It’s Not Just Broken, it’s Fractured

When I first learned of my diagnosis, it was essential to my husband and me that we consider a cancer center that would offer cutting-edge research and clinical trials. We wanted to make sure that I would have every treatment option available. That’s why I am also a patient at Memorial Sloan Kettering. At my first meeting with my oncologist there, we discussed clinical trials. I had even asked if there was one I could get into immediately. That’s how important I felt they were. Now, I’m not as confident as I was then.

Research Matters

While I didn’t know a lot about cancer research, I knew that research would be my only hope to keep on living. I counted on whatever clinicians were currently working on would be FDA approved and for my specific pathology before I exhausted my options. In the beginning, doctors told me I might have 2-3 yrs with the current standard of treatment. I wanted longer – a lot longer. I wasn’t going to accept what was “my fate,” and I became a vocal advocate for metastatic research. I was disgusted with how little money was going to metastatic breast cancer research. Large non-profits known for bringing awareness to breast cancer were mainly focused on preventing and treating early-stage disease. That’s great, but where does that leave me and others like me? It left us forgotten and ignored. We were the misfit toys on the island far out at sea.

After all, we are dying, and research typically moves at a snail’s pace. Doctors were treating us and keeping us as comfortable as possible. Another organization bluntly stated that metastatic breast cancer is just too complicated for research to focus on. Prevention was the key to save future generations, and we should accept that because it was too late for us. Whelp, the joke is on them. Shortly after my diagnosis, in 2014/2015, the first CDK4/6 inhibitor was on the market. Ibrance was the game-changer for estrogen-driven breast cancer. Maybe research wasn’t as slow as I thought. Little did I know.

There Is A Process

Over the last eight years, I have had extensive education in all things MBC. If one wants to create change, one must learn all about what needs to be changed. What I learned was disturbing. Clinical trials are a complicated process. There are four main phases each new drug must go through before getting acceptance from the FDA. Here is the cliff notes version for those that aren’t familiar with them. 

 Phase 1 is for figuring out what dosage is enough without being toxic and whether or not the drug effectively treats cancer in humans.

Phase 2 takes that dosage Phase 1 resulted in and monitors the drug’s safety and possibly pair it with existing drugs. 

Phase 3 tests against the current standard of care. Patients are usually randomized, so clinicians can assess patients by which group they are in. 

Phase 4 tests drugs that the FDA approves. These people are monitored to get better data on side effects previously seen in earlier phases. 

This entire process can take YEARS—five to ten years in some cases. 

Before ANY of that can happen, clinicians need people to qualify for the trials. It’s not just a matter of identifying people with a particular kind of illness. If it were, every clinical trial would be full. Patients must meet a laundry list of qualifications & parameters set by drug companies. The number of inclusionary criteria can be (and usually are) in the double digits. There are also exclusionary criteria that can deem you as not acceptable. That list can be just as long or longer, including previous biologic (cytotoxic) chemotherapy, having brain mets, prior radiation, etc. Scans have to be done, forms have to be filled out, and patients must adhere to a washout period. Patients can not have any trace of treatment drugs in their system before starting a trial. However, this “period” can be as long as six weeks or, in some cases, even longer. Think about that for a moment. Do you know how fast metastatic cancer can progress in six weeks? When the cancer is already active, not being on any treatment can make it progress exponentially quicker. Some patients die during this washout period. Next time you hear there aren’t enough people for clinical trials, remember that washout period.

What I find unacceptable is when clinical trial parameters don’t/won’t make reasonable accommodations for patients who have common and real-world contraindications because “it’s how other locations are doing it.” Even something as simple as how the stability of disease is measured can add another layer of anxiety to a patient participating in a clinical trial. Imagine a patient whose PET scans have previously been monitored due to a common iodine allergy to CT dye unable to have contrast in scan required to monitor the patient in the study. The only way they will monitor if the trial drug is working is with a CT WITHOUT contrast. PET scans are not allowed because the other locations/countries involved don’t do PET scans. Having a scan without contrast is similar to being in a room with the lights off and trying to get around. Something is bound to be overlooked. Even things as simple as blood work for the trial can require the patient to travel to the trial’s location weekly, or in some cases even more, JUST to get a basic CBC Blood test that is common enough to be run at home. What could be a local trip now requires commuter patients to potentially drive hours or find a flight to have a basic lab draw. Sure it’s good and convenient for the trial, but it can be utterly prohibitive for the patients, even if it’s their last hope.

