More of me

Mother Linnea…striking a pose

I had another biopsy on Wednesday. And y’all are going to be proud of how it went down..

When they wheeled me into the procedure room and introduced me to the operating surgeon, I gave her my spiel. How I’d been participating in clinical trials for more than ten years now but had only just learned that there is a significant difference between a biopsy for research and one for clinical assessment. I said that I considered an intrathoracic biopsy to be a big, big ask and that I believed it only fair that my tissue be shared with me. I understood the sponsor was paying for the biopsy, but that didn’t make it any better. I still felt like a cow being sent off for branding. And that there should be some implicit quid pro quo but as I had signed a contract I was now bound to donate a piece of me. I explained that some extra tissue for MGH labs might yield information that could be extremely helpful to my case, and that if at all possible, I wanted her to go for it. And lastly, that the language in the consent form was unnecessarily vague and that this endeavor was bullshit.

Well that surgeon listened to me. Better yet, she heard. This time, instead of one small plug, MGH got two.

The resistance starts here–with each and everyone of us. We don’t have to accept the status quo and this was a lesson in the importance of talking not just to the policy makers (sponsors) but to the doers—other members of the team. I mean, it’s difficult to ignore a bald lady in a johnnie when she’s sitting right in front of you talking about the plunder of her own tissue.

So, as I used to say to my children in certain situations that involved small victories–yea for our side. And what’s mine is once again–mine.

As it should be.

xo

Feeling…

Vulnerable. And not liking it one bit.

Kind of a perfect storm, this COVID-19 coming at the same time I’m getting infusions. Age 60, compromised lung and immune function, in treatment. Damn.

And I have been uncharacteristically depressed. Obviously some of it could be situational but I’ve been through many a storm and always managed to keep my head above water.

I’m super fatigued and those mouth sores are flaring up again, but hey, my breathing continues to improve. That alone should be cause for good cheer. So what gives?

I finally contacted Dr. Lin today to inquire if there was any possibility that mood dissonance could be a side effect of DS1062-a. Unlikely, as it is not known to impact cognition. However, she did have a thought. I have been pre-dosing with mega quantities of steroids. Maybe, just maybe, this black mood of mine is related to that roller coaster effect.

Next go around we will see if we can skip the mid infusion dose and after that, maybe back off on the steroids just prior to infusion as well.

I miss happy me. I need happy me to get through this challenging time.

Sadness, begone.

Two down

Infusion number two of DS-1062a went off yesterday with only a minor hitch. Due to the profusion of side effects post one (my hair starting falling out a few days ago as well) it was determined that going down in dose was probably a good choice. In addition, I took 40 mg of dexamethasone the evening before and morning of and 20 mg more just prior to infusion, plus 1080 MG of fexofenadine HCL. Infusion was slowed down to three hours and half way through I was given an infusion of Benadryl–50 mg.

My throat got a little bit sore but did not swell up and I had no rash. The only issue was the over the top restless leg/crawlies from the Benadryl–I thought it would drive me out of my mind. JesY Wittebort had sent me some nifty leg compressors to help with the restless leg, but they just moved the sensation up to my arms. Hopefully I will be able to forgo Benadryl entirely next time–I wonder if I am part of the population who experiences paradoxical excitation. Whatever it is, I don’t want to feel that way again.

However, given the lack of an infusion reaction the day was ruled a success. Now I am at home resting, both out of necessity and also out of avoidance. I was thinking of going to the movies tonight but Alice and I spoke by phone and she feels it prudent that I keep myself out of harm’s way (crowds) as much as possible over the coming weeks. Introversion is not my nature but I really do not want to be exposed to COVID-19, a potential devastation for someone with compromised lung and immune function. I have a tall stack of unread books and my sons are getting me hooked up with Netflix so that I have diversion. And Diane continues to reach out to make certain I don’t need anything–from the store or otherwise. So I am in good hands.

Spring, clearer breather, making of art—these are the things I am focusing on now. I did get to the studio the day prior to infusion and I made myself walk the five flights up rather than taking the freight elevator. Up, it’s only up from here.

xo

Just a little documentary

I have now been in phase I clinical trials for two Pfizer drugs—crizotinib and lorlatinib (Xalkori and Lorbrena). A few weeks ago I travelled to La Jolla for a CNN produced documentary. Perks of this project included spending time with rock star researcher Ted Johnson as well as a tour of the Pfizer Labs. And of course anytime I get to see the sun setting over the Pacific ocean, that’s a plus as well.

As for the documentary, it speaks for itself. Give it a little gander. Pfizer, thanks for letting me represent. And for keeping me at this party.

xo

Taking a breather from being brave

The last few days have been tough. I’ve now got ulcers all throughout my mouth and down my esophagus. My sinuses and ear canals hurt as well and it is my guess that anywhere I have a mucous membrane has been affected.

This has impacted both my appetite and my ability to eat. Basically I am getting down whatever I am able to and a case of powdered ensure arrived on my doorstep yesterday.

I had been told that hair loss was a possibility and three days ago it started coming out in handfuls. I’m rocking the plucked chicken look now and my follicles are all hyper sensitive. This afternoon Diane is taking me to a friend of hers for a buzz cut—somehow more dignified than heading to Super Cuts.

