Trial #3: TAS-120
Hi. It's been forever - I know. And I'm sorry. 3 months is a long time when you've been counting time like I have been. And yet it goes by much faster than I'd like it to. In a blink it feels like Christmas is over and the new year is only a couple days away - which is actually what's true. Christmas is over and New Year's is literally 2 days from now.
In the last 3 months - I've managed to officially get myself into a new trial. Last post I was lamenting about how my tumor markers were starting to climb on the last treatment line (Eribulin and Herceptin). I had scans in mid-October and sure enough - there was progression and EL CANCER has yet again found a way around the chemo. There was new growth in the existing tumors in my liver and lung and new activity in my bones. My bones have been relatively quiet the last couple years, so to continue to see activity throughout 2018 is frustrating. It's like some imaginary control that starts to slip ... like if I can just keep it contained to my liver and right lung ... then it's not so bad - it's not "spreading" ... when in reality ... I can't keep it from doing anything ... and in my liver and lung really is bad.
Currently I've got a (roughly) 4 inch tumor in my liver, in addition to a few other (3 or so) couple-inch ones taking up space in there as well. From what I can tell - I don't have a "swollen" liver - but it feels tight when I press on the area and sometimes it feels sore. In my lung, despite the removal of a larger tumor with the piece of my lung, I have some other ones that are collected near the inner, center edge of my right lung and potentially something close to my heart. I have a lymph node just under my right clavicle that evidently has cancer cells growing there - which is where I've had my most recent biopsy. So yeah ... contained to "just" my liver and lung is not so good. Contained to "just" my bones would be better right now. But that's not my reality.
What's real is that I've finally manged to get to the step in a clinical trial where you ACTUALLY get the medicine. It's a pre-Christmas miracle. If you recall, I've been looking at clinical trials since stage 4 diagnosis. At that time, it was a sister drug to Ibrance (which was my first-line). But Ibrance had just been approved, so I went with what was a guarantee that I'd get the medicine and not a chance at the medicine in the trial scene. (So we'll call that trial zero - as I didn't even consider it).
Next was the NCI MATCH trial (trial #1). I went in for a biopsy for that based on my FoundationOne genomic mutation report. I was trying to get into the arm of the trial that targeted the FGFR2 amplification that I had. That biopsy revealed two things - first, the FGFR2 amplication was absent in that sample and thus I wasn't eligible for the trial, and two - I had a totally different colony of hormone negative, Her2 positive cancer that had taken up residence in my liver. Talk about a surprise.
Clinical trial #2 was the TIL trial, also with the National Cancer Institute, but this time in Bethesda, MD. This was the one where I went in for surgery, they removed a part of my lung with the tumor, collected my lymphocytes and under the microscope tested the reactivity of the lymphocytes against the cancer cells to see if they would naturally attack. They didn't. Trial over. But hey - they removed a tumor and fixed the plueral effusion I was having that was serially collapsing my right lung. So - not all bad I guess, but still kinda bad. It showed that - for whatever reason - my own immune cells didn't see anything wrong with the cancer cells.
Clinical trial #3: TAS-120. This is where we are today. I was screened, scanned, biopsied, worked up in labs, sent to the ER, and FINALLY - was admitted in. I took the first dose of the new trial medication (TAS-120 is what the medicine is called) on 11/21, the day before Thanksgiving. So call it a Thanksgiving miracle I guess.
When I talk about the available treatments that are out there for metastatic breast cancer patients - and I say that the list of treatments we have is not infinite, that it is in fact quite short, and that the farther down the list of treatments you get, the less effective they become - "people" say well there's always clinical trials right?!
Wrong.
I GET it. (Have I gone down this rant already? I feel like I may have. I apologize if I have. But it bears repeating I guess so I will continue.) I get it. "People" are trying to be optimistic and are trying to help and are searching for something positive and hopeful to say in response to news that is really grim. It's a programmed response I feel like to the news that someone is likely to die from cancer (breast cancer no less) and there isn't anything to prevent it (when the insanely, incorrect, pink message for 40 years has been the opposite - that breast cancer can be cured). So yes - I understand the perhaps "this will fix it" response. But clinical trials are not easy to get in to. They're really hard.
And by design - clinical trials are meant to very strict so as to generate accurate data. Getting in isn't willy-nilly. Getting in isn't guaranteed. You have to have the right kind of "cancer of origin" (breast, lung, colon, blood, etc.), you can/cannot have X number of treatments to be considered, you can/cannot have any metastasis of the cancer to your brain, you can/cannot have had a certain medication already, you can/cannot have your liver/kidney/other organ function at a certain level above normal ... and the inclusion/exclusion list goes on and on and on. The circumstances of getting in have to align like the stars.
