Category Archives: Clinical Trials

Loud uncle paired with a quiet whine

Yesterday was a humdinger. Two treatment-related mistakes in, I realized that not only am I over-overwhelmed, it’s time to do the big ask: Help!

Shortly after after posting my previous blog (and following much back and forth), Dr. Shaw and I decided that canceling my mediation was not a good idea. The prospect of getting three lawyers to readjust their schedules just felt too daunting. And, until we reach a settlement, I am still completely dependent upon David financially and that is not where I want to be.

Alice (Dr. Shaw) very kindly opined that medically it would be okay to wait a week. I emailed back that I would then delay wash-out and continue taking my Xalkori for one more week. This was her adorable response:

Yes. Twice per day! ūüôā

Well, evidently I overdid it by one pill, and because of that the trial start date could be delayed (really?). That was mistake number one. The second screw-up was getting confused as to the time of a scheduled MRI and arriving fifty minutes late. They graciously squeezed me in but it easily could have meant another trip/potential delay.

So let me describe my little day from hell. I was up at 6:30 am with the intention of getting on the road by 7:30 for a 9:30 am dermatology appointment. A mere 24 hours earlier I had been looking at my left shin with my glasses on. I have very long legs and increasingly poor eyesight and if my glasses aren’t on, anything below the knees is blurry. Well, there’s a mole mid-shin that a dermatologist at MGH has been watching, and what I saw when I looked closely was concerning—particularly the numerous small black spots that now peppered the surface of this little ‘beauty spot’. I had a basal cell cancer removed at the age of thirty and my father Ollie had numerous basal and squamous cell cancers as well as melanoma. My chart must have me ID’d as high risk, because when I called for an appointment they marked it urgent and got me in yesterday.

Anyway, that’s the back story. I got on the road by 7:45 and realized I had missed Peter’s 7:20 wake-up call. Placed that–we’re getting this routine down, and as silly as it may seem, I love speaking to him briefly each day. And then I settled into what is always a horrific commute. What can take half an hour turned into and hour and a half. I got to dermatology just before my appointment. Fifty minutes and five magazines later I asked the receptionist if I’d be seen soon—as I had more appointments over at Yawkey starting at 11 am. Oh dear. Seems she forgot to let them know I was there‚Ķshe was very apologetic and I was seen shortly thereafter but it was some additional stress I could have done without.

Anyway, one look at the mole and the dermatologist said ‘biopsy it’. His feeling was that it represented a basal cell, but given the pigmentation and appearance, melanoma could not be ruled out until the pathology report came back.

I had a punch biopsy¬†performed and I will hear the result in seven to ten days. As the doctor said (a wee bit too glibly, I felt). ‘You don’t want to hear back from me.’ If a nurse calls, I will know it is reassuring news. If it’s the doctor, do you think hanging up would make it go away?

I had to practically run back to the Yawkey building (a challenge at this point) as an Echocardiogram was scheduled for 11 am. I was ten minutes late and breathless to boot, but the test proceeded anyway. Evidently I shall have these periodically during the upcoming trial, as there have been some (asymptomatic) reports of prolonged QT interval.

After that, it was labs and an EKG on Yawkey 7B. I spoke to the trial nurse and my scheduler, and ended up with just enough time for lunch before I had to begin fasting for my pre-trial abdominal CT scan. I enjoyed my rushed meal but for dessert I had a brain fart—thinking I had time to sit in the MGH cafe and browse on my laptop before heading over to Chelsea where the scans were scheduled. Oops. At 3:20 I realized my brain MRI was supposed to occur at 3:15. I placed an apologetic phone call and did my best to rush over—something that is impossible at that time of day. Forty five minutes later I arrived at Imaging in Chelsea and (because sometimes you do what you have to do), drank one of those hideous barium shakes. I did beg off the second one.

Well, it looked as if my MRI would need to be rescheduled, but bless their hearts, they squeezed me in. It was almost 7 pm when I left. Exhausted.

So here’s the ask. I’m an independent sort by nature and a good deal of my journey with cancer has been rather solitary. Sometimes that has sucked but mostly I have managed (got my own back sort of thing). However, I confess to harboring a small amount of envy for those cancer patients who have a lot of support. Medically I’ve got the best squad a girl could ask for but I’m thinking I could use a little‚ĶTeam Linnea. Family/friends/folks who might be willing to go to appointments with me. I’ve got some long ones coming up as I start the trial and it is always easier with company.

As soon as it is finalized, I am going to publish my schedule. If you’d like to spend a day in the life of a patient in a phase I clinical trial, don’t be shy! All comers welcome!

