REGN4018 Clinical Trial for Ovarian Cancer: Week 15 (Patient Perspective)

My cancer is back and while I was told I would be able to get the second immunotherapy drug, Cemiplimab, when I progressed, because the protocol was changing to allow that option, when I actually needed it because I progressed, I was denied.

I don’t know if it’s because the protocol has not formally changed yet or the drug sponsor changed their minds on making that change. I just know, that once again, I’m shit out of luck and scrambling for new options.

To say I am disappointed is an understatement. It’s more like I was despondent which is why I needed a break from writing, talking, and sharing.

So, not only did my medical team mess up by scheduling me for Cemiplimab two days after the treatment window ended, which is why I couldn’t get the drug the first time, now, Regeneron went back on their word about changing the protocol to allow for this drug upon progression.

It’s hard to tangle out what I feel about what. On top of the cancer recurrence crummy news, knowing this trial didn’t buy me more months or years, I’m feeling crushed by my experience with this clinical trial. I have questioned my trust in my own team too.

So, while I believe in the power of joy-stalking and understand the reality that every single one of us is in fact terminal, I also felt the weight of another treatment door closing and fear about how smart and quick my cancer seems to be. While I know, intellectually, I’m not responsible for how others feel about my diagnosis and prognosis, I still feel bad being the bearer of lousy news over and over and over again.

It feels like I’m letting my loved ones down over and over and over again.

It feels like I’m a one-note wonder constantly singing the “more bad news” song.

And also, when it comes to this trial, I can’t say anything other than the truth which is that I’ve been jerked around and let down. I can’t give good answers to the most basic questions such as:

What?

Why?

How come?

Can’t your team do a, b, or c?

Why can’t your team do more?

It’s been a stew of helplessness I’ve been swimming in and my loved ones feel it too.

I don’t see the point in torturing everyone with the same uncertainty I’m facing. I tend to wait to have a plan or some definitive information to share.

So here’s a brief overview of the last month and what’s next.

First, I had a PET CT in Chelsea that showed that I’ve had a partial response to treatment, and while some of the places where cancer was growing had indeed shrunk, there was new places cancer traveled and/or lymph nodes which got larger. At first this pointed to what is called pseudo progression which is basically a “things can get worse before they get better” situation and the tumors can seem to be growing while they are fighting the cancer. It seemed possible, per my oncologist, but not definitive. Still, it meant six more weeks of at least a stable treatment response, which, the longer you have cancer is sometimes the best news you get when the cancer won’t go away completely. So, this felt like good news at first.

But, I also had a visible lymph node growing in the base of my neck which could be biopsied. The biopsy could show if I had mostly inflammation or if the growth was more cancer. Unfortunately, the biopsy showed only ovarian cancer growth and dashed our hopes of pseudo progression. While I hoped it would be all inflammation, or maybe a response to the staph infection I’d had, I worried that it was cancer because my CA-125 was increasing and even though it’s not known how accurate the CA-125 in these trials for bi-specific antibody drugs, for me it has always been a reliable marker so I was nervous.

So, while I was bummed (to put it mildly) I thought I’d finally get to see if the combination of REGN4018 would do anything, such as cause fevers, or stimulate an immune response. My oncologist thought we’d tell the sponsor about the progression and they would speed up adding it to the protocol so maybe I’d start treatment in a week or two with the combination.

And why I’d been told my team, who was told by Regeneron that the second drug would be added to the protocol for patients who progressed, when I progressed, I was told my oncologist had to seek permission for the second drug, and when he did, he was denied.

Why?

Is it because the protocol hasn’t been updated yet?

I don’t know.

Will the protocol be updated later?

I don’t know.

Did my oncologist misunderstand the drug sponsor?

I don’t know but I doubt it because he’s always kept his word with everything in the more than two years we have worked together.

Is this just another cause of terrible timing or, as my friend Beth says, Mercury being in retrograde and f’ing up everything?

I don’t know.

So even though I had to sign paperwork saying I’m willing to die by trying this treatment combination, even though I was willing to withstand fevers for almost a month, non-stop, as a guinea pig for this drug (and happily would continue to do so if it makes a dent in my cancer), I don’t get to know why I don’t get the drug now when trying it might offer hope, help, and the “miracle” that at least one other patient got.

I just don’t get the drug and that is that.

It makes me mad and it makes me feel helpless.

It’s strained my relationship with my team a bit, and rattled my confidence in the clinical trial process.

