Health Update #31: Change of Plans from Phase 1 Trial to Gemcitabine

A Chair with a View: Rooftop Cows at Northwestern Children's Hospital

UPDATE (5/24/2024): I had the follow-up with the oncologist today. In discussing side effects with the palliative care specialist, I noted that I had much more energy last week while I was taking steroids in preparation for the transfusion. I asked if there were meds I could take to help combat the overall fatigue I've been feeling -- steroids, Adderall, cocaine . . . what do I have to lose at this point? She laughed and said that yes, it's become fairly common to prescribe Ritalin (Methylphenidate) to help with the fatigue during the day. She wrote me a prescription for 5 mg at 8 am and again at noon if I needed it. How many other helpful meds are out there that I don't know about unless I ask?

I met with Dr. G, who said that the Northwestern tumor board recommended against surgery and radiation for the kidney mets, partially because of additional mets in my lungs that we had skimmed over when reading the scans earlier. That was disappointing, but expected.

That leaves two options:

1) Standard of Care, which is Gemcitabine on 3 week cycles with infusions on Day 1 and Day 8. Gemcitabine has a low (20%) efficacy rate though mild side effects.  

2) A brand new Phase 1 trial of TAK-500, possibly in combination Pembrolizumab (Keytruda). TAK-500 may trigger my body’s immune system to help fight the cancer. Individuals enrolled in this study -- 82 in all across the country -- will be the first humans to receive this treatment. 

They brought in another staff member who went over the details of the trial and answered questions about the process, the duration, and expectations. I told her that I wanted to protect the time I've set aside to travel to Louisiana -- June 9 through the 25th -- and we looked over the timeline and determined that that's workable. I will probably take care of preliminary scans over the next couple of weeks, and then start the trial at the end of June. I have 28 days from signing the consent form to start the trial. 

I am most likely to go with the Phase 1 study, if for no other reason than to contribute to the research. I’ve also seen a lot of positive chatter about Keytruda. If we go that route, the first week of actual treatment in late June is involves overnights in the hospital for observation and testing and then after that is on a similar schedule as the Gemcitabine — 3 week cycles with infusions on Day 1 and Day 8. There may be a lot of scans and tests while I’m in the study but I’m hoping that I can still schedule some short travel experiences (such as to Philly in late July) around the treatments and assessments. 

If I’m removed from the study, the Gemcitabine will still be available as a next option. But if I start with Gemcitabine, I might not be able to enroll in the study afterward. So it looks like I'll be signing up to be a Phase 1 guinea pig. 

Corrine and I went and sat in a booth in the bar at Tom's Steak House for cocktails and snacks to celebrate. I ordered the coconut daiquiri with a float of dark rum. I'm liking the beach drinks at this point, paired with Yacht Rock. She ordered the dirty martini because that's what she likes. Cheers!

UPDATE (JUNE 2, 2024): Latest brain MRI on Friday came back with no evidence of metastasis. So, other than personality disorders, my brain seems fine. I have a CT scan of a lump in my left shoulder scheduled for Tuesday and consultation with a radiologist on Thursday. If the lump shows signs of disease, we'll probably radiate it at the end of June if we can't squeeze it in this week. Unfortunately, Northwestern doesn't upload those cool brain scans like Corewell did, so I don't have a visual image to go with those

When I arrived to sign the consent form for the Phase 1 trial on Friday, Dr. G. said that she was concerned about postponing treatment for a month for my trip and didn't want to suspend all treatment for that long. I told her that cancelling my trip was non-negotiable, that I needed to live my life and take advantage of opportunities like this unless there was clear evidence that I'd be worse off from delaying the treatment. The treatment team was supportive of this decision.

