S1Ep7 Immunotherapy Trial: No Regrets

Welcome to the seventh episode of Care Partner's Compass: Navigating CRC where I talk about my wife Kristine's very recent immunotherapy trial and all that it entailed.

This is the first episode where I talk about something that is so recent (spoiler alert, she exited the trial officially this weekend). So I don't have the benefit of time and other experiences for comparison. It's still very fresh, and upsetting. But, that's how stage 4 cancer works. As a care partner, you make sure that your loved one has all the information that they need to make an informed decision, and then back them up and care for them.

Cancer is hard. And change is hard. But having options is everything. We just need a lot more of them. Hence, trials. There will be a future episode on how to find trustworthy information, and also how to search for trials.

Full transcription can be found on the website (http://carepartnerscompass.transistor.fm)

Host, producer/editor, and composer: Elsa Lankford

Kristine - I know this was difficult. But I know that the immunotherapy and chemo are going to work together to kick some cancer butt.

Please remember to share, subscribe, like, and rate the podcast.

Helpful links related to this episode:

• ClinicalTrials.gov - this lists clinical trials not just in the United States, but many international trials as well.
• Fight CRC Clinical Trial Finder - a very helpful set of trials just for CRC with some commentary. You can include in your search if trials allow previous immunotherapy.
• No Regrets Spotify music playlist - Kristine creates a new dance playlist for each new chapter, including this one as she goes back to chemo. This is her newest playlist, that we danced to today during her chemo infusion. 

• (01:32) - Leading up to the trial
• (02:33) - MRD Trials - Minimal Residual Disease
• (03:25) - Immunotherapy and MSS CRC - getting there, but still a ways to go (mainly through trials)
• (04:41) - Getting the call to be on the trial
• (05:55) - Why this Phase1B trial was a good idea for Kristine
• (06:58) - Starting the trial - paperwork and plenty of eyes on the case
• (07:47) - Allergic reaction and Benadryl to the rescue
• (09:01) - Trial side effects - even one good one
• (10:46) - We need more info for Stage 4 MSS CRC, especially for immunotherapy trials
• (11:39) - Why it is so tricky to know when/if immunotherapy is working
• (13:43) - Getting as much information as possible, even if it says things you don't want it to
• (14:25) - Being a care partner when your loved one is doing a clinical trial
• (17:05) - Being optimistic and realistic when there's yet another pivot

Creators & Guests

Host

Elsa Lankford

I'm the host of Care Partner's Compass: Navigating CRC, a patient advocate for colorectal cancer, and a care partner to my incredible wife Kristine. I am an artist, composer, educator, and podcaster. I'm a professor in the Electronic Media and Film Department at Towson University.

What is Care Partners Compass: Navigating CRC?

A podcast for care partners, cancer patients, and anybody who knows or loves somebody with cancer, particularly colorectal cancer (CRC). Care Partners Compass is told through the lens of a Stage 4 CRC care partner with occasional guests.

Season 1 will be primarily from my personal experience as a stage 4 CRC care partner. Topics will include diagnosis, biomarkers, clinical trials, second opinions, finding hope and joy, and more.

The podcast trailer is out now. Please listen and share widely.

Logo design: Kristine Dunkerton

Episodes will be dropping in March 2024 - Colorectal Cancer Awareness Month.

If you are 45 and older, or are any age and are experiencing anemia, unexplained weight loss, or other symptoms, please schedule your colonoscopy.

Disclaimer:
This podcast and its content is for entertainment purposes only. The views and opinions expressed by any hosts or guests on this podcast are their own personal opinions.

Reference to any specific product or entity does not constitute an endorsement or recommendation.

This podcast does not contain medical or legal advice. Please consult your medical professional about any medical questions or concerns.

