Tag Archives: clinical trials

And some piece of mind

I have scans again one week from today. Two days later I am to review them and to have another infusion. I already know that my new oncologist will not be able to meet with me that day—I believe she shall be in the ICU. Younger doctors are being asked to fill all sorts of roles now—previously she was on the COVID19 unit. I am sure they are receiving a phenomenal education but the stress must be extraordinary. And of course, it is hard for their cancer patients as well.

Given the gravity of my decision (yes) I decided that it was best to get in touch with Alice. Yesterday I sent her this message:

“Good morning. Scans a week from Tuesday and I won’t actually be seeing Jess so thought I’d discuss with you. I have been pretty flipping miserable for weeks now—physically and emotionally. Last night my mouth/throat/tongue were the worst yet. Unless those scans show some very compelling reason as to why to stay on this I am done. Done to the point that even if there is not a good next choice done. If I have six months to live I’d rather not be miserable. If there is a good chance the MEK inhibitor will have similar side effects than it is not the drug for me. Honestly I have been so depressed that at times I have been ready to call it quits all together. However, given the possibility of improvement while retaining quality of life, I could rally. So let’s discuss what that might or might not look like.

She responded immediately and then called me later. This next scan shall be telling but my mind is made up per suffering—if it is for naught, I am not on board.

Today was better—the discomfort remains great but knowing that I have drawn a line in the sand I feel safer somehow. Just as it is powerful to know one’s strengths it is also imperative to appreciate one’s limits.

I love life. So very much. But pain is incredibly demoralizing and I have made the choice that for me, not how I wish to spend the rest of my time here.

Fingers crossed that there is an easier option.

And so it begins

Milk thistle and dandelion tea plus a hella lot of water and I got those enzymes down more than forty points. So my biopsy was a go yesterday.

Happy to report that it all went smoothly and to my delight (the perks of a progressing cancer) the surgeon was able to go in from the side of my chest rather than straight through my left boob (no fun). This meant that A. I could watch the biopsy on a screen–not everyone’s cup of tea but I thought it was wicked cool–and B. my time in recovery was spent on my side rather than flat on my stomach; so much more comfortable.

It was a long, long day and big credit to my friend Diane who ferried me to and from. I am so very grateful for my incredible cadre of friends.

This morning a friend of Diane’s kindly picked me up at 5:30 am for the first day of the DS-1062a trial (‘DS1062aΒ is a trophoblast cell-surface antigen 2 (TROP2)-targeting antibody drug conjugate’).

Room without a view

I have now been at the Termeer Center for Targeted Therapies for almost five hours. In that time I have been weighed, had two vials of blood drawn, and the first of three EKG’s taken. I have also peed twice, napped, and met with Dr. Lin, my new oncologist now that I am on trial. Drug was finally released an hour ago but it is frozen and takes three hours to defrost, so infusion will not begin until one. Lots of hurry up and wait.

Last night I was pre-dosed with five 4 mg tabs of dexamethasone as well 360 mg of fexofenadine, both of which will be repeated just prior to infusion. There have been lots of reactions to this experimental therapeutic but fortunately I am entering trial after MTD has been established and they are getting a better handle on how to handle side effects. Also anticipated are some pretty gnarly sounding mouth sores (dime size, painful plaques) which could put a crimp in my dating schedule πŸ˜‰ I am to prophylactically swish with a steroid mouthwash and have a paste for when they emerge. I have been advised that I shall likely lose weight (those sores) and may lose my hair as well. And there have been some eye issues, so I have been using lubricating drops. Aside from that, fatigue and mild nausea. There is always a price to pay.

On a positive note, some of the side effects of lorlatinib have noticeably receded. My skin—a mess of crusty sores as of late, has begun to clear up and heal (hallelujah). I had to go off of statins because of my elevated liver enzymes and my cholesterol was through the roof last time (high 300’s) but hopefully that shall start to come down as well. The cadence of my speech is speeding up (‘So you’re not going to sound like John Wayne anymore?’ asked one of my friends) and I am already feeling more like me: Linnea pre lorlatinib. Less rage-y, more clearheaded. I like it.