My usual joie de vivre and can do spirit has taken a (temporary) hit as well. I’ve spent a lot of time on the couch doing nothing, just literally riding this wave until it’s over; the wave being depression.

Even warriors have their down days–this shit gets old. On Thursday I will have my second infusion and have to hope that by pre-dosing with steroids and Benadryl we are able to avoid an infusion reaction. My team will be on high alert with epipens at the ready.

In the meantime I am trying both to be gentle with myself but also to push forward. Nobody said this would be easy. I just didn’t think it would be this hard.

But…(because I do like to end on a positive note) my breathing really is better. That is a wonderful thing and (if I believe my own pep talks) worth wading through. I can do this.

I can. And I will.

What can be lived with and what cannot

I’m not gonna lie. Mucositis might be the most unpleasant side effect I have dealt with yet. Currently I have an ulcer on the side of my tongue, on both inner cheeks, and covering the back of my throat and trailing down my esophagus. Excess mucous that causes me to gag and choke is part of this not so pretty picture.

Sucks and certainly has a negative impact on quality of life. However, and this is a big however, my breathing has improved. Markedly.

I can’t live if I can’t breathe. These side effects blow but there aren’t going to kill me.

So there you go. The things we do to stay alive. And I have already noted that I am willing to do just about anything to stay at this party.

Even the stuff that’s hard to swallow. Pun intended.

xo

Gains and losses

I am currently dealing with a whole new set of treatment side effects. Fatigue, persistent nausea, mucositis, and weight loss.

Weight gain is a side effect of lorlatinib, and over the past few months my degree of activity had slowed down significantly. As a result, I was heavier than I ever have been aside from when I was pregnant. That extra heft around my belly is proving to be a good thing, as I dropped five pounds the first week of treatment with DS-1062a. Nice to know I have a little buffer.

Washing out of lorlatinib may be part of the reason I am so fatigued. However, there have been some good changes as well. The cadence of my speech has sped up noticeably–even Alice commented that I am talking faster now (adios John Wayne).

I had been on lorlatinib since May of 2014—likely longer than almost anyone else. Two years ago I began to experience what I referred to as long term side effects. Small blemishes would quickly become gaping holes which simply would not heal. Crusting is a known side effect of lorlatinib and that was the primary issue, as those crusts seemed to burrow into my epidermis. My oldest son, who I visited over Christmas, later shared with me that my skin looked like that of a drug addict–that it appeared I was rubbing my flesh away.

My nails were also an issue, particularly on my feet. Nine out of ten toenails became ingrown and even surgery would not make them straighten out.

Anyway, a week after my last dose of lorlatinib both my skin and my nails began to heal. I shall be left with some scars but my self esteem is improving as well–it’s no fun walking around with open wounds on your face.

Best of all is the impact on my cognition. Suddenly my thoughts are more dense. The best analogy would be thread count–I have gone from 200 to 500 in two weeks.

So life goes on, one set of side effects traded for another. However I am reveling in the joy of clear thinking, clear skin and the potential of an extended horizon.

xo

Billing: research versus stand of care

I was billed for my recent biopsy but evidently that was in error and charges will be reversed. On Tuesday I sat down with my research coordinator and we went through the procedures one by one to break down what was billed to insurance, and what was covered by the sponsor.

So here goes. Considered standard of care (and therefore billable) are these items:

Physicals

Skin exam

Blood work that is CBC (complete blood count) with DIFF or differential

Blood work that is comprehensive metabolic

CT scans that fall within SOC schedule (every twelve weeks)

And these are the procedures that are considered research only and which are expenses picked up by the sponsor of the trial:

Eye exams

Echocardiogram

EKG

Pharmacokinetics or PKs (all other labwork)

Urinalysis

CT scans done more frequently than every twelve weeks

RECIST measurements

Tumor biopsy

Drug

And so it is not as bad as I imagined per expenses expected to be covered by me, the participant. However, the language in the consent form is exceedingly vague (Standard of care versus research) and I would urge anyone participating in a clinical trial to have it spelled out ahead of time.

I would also point out that my travel, lodging (back to back late evenings with early morning appointments the next day sometimes make this necessary), meals and parking are still picked up by me. This is no small potatoes in a trial that had me at the hospital four out of seven days last week. In addition, should I suffer a side effect related to trial, any subsequent treatment shall be billed to insurance: ‘The treating hospital will offer you the care needed to treat injuries directly resulting from taking part in this research. These treatments will be billed to your insurance company. You will be responsible for deductibles and co-payments. There are no plans to pay you or give you compensation for your injury.’

It is good to know that the biopsy was not correctly billed to me which would have been insult to injury. However I am still angry that I am required to effectively donate tissue from an exceedingly invasive procedure (not once, but twice–and they had asked for a voluntary third biopsy). Evidently a small core sample was obtained for MGH and it was sent to pathology confirming cancer cells were present (duh). However, there is not enough tissue to, say, make mouse models. Or to run genetic sequencing with tissue to spare should it be needed later. Both of those things would be helpful in a complicated case like mine–three known secondary acquired mutations conferring resistance. The sponsor got the bulk of the tissue–any effort to acquire more would have been considered risky to me.