I know my oncology team cares about me, is responsive, caring, and creative. And I also know that the experience on the past 3 and a half months has been harrowing. I finally did say how frustrated and disappointed I am, which is not easy when your life is dependent on people you feel hurt by, but I knew if I didn’t say anything, I would lose trust in my team. So, I was able to share my disappointment and I’ll be sharing more on that later in other writing.

For now, we are on to looking for another treatment.

And once again, I reached out to the Clearity Foundation and got a list of several trials and an overview of treatment options available to someone like me who is platinum resistant (means I can’t do more platinum based chemo). I’ve now had three lines of treatment that have not worked, plus a maintenance line, so in less than three years that is a lot of treatment.

I’ve aged about 10 or 20 years, at least, but I am have also never been more grateful to my body for working so hard, tolerating and withstanding so much, and for rebounding so quickly. I don’t think exercise and diet and supplements and alternatives are enough, alone to beat ovarian cancer (though I wish research proved that to be the case because I’d love less toxic treatments). However, I think all I do for my health if my way of saying thank you to my body and for helping my body to stay strong. I’m able to do a lot still, though I move more slowly and need to conserve my energy, and now sleep about 10 to 12 hours a night. I’m still very anemic, not at the transfusion level, but enough that I am tired all the time.

Later today, I’ll be starting radiation to shrink the tumor at my neck which is getting larger and larger and is too close to blood vessels to be surgically removed.

I am brand new to radiation and learning about it now. It’s a relatively short cycle of 5-6 treatments over the next week. Most people get four to six weeks or more of treatment so as radiation treatment but mine is just to target and shrink one lymph node.

The most likely side effects are fatigue, a sore throat, but can also be nerve damage and a secondary cancer. Secondary cancers from radiation tend to impact younger people more than a 55-year old who is three years into a less than 50% chance of living five-years. So, as I said to the radiation oncologist as she went over side effects, “I don’t really have a choice anyhow” because the lymph node is growing unchecked and can’t be surgically removed. I signed the informed consent in with my what else can I do signature.

So, since I’m getting radiation, I will also get more immunotherapy, through compassionate use means, what I can hope for is something called the Absocpal Effect, which is, according to verywellhealth.com: “a theory that describes why sometimes using local treatment to one area of a metastatic cancer (such as radiation therapy) may result in cancer shrinking in an untreated area. While this phenomenon was seen as a rare occurrence in the past, it has become more frequent with the arrival of immunotherapy drugs such as checkpoint inhibitors to treat cancer. The underlying mechanism for this phenomenon is still unclear, but it’s thought that the localized treatment might prime the immune system to attack cancer cells in a distant region.”

I will hope for that, and if you wish to hope or pray along with me, I would appreciate that.

I’m in a much better state of mind and I remain grateful for everyone and everything, even though I’ve been a bit of a turtle taking shade under my shell.

I’ve gone over other treatment options with my team, and got a consult once again with the Clearity Foundation which offers free treatment support to people with ovarian cancer. They always remind me that there are options for treatment, that there are new drugs in development which I may be able to access over the next six months to a year, and that other people do survive, at least for a while, even it means going from treatment to treatment to treatment.

I am so grateful they exist and have reached out to them every time my cancer recurred and/or a treatment protocol failed me.

By the way, I refuse to say I failed on a treatment because that feels like I’m blaming myself. While I do sometimes feel self-pitying, and wonder why I don’t respond more or for longer to treatment, I’m not going to blame and hate on myself because I would never blame or hate on others who had a persistent mother-f*cker cancer. Plus, when 85% of us fail the standard of care, that’s a failed treatment method and a predictable response, and I’ll keep calling that a standard of fail until the stats change.

My friend Laura Parrot Perry is a beautiful writer. She has long talked about putting work boots on our pain so that none of it is wasted. Even when we can’t control what is happening to us we can control what we do with it. Along those lines, I’m working with a few radiation oncologists on a process for increasing patient awareness of radiation plans and will use my experience to contribute a patient’s perspective, which I believe should be built into any and every process related to patient care. Should something come of that collaboration, I’ll share it on the blog. No matter what happens, I’m happy to know that there are many radiation oncologists in the world who wish to hear from and work with patients and patient advocates and that will, no doubt, help change and improve all things related to shared decision-making. And, it makes me feel like I’m able to do something positive with a challenging experience and that, for me, is monumentally meaningful.

Plus, despite the rough patch, I’m thoroughly enjoying my daughter being home from college, my friends and family and pets and the glorious yellow irises blooming out front. There’s plenty of joy juice to sip, and joy stalking to pursue, always and every day.