OH - and the trial you want to get in to - may or may not be within driving distance to you. Not all clinical trials are located at ever cancer treatment center/hospital. You (most often) have to find trials on your own (nationwide), and then figure out how to get there (cost, child care, leave from work, travel, lodging, etc.) They don't pay for anything until you are officially accepted into the trial. They don't even pay for you to come out and be evaluated for the trial to see if you can get in - that's on you.
OH - and even if you can meet all the criteria and afford to be where the trial is ... the trial has to have space for you. Yeah - they limit the number of participants as well. So there's not always an opening that aligns with an opening in your treatment regiment (which is usually when a treatment fails, which is unpredictable).
It's harder than forcing the stars to align.
So - I'm eternally grateful for the chance of being admitted into this trial, to see if TAS-120 will even work. TAS-120 is an FGFR inhibitor. FGFR is "fibrogrowth factor receptor." Similar to how the cancer cells are/were (who knows) feeding off of estrogen and progesterone in my blood, it can also feed off the fibrogrowth factor in my blood. The receptors are the "mouths" if you will - gobbling up the FGF in my blood. Who knows which is the primary driver of the cancer - the estrogen/hormones, the Her2, the FGFR, or something else entirely ... all we know is that when tested - my EL CANCER cells have an amplification of FGF receptors. Specifically FGFR2. Additionally, my EL CANCER cells have FGFR2 rearrangement as well as FGFR1 amplification. (The numbers are like - just different kinds of "mouths").
SO - the TAS-120 trial is in phase 1 expansion, which has shown promise against bile duct cancer - which is a notoriously difficult to treat cancer. It was first tried in bile duct cancer in phase 1 dose escalation, and then "expanded" to other solid tumors with the FGFR2 alteration specifically.
Enter me.
Perhaps I wasn't meant to get into the NCI MATCH trial where I was trying to target FGFR2. Perhaps I was set on that path to identify the Her2 positive cells, which opened up additional treatment options for me ... making a short list of treatments, just a tiny bit longer. Maybe I was meant to be on this trial that's going after FGFR2 with "one of the most promising FGFR inhibitors in trials to date." Maybe it's working and the scans that I had this past Friday and Saturday will show - at minimum - stability in the disease.
I've been on the medication for 42 days. Each cycle is 21 days and at the end of each cycle, and a couple times in between, I have to drive out to Houston for lab tests, protocol exams, meetings with the doctor, picking up more medication, etc. During these past 42 days - I honestly can't tell if the medication is working. All I know is I've been in for blood tests of my phosphorus level almost every 3 days and each time I go in for blood work, I get a call that I need to take more of the phosphorus binder medication that I'm also on. Elevated phosphorus is one of the side effects of this medication. Sustained elevated phosphorus can pull calcium out of your bones and weaken your bones, among other things. So in addition to the actual cancer medication, I'm on a lot of phosphorus binder. I try to watch what I eat and eat low phosphorus foods but honestly ... everything has phosphorus in it ... except sugar. And while I'd LOVE to live on just cocoa puffs and starburst ... Ican't shouldn't.
Aside from the elevated phosphorus ... super duper dryness, thinning hair, nausea (from the phos binders) and noticeable fatigue are my big side effects right now. A bonus side effect is long eyelashes. I know! Random. I'll take it though. Overall the quality of life on this medicine isn't terrible. I am tired though. And about 3 or 4 pm, it starts to set in like a battery running down. I'm hopeful that after the holiday break when things get back to a normal schedule, I can catch a mid-day nap and hopefully offset the evening fatigue a little so I can be a non-grumpy nighttime mommy.
And if you picked it up earlier - yes, I've been driving back and forth to Houston a few times a month the last two months. Sometimes with Mike when he can make it, most often just on my own and sometimes overnight. We just got back actually from our most recent trip. It was the scan trip. We're 6 weeks in and just like any other treatment, after the first 6 weeks - we scan to check for efficacy. This time however I won't likely get my scan results until 1/2/19. MDA doesn't release scans as easily as my local Austin imaging center does (meaning there isn't a front desk that I canbully pester to release my results the same day ... at least I haven't found it ... yet).