In the consent form I signed it is acknowledged that performing a biopsy comes with associated risks including this little nugget “There is risk of regional spread of cancer cells when the needle is removed from your tumor. Although very rare, there is a risk of serious complications (such as pneumothorax)…and death.”

Yeah, death does sound serious. But so does regional spread of cancer cells. Essentially the sponsor is paying for a piece of me, not an optional piece, but a required piece. I am glad that there is not associated financial burden but the physical burden is still huge. And if someone is going to be harvesting my tissue, well then by all means they should share that bounty with me, so that I too can benefit from my sacrifice.

Bottom line, ask questions, lots of questions. Of course it is difficult to ask what you don’t know, and even though this is my fourth trial, I am still learning. I would also suggest that consent forms could be much better at spelling things out–as they stand now, there are just too many vagaries.

Ultimately, I want some of my tissue. And a net zero balance per my expenses related to participation. I do not feel this is too much to ask. In an ideal world I would also be compensated for my time.

Just as astronauts are. 🙂

xo

Getting it right about research

Medical Research (capital M, capital R) is often the star when cancer patients talk about their continuing survival.

I’ve sung the praises of research again and again. Without it, I’d be dead.

However, the part of the story that often gets glossed over is that medical research requires human subjects. And that particularly in phase I trials (designed to assess safety not efficacy), these human subjects are taking on quite a lot.

MTD, or maximum tolerable dose, is determined in phase I trials. You know how? Someone experiences side effects that are not tolerable. Tolerable is a word with a lot of latitude. As I begin my fourth phase I clinical trial, I can tell you that it takes both courage and an ability to navigate uncertainty and discomfort that frankly, many don’t possess.

Clinical trial participants are the unpaid labor force that moves experimental therapeutics to market. We take on enormous risk as well as additional expense. Our skin in the game is the real deal, from blood draws (thirty teaspoons at cycle one this time) and biopsies, we provide the necessary specimens. We agree to take drugs that no humans have taken before. In exchange, if we are lucky, our lives might be extended—maybe even long enough to enter yet another trial.

Because frankly, if trials are not a one and done, then they become a literal way of life. I have now spent a decade, or one sixth of my life, as a clinical trial participant. That’s a lot of heavy duty community service.

However, it wasn’t altruism but rather a desire to stay alive that led me to my participation. That in no way lessens the contribution though. Veterans of combat are honored for their service, not their motivations.

If we want to have clinical trial participants recognized as partners rather than merely participants, we need to change the way we talk about trials. Don’t just thank medical research, acknowledge as well the contribution of those individuals who ‘volunteer’ their time, tissue and finances. Recognize that medical research simply could not happen without these sacrifices.

Next time you express your gratitude to medical research, try saying this instead: “I would like to thank medical research and all those brave individuals who participated in the clinical trials that brought this drug to market.” It’s a mouthful. But frankly, it’s the least we can all do. Remind the world that without trial participants, research isn’t going any further than the lab. And I’m not just talking tissue, this is all about teamwork.

Honor that.

Piece of me

You’d think after all these years of clinical trial participation I would have this thing completely figured out. But no.

When I spoke to Alice yesterday I asked her if we would get some results from the lung biopsy on Monday. Post procedure it was explained to me that enough tissue had been successfully removed for the trial requirements, but that they weren’t able to get any extra. At the time (still groggy from the sedative) I wasn’t even sure what this meant.

If you recall, I had a biopsy on lorlatinib where there was an attempt to get extra tissue so that Alice could determine my mechanisms of resistance. Our sample came up empty and she asked the sponsor of the trial if they would be willing to share some of their (my) tissue with us. It cracked me up at the time (and infuriated me) that we had to even ask for my tissue. MY TISSUE. But I also didn’t understand how endemic this was.

Anyway, the answer to my question was that we were unlikely to get any results back from my biopsy (the first of two that are required). And this is when I finally understood that there is a big difference between a biopsy that is for research purposes and one that is for the clinical benefit of the patient.

What is the same is this. It is my tissue, my time, my insurance that is billed for the procedure. My risk, considered high with an intrathoracic procedure.

In other words, this (a biopsy) is something I am doing just for the good of science. Willingly, as I signed the protocol. However, it would not be difficult to argue that I feel coerced by both my imminent demise and the lack of potential treatment options.

For those of you who wonder how I can be grateful for the opportunity to participate in trials (beats the alternative) but also angry, well, here you have it.

Tell me what is fair about requiring me to undergo an invasive procedure, pay for it (billed to insurance), undertake extra risk and potential expense–I have often had a pneumothorax following a biospy, which meant a night in the big house), and to do so simply in a spirit of altruism.

Fucking A. If biopsies are required, then there should be some quid pro quo here. Results should be shared with me and better yet, there should be an emphasis on finding clinically relevant information. If this is not the height of bullshittery in clinical trials, I don’t know what is.

And as it turns out, ASCO agrees with me. Somewhat tepidly, but for their viewpoint on research biopsies, click here.