Tag Archives: clinical trials lung cancer

Don’t call me partner

Warning: this may be the most contentious blog I’ve ever written.

That is because I am about to desecrate a sacred cow–the idea of patient as a partner in medical research. Lovely in notion, the reality is something quite different and nowhere has that been more clear to me than sitting in the audience at DPharm 2018.

Let’s start with the straightforward definition of partner:

And then let’s parse that definition, piece by piece. A person who takes part in an undertaking with another or others. I have no quibble with this. As a participant (I refuse to call myself a volunteer—I did not ‘volunteer’ for this shit) in a clinical trial, I am a member of a ‘team’ composed of researchers, other participants, clinicians, schedulers, nurses, sponsor, phlebotomists, techs, lead investigator, regulators; even payers.

Every member of this team has an important role to play and, as the term stakeholders implies, to a certain degree the outcome of our endeavor will impact each of us personally.

However, this is where the concept of partner starts to fall apart; shared risks and profits.

No one has more on the line than the participant. The skin in the game is not figurative for us, it’s our actual tissue. Best case scenario: we get to continue living. Worst case scenario: we die. Those are some pretty bloody high stakes and not in the same category as fourth quarter losses.

And now we get to the word profit. Don’t even get me started. I pay for the privilege of participation. Clinical trials are not gratis. The experimental agent/therapy is provided to me free of charge and sometimes certain labs or procedures; in the trial I am currently enrolled in echocardiograms are covered by the sponsor. However, everything else is billed to insurance, and I am responsible for deductibles and copays. Gas, parking, lunch—all paid for by me.

And then there is the physical toll. One hundred and one chest CT scans, 60 abdominal CT scans, 42 brain MRI’s.

So, let’s just get really real here and stop the pretense. I am not your partner and if I am, this is one heck of an abusive relationship. One in which I am bound to you by desperation, you call all the shots, and my only true power is to withhold. Where words like compliant and noncompliant are used to describe me. One in which your need for data is greater than my need for autonomy/personal safety. Sure, you keep me alive but you can also kick me to the curb if my cancer gets out of line again. And when and if you do, there will be nowhere else for me to turn.

We are codependent, you and I. That much is true. But we are not equals and certainly not partners. And we won’t be until you recognize that I am a human being. That I have hopes and dreams and family too. It is my bad luck that I also have cancer. I want to live and I will do almost anything to stay alive. You know that. But don’t exploit it. Do not continually ask me for more blood, more sweat, more tears, more money.

Instead, provide me with genuine support. Understand what I have sacrificed and compensate me for my time, just as you compensate healthy ‘volunteers’ in clinical trials. Being a subject in a trial does not mean that I am also subhuman so treat me with the respect that I deserve. Let’s ditch the condescension and start with transparency. Stop pretending that I am your partner. I know what a true partnership looks/feels like, and baby, we’re not there yet.

Baller

Let me start by saying my last scans showed continuing stability. Fifty (50!) months and counting; thank you lorlatinib.

And then, a salient detail per those last scans.

I walked out on my brain MRI.

Yessiree bob. Alice and I had talked about the fact that given my persistent lack of brain mets, MRI’s of my brain every three months (mandated by the protocol of the clinical trial) were not clinically indicated. And that it might be more appropriate to get them (yea!) annually.

I hate brain MRI’s. Yep. I’d rather have twenty needle sticks in a row. The percussive and excessively loud noise of an MRI makes me hyper anxious. As I drive to scans by myself, I cannot medicate for anxiety, and so I simply ask them to stuff as much wadding in around my ears as is possible.

To date, I have had 50 (FIFTY) brain MRI’s (hold the presses—I need to get myself up to the records department to check this #. Patient Gateway is a cluster fuck and I’m not sure my tally is accurate. In the meantime, know that it has been a lot.) Wrap your mind around that number in a slightly different context. Since 12/22/16, it has been known that I have gadolinium deposits embedded in the tissue of my brain; secondary to intravaneous contrast. Although it is unknown if I shall suffer side effects secondary to gadolinium deposition, it is concerning and I have been forgoing contrast for two and one half years now.

When I showed up for my scans last Thursday, I was scheduled for a brain MRI in addition to the chest CT (I am non-compliant per the abdominal CT scans, with 44 of them below the belt to date). As I lay in the CT scan I had this little conversation with myself. It went sort of like this: ‘Would I rather be sitting in the MRI machine or in my car, with the radio cranking?’ Then of course the guilt set in. Lorlatinib is months away from FDA approval. If I walked out on my MRI could my non-compliance throw a snag in the trial? Should I simply take one for the team?’