So here we are. I'm trying not to make myself crazy waiting for my upcoming doctor's appointment to discuss results. I did email my doctor already and ask her to release them before the appointment. My rationale was - if they're bad - I need time to process those emotions ahead of time. Because in a 20-30 minute appointment, you can't expect me to process the emotions that come with bad results AND pay attention to, or retain, anything else you tell me after that related to next steps. I just can't. I'm only so amazing. So we'll see. She's without access to patient records and will try as soon as she can she said.
I'm trying not to jump to conclusions that perhaps the medicine is working like gangbusters because we've had such a time trying to keep my phosphorus low ... maybe that's an indicator that my body is processing the medicine really, really well and it means good things. I'm trying not to think this new weird lump I found on my back near my ribcage is anything except a weird lump that will just go away and NOT a new lymph node with cancer in it - like the one in my clavicle ... that they biopsied ... with just local anesthesia ... so I was awake ... so I heard each "click" of the tool that snapped up a core sample of cancer from my neck ... 8 clicks ... as I partially saw the top of the doctor's hand, his knuckles ... every time he went in for a sample. My head was turned to the left, my face was partially draped so I had limited vision out of my right eye ... I could hear, see and smell everything going on in the sterile, white surgery room as the doctor, nurses, techs, etc ... fell into their procedure rhythm that usually happens when a patient is sedated or unconscious ... their "daily work conversations" that are had in that kind of environment. It was surreal ... so surreal.
Purely by accident I managed to make it through Nicholas' 3rd birthday without the morbid thought that I may not get to see him turn 4 ... that I might not be physically capable of making his 4th birthday cake. It hit me the day after. I realized that I didn't think about it once that day - unintended. It was a nice feeling. I was grateful to have a day that important not tainted by cancer. It was a gift.
This Christmas I've been wishing people a "holiday as meaningful to them as meaningful as this holiday is to me." For those that know what's going on - I assume they understand that what I'm saying is treasure this holiday as if it were your last, because that's what I'm doing ... because that's what I'm facing. It very well could be my last Christmas season. And again ... it hit me later that day. After the chaos that is Christmas morning, after presents and cinnamon rolls, and paper and boxes and new toys, and fights over new toys, and playing outside on new toys, and assembling new toys, and reading new books ... I sat frozen for a moment thinking to myself, on the floor, next to the tree ... it was a good Christmas. And it was bitter sweet ... because it was good - and I don't want it to be my last.
And so we wait until the new year to find out if this is working ... or maybe 12/31 ... to get a glimpse of whether or not it's working before I "officially" meet with the doctors. And truthfully - I'm terrified. Part of me doesn't want to even see the results because can't we just pretend? If I don't know the results then - at least for a little while - I can pretend all will stay the same. And at least for a little while ... I'm still around.
In the last 3 months - I've managed to officially get myself into a new trial. Last post I was lamenting about how my tumor markers were starting to climb on the last treatment line (Eribulin and Herceptin). I had scans in mid-October and sure enough - there was progression and EL CANCER has yet again found a way around the chemo. There was new growth in the existing tumors in my liver and lung and new activity in my bones. My bones have been relatively quiet the last couple years, so to continue to see activity throughout 2018 is frustrating. It's like some imaginary control that starts to slip ... like if I can just keep it contained to my liver and right lung ... then it's not so bad - it's not "spreading" ... when in reality ... I can't keep it from doing anything ... and in my liver and lung really is bad.
Currently I've got a (roughly) 4 inch tumor in my liver, in addition to a few other (3 or so) couple-inch ones taking up space in there as well. From what I can tell - I don't have a "swollen" liver - but it feels tight when I press on the area and sometimes it feels sore. In my lung, despite the removal of a larger tumor with the piece of my lung, I have some other ones that are collected near the inner, center edge of my right lung and potentially something close to my heart. I have a lymph node just under my right clavicle that evidently has cancer cells growing there - which is where I've had my most recent biopsy. So yeah ... contained to "just" my liver and lung is not so good. Contained to "just" my bones would be better right now. But that's not my reality.
What's real is that I've finally manged to get to the step in a clinical trial where you ACTUALLY get the medicine. It's a pre-Christmas miracle. If you recall, I've been looking at clinical trials since stage 4 diagnosis. At that time, it was a sister drug to Ibrance (which was my first-line). But Ibrance had just been approved, so I went with what was a guarantee that I'd get the medicine and not a chance at the medicine in the trial scene. (So we'll call that trial zero - as I didn't even consider it).