So consider this installment one. More to come post infusion.

xo

It was

Me giving me encouragement: the Wall of Hope on floor eight of the Yawkey building at MGH. When I first started getting treatment, a secret goal was to one day appear on the Wall of Hope. πŸ™‚

A long, long day. But in the parlance of my kind (the terminally ill), a long day beats a short day all to heck.

First, my life is blessed with a plethora of goddesses. Childhood friends, my daughter, sisters, my many new friends, nurses, phlebotomists, counselors, medical doctors. Men are great and I love a heap of them as well but this group of women has been my consistent go to for the tough stuff.

One goddess was in tow yesterday, my friend Sally: pals since the fifth grade. I am beginning to realize how beneficial it is to have company at these visits, after years and years of going it alone.

I had an appointment with the goddess who takes care of me from the neck up (as I like to say), Mary Susan Convery, my thoracic social worker. She keeps my head on straight.

A quick trip down Charles St for a hug from my daughter (Sally is her actual godmother) and a delicious lamb sandwich at Tatte. And then a long wait in those spaces appropriately called waiting rooms.

Oh, the irony. Those of us to whom time is so precious spend far too much of it waiting.

Anyway, the action got started around four with a visit from the head goddess, Alice. Chit chat about how I am feeling (great for the moment, on that artificial steroid high, my dyspnea temporarily under control.) But I was eager to cut to the chase—how about those scans? She had read them herself and her assessment was that they were mildly worse than the ones in December. Now remember this is while getting chemo so bummer. Of concern is the lymphangitic spread as well as the fact that the slight amount of fluid in the bottom of my left upper lobe is also increasing.

Alice puts more store in symptoms though and mine are not encouraging. Definite downward trend. So we agreed that I’d go ahead and get chemo one more time (and possibly two, depending on timing and tolerance) in the hope that it is at least slowing down progression.

There was a bright spot though and that was in the form of options. I figured we were down to one–lorlatinib plus a mek inhibitor. But Alice described yet another possibility. That after all these years on TKI-s it might be good to take a break. Maybe let my cancer forget some of what it has learned. To try a novel therapeutic, one my cancer is completely naive to.

While getting infused I signed the consent forms for a phase I clinical trial for a drug called DS-1062a; an antibody drug conjugate which targets a protein called trophoblast cell-surface antigen2 (TROP2), which is found in copious quantities on the surface of cancer cells.

This sounds exciting to me–a fresh possibility. But it is going to be intense. First there are the necessary hoops to jump through in order to qualify, including a lung biopsy, heart scan, ECHO, and eye exam. And all that blood, blood, blood (30 teaspoons for the first three cycles).

Every three week infusions but the first week, at least two additional visits. And then for the subsequent nine weeks, I return to the hospital once a week, with a second lung biopsy at week two. It is going to be consuming–that is, assuming I qualify.

But it also has given me fresh hope (I love the luxury of choices).

Good thing. Chemo may not be kicking cancer’s ass, but it is kicking mine. My liver is a tad inflamed–Alice asked me if alcohol might be involved. Truth? Yes. Goodbye to that for the time being. Sally filled me with healthy fluids last night and this morning she made me oatmeal, hot lemon water, and a vegetable chicken soup. I am in good and loving hands.

So yes. Stability or response would have been the preferred report but this feels if not a door, at least a window. And that’s what I need. Fresh air and a bit of a vista to contemplate.

xo

Working it

Last week I spent two days at pharmaceutical companies in Cambridge MA (a mecca for pharma) describing my personal experience with cancer and clinical trials.

As an advocate/activist for lung cancer, I continue to represent the viewpoint that those of us in clinical trials should be treated with deference and respect. That words such as compliant and noncompliant should just go away. That we be compensated for our time just as healthy volunteers are. Perhaps most importantly, that no one lose track of the fact that we are human beings, who are enrolling in medical research not because we want an advanced degree in community service, but rather because we are hoping that these experimental therapies will extend our lives. As people, it is our right to assume that we will not be subjected to a plethora of non clinically indicated testing–we are more than our tissue. That we are pleased that our contribution will help others but that it is not and should not be our primary onus. We, like everyone else, wish to live. And we want to do so with dignity and respect. The current model of more blood, more sweat, more tears, more money has got to be realigned. If it is, recalcitrant issues like accrual and disparity will be addressed as well. Win win.