The High Cost of Trials

Not all trials are local to where patients live. They often require regular travel, extended stays in the city the clinical trial is in, which means money for food. The clinical trial doesn’t always cover all of these expenses, so there is a component of financial toxicity that can be very overwhelming on top of everything else. Hotels haven’t gotten cheaper during the pandemic. Many of the free or reduced lodging programs through major cancer centers have stopped during the pandemic making it nearly impossible to find free or deeply discounted lodging for the patient. You would think by now we would be in a place where people could participate in a trial from their home base and have doctors communicate with each other. 

So, what if you’re in a trial that’s located at a different hospital? Who is responsible for your care above and beyond the clinical trial? If you develop a problem while you’re home, do you go to your doctor? I would assume it to be yes. I found that it’s not that simple. Clinical trials can complicate things. If you need a medication for a separate issue, will it kick you out of the clinical trial? Maybe.

In one situation, a patient currently in a clinical trial has all but been dropped by her local medical team. When she called her oncologist about a new infection that is not a side effect of the trial, her doctor told her to let the people overseeing the clinical trial know or go to urgent care. As far as they are concerned, she’s now under the care of the clinical trial 4 hrs away. The clinical trial folks instruct her to see her regular doctors. Palliative care has all but been stripped from her. Imagine having breathing issues with oxygen levels that don’t even reach in the ’90s, and NO ONE is monitoring you. She’s now in cancer limbo. You’d be OK with that. No, no, you would not.

Now when I hear there’s “not enough people for clinical trials,” I think, no shit. Why would anyone enroll? The burden on us patients is too high a cost -financially, physically, and emotionally. It outweighs the benefits. Becoming a human hot potato tossed back and forth between doctors while they cry “not it” is very unappealing.

It’s not a secret that the clinical trial process is broken. Those involved in advocacy have been trying to make changes with clinical trials – making them more inclusionary, basing the washout period on the most recent drug the patient has been on (they don’t require the same amount of time to leave the body). From my perspective, it’s not only broken; it’s fractured. In order to remedy this, drug companies must make clinical trials easier on the patients they need. After all – the goal is to help extend the lives of people, right? Maybe by allowing for basic accommodations, we can reiterate that the data points in studies all have faces, families, and stories that shouldn’t include extra barriers beyond their diagnosis to survive. The following MUST be part of the clinical trial protocol:

  • Provide a clear understanding of the financial toxicity in and outside the clinic to participate in the trial and were to apply for grants or assistance if the clinical trial doesn’t help pay these costs.
  • Make reasonable testing accommodations. 
  • Regular communication between the patient’s medical team to ensure proper care is provided.
  • Have palliative care continue or be available to those that need it.
  • Assign a navigator that patients can address questions or concerns.

I still support funding research; howthefuckever, something has to give for the clinical trials themselves. We are people who are sick that want more time. We do not need to be spending the extra time we are gaining, falling into crippling debt, or pushing to have our humanity acknowledged. 

We deserve better.

Sometimes It Takes A Village

There are certain times in our lives when we can’t do it all on our own. It can be very frightening, especially when your life is literally on the line. What started out as dire situation last Friday afternoon, for my friend Amy, ended up being a testament to how people can pull together and help their fellow man (or in this case – WOman) simply because their story was shared through social networks.

Here’s what happened…..

Last Friday afternoon, I received a text from my friend (and fellow MBC sister from another mister) Amy. After a bit of texting/venting, the situation was this: Amy had been accepted into a clinical trial at Weil Cornell in Manhattan – which is fantastic because Amy’s breast cancer had now progressed to her brain and there are few if ANY clinical trials for cancer patients with metastisis to the brain, let alone trials specifically for MBC patients with brain metastisis – so this was a BIG fucking deal. The issue at hand was that she had just been informed she had to return to Cornell that following Monday (2 days) to begin the trial and she had to stay for five days.

It’s December. It’s the week before Christmas. In Manhattan. Do the math.

:Breathe:

Amy had already called the American Cancer Society. The Hope Lodge was not an option as they needed more than 2 days notice & they were full. That’s helpful, right? I suggested she call back and inquire about another program they have called Keys of Hope and while she did that I would check on a ‘few things’. I may have lied – a little. What I actually did was the only thing that I felt was going to give Amy the best possible chance of finding someone anyone that had a suggestion, a link, an idea or something:  I made a video and posted it on Facebook. If you know me – really know me – you’d know that I am not comfortable making ‘impromtu videos’ for social media. Public speaking and interviews, sure – IF I am prepared. Off the cuff videos, not so much. But this was important and not about my comfort level. ugh  video

It wasn’t long before friends were sharing the video on their pages, in groups, and tagging friends that might be able to offer suggestions or even help. As much as social media can be a detriment it can also bring out the very best in people – all working together because someone is in need. This was one of those times.