Next was the NCI MATCH trial (trial #1). I went in for a biopsy for that based on my FoundationOne genomic mutation report. I was trying to get into the arm of the trial that targeted the FGFR2 amplification that I had. That biopsy revealed two things - first, the FGFR2 amplication was absent in that sample and thus I wasn't eligible for the trial, and two - I had a totally different colony of hormone negative, Her2 positive cancer that had taken up residence in my liver. Talk about a surprise.
Clinical trial #2 was the TIL trial, also with the National Cancer Institute, but this time in Bethesda, MD. This was the one where I went in for surgery, they removed a part of my lung with the tumor, collected my lymphocytes and under the microscope tested the reactivity of the lymphocytes against the cancer cells to see if they would naturally attack. They didn't. Trial over. But hey - they removed a tumor and fixed the plueral effusion I was having that was serially collapsing my right lung. So - not all bad I guess, but still kinda bad. It showed that - for whatever reason - my own immune cells didn't see anything wrong with the cancer cells.
Clinical trial #3: TAS-120. This is where we are today. I was screened, scanned, biopsied, worked up in labs, sent to the ER, and FINALLY - was admitted in. I took the first dose of the new trial medication (TAS-120 is what the medicine is called) on 11/21, the day before Thanksgiving. So call it a Thanksgiving miracle I guess.
When I talk about the available treatments that are out there for metastatic breast cancer patients - and I say that the list of treatments we have is not infinite, that it is in fact quite short, and that the farther down the list of treatments you get, the less effective they become - "people" say well there's always clinical trials right?!
Wrong.
I GET it. (Have I gone down this rant already? I feel like I may have. I apologize if I have. But it bears repeating I guess so I will continue.) I get it. "People" are trying to be optimistic and are trying to help and are searching for something positive and hopeful to say in response to news that is really grim. It's a programmed response I feel like to the news that someone is likely to die from cancer (breast cancer no less) and there isn't anything to prevent it (when the insanely, incorrect, pink message for 40 years has been the opposite - that breast cancer can be cured). So yes - I understand the perhaps "this will fix it" response. But clinical trials are not easy to get in to. They're really hard.
And by design - clinical trials are meant to very strict so as to generate accurate data. Getting in isn't willy-nilly. Getting in isn't guaranteed. You have to have the right kind of "cancer of origin" (breast, lung, colon, blood, etc.), you can/cannot have X number of treatments to be considered, you can/cannot have any metastasis of the cancer to your brain, you can/cannot have had a certain medication already, you can/cannot have your liver/kidney/other organ function at a certain level above normal ... and the inclusion/exclusion list goes on and on and on. The circumstances of getting in have to align like the stars.
OH - and the trial you want to get in to - may or may not be within driving distance to you. Not all clinical trials are located at ever cancer treatment center/hospital. You (most often) have to find trials on your own (nationwide), and then figure out how to get there (cost, child care, leave from work, travel, lodging, etc.) They don't pay for anything until you are officially accepted into the trial. They don't even pay for you to come out and be evaluated for the trial to see if you can get in - that's on you.
OH - and even if you can meet all the criteria and afford to be where the trial is ... the trial has to have space for you. Yeah - they limit the number of participants as well. So there's not always an opening that aligns with an opening in your treatment regiment (which is usually when a treatment fails, which is unpredictable).
It's harder than forcing the stars to align.
So - I'm eternally grateful for the chance of being admitted into this trial, to see if TAS-120 will even work. TAS-120 is an FGFR inhibitor. FGFR is "fibrogrowth factor receptor." Similar to how the cancer cells are/were (who knows) feeding off of estrogen and progesterone in my blood, it can also feed off the fibrogrowth factor in my blood. The receptors are the "mouths" if you will - gobbling up the FGF in my blood. Who knows which is the primary driver of the cancer - the estrogen/hormones, the Her2, the FGFR, or something else entirely ... all we know is that when tested - my EL CANCER cells have an amplification of FGF receptors. Specifically FGFR2. Additionally, my EL CANCER cells have FGFR2 rearrangement as well as FGFR1 amplification. (The numbers are like - just different kinds of "mouths").
SO - the TAS-120 trial is in phase 1 expansion, which has shown promise against bile duct cancer - which is a notoriously difficult to treat cancer. It was first tried in bile duct cancer in phase 1 dose escalation, and then "expanded" to other solid tumors with the FGFR2 alteration specifically.
Enter me.