Blue in the face I am, repeating this message for so long now. However, and this is important, I am beginning to feel heard. The emphasis on partnering with patients—more an aspiration than a reality—means there is far greater interest in learning from patient experiences. ‘We are sentient beings’, I remind my audience. Unlike the white mice who are our direct mammalian predecessors when research moves from in vitro to in vivo, we can communicate. ‘Talk to us’, I say. Listen. Learn. Stop making it so damn complicated. Make us true members of the team and treat us like the astronauts we are.

In September I will have the opportunity to travel to Barcelona as faculty for the annual meeting of the IASLC. I will once again be discussing my experience in clinical trials. Patient as partner; and faculty. It has taken a long time and we have far to travel yet, but progress is being made.

Keep talking.

Patients talk about Clinical Trials

Couple of my friends/fellow panelists shared this video on facebook and I felt I probably ought to do the same. This is from last spring–thank you Bonnie Addario for inviting us to participate and share our experiences and viewpoints. Together we are moving that needle.

Clinical Trials Transformation Initiative

Every once in a blue moon I have the opportunity to participate in a project that feels truly substantive. Transformational, even. Last week I was in Silver Springs, Maryland serving on a panel at a workshop that was a collaboration between CTTI (Clinical Trials Transformation Initiative) and the FDA (Food and Drug Administration).

The last supper? Hopefully one of many.

It was a full day of intelligent dialogue about the actual patient experience per clinical trials. Barriers, burdens, successes, failures. With a clear focus on ways of doing better.

Cary Medosch, Bray Patrick-Lake, Linnea Olson πŸ™‚

I am grateful to Duke, CTTI and the FDA for the opportunity to have this conversation. I left feeling very hopeful. For those of you who are curious as to what transpired, the workshop was recorded and you can view the video by following this link. My session was the third; but all of them well worth watching.

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 partnerΒ 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.Β 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 payΒ 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 elseΒ 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.

For the record: my contribution to medical research

First, a proposal. All you clinical trial sponsors, listen up. I really feel that upon enrollment in a clinical trial, each participant should be assigned a case manager as a perk of participation.

In reality, it is a necessity.

Take my case as an example. Thirteen going on fourteen years of surviving. A complicated treatment profile that involves surgery, four different chemotherapy regimens, as well as a TKI unrelated to ALK. Participation in three phase I clinical trials added into the mix.

When a protocol for a trial is established, it is viewed as a discrete event. IRB (internal review board) notwithstanding, there is currently no way to take into account individual circumstance. Say, how many clinical trials you’ve been in previously.

Or, do you have a cancer that is histologically different than the other clinical trial participants. Again, myself as an example. My cancer is invasive adenocarcinoma, mucinous, once referred to as mucinous BAC. Although every bit as lethal, it does have a distinct advantage in that it generally stays confined to the lungs–no distant metastases to deal with.

This histology makes me an odd peg when it comes to a one size fits all clinical trial. And it means that I have been subjected to excessive scans that were not clinically indicatedΒ and yet were mandated by protocol.

It is already well established that I have mutable cells. When I finally took a tally of all my scans, I became concerned and made a formal request that my scanning schedule be amended. I should add that at this point the schedule bore no resemblance to standard of care, with scans every six weeks. Part of what I was asking for was that scans be moved out to every three months once a participant had been in trial for more than a year. My request was denied.

And that is when I became officially noncompliant–refusing to get anymore abdominal CT scans. Per my insistence, my chest CT scans were also moved to every three months. Eventually, protocol was changed to my original request, with the scanning schedule changing to every three months once a participant had been enrolled for one year and I like to think my noncompliance made a difference.