And while you’re at it, please cross your fingers that the skin biopsy comes back benign (best) or basal cell (better than the alternative). I don’t need any more wrenches thrown into this affair. My son August sent me this e-card, which nicely sums up my current sentiment:

10152646_10152422082198708_4231432561548744429_n

 

 

Word of the day: Optimism

I just made an appearance in the Massachusetts General Hospital Newsletter:¬†Targeted Cancer Therapies Make MGH Patient Optimistic — MGH Giving.

Serendipity I guess, as it looks as if I’m about to enter my third clinical trial for a targeted therapy. On the 28th of April I will have a CT scan and then meet with Dr. Shaw. The expectation is that the scans will show progression; (but it sure would be nice if that expectation was inaccurate) and the plan is that I will sign the paper work to enter the¬†PF-06463922 trial. If it’s a go,¬†washout¬†begins the following day; I will likely start the trial two weeks later.

In the meantime, I’m getting excited. Teeny bit nervous, but overwhelmingly (yes, it’s true) optimistic. Here’s hoping the third times a charm‚Ķ

Straw houses: feeling a bit blown away…

I’m in a funk. The kind of piss poor and discouraged frame of mind that has left me wondering just how much more I can handle.

Of course, I know exactly how much—whatever life throws at me. In fact, I’ll borrow a quote from an article in yesterday’s NY Times (and originally quoted from Samuel Beckett): ‘I can’t go on. I’ll go on.’ The beautifully written opinion piece from which I snagged the Beckett quote was composed by Dr. Paul Kalanithi, chief resident in neurological surgery at Stanford University.¬†Diagnosed with advanced lung cancer at the age of thirty six, Dr. Kalanithi has been learning how to navigate the tangible (statistics) versus the intangible; hope. You can read his thoughtful and moving commentary at this link:¬†How Long Have I Got Left?

It’s cold, windy and dreary outside. At times like this it is my habit to note how happy I am to have a home. Only, right now I kind of don’t. Which is not to say I’m homeless.¬†I’ve¬†been temporarily evicted–make that evacuated–from my own apartment. A week ago I traced an unsettling dirty foot smell to the utility closet. There was standing water on the floor all around the hot water tank. I sent an email to Mark, the wonderful maintenance man by day/sometime drag queen by night. He called me within an hour (leaks are the chest pains of the world when it comes to apartment triage). His thinking was that it might be a loose gasket in the garbage disposal, as the sink was directly adjacent to the utility closet. He said he’d come by in the morning.

The next day the floor of the closet was dry. I ran the disposal, but no water appeared. I took a shower–to test the water heater. Again, no dampness. And then, just to be thorough, I started the dishwasher. Bingo!

Long story short, the dishwasher had a cracked drum which had obviously happened prior to or during installation. What may have started as a slow leak (clearly unnoticed by prior tenants) was now a gush. And bleeding up the drywall behind the dishwasher was mold—the black, nasty kind.

I was calm at first. Took myself to Five Guys and had a burger and a think. I followed that up with some internet research on black mold; some of it quite alarmist. The most reasonable source of information was from the EPA and CDC. I have a known allergy to mold and after a bit of reading I concluded that I was showing signs of acute exposure, as my eyes had been red and irritated for weeks and there was a rash on my wrists as well. And, of course, I’d been coughing. Clearly my lungs were at risk. Everyone involved quickly came to the same conclusion–I’d need to vacate my unit while the mold was remediated.

Fortunately there is an empty apartment in the lofts; a showroom of sorts and it is equipped with an airbed. I went back to my place and grabbed some clothes, sheets, a towel, a plate, a cup, glass, fork, knife and spoon. My teakettle and my laptop. Medication. I turned the forced air heat off and Mark and I plugged in some electric heaters. Jim from Servpro came by. He assessed the situation making use of a cool little device that picks up the temperature differences in moisture, and then he made his recommendations. The area around the mold would have to be contained within a ‘tent’ constructed from strapping and plastic sheeting. Servpro employees would then suit up before removing the kitchen cabinets and replacing two sections of drywall. Two big air scrubbers were plugged in and I said goodbye to my stuff and decamped down the hall.

That was a week ago. The air intake for the furnace is located just behind the moldy wall and as indicated by air quality testing, the heating vents were pressure cleaned. A natural product made from botanicals (Benefect) was fogged throughout the unit. Today, the drywall was replaced and the wall repainted. New cupboards and a dishwasher have been order and will be installed as soon as they arrive. I hope to be back home within a couple of days. 

Of course, I’ve got more on my plate/mind than housing. Tomorrow I have a chest CT scan as a follow-up to an appointment with Dr. Shaw two weeks ago. At that time I learned that I do not qualify for the trial of the new ALK inhibitor,¬†PF-06463922. There is a requirement that your last treatment was an ALK inhibitor and you showed measurable progression while on it. The fact that I had chemotherapy after coming off of LDK378 means that I am ineligible.