S1Ep7 Immunotherapy Trial: No Regrets
Elsa Lankford

Elsa 0:01
Welcome to Care Partners Compass Navigating CRC. My name is Elsa Lankford. I am the care partner to my incredible wife, Kristine, who has stage four colorectal cancer. As a disclaimer, this podcast and its content is for entertainment purposes only. The views and opinions expressed by any hosts or guests on this podcast are their own personal opinions. Reference to any specific product or entity does not constitute an endorsement or recommendation. This podcast does not contain medical or legal advice. Please consult your medical professional about any medical questions or concerns.

Elsa 0:47
As I had said in one of the earlier episodes, this podcast is not going to necessarily happen in chronological order. What I've done so far is topics have been in the past. There's been time to heal, time to gain, knowledge. But not this time. This is going to be fresh and something that just happened. This episode is going to be on trials from the viewpoint of a stage four care partner, which is me. I'm going to talk about the trial that my wife Kristine was on that she exited this past week. I'm going to talk about the benefits, the concerns and why trials are so important, especially for stage four CRC. But where I'm going to start is how this trial came about for Kristine.

------ Leading up to the trial ------ 1:33

Elsa 1:34
Kristine had been Ned NED no evidence of disease after protons. That was in December 2022. Bu her CTDNA, which is the little bit of tumor in the blood, was not zero and it was going up. She had a clean scan in January of 2023. But because of the CT DNA number going up, she had an earlier scan that showed that her ovary was enlarged. ten days later it was removed. In February 20, 23, But it had ruptured just before the surgery. she went back to chemo. S had six rounds. Her numbers were normal, clean scans. but because she had had some recurrences before she went to Xeloda, which is

2:32
5FU in pill form.

------ MRD Trials - Minimal Residual Disease ------ 2:33

Elsa 2:33
We looked into MRD, which is minimal residual disease trials, including one in Houston. We've been looking for trials for a while. And the frustrating thing that I found with trials and stage four is that for some trials, she had too much cancer. other trials, she had too little. it turned out that the MRD trial was not possible. And she had an iffy scan. In November of 2023. So her oncologist mentioned that if something did grow, depending on where it was and how much growth that there'd really be kind of two main choices. And that would be back to chemo or this promising immunotherapy trial.

------ Immunotherapy and MSS CRC - getting there, but still a ways to go (mainly through trials) ------ 3:26

Elsa 3:26
With microsatellite stable MSS stage 4 colorectal cancer. Immunotherapy is really only possible through a trial. What immunotherapy means is that you are in some way utilizing the body's immune system to fight against the cancer. Chemo destroys anything that's quick growing. This is a way to get the body to learn what to go after. There's something called cold and hot tumors MSS CRC. It's considered a cold tumor. The immune system doesn't recognize it as foreign Or there's something about the tumor, what scientists call the tumor microenvironment that's creating a barrier that just doesn't let the immune system in.

4:23
So it turned out that she had more growth in the scan in January 2024, just enough for this trial to be possible. That meant that she had at least one tumor that was over a centimeter and it was just over a centimeter.

------ Getting the call to be on the trial ------ 4:42

Elsa 4:42
Her scan results came in and like 15 minutes later, her oncologist called to ask if she wanted the last spot in this trial. even though this was something new, she went for it and signed up for the trial. This particular trial used an existing immunotherapy drug called pembrolizumab or pembro or KEYTRUDA. You've probably seen a TV ad for it if you live in the US or Australia. The only two countries that allow pharmaceutical advertisements The trial has an experimental drug that is hopefully breaking down the walls around the tumor and allowing the pembrolizumab to aid the immune cells to get into the tumor. The trial didn't allow people that had liver mets, but Kristine hadn't had liver mets since September of 2022 in the past, Kristine had been very wary of a phase one trial, phase one trial means that a new drug is being experimented with.

------ Why this Phase1B trial was a good idea for Kristine ------ 5:55

Elsa 5:55
In this case, it was a phase one B trial, and that meant that the drug had already gone through a phase one trial. So people had had this drug before and it was considered relatively safe. The pembro has been used and thousands of people all across different cancers. So they already knew what the safety profile was for that.