In truth I’d been taking one for the team for a decade now. And, if my walking out today truly screwed things up, I could always get an MRI at a later date.

When I told the technician that I would be skipping my MRI she warned me that patients are sometimes kicked out of trials for this sort of thing. ‘Well, then wish me luck’ I said.

I walked out to my car, put the key in the ignition, and drove north. Balls out, y’all. This girl’s gonna live and although that’s a big YES it sometimes requires just saying no.

It was good while it lasted.

Stability, that is.

As any metastatic cancer patient understands only too well, what doesn’t kill you often just keeps trying.

I’ve been in this battle for so long now–more than eleven years–and most of that time has involved active combat with an ever advancing foe. But thanks to lorlatinib, my disease has been stable since June of 2014; my most sustained period of response yet. As a bonus, I’ve felt so damn good it’s been easy to imagine myself cancer free.

However, my scans have always told a slightly different story, with remaining nodules and opacities scattered here and there.

Lungs and Airways: The patient is status post left lower lobectomy for lung
cancer. There is a left lower lobe solid nodule on image 41 series 201 measuring
5 mm unchanged dating back to 5/14/2015. There is also subpleural patchy opacity in the left lower lobe image 63 series 201 that remains stable compared to 5/14/2015. There are small centrilobular groundglass nodules in the left lower lobe image 51 series 201 also stable compared to 5/14/2015 the largest of which measures 9 mm. There is a stable 2 mm right upper lobe nodule image 32 series 201. There is a stable subpleural groundglass nodule in the right upper lobe image 48 series 201 measuring 5 mm. A second groundglass right upper lobe nodule measuring 5 mm but is essentially unchanged from 12/10/2015 and 4/14/2016. A 4 mm solid nodule along the right minor fissure is stable. There are no new nodulesPleura: There is a small left basilar postoperative pleural effusion that remains essentially stable.

The words unchanged and stable are absolutely key here.

However, on my scan report today it was noted that one nodule had in fact changed size: There is a 5mm nodule on image 52 that appears to have grown since 5/14/2015 when it measured 3 mm but is unchanged compared to 3/6/2016.

Obviously it had escaped the notice of previous radiologists. However, upon reading today’s report, my oncologist Dr. Shaw reviewed the scans and agreed that this particular nodule had in fact enlarged and likely represented progression.

Nothing to panic about but a potent reminder that shit is still real.

Dr. Shaw is already talking game plan. We will scan again in three months. If the nodule continues to grow, we might biopsy in an effort to determine what the mechanism of resistance is. If it can be identified, I might be a candidate for a combination therapy of ALK inhibitors. As this is a solitary nodule and in my right lung this time, surgery is a possibility. So is radiation.

Stability may have been rattled but I’ve still got options.

And honestly, that’s the most important thing.

Soldier in the war against cancer

Some of you may be wondering where that nice girl Linnea went. Well, beneath my relatively calm, cool facade lurks someone who simply won’t stand down if I feel there is something that can be done to make a situation better. And in this case, any change that comes about is going to happen only after some intense dialogue. In others words, we’re just getting started.

Secondly, I want to make it clear that I am not thinking only of myself. I was in the right place at the right time and have been fortunate to have been breaking trail ever since. As I have pointed out to those willing to listen, very few people in the world have had the opportunity to be in three phase I clinical trials—generally people died while enrolled in their first trial. There are going to be a lot more folks coming down that trail of multiple trials (hallelujah!), and I feel a great responsibility to make the path ahead as accessible as possible.

I also don’t wish to downplay the additional psychic benefit that I and my fellow trial participants get out of knowing that we are making a viable contribution to medical research. Take twelve minutes to watch this video about David Phillip Vetter, the child once known as the bubble boy. His mother dreamed that one day he would leave the bubble and engage in research himself. Ultimately it was his personal ordeal that made the greatest contribution.

Most of us fantasize about doing something significant for mankind and finding a cure for cancer is at the top of the list for many. We can’t all be scientists but there is another way to advance medical research. In the war against cancer those of us who participate in clinical trials are soldiers on the front line, and it is time that we be accorded the same respect as veterans of other wars.