Category Archives: Uncategorized

The necessity for compassionate use/expanded access

My participation in this, my sixth phase I clinical trial, would not be possible without the concept of compassionate use/expanded access.

That is because I did not qualify–was precluded–from the actual trial. The reason? Because I’ve had too many previous therapies–specifically ALK inhibitors. Three to date. Well, until yesterday 🙂 Now four.

Fortunately, there was a back door. And I had a crew of people knocking on it for me. Colin Barton, who works so much magic behind the scenes at ALKPositive as chair of the Medical Committee. I talk a lot about goddesses; this man is a god of good. An ALK+ patient himself, he uses his smarts, personal resources and the fervor of a man on a mission to advocate for the other members of this club. He has initiated conversation with the decision makers at various pharmaceutical companies. I shared with him that at first I thought this might be a fool’s errand, but Colin is a visionary and he saw something I did not. And he has assembled an amazing team of fellow patients who work tirelessly to ferret out potential treatments that could benefit the ALK community.

My oncologist Dr. Jess Lin was also relentless on my behalf–contacting the sponsor almost daily. Jess presents as sweet and mild mannered, but she can be ferocious when it comes to her patients.

Of course, this was a time sensitive matter and some of my friends (talking about you Rob Densen) were not satisfied with the pace as I waited for drug. Where I was hesitant to reach out he was not and I am grateful.

So there we have it. Today I took my second tablet and then lay down for an hour so as to better visualize the cancer exploding like a mouthful of Pop Rocks. And, to continue with that metaphor, my mind continues to be blown by what a long, strange trip the last two months have been. I spent a whole lot of time thinking about dying all while hoping it wasn’t true.

Not natural bedfellows–these two thoughts. At least if you are hoping for a good nights sleep.

Therefore I am happy to report that I am still feeling good/better and that my dreams last night were sweet.

xo

TPX-0131

A fourth generation ALK inhibitor provided to me by Turning Point Therapeutics through compassionate use.

At 1:30 pm today I took the first dose. Before handing me the tiny tablet (it is one mg), Dr. Lin and my nurse Heather performed a little ritual—a blessing of sorts. And then, down the hatch.

By Dr. Lin’s estimate I am the third person in the world to take this drug (it is in clinical trial in Australia) and therefore it is impossible tp predict side effects.

Truthfully, I am far more interested in efficacy. And the thing is, if this experimental therapeutic is going to be effective for me, I may know very soon. Likewise if there is no response.

After dosing I hung out at the hospital for an additional two hours of observation. I squeezed in my second nap of the day (I had been there since 7:30 am) and when I awakened I just had this sense that something was going on in my body. Something good.

So light some candles. Cross some fingers. Have a chat with the universe on my behalf.

xoxo

Drained

What a busy seven days it has been. Melinda and Sally, Jemesii, Peter and his girlfriend Caroline and my brother Bink and sister John have all visited over the past week. It has been great fun, much has been accomplished and I am exhausted.

However, I also have had more baseline energy. A function of restarting TNO155? Perhaps.

This morning I was scheduled for installation of a PleurX-cath–financial assistance approved. My breathing has also been some improved and I went to the appointment hopeful that I should be turned away again–but this time for lack of necessity.

And indeed a Pleur-x was deemed unnecessary at this junture. Instead I had another thoracentesis which yielded 150 ml of serosanguinous fluid.

Last night I learned that TPX-0131 would be at MGH no later than early next week. I know my oncologist has been working tirelessly on my behalf to forestall more delays, and my friend Rob Densen and his pals at Senator Markey’s office got involved as well. Moral of the story? Choose your oncologist’s, your friends, and their friends carefully.

To put a dot on that i, I shall take my final dose of TNO155 tonight—and my final dose of lorlatinib on Sunday as I begin washout. And then, next Thursday, my lead in dose of TPX-0131.

There have been moments (hours, days) in the preceding weeks where I felt I was down for the count. I don’t feel that way today. Raggedy and realistic about the fight that lies ahead, but confident that I’m going to get a shot at it.

xo

Waiting.

And (allow me some dark humor please) the suspense is killing me.

Unfortunately hurry up and wait can play an overarching role in the management of cancer. There are even rooms for this–Waiting Rooms. And I have spent far too much of my precious time in such.

At the moment my waiting is of a different sort. The expectation was that I should be starting on TPX-0131 this week. However, at my appointment last Thursday, I learned that lead in dose has been pushed back by another week. FDA and the IRB have both signed off but this holdup is in manufacturing and labelling. Whatever that means. At this stage, I am nervous that this won’t be the last delay and–between you and me–it’s getting more and more difficult to hold my breath in the interim.

What did happen last Thursday is that I started back on the SHP2 inhibitor TNO155.

