says she’s in the same situation (“positive below analytical range”). You can’t really trust random strangers on the internet, of course,  but the upside of all this escalated testing is that there are going to be more people in my shoes, which means more scientists trying to clarify what all of it really means, and more oncologists working on a plan. I still hate Signatera, and the clinical trial people have pretty strong opinions about them, as well…but since it *has* been released to the masses, I do think major advancements are going to happen, and happen sooner than they otherwise would have. The ethics of all of this took a backseat to the potential profits, but I  believe that good scientists and doctors will make the most of the hand they’ve been dealt, and that will ultimately benefit all cancer patients.

I guess that’s it for now. Friday is New Boobs Day!! That’s been the running joke around here, but my port has been pulling in my neck lately, so I’m really more ready to get that out than anything else. I’ll let you know how it goes!