More Crazy

Thank you for all your comments in response to my last post. No matter how many of you may call me strong and courageous, I need to believe that I am strong and courageous because those traits lie at the very heart of how I view myself and what I like most about myself. Indeed, self-perception matters more to me than what others think of me. (That’s something I wish I could have taught myself much earlier in life.) I need to go to my death liking, even loving, myself, and loving the narrative of my life I have constructed, a narrative that embodies strength and courage. And so, I must choose, what for me and for now is, the path of greater resistance, the one I deem more terrifying, more uncertain, more difficult, for that to me is the definition of strength and courage and what will epitomize most my deep love for my husband and children. Death is a certainty and not even that terrifying a certainty. I’ve seen enough people die from cancer; I have a pretty good idea of how it will progress, how I would die, and with enough narcotics, it shouldn’t be that terrifying at all. 

What is far more terrifying than dying from an unchecked colon cancer is inflicting myself with experimental combination of drugs and radiation, that has never been tried on any animal much less a human being, that will more likely than not alter the way I die and indeed probably accelerate my path towards death. But there is that smallest of smallest of possibilities that doing so will fend off death, at least for a little longer than if I had chosen to do nothing. And that is the gamble I am prepared to make.

But any path I choose must be based on some modicum of science. I will never drink green sludge drawn from a swamp given to me by some charlatan. And so, after my last post, I asked for another treatment of Irinotecan and Avastin (the old treatment) to tie me over during my long-planned trip to Los Angeles at the end of June. I had signed my girls up to do swimming camp with my nephew for two weeks – swim camp is much cheaper in Los Angeles and I wanted my girls to really get to know their cousin. With this new medical development, I wanted to spend those two weeks researching and thinking about next steps.

And that’s exactly what I did. I looked into clinical trials for colorectal cancers and solid tumors generally. I read about the theorized synergies between radiation therapy and immunotherapy. I looked at the results of immunotherapy trials in colorectal cancer thus far. What I found was scientific evidence about what would likely not work on me.

I wasn’t impressed by the clinical trials I saw. There was great excitement a few weeks ago when success in a Phase 1 trial of cobimtenib and atezolizumab prompted the trial’s sponsors to skip Phase 2 altogether to start a Phase 3 trial (which is the broad double blind randomized trial that the FDA requires of any drug before approval). My oncologist wasn’t impressed with the Phase 1 data – 17% response and all in people with KRAS mutation (which I do not have). Additionally, participating in a Phase 3 trial means potentially receiving the control drug, which in this case would be regorafenib, which is so toxic I swore I would never take it.

Of course, there were other trials but all were Phase 1, which held little appeal to me. Phase 1 is the use of a drug on a human being for the first time and under the rigors and demands of the study’s protocol. So, not only would participation mean constant testing and monitoring, but other treatments not contemplated by the protocol would be prohibited. So for example, if I discovered I had a brain met or had an adverse reaction to the dose, instead of allowing me to radiate the brain met or reduce the dosage, I would likely be kicked out of the study.

I’ve interacted with many in the colorectal cancer community and I have not heard of one person doing anything “off-trial.” I’m guessing my oncologist is unique in his willingness to do things on his own, which I like. If I’m going to be experimented on, I’d rather be in control of the terms of that experimentation.

By now everyone has heard about immunotherapy, the use of drugs to activate the body’s own immune system to fight off the cancer. Based on the media’s excitement about immunotherapy, you might believe that we’ve found a cure for all cancers. Hardly. What most people don’t know is that it’s been shown to be successful, and is FDA-approved, only in lung cancer and melanoma. Immunotherapy has also been shown to be successful, although not yet FDA-approved, in treating colorectal cancer, but under a very limited circumstance, i.e. those cancers that are characterized as “MSI-High”. I’m not going to get into all the technical details of what MSI means, other than to describe it as a particular genetic characteristic of the cancer cells. Only 5% of all colorectal cancer patients are MSI and even a smaller percentage are MSI-High. Similarly, in lung cancer – I don’t know about melanoma — immunotherapy has only been successful where the cancer is comprised of highly mutated cells (typically in smoking-induced lung cancer).

I am not MSI-High. I am not even MSI. I am part of the 95% of colorectal cancer patients who are MSS. Single-agent immunotherapy has not worked in MSS people. Data was presented at the 2016 ASCO (American Society of Clinical Oncologists) meeting on a Phase I immunotherapy trial using nivolimab (“nivo”) alone and in combination with ipilimumab (“ipi”), showing response in patients with MSI-High and I believe better response with the combination as opposed to just the single agent.

As some of you may recall, Dr. AC suggested the use of nivo and ipi as part of his “crazy” idea, but he also wanted to throw in radiation therapy (since based on the above-referenced study, nivo and ipi alone would not work on me).