Per my oncologist’s advice, I shall not be getting a pleurodesis, but rather a (déjà vu!) pleur-x catheter. Financial assistance has been applied for and the pulmonologist’s team spoken to. That will take place Thursday morning, after which a visiting nurse shall make two visits both to drain the catheter but also to teach someone else how to do so–it is not possible to do alone.

And then, hopefully, a week later I shall be taking a fourth generation ALK inhibitor.

It is early days–I shall be one of the first–but this is the best of my current options. One on which I am pinning a whole lot of hope.

In the meantime, I am laying low. Continuing to tie up ends with my committee of personal assistants (bless each of you) and also spending time with my two kids who live in Boston. Today we went through family photos and despite their trepidation (what all this preparation represents), had a wonderful day.

And I, of course, hope that there shall be many more.

Wonderful days.

xo

Mis-Maligned

After a pleural effusion, a cytology test is performed. The results of my first two were reassuring. No cancerous cells found. However, there was a note of caution: the left pleural fluid cellblock contained ‘rare groups of highly atypical epithelial cells, consistent with metastatic adenocarcinoma.’

My third cytology exam, following last week’s procedure, was unequivocal: malignant.

Acccording to Medscape, ‘Development of a malignant pleural effusion is associated with a very poor prognosis, with median survival of 4 months and mean survival of less than 1 year.

Any treatment is considered palliative.

Grim and grimmer. However, my first response was take that twelve months and double it. Unrealistic? Sure, hell, why not. However, little about my last sixteen years has been realistic. Surreal is certainly a better adjective.

On Thursday I will see both Jess Lin and Alice Shaw and we shall discuss a pleurodesis.

And, a week later, I will hopefully be taking my lead in dose of TPX-0131. In my wildest dreams, I shall respond and begin to feel better.

In the meantime, I am still adjusting to, well, limitations. Because of fatigue, I had pushed last Sunday’s date night to this evening. However, after showering in preparation, I immediately felt nauseous and vomited. This is likely a side effect of the pleural effusion.

I called my (very understanding) date, who was already enroute, and told him I would need to cancel. Again. And that, in all honesty, I was fooling both of us in thinking that I was well enough to socialize. As an enthusiast, I sometimes operate under the assumption that I can just power through. However, my body is making it increasingly clear that it is time to rest.

So I shall. Pace myself. But, with not just the hope, rather the expectation, that I shall rise (and date!) again.

xo

Death benefits

This one’s staying.

Dying is a permission. Even might be dying but damned well hope not. Yes, I’ve been taking care of the necessaries. Just exchanged some texts with a dear friend who is an attorney and who is drafting a document that shall specify where I’d like my body to go. Her last text asked about who is to receive my cremains. It is all that casual.

That’s the heavy stuff. On a lighter note I am buying the better bottle of wine. Lying out in the sun, because Vitamin D is good for you and fuck wrinkles–not my problem. Time to–as someone once said–get the good china out.

Death is about letting go. And I am–on so many levels. I’ve started going through my closet, and anything I don’t love is being donated. How freeing is that? And how ironic that the expectation of many years ahead wasn’t all the permission I needed.

That’s life, I suppose. Learning is coming at an accelerated pace these days. Sometimes I feel this is a bit of a joke–the cosmic irony that I should figure so much out now, at the end. Other days I think well what if I do go on living, with my affairs in order and my literal load lightened.

How very liberating.

How very.

xo

But the show must go on

I was to get a PleurX catheter installed on Tuesday. However, I thought my appointment was in the afternoon whereas it had been in the morning. It was rescheduled for the next day and I spent Tuesday sleeping–exhausted as the day before the rest of the contents of my studio had been moved by (I kid you not) the two slowest movers on the planet. They did a good job though so all’s well that ends well.

My appointment on Wednesday was of the bright and early variety but this time I was where I was supposed to be when I was supposed to be. Johnnied up, on the table, being prepped. And then the surgeon comes in and tells me that they won’t be installing the PleurX because my insurance covered the procedure but not the supplies ($1000 a month to maintain).

I was stunned. ‘Why could you have not told me this before I was on the table?’ I asked. No response. The surgeon then went on to explain my options–another thoracentesis or a talc procedure, which would require admission to the hospital. He also allowed that after two thoracentesis’ the risk becomes greater than the value.

Fabulous. I asked them to call my oncologist (they texted her). Explained that time was of the essence here–that I would be starting back on the same drug (TNO155) that almost certainly initiated my rapid onset plueral effusion. That the PleurX catheter was being installed so that if my lung started to fill with fluid again, it could be managed.

In the end, I had my third thoracentesis in a two week span. It hurt like hell. This time they were able to extact 250mm of very viscous fluid. The x-ray following the procedure reported ‘residual loculated left pleural effusion.’ So, in short, my left lung is a project.

