Category Archives: Uncategorized

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. πŸ™‚

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.

Scoop

I had a chance to speak to Alice today about my reaction on Tuesday and one of my questions was how common IR’s or infusions reactions, are. Not rare, but in the single digits as far as percentage.

So far I’m not doing a very good job of being unremarkable.

The good news is that we have the go ahead to try again. Plan of action is to stick with the pre-dosing of Allegra and steroids, but to also dose again just as we are beginning infusion. And to infuse at 1/2 the rate with Bendadryl administered intravenously simultaneously.

I’m going to be coming and going and am definitely not looking forward to a repeat of the Benadryl crawlies. My friend Gina sent me a weighted blanket and I will bring that with me on the day of infusion to see if it makes a positive difference.

In the meantime I’m feeling OK. Profoundly tired yesterday but I have to wonder if some of that was just coming off all the steroids. My fatigue is more low key today.

Onward. I hope this shit works. Particularly as this is mutation agnostic, and therefore potentially a viable treatment option for a large number of people.

I shall keep you posted πŸ™‚

xo

Infusion confusion

So oh boy. Infusion began around 12:40 pm with little drama. However, just about an hour in, my throat began to suddenly hurt. I was looking for the call button but my nurse was peeping through the glass doors. When she came in I explained that not only was my throat painful, it felt as if it was swelling shut.

Gatekeeper to my veins

She immediately turned off the infusion and then things got a little bit more exciting. My neck and back developed a rash and hives and the strange feeling in my throat moved to my palate. It was getting harder to breathe and an oxygen mask was put on and I was given intravenous benadryl as well as more steroids. Lots of people in the room assessing the situation as this was a classic infusion reaction/hypersensitivity–despite pre-dosing with antihistamine and steroids.

Damn. I was hoping I could will myself to not react. But no. Saline was administered next and a repeat of steroids as my throat wasn’t feeling any better and I was starting to cough as well. And then restless leg syndrome kicked in crazy bad as a result of the Benadryl.

An hour passed before the symptoms of hypersensitivity subsided (but not the restless legs) and we gave it another go at a titrated speed. Forty five minutes later, my throat was suddenly very painful and swallowing difficult. The back of my neck started to itch and rash out as well and so the infusion was stopped. I was given more steroids and an executive decision was made not to finish dosing.

We clearly have a complication going forward. I really don’t want to drop down on dose if I don’t have to. Dr. Lin is going to have a discussion with the trial team and sponsor to see if they can come up with some strategies to get me through an infusion.

So here I am four more EKGs (I was mistaken as to how many were required today) and a whole lot of blood draws later. One more EKG at 7:30 and two more vials of blood and then I am released. Long, long, slightly disappointing day.

Hopefully my cancer is currently as uncomfortable as I am.

xo

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