However, for myself, the collateral damage has been tremendous. I have had a mind boggling number of scans, most of them medically unnecessary. It is infuriating, frightening and sad. Had I a case manager, I like to think this sort of thing would not have happened. At the moment, I am down to a chest CT every three months and brain MRI’s once a year. When you see how many scans I have had, imagine how many moreΒ there would be if I had not become noncompliant several years ago.

We’ll start with the small stuff. Keep in mind that this is only tests I’ve had done at MGH. It does not included x-rays (including those at a community hospital where I was diagnosed with lung cancer), scans, MRI’s prior to my time at MGH nor does it take into account dental imaging, colonoscopy or mammograms.

πŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”ΉπŸ”Ήβž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βž—βœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβœ–οΈβ­•β­•β­•β­•β­•β­•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•βž•β­•β­•β­•β­•β­•β­•β­•β­•β­•β­•β˜’οΈβ˜’οΈβ˜’οΈβ˜’οΈβ˜’οΈ

The thirty-seven blue diamondsΒ πŸ”Ήrepresent chest x-rays.

Brain MRI’s are represented by a division sign:Β βž—Β andΒ I have had forty-two brain MRI’s. In case you didn’t catch that, 42. And I have no brain metastases.Β 

The black multiplication signΒ βœ–οΈΒ represents abdominal CT scans. I have had 54Β CT scans of my abdomen. Plus six more, represented by the red circleΒ β­•Β that were combination PET/CT scans (unbeknownst to me—the PET/CT combination). So, a total of 60Β abdominal CT scans and no abdominal metastases.Β Yet. Abdominal CT scans have a formidable amount of background radiation and it pains me to know that I have had so many unnecessary scans due to my participation in clinical trials.

And now the really, truly impressive number. Represented by a plus signΒ βž•Β .Β I have had 91Β chest CT’s—plus an additional 10Β PET/CT’s of my chest, again represented by the red circleΒ β­•Β . One hundred and oneΒ chest CT scans. At least there is some clinical justification here, as I do have cancer in my lungs. However, even given that, had I not spent so much time in clinical trials, there is no way I would have had so many scans.

Oh and this symbol, the radioactive emoji: ☒️ . That’s a stand in for the full body PET scans and Bone Scans I have received. I should add that when I began this trial there was a requirement that a bone scan be given every three months. I told my oncologist that I would drop out of the trial before I’d get a bone scan that often and she contacted the sponsor and in that case the protocol was changed.

My calculated cumulative radiation exposure

For those who are curious, here is a graphic on the amount of radiation received by survivors of Hiroshima compared to other sources of radiation.

On the balance, there are patients who are underscanned. All of us would rather err on the side of caution. However, I would argue that in my own case, caution was thrown to the wind. As I moved from patient to participant, I lost my autonomy/individuality, as the need for data superseded my own clinical necessity.

There is no justifiable excuse for the fact that I endured 60 abdominal CT scans and 42 brain MRI’s and that as a result of this excessive scanning, I now have a gadolinium deposit in my brain–a finding with unknown clinical significance.

What is known is that no human being should receive as much radiation as I have unless it is absolutely medically necessary. And it is not hard to argue that given my lack of distant mets, those 60 abdominal CT scans and 42 brain MRI’s were not for my benefit.

Nope. I have, in so very many ways, already donated my body to science. And that’s why my gratitude is tempered.

My participation in clinical trials has been a privilege. But also a burden. In forthcoming blogs I shall reiterate my stance that clinical trial participants should be not only recognized for their tremendous contributions to medical research, they should also be offered support in multiple ways. A case worker. And compensation.

The down, the dirty, the skinny, the scat.

Gadolinium: heavy on my mind

You have no idea what’s going on in my head. Really. And, nor do they–the authorities.

That’s an MRI of my brain, demonstrating gadolinium deposition secondary to injected contrast. It is the rather faint, white, symmetrical ‘stain’ (it is actually referred to as a brain stain). Rorschach like. It’s been there since at least December of 2016, when it first showed up in my radiology report:Β There is nonspecific intrinsic T1 hyperintensity involving the globus pallidusΒ and dentate nuclei bilaterally likely secondary to gadolinium deposition ofΒ uncertain clinical significance.