6:23
Kristine had had multiple recurrences in the past, and the thought was that she had chemo resistant cancer cells in her body. chemo would be very effective with tumors. But there would still be these cells left that could create new tumors. That's why we'd been searching for immunotherapy and vaccine trials for so long. And why this opportunity to not just be an immunotherapy trial, but at her cancer center and with her oncologist, it seemed like a no brainer.

------ Starting the trial - paperwork and plenty of eyes on the case ------ 6:59

Elsa 6:59
When your loved one starts a trial, there's a lot of paperwork have to go through what all the possible side effects are. There's going to be a lot of bloodwork, both for the cancer center and also for the drug company, depending on who is running the trial, if it's a drug company or if it's run through an NCI center directly. But what this means is that there's a lot of eyeballs. they are checking for side effects and getting an early jump on them. The first time that she had the drug infusion. since it's at her cancer center, it's in the same infusion rooms with the same oncology nurses.

------ Allergic reaction and Benadryl to the rescue ------ 7:48

Elsa 7:48
So the first time she started the drug, like ten or 13 minutes in, she started to cough a little bit as she was talking and then had a scratchy throat. The oncology nurse immediately stopped the infusion. They got an on call doctor down and gave her Benadryl through her port. That made her immediately very sleepy, but stopped the allergic reaction and both infusions went fine. The way this trial worked was it was a six week cycle with infusions every two weeks. That meant on the first day of the cycle, she would get pembrolizumab have a half hour observation, get the experimental drug, and then in the beginning have a two hour observation. this was to make sure that there were no allergic reactions or side effects, that they had medical personnel there just in case. So after that first allergic reaction, it was determined that she would get Benadryl before each pembrolizumab infusion. So every six weeks she would get some Benadryl before the infusion.

------ Trial side effects - even one good one ------ 9:01

Elsa 9:01
That next day, she said multiple times how good she felt in terms of the chemo fog from the 28 past infused chemo that she'd had and the ten rounds of chemo pills that that chemo fog had lifted. So she actually had a good side effect on this trial. She also had a couple other side effects that came up through the trial that involved bringing other doctors into the team. She had some arthritis in her back that got pinged by the immunotherapy. So that needed to have another doctor on the team to give her some medicine, which did take care of that. After a month and then her blood sugar really went up. So and she was having thyroid issues, losing weight, her heart rate went up. So an endocrinologist ended up being involved. Also.

10:02
The next infusion two weeks later with just the experimental drug went fine the following week with just the experimental drug. She had an allergic reaction after the infusion was done. She started to get cold. I ran to get the nurse and by that point she was starting to shake from the cold. They gave her blankets. They gave her hot packs. But what really did it was more Benadryl. So while she was in the trial, she'd have Benadryl and Tylenol before each infusion, which did make her drowsy. But she had no other allergic reactions to the three months that she was on the trial.

------ We need more info for Stage 4 MSS CRC, especially for immunotherapy trials ------ 10:47

Elsa 10:47
there is a lot that is needed for stage four CRC, and that includes more information, more options and more chances to get immunotherapy and vaccines through trials or otherwise. There's only a few ways to get information about what the cancer is doing. The CEA, the CTDNA and scans

11:17
her CEA through this trial was going up. Although it wasn't measured every infusion, it was going up. Her ctdna had not been taken for three months prior. That was up

11:33
her first scan. There was more cancer and everything was bigger.

------ Why it is so tricky to know when/if immunotherapy is working ------ 11:40

Elsa 11:40
And this is where it gets tricky

11:43
because there's something called pseudo progression that is only seen with immunotherapy

11:50
in terms of what these trials are looking for and what patients are trying to get out of trials ranges from a complete response to progression. So complete response means that the tumor that they're looking at is gone.

12:09
Partial response means that the tumor that they're looking at is at least 20% smaller.