Also presented at the 2016 ASCO meeting were the unsuccessful results of a study using pembrolizumab, another immunotherapy drug that works in the same way as nivo, in combination with radiation for colorectal cancer. Many researchers have long believed that radiation could, when combined with an immunotherapy agent, trigger an immune response against the cancer. Proponents believe that it is a matter of simply finding the right agent and the right amount of radiation. Dr. AC has successfully used nivo and radiation to treat lung cancer as well as ipi and radiation to treat lung cancer, but not both and radiation. Indeed, it seems like most of the success in the immunotherapy-radiation combination has been thus far seen in lung cancer.

During my first week in Los Angeles, Dr. AC was in Paris attending an oncology conference. He asked me to call him upon his return to run yet another crazy idea by me. At the conference, someone leading a trial at Princes Margaret Hospital in Toronto presented pre-clinical data (i.e. data from mice) about the potential synergies in using Vidaza (a long-established chemotherapy drug used to treat leukemia and myelodysplastic syndromes (“MDS”), a blood disorder) in combination with an immunotherapy agent for patients with MSS colorectal cancer. Vidaza is an “epigenetic” drug meaning it works by altering the genetic characteristics of certain cells, in this case changing the cancer cells from MSS to MSI and therefore theoretically making them more susceptible to the immunotherapy agents.

So now Dr. AC is proposing to pre-medicate me with the Vidaza but at a much lower dose than what would be administered for MDS. Then, the radiation oncologist would radiate the spots in my pelvis, again at a much lower dose than would be typical if one were just using radiation alone to treat those spots. Then, Dr. AC would give me the nivo on a 3 week schedule and the ipi on a 6 week schedule. The nivo is reputedly a walk in the park in terms of toxicity. The ipi is more toxic but its experimental use over the years seems to have led researchers to figure out the appropriate dosing.

And of course, other than the radiation, insurance won’t cover any of the drugs, not nivo, ipi nor Vidaza. Although all are FDA approved, none are approved for colorectal cancer. Bristol Myers Squibb, manufacturer of nivo and ipi, quickly gave me access to those drugs through their patient support programs. Celgene, manufacturer of Vidaza, said I and Josh make too much money. For two treatments, which is what Dr. AC is proposing in order for us to know if it is working, I would have to come out of pocket $27,000. If the treatment worked, I think we would have a compelling case for insurance reimbursement.

I have an appointment with the radiation oncologist next Friday to start the radiation process so I suppose at a minimum I will do the radiation and the ipi and nivo. I just now have to decide whether to spend my own money for the Vidaza. It’s a lot of money for a very risky gamble.

Also in play are the mice that were implanted with my cancer. A few weeks ago I learned that the mice accepted my cancer tissue, so the implantation was successful. The next phase is for the scientists to transplant the cells into a new generation of mice, upon which drugs chosen by my oncologist will be tested. There is expense associated with each test, and if any of those drugs are successful and I wanted to sue them on myself, I would likely also have to come out of pocket for that treatment since none of the drugs we will be testing are FDA-approved for colorectal cancer. Because the mice are immunosuppressed so as to permit them to accept my cancer cells, we cannot use any immunotherapy drugs on them.

So is your head spinning yet with all this? Mine is and I’ve been churning all the information around in my head for weeks now.

8 Comments (+add yours?)

  1. Chris Rice
    Jul 13, 2016 @ 23:53:48

    No my head is not swimming… you nailed it here… simple for me to understand and indeed a great deal of information that you condensed into a patient friendly review.

    Julie, I am glad you starting to love yourself… cause I already do and have never met you in person. But, somehow I know that we would be fast friends.

    My thoughts are similar to yours in taking calculated risks that I have research and churned in my head. So I feel positive about your choice and believe as do you that death from crc cancer is going to happen… so why not try what is unconventional and with the help of such great doctors who are invested as well in your recovery.



  2. Skye
    Jul 14, 2016 @ 00:32:09

    Have you considered starting a GoFundMe or other fundraiser to help with out-of-pocket costs? I have a friend with stage 4 breast cancer who has successfully raised funds to help pay for her extraordinary health care expenses (she, too, is doing a lot of treatments that are not covered by insurance). Best wishes deciding the best path forward for you.


  3. Paul edelstein
    Jul 14, 2016 @ 10:13:36

    Holy crap
    I think perhaps the world would really be fit by you’re surviving and becoming an expert on these treatments
    Keep going if not for the obvious reasons then how about the secondary?


  4. Jennifer Knee
    Jul 15, 2016 @ 11:27:07

    I admire your fight!! You are truly one of a kind!!!!


  5. J.L.
    Jul 16, 2016 @ 17:49:17

    I love that your doctor is so willing to think outside the box and do some carefully calculated risk-taking. Should I ever progress to stage IV, this is exactly the kind approach I’d want to consider.


  6. Jeanine
    Jul 19, 2016 @ 11:42:20

    So great to read about these choices. You are certainly worth the $27,000.00 and more. I feel real hopeful. Go for it!! Prayers….


  7. Ethan
    Jul 19, 2016 @ 23:23:01

    Thank you


  8. Amy
    Feb 09, 2017 @ 08:06:14

    Thank you for sharing your story. My dear friend was diagnosed last June. She had HIPEC and right after found more/larger liver metastasis. Your Grace and willingness to put your raw story out there is helping countless others. Blessings.


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