As a patient, I struggle sometimes with the rigor that is part of a clinical trial. The need for clean data (intrinsically related to FDA regulations) mandates a strict protocol for drug trials. That doesn’t always leave a lot of wiggle room for what might seem like compassionate and humane clinical decisions.

I have a friend who is also unable to qualify for the PF-06463922 trial because the tumors in her lungs have responded so well to treatment. However, she has numerous brain metastases and PF-06463922 is rumored to be effective at treating brain mets. In the strangest of catch-22’s—the current lack of cancer in her lungs means that there is no way to measure the effectiveness of the trial drug on thoracic neoplasms and therefore she is not a suitable subject.

There is a required two week washout period (again in the interest of clean data). This is tough, as many if not most patients with ALK mutations experience a flare of disease when coming off of ALK inhibitors. Again, I feel torn between the future (FDA approval) and the present, the urgent need of patients with ALK (and ROS-1) mutations for effective inhibitors.

In my case I will likely go back on Crizotinib, now marketed as Xalkori and available by prescription (so this time I, or my insurance, will have to pay for it!). Once I’ve shown progression, than I can get back in line for PF-06463922. So, it’s a toss-up. I hope the Xalkori is again effective for a sustained period of time, but I also don’t want to lose a chance to get on trial.

I’m feeling frustrated, for certain. On so many levels. I have been living an unsettled life for some time now. But, I continue to have much to be grateful for. A caring and responsive landlord. My amazing oncologist. And my innate tendency to persevere.

Blow my house down.

As it turns out, not quite enough (of me)

The word from the lab looking for the PD-1 protein in my biopsy is that there weren’t enough cells (cancerous or otherwise) for a thorough analysis. If it is determined that enough tissue was ‘banked’ after the biopsy, a sample will be resubmitted. Dr. Shaw is not particularly optimistic.

So, the plan for the moment is to watch and wait. We will rescan in November and as long as I don’t become significantly more symptomatic, my situation will be reassessed at that time. In lieu of a PD-1 antibody, I could potentially return to one of the ALK inhibitors which I previously benefitted from: ¬†LDK378 or Crizotinib—although as the LDK is still in trial, I’m not sure how that would work. Chemo remains an option but given the slew of side effects, I would say it is the least attractive choice. What I’m really hoping is that I can hold out until the next ALK inhibitor comes to trial (rumored to be end of this year or beginning of next)—the timing could be just right for me.

In the meantime, my plate is plenty full. I’m looking for a place to live as well as a means of support. I realize that statement implies much and answers little; I’ve got a lot to process and when the time seems right, I will discuss this new chapter in my life.

Piece of me

Life can’t just be fun and games, and on Friday I had a needle core biopsy. Yes, my last CT scan showed some progression. Not a lot—characterized in the radiology report as “slight interval increase” but also not a little—“consolidation at the periphery of the remaining left lung has increased in size compared with 6/17/13, now measuring 4¬†√ó 1.9 cm in greatest axial dimension compared with 3¬†√ó 1.8 cm on 6/17/13.

It was a great summer and my break from treatment was absolutely worth it. However, my lungs are getting a little noisy at night again and I’ve noticed more shortness of breath as well as a reduction in my level of energy. So…Dr. Shaw and I concluded that it was the right time to start looking into my next option. That may well be an anti-PD-1 human monoclonal antibody; ¬†an experimental treatment which falls under the umbrella of immunotherapy. An explanation of PD-1 quoted from InforMEDical: ¬†“The programmed death receptor 1 (PD1) and its ligands make up another physiologic immune checkpoint that is co-opted by some tumors leading to immune tolerance. Programmed death ligand 1 (PDL1) is expressed on several tumors, and can be induced by inflammation in the tumor microenvironment. On binding to PD1 on activated T cells, an inhibitory message is delivered to the T cell, resulting in T cell inactivation. Monoclonal antibodies to PD1 and PDL1 can block PD1 messaging, and allow T cells to proceed with a co-ordinated immune attack.

Essentially, the hope is to kick-start or wake up a specific pathway of my own immune system. For a very accessible overview of PD-1/PDL-1, check out my friend Janet Daily-Freeman’s post on this subject. Janet is smart, funny, kind and a whiz at explaining and I highly recommend that you take a look at¬†her wonderful blog;¬†Gray Connections.

The experimental therapy which I am hoping to get a shot at is MK-3475 ¬†or lambrolizumab; this agent has shown impressive results in patients with advanced melanoma. However, before I can be admitted to the trial, a fresh biopsy was required. If PD-1 protein is isolated in my tumor sample, I’m a potential candidate.

So on Friday I had yet another needle core biopsy. The location of the greatest consolidation of my cancer remains problematic; against the pleura and adjacent to my heart. Last time the radiologist went in right through my left breast (!)—this time, the approach was from the side.