12:18
Stable means that maybe the tumor got a little smaller, maybe got a little bigger, maybe it's the same size, but it's within 20% bigger or smaller. And then there's progression, which is when it's over 20% bigger. But then there's this other thing just to be confusing called pseudo progression, which doesn't happen all the time, but that means that it looks like the tumors are bigger because the immune cells have gotten into the tumor and they're working on it from the inside out and it's expanded the size. T doesn't always happen, but it means that the first scan things might be bigger CEA The tumor marker might be higher because there's inflammation. But then by, after some amount of time, usually the second scan, things have gotten smaller. It's like you if you think of, a line graph and think of it being like a like a mountain going up and then down. So when we got this scan that showed that there was more cancer and it was bigger. Kristine wanted to continue on the trial. We didn't know if it was pseudo progression or not. So we had a couple of options. And what we decided to do was get as much information as possible.

------ Getting as much information as possible, even if it says things you don't want it to ------ 13:44

Elsa 13:44
So that involved getting a biopsy, which the drug company needed. And her cancer center also got some samples to look for immune cells in the tumor. And there was that took some time, but there was But her CEA also went up again. it was decided that she would do a second scan and that would determine if if things were bigger, she would stop doing the trial and switched to chemo. Things were bigger By the time this podcast comes out, she'll have started back up on it. hopefully the chemo works even better now that she's had immunotherapy.

------ Being a care partner when your loved one is doing a clinical trial ------ 14:26

Elsa 14:26
So in terms of as a stage four care partner, I was very excited that Kristine had this opportunity and was interested in the opportunity to do immunotherapy. I did make sure, like with each infusion that I stayed in the room because these are these are new drugs for her and the experimental drug, even though other people had had it before, I think it was less than 100 people.

14:58
So there's definitely just like everything else in cancer land, some helplessness about, you know, I'm going to stay in this room with you even though I can't do anything, but I can run and get a nurse. I can get somebody that can help you

15:15
So in this case, it is unclear what the trial did. I do think that it revved up her immune system and I do think that it's going to help in the long run. And in the short run stage 4 CRC patients and oncologists that work with stage four CRC patients tend to think of trials as a last resort. After all the lines of chemo have been used up. Then do a trial. I would like to offer a different opinion and I think the trials are incredibly important. The only way that CRC patients of any stage get new treatments is through trials. There can be a risk in that your loved one may not be doing a safer bet, but please think about and discuss the fact that those safer bets lines of chemo can be done after a trial. Al, if it didn't work out, I'm going to do another episode on researching for trials and I'm sure I'll talk about trials more just because this trial may not have Kristine may not have had a, you know, complete or partial response. I, as a care partner, have been keeping tabs on other possible trials

16:56
because the trial isn't chemo. A trial has the chance to offer something that chemo doesn't.

------ Being optimistic and realistic when there's yet another pivot ------ 17:05

Elsa 17:05
And I guess this episode is perhaps highlighting the optimism that still resides within me.

17:19
But there are so many trials that are out there. And as we know, there are not enough options for people with stage four CRC. The options are the trials. The more people that get into these trials, the faster that you know, if they're successful, they will become real options.

17:43
When it's time to pivot because this involved pivots in multiple places or it's time to think about what could be next. Thinking ahead, Keeping in mind that there are ways to go after the cancer, but there's also quality of life.

18:09
And what I truly appreciate from this is that Kristine felt really good on this trial. Despite the side effects that she did have, she felt really good.

18:26
I am really struck by some words that Kristine said just a couple of days ago when she was confirming with her oncologist that she was going to be off the trial.

18:40
And that is that she said that she had no regrets.

Narration 18:53
Thank you for joining me for this episode of Care Partners Compass: Navigating CRC. Please listen up for the next episode, which will come out next week. If you subscribe to the podcast on your favorite podcast app, you will know exactly when the next episode comes out.I hope that you'll share the podcast with your friends and family. The transcript of Care Partners Compass: Navigating CRC and additional links can be found on our website

19:28
Carepartnerscompass.

19:30
transistor.