Yesterday I met with Jess. The good news is that I may be able to start on TPX-0131 in two weeks. Having a horizon line is helpful in these circumstances and now my eyes are set on that. And my blood work looked great.

As for the aborted catheter, perhaps it shall be a non issue. I took my dose of TNO155 on Wednesday, but the way the trial cycle works, this week is my week ‘off’—no TNO155, just lorlatinib. So that alleviates my worries per another massive pleural effusion in the coming days. As it looks now, I may have to go back on TNO155 for only one week. There may be need for yet another thoracentesis, but a catheter may have been of limited usefulness anyway.

I remain exhausted and short of breath (but less so after I get my lung drained). However, this body of mine still wants to live.

I plan on honoring that. Much time has been devoted to getting my affairs in order–a great comfort. But now I need to get back to the good stuff. To that end, dinner out with Diane and her husband Dave last night, a meal with another friend on Saturday and a date on Sunday.

I’m alive I’m alive I’m alive.

xo

And a few more salient details

I am exhausted. Spent, if you will. Therefore today’s blog is a cut and paste–taken from a message I sent out to my siblings and some close friends.

Another update. Not the kind I like to give. I hadad scans and saw both of my oncologists today. In short, it is still a shitshow in my left lung. Pleural effusion, partial collapse, possible pneumonia and a super aggressive cancer (Alice compared scans that were eight days apart and it had grown). And, unfortunately, my fever returned today–still low grade but not a good sign.

 
Next week I shall have a drain installed in my left lung and on the same day, I shall start back on the same drug that likely caused the pleural effusion–TNO-155–at a lower dose and with the hope that if my lung blows up again, we can control it with the drain.


My oncologist applied for (and received) compassionate use for the 4th gen ALK inhibitor that I had been precluded from (due to too many prior treatments)–TPX-0131. This is a great scenario as she gets to write the protocol. However, with paperwork it will be four to five weeks until I can start. Our goal–bluntly put—is to try to keep me alive that long.

 
This is brutal, I know. However, I thought it best to let you all know. If things don’t change course, I am wrapping it all up and sooner than I expected.


Please know how much I love you all and also that I am going to continue to fight like hell. I just need a miracle 🙂 And–an ask–please look after my kids. They are having a really tough time–Peter told me tonight he is barely holding it together. In the end, it doesn’t matter how much time you’ve had to prepare. None of us are ready.

xo

Time for a proper update

Last we spoke I was post thoracentesis and home with a Z-pack. I had that thora on a Friday and by Monday I was running a fever and experiencing chills. Jess wanted me to go to the ER but I resisted. We made a deal that if my temperature rose, in I would go. When it hit 101 that evening I relented. Per Jess’s instructions, I was not to drive myself

Well, my fabulous landlords rose to the occasion and ferried me to MGH—complete with a blanket and a hot water bottle. They also offered to take care of Kumo–for what would turn out to be an extended stay.

The ER. First they took my temp with one of those little wand-y things, which said I had no fever. It would take another 36 hours for someone to stick a digital thermometer in my mouth and for all to realize that I still had a fever of 101+. If you have a wand-y thing (they screen for COVID with those), throw it out. Piece of shit.

As an oncology patient, I was paid a certain degree of deference. Which meant my own private glass cubicle. But I, like everyone else, had a gurney and no pillow.

Going to the bathroom was a trip. The further you went down the hall, the more it resembled skid row, with gurneys lining the halls (addicts, drunks, psych evals) and people sitting in chairs like hall monitors. Which they essentially were.

‘It would be my unfortune (not a word, but let’s make it one) to spend almost 24 hours in that ER. The nursing staff was exemplary. But the slice of humanity—it’s hard y’all. I saw some guy’s junk (I was on the phone with my friend Annie who said ‘don’t tell a lesbian that!). I was bombarded by bells. Some woman came in screaming ‘don’t you shoot me with that fucking epipen–you killed my kid, I’m going to sue you all’ and so on. Ten minutes later she was quiet and when my nurse came in I commented on that fact. ‘She had some help’ he said. ‘And that’s what she was screaming about’ I replied to which he responded ‘And that’s what happens when you spit on somebody.’

Another of my fellows came in with a police escort of at least seven officers. A big city emergency room is, quite simply, a portal to hell.

When I was admitted, it was to a room with a roommate. In short, a hospital is no place to heal.

However, my situation was such that I needed to be stabilized. A complex cocktail of intravenous antibiotics. A second thoracentesis. Discussion as to the fact that if my fever did not abate, we might need to attribute it to my cancer—which remained so obscured by pneumonia and the pleural effusion—it could not be assessed.

It was a scary time. A time of difficult possibilities and discussion around whether or not these were in fact probabilities.