I had been aware of the possibility of gadolinium retention for at least a year prior to this finding and because of my concerns, had once again become non-compliant—in this case, refusing contrast.

To be clear, I have more latitude here than someone with either active or a history of brain mets. I’ve never had mets to my brain, which is part of the reason I have pushed back on scans that were mandated by protocol but not clinically indicated. Part of the rub when one is a clinical trial participant rather than a patient.

The day I found out about the gadolinium I was pissed. Really, really pissed.

As a requirement of the trial we took a cognitive test at each visit and part of that test was to write a simple sentence. I had a monkey in the cage/rage moment; threw a little scat at the keeper, if you will. My sentence that day read ‘Fuck you (sponsor of the trial), I have heavy metal on my brain.’

The jury is still out as to whether or not there already have been or will be side effects associated with gadolinium retention. Although everyone can certainly agree that it’s probably better notΒ to have gadolinium in one’s brain.

And before anyone panics, know that it is still extraordinarily uncommon (and no, I did not want to be the poster child for this one). I believe I am Dr. Shaw’s only patient to date with this finding. And in discussion with her about this issue, she is adamant that a CT scan of the brain without contrast is basically useless.

My frustration was with the fact that I didn’t need the bloody MRI’s in the first place and I have had–at MGH alone–42 of them. That, my friends, is why I no longer hesitate to be noncompliant.

Filthy lucre

Screen Shot 2018-07-10 at 11.28.22 AMOk, let’s get real. I don’t expect to get paid $5000 a month to participate in a clinical trial and I deleted that rash comment from my last post. Fantasy, folks, that’s all. However, any sort of financial assistance in the form of compensation would be welcomed. When I met with the head of the cancer center, I also suggested that greater supportive services would go a long way. Free parking and a comped lunch, but also someone to help me navigate the financial morass while I’m on a drug with known cognitive side effects. Visits to a nutritionist, as just like everyone else on my therapy, my cholesterol is through the roof. How about some free massages—to make my life better/more relaxed? And I mean gratis—not billable to insurance.

In other words, there are ways to make the whole clinical trial experience more welcoming and sustainable. These are relatively new concepts as not so very long ago, most clinical trial participants were a one and done—in the most literal sense.

That was the expectation when I enrolled in my first trial ten years ago. That, best case scenario, my life would be extended for a few months. I am incredibly blessed that I have had the opportunity to go on to subsequent treatments and trials, extending my life far beyond what I ever thought possible. I am sensitive to the fact that my grousing about money is potentially Β unseemly for those who would give anything to be in my position–alive.

Gratitude is far more palatable and it makes my disease/continuing survival easier for all to digest. However, the problems I face are faced by others as well and as an advocate/activist, I feel it is vitally important to discuss them—in a public forum.

Being alive is a good problem to have. But having to worry all the timeΒ about the expense associated with your medical care is not. I now have way more anxiety about my money than my cancer. How crazy is that?

And the thing is, I am not poor. However, with health costs exceeding a third of my income, it’s not doable.

What if (and I don’t feel this is unreasonable) trial sponsors covered all medical costs for participants, just as so many people already assume is true? If that was taken off my plate than I could pay my other bills. My financial situation would still be tight but it would be tenable. And that is all I’m asking for; (I’m talking to the medical establishment now) don’t make this already tough situation–living with a terminal illness–more difficult than it needs to be. Show some appreciation for the very real contribution I and other clinical trial participants make. Without us and our mutations (that’s right, we actually represent a rare commodity, not just an opportunity) these drugs would never make it to market. That would be a real loss, both in terms of lives and dollars.

So let’s keep this conversation going. My experience might be fairly unusual in terms of years spent in trial, personal finances and marital status, but it’s not unique. Clinical trials are the lynch pin when it comes to cancer therapeutics. Things have been done a certain way in large part because few have questioned the status quo. We, as consumers, have greater value than we sometimes realize and it is time we demand a better experience. As a society, let’s stop asking clinical trial participants for more blood, more sweat, more tears and instead find a way to support them as they lead the way. It’s the right thing to do from both a humanitarian and a business perspective—in a word, profitable.