Prep involved fasting and although I was initially scheduled for early in the morning, my procedure was shoved back by several hours. The biopsy itself is a curious thing; you are given ‘twilight’ or light anesthesia so you remain awake but in a rather somnolent state (not prone to arguing). After my body was arranged on the table, I was strapped in and instructed to neither move, cough nor speak. I did none of the above and I’m pretty sure that when I was taken back to recovery, I was introduced as the best lung biopsy patient ever (I really though I heard that—may well have been a sweet dream induced by twilight!).

Then the hard part started, as you must lie on your stomach for three hours post-biopsy without moving or talking. Although it was a full house when I was wheeled into recovery, I was the last to leave. At one point two nurses started talking about cider donuts…it was torture. However, not being able to speak or even move a finger, I was unable to express my displeasure.

Room with a view

Room with a view

At hour one and three a portable x-ray machine was rolled in and the condition of my lungs checked. I developed a small pneumothorax¬†and so earned myself a suite in the Swedish Hotel for the night—I mean Lunder Building. Not a bad place for a sleep-over.

Although the main objective of the biopsy was to attain tissue for the clinical trial, we had hoped that sufficient material would be recovered to start a cell line. Dr. Shaw called this morning with the news that once again, there were only enough cells to check for PD-1. Oh well–no cell line or mouse model this time. We also discussed a story on Yahoo News pertaining to Roche’s anti PD-1 antibody; specifically the fact that when the numbers were parsed, smokers showed a greater over-all response (26%) than non-smokers (10%). Although personally discouraging, in the bigger picture, it is great news. Smokers tend to have a more complicated mutation profile at diagnosis, and therefore have not responded as well as non-smokers to the inhibitors that target a specific mutation, and which have monopolized breakthrough status in the treatment of lung cancer in recent years.

I see Dr. Shaw in a week and at that time we should know whether or not my biopsy was positive for the PD-1 protein. If it is, I will likely go on trial and cross my fingers that I’m one of the 10% who respond. And if no PD-1 protein is found in my sample, well, that’s another discussion.

Picking up the narrative thread and pace as well…

On Friday, March the 15th, I was back in Boston for my biannual appointment with my ear nose throat doctor. In addition to discussing the virus I hadn’t quite shaken, I brought up the tinnitus and loss of hearing that I had been experiencing ever since the third infusion of carboplatin and alimta. I explained that the symptoms were particularly pronounced on the right side, which did not surprise the ENT, as that ear canal was completely blocked by wax. He asked if I used q-tips and I allowed that yes, I did, but carefully. As expected, I was advised to drop that practice and to simply clean my ears with a tissue (so why do they still sell the damn things?).

Anyway, he carefully scooped away the blockage and what do you know, for the first time in five weeks, I could hear out of my right ear. When I told my tale to Dr. Shaw later in the day she laughed and said she would have to start looking in people’s ears (if you recall, my final dose of carboplatin was reduced yet again due to the combination of low white blood cell count and my hearing loss).

Jemesii joined me for lunch, and afterward I zipped up to the 6th floor for a CT scan. When I finished up there, I headed over to the main hospital, as a buddy of mine had been admitted. I hung out for an hour and then I took my place in rush hour traffic.

Dr. Shaw was good enough to call that evening with the initial read on my CT scan and although nothing had improved from the last session of imaging, it also wasn’t worse. We would stay the course and move on to alimta maintenance.

L1020827Saturday was an even bigger day, as I was going to be in attendance at the annual conference for the Association of Health Care Journalists. Better yet, I would be part of a panel devoted to clinical trials: What you need to know about clinical studies but were afraid to ask. My fellow panelists were Dr. Jeffrey Drazen, editor in chief of The New England Journal of Medicine, Dr. James H. Ware, Frederick Mosteller professor of biostatistics as well as associate dean for clinical and translational science at the Harvard School of Public Health, Ron Winslow, the deputy bureau chief of health and science at The Wall Street Journal, and moderator Scott Hensley, a digital correspondant and editor at NPR.

Speaking in front of a large crowd is something that pushes me way¬†out of my comfort zone, but when asked to do so, I don’t say no. So there you go. Fortunately, I had a few friends in the audience who were pulling for me (Anjali Thomas, John Novack, and Christopher, Melinda and Dr. Kihan Lee). It ended up being an entirely positive experience with a lot of nice feedback and support from the journalists in attendance. Should you like to read a nice write-up about the panel, check out¬†Covering Clinical Trials: ¬†a message for journalists and ¬†critical readers, from Dr. Judy Stone and the Scientific American blog Molecules to Medicine.

At the conclusion of the session, my five friends and I went out for a lovely meal. I was (I know I’ve been saying this a lot lately, but it is in fact a recurring theme) utterly exhausted, but oh so happy too.