So we went with the Option 1 -- three cycles of chemotherapy with Gemcitabine on Day 1 and Day 8. We already had a chair reserved for that day, so I got my first dose then and scheduled the 2nd dose next Friday, June 7th, so that I could fly out for Louisiana on June 9th and start a second course when I get back at the end of the month. The side effects on the first cycle were pretty bad on the first night with nausea and aches and fever, but I felt better the next day. A few tweaks to the meds (anti-nausea and steroids) should help with the next infusion.  I'll also move forward with the intrathecal pain pump implant when I come back from the trip and tweaking meds in the meantime to deal with pain and fatigue. Who knew that Ritalin was in the toolbox for cancer palliative care? We decided to double the dose of Ritalin:8 mg at morning and noon.

One notable change -- All the staff here have started using their soft voices with me, and long dramatic pauses and wistful deep eye contact. One nurse hugged me. Awkward, but ok.

We had a lovely visit with Rebecca and Bill that next night. Cocktails (Sgroppino hand made by Corrine and Boba tea for me) and Indian carry-out from Khyber Pass! Both comfort AND joy.

HISTORY OF TREATMENT:

Just to bring latecomers up to speed, when I first started this process last April (2023), the primary goal of treatment through Corewell Health in Northern Michigan and Grand Rapids was curative for non-small cell lung cancer (localized stage IV in the right lung and right humerus metastasis) by using the big guns -- a humerus implant, radiation to the lung and humerus, and a course of treatment -- several cycles of carboplatin chemotherapy plus immunotherapy involving paclitaxel, bevacizumab, and atezolizumab with 3-week intervals. The resulting side effects were clearly too intense (fatigue, mouth sores, falling, hair loss, weight loss of 40 pounds), even though I argued that a bit of discomfort and low quality of life for one summer might be tolerable if it meant extended life expectancy. The treatment team felt there wasn't enough benefit out of that plan to warrant continuation at that high of a dosage and that the side effects were too dangerous. We dropped the bevacizumab immunotherapy drug altogether as having the least benefit and cut each of the others back by 20% after the first cycle. Still, even with those changes, it was a rough ride throughout the summer struggling with side effects, much of that time spent prone in bed and a few spells of dizziness and falling that resulted in injuries.

I had my last cycle of carboplatin in mid-August and we continued with the immunotherapy alone every three weeks. We ran a PET scan at the beginning of September that showed definite disease progression. Not good. Dr. H described the treatment and results this way: "As soon as we took the foot off the gas pedal with chemotherapy, the cancer came roaring back even though we continued with immunotherapy." We radiated a new lesion in the right sixth rib that had caused another pathological fracture and I was in a good deal of pain at that point, both with the rib, the prior humerus implant from summer, and with a sacral fracture from a fall during summer. The radiation was successful, as well as focused radiation to a brain lesion that had popped up on the PET scan. The brain metastasis was completely eliminated and the rib metastasis was halted and receded and began to heal. But there was also a newly inflamed spot on my left supraclavicular lymph node near my neck and shoulder. The Corewell team advised me to seek further experimental treatment at the University of Michigan. 

I was able to enroll in a Phase 3 study at the University of Michigan on Keytruda, but unfortunately was randomized into the Standard of Care control group (Docetaxel with Ramucirumab), so I don't know that the change really impacted anything other than delaying treatment by a couple of weeks. The experience in Ann Arbor was relatively unpleasant with the clinical environment. I was able to complete 3 cycles of chemotherapy there with docetaxel before a CT scan showed disease progression in my right kidney and I was able to transfer treatment to Northwestern Hospital Cancer Center in Chicago. 

Northwestern has been a remarkable experience. They are a highly ranked cancer center, both in the US and globally, and it shows. The oncologist and palliative care doctor and the pharmacist work closely together, often in the same room at the same time, and have been highly responsive through the portal and in person. Despite their best efforts, though, after a cycle of Gemcitabine, there was disease progression in my right kidney. But the source of my pain was elsewhere -- the lower back, the midback, and the left shoulder. The CT scan of my left shoulder showed metastatic material in my supra-sacral lymph node that the University of Michigan had picked up on (though they didn't seem worried about it), and indeed, there were signs of trouble in that spot showing up on CT scans going back to September. So now we're focusing on radiating that spot to halt the growth and relieve some of that pain.