And of course, the demands of life continued. I needed to vacate my studio. Stat. And now physically impossible. I called Annie–said I needed a project manager. She—without hesitation—agreed. I then sent out an email to some of my closest friends and my youngest son. While I was in hospital, Annie drove two hours to my house, got the key to my apartment from my landlord, and then met my friend Marc at my studio to start packing. The next day they were joined by Brian, Chi and Susan.

My son Peter had the task of bringing me home from the hospital on Saturday, but on Sunday he joined those assembled. And this marvelous crew both packed up and moved most of the contents of my studio. Unflipping believable.

Of course, there were other matters to attend to. Melinda and Diane tag teamed. Once I was released, Melinda and our friend Amy came to my house to cook but also to help me tie up some important loose ends. My will. ( a visit to the notary). Taxes paid. A spread sheet created for my bills and passwords. Power of attorney to Melinda–as well as giving her access to my bank accounts. And then Melinda went above and beyond–looping in with my financial advisor to help me manage assets.

There are still things to attend to. Copies of keys, arrangements as to how I’d prefer to die and where my body shall go (research) once I do.

Sobering. This head on confrontation with mortality. But also incredibly comforting–wrapping things up. Of course, I still hope this is all a little premature. However, my eyes are wide open. Stage IV lung cancer, a massive pleural effusion and pneumonia are all indicators of a body that is struggling. Tomorrow I have another chest CT and will meet with Jess. It is likely my left lung will be drained again and possible that a PleurX catheter will have to be installed. Once it’s a tad drier in there, we can figure out what’s been going on with my cancer. And make some choices as to how to move forward.

Forward 🙂

xo

Getting crowded in here

You are not incorrect. There was a post up for less than 24 hours. I pulled it at the request of a beloved and if you were paying attention, not who you are thinking. C’est la vie.

First do no harm. In succinct summary, I had a no good very bad week. I also had a successful (as in, tissue was able to be harvested) biopsy and the following day, began my 6th phase I trial—lorlatinib plus TNO-155.

Initially it was all completely noneventful. Vomiting, diarrhea—garden variety and managed. But I was also dealing with increasing pain (possibly the tumor pressing on nerves) and shortness of breath. By week two the shortness of breath could be pretty profound and I was also experiencing night sweats. By the time I had my end of cycle appointment last Thursday, I was feeling really, really bad.

The technician who took my physical intake asked if I was ok–‘your blood pressure and heart rate are through the roof.’ My labs were not alarming but Jess did feel I might be dehydrated. I told her I felt I was experiencing a pleural effusion. And perhaps an underlying infection–those night sweats. In short I believed my body to be under a great deal of stress–that I was in trouble.

We agreed that I would get IV fluids, hold the drug and move up my scan.

First the chest Xray. My right, healthier lung is on the left–dark, as it should be. My left lung has been subsumed. This is only echoed by the CT scan. Airspace on the right–hard put to find any on the left.

There was a pretty clear reason for my misery and steps that could be taken to alleviate it.

A Thoracentesis was scheduled for the next morning. I was going to finish up with infusion around dinner time and then it would be long drive home in rush hour. While feeling like shit. ‘No way’ are you going home, said my friend Diane. I brought it up with the infusion nurse who said being admitted to the hospital was not a matter of convenience. Sigh. Stage IV lung cancer, major pleural effusion, pneumonia, and I have to explain to someone that a night in the hospital would not be about convenience. I live alone, live more than an hour distant, and I am sick as a fucking dog.

Advocate, Linnea. Explain to others what you really need.

Jess Lin called me and that was enough of a nudge. I asked if I could be admitted for the night. She hesitated for a moment (I mean, everyone is accustomed now to me driving back and forth) but then said sure, she would see what she could do.

Turns out there is a pilot program, just a week old, for a transitional Emergency room/ICU affair–kind of a hybrid. Low frills but a warm bed and all the attention I required. I was their patient 🙂

Yesterday morning I lay with my head in my arms as 1.5 liters of claret colored fluid was drained from my left lung. When I started to cramp, the surgeon stopped siphoning. A subsequent x-ray showed pneumonia and a moderate plueral effusion–there will be a redux.

In the meantime, relief was immediate. Excruciating pain became mere discomfort and I was no longer panting for each breath.

The irony? It is highly likely the pleural effusion is a side effect of TNO-155–an extreme form of fluid retention.

I am on two different oral antibiotics now and next Thursday we shall scan again. It the effusion is out of control, we will deal with that. If it has subsided to any degree, we might be able to assess my cancer, and to make a decision as to whether it is worth risking another round.

Hopefully the pneumonia will begin responding as well.

In the meantime this battered body of mine is resting. A lot.

PS: My friend Diane and my friend Melinda started texting each other. And Diane told Melinda that she tracks me on a find your friend app. Which, of course, Melinda wants in on now too. Two of my many angels, joining forces, on my behalf.

xo