Angels Do Live Among Us

Not thirty minutes after posting my plea for help, I was put in touch with Tracy Milgram thru METUP Board member, Abigail Johnston. Tracy is the founder of BRCAstrong a non-profit organization that supports and educates Previvors and Survivors. Tracy’s organization recently partnered with PALS – Patient Airlift Services. PALS, is a non-profit that provides free air transportation to medical treatments/appointments to those patients in need. Tracy was confident that through PALS, Amy would be able to get transportation to her clinical trial and have one less thing to worry about.

WHAT?? I immediately started texting Amy while I was messaging Tracy on Facebook. Multi-tasking! Soon Amy was talking to Tracy and working out the details of her flight.

I went back to Facebook to check notifications, comments and suggestions about lodging for Amy. Everyone was being so helpful. There were attachments with lists and websites, names of other people to contact AND THEN…….

Almost at the same time, I received a message via Facebook and a text. The text was telling me that someone was trying to reach me and the message on Facebook was from that person trying to reach me asking me to call her. I called Sara (I am changing her name per her request). Sara is someone I know in real life. I met her this past summer. I can’t say enough about her – love her to pieces. As Sara and I were talking she told me she saw the video and she couldn’t not help. I told her Amy has transportation secured thanks to Tracy and PALS and the only thing we were working on was lodging.

Then Sara said this…..

I want to pay for Amy’s hotel

OHMYGOD!! I cried. Amy was all set. She was going to be at her clinical trial on Monday.

I hung up with Sara and called Amy. I will never forget the sound of joy in Amy’s voice when I told Amy she had to call Sara immediately and why. It was a combination of surprise, tears, relief and laughter. It was the absolute best sound ever.

There was only one thing left to do.  ugh.

(And now you know why I don’t make videos. Can you say “Hot Mess”??)

It was a long afternoon. It was a stressful afternoon. But it is true, sometimes it does take a village. On December 14th, that village rallied for Amy and took care of one of it’s own. I am happy to report that Amy has spent this past week in NYC getting the treatment she needs in the clinical trial that will eliminate the little bastards in her brain and keep them from returning.

Thank you to everyone that shared the initial video, tagged friends, sent me messages and offered suggestions. This is the power of community and how the connections we make, the people we meet; we never know how important they may become or how big of a role each of us could play in one another’s lives. Those of us with metastatic cancer knows how much time we have; using that time to help where you can and work together is so much more fulfilling. I especially want to express a heartfelt, huge thank you to: Tracy Milgram, BRCAStrong, PALS and Sara or as I collectively call them angles on earth without whom none of this would have been possible. 

My dearest friend Amy ~ I love you so much and when you get back home….                   you owe me lunch.

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Questions Go Unanswered

Well, I did the blood work..I had the PET scan and we met with my Oncologist. I had been preparing to hear not so great news. I was not prepared to hear what I did.

The PET Scan didn’t show any progression. It did show inflammation where my rib tumor is to indicate trauma or recent injury. OK…so I’m not crazy and the pain I’ve been having isn’t in my head after all. To rule out a fracture my Dr had me do xrays on the rib. Because the rib is compromised a fracture would make sense.

Then we talked about the blood work. I told her about the one marker Antigen 27.19 and how it’s been steadily on the rise and I’m now over the high end. She explained that in some cases blood work is ahead of PET Scans. So what she said was this PET could be a false negative. I asked about clinical trials and if I might be eligible for one. I explained that I want to get ahead of this and make sure that this cancer doesn’t get to an organ. I signed paperwork for the hospital to do more testing on the biopsy slides to see if they can get more information about my cancer and place me in the best clinical trials. If I can’t do a clinical trial we will then discuss tweaking my meds or possibly even chemo.

I’m meeting with my local oncologist this week armed with my PET results and blood work. Even though she isn’t my primary Dr I do value her opinion and input. She knows I want to get ahead of the beast before it gets ahead of me. I’ll have to be patient and wait a few more months before I will feel more comfortable in my treatment plan.

I’m going to stay positive and keep focused on being bigger than this cancer.