Perhaps I wasn't meant to get into the NCI MATCH trial where I was trying to target FGFR2. Perhaps I was set on that path to identify the Her2 positive cells, which opened up additional treatment options for me ... making a short list of treatments, just a tiny bit longer. Maybe I was meant to be on this trial that's going after FGFR2 with "one of the most promising FGFR inhibitors in trials to date." Maybe it's working and the scans that I had this past Friday and Saturday will show - at minimum - stability in the disease.
I've been on the medication for 42 days. Each cycle is 21 days and at the end of each cycle, and a couple times in between, I have to drive out to Houston for lab tests, protocol exams, meetings with the doctor, picking up more medication, etc. During these past 42 days - I honestly can't tell if the medication is working. All I know is I've been in for blood tests of my phosphorus level almost every 3 days and each time I go in for blood work, I get a call that I need to take more of the phosphorus binder medication that I'm also on. Elevated phosphorus is one of the side effects of this medication. Sustained elevated phosphorus can pull calcium out of your bones and weaken your bones, among other things. So in addition to the actual cancer medication, I'm on a lot of phosphorus binder. I try to watch what I eat and eat low phosphorus foods but honestly ... everything has phosphorus in it ... except sugar. And while I'd LOVE to live on just cocoa puffs and starburst ... I
Aside from the elevated phosphorus ... super duper dryness, thinning hair, nausea (from the phos binders) and noticeable fatigue are my big side effects right now. A bonus side effect is long eyelashes. I know! Random. I'll take it though. Overall the quality of life on this medicine isn't terrible. I am tired though. And about 3 or 4 pm, it starts to set in like a battery running down. I'm hopeful that after the holiday break when things get back to a normal schedule, I can catch a mid-day nap and hopefully offset the evening fatigue a little so I can be a non-grumpy nighttime mommy.
And if you picked it up earlier - yes, I've been driving back and forth to Houston a few times a month the last two months. Sometimes with Mike when he can make it, most often just on my own and sometimes overnight. We just got back actually from our most recent trip. It was the scan trip. We're 6 weeks in and just like any other treatment, after the first 6 weeks - we scan to check for efficacy. This time however I won't likely get my scan results until 1/2/19. MDA doesn't release scans as easily as my local Austin imaging center does (meaning there isn't a front desk that I can
So here we are. I'm trying not to make myself crazy waiting for my upcoming doctor's appointment to discuss results. I did email my doctor already and ask her to release them before the appointment. My rationale was - if they're bad - I need time to process those emotions ahead of time. Because in a 20-30 minute appointment, you can't expect me to process the emotions that come with bad results AND pay attention to, or retain, anything else you tell me after that related to next steps. I just can't. I'm only so amazing. So we'll see. She's without access to patient records and will try as soon as she can she said.
I'm trying not to jump to conclusions that perhaps the medicine is working like gangbusters because we've had such a time trying to keep my phosphorus low ... maybe that's an indicator that my body is processing the medicine really, really well and it means good things. I'm trying not to think this new weird lump I found on my back near my ribcage is anything except a weird lump that will just go away and NOT a new lymph node with cancer in it - like the one in my clavicle ... that they biopsied ... with just local anesthesia ... so I was awake ... so I heard each "click" of the tool that snapped up a core sample of cancer from my neck ... 8 clicks ... as I partially saw the top of the doctor's hand, his knuckles ... every time he went in for a sample. My head was turned to the left, my face was partially draped so I had limited vision out of my right eye ... I could hear, see and smell everything going on in the sterile, white surgery room as the doctor, nurses, techs, etc ... fell into their procedure rhythm that usually happens when a patient is sedated or unconscious ... their "daily work conversations" that are had in that kind of environment. It was surreal ... so surreal.
Purely by accident I managed to make it through Nicholas' 3rd birthday without the morbid thought that I may not get to see him turn 4 ... that I might not be physically capable of making his 4th birthday cake. It hit me the day after. I realized that I didn't think about it once that day - unintended. It was a nice feeling. I was grateful to have a day that important not tainted by cancer. It was a gift.
This Christmas I've been wishing people a "holiday as meaningful to them as meaningful as this holiday is to me." For those that know what's going on - I assume they understand that what I'm saying is treasure this holiday as if it were your last, because that's what I'm doing ... because that's what I'm facing. It very well could be my last Christmas season. And again ... it hit me later that day. After the chaos that is Christmas morning, after presents and cinnamon rolls, and paper and boxes and new toys, and fights over new toys, and playing outside on new toys, and assembling new toys, and reading new books ... I sat frozen for a moment thinking to myself, on the floor, next to the tree ... it was a good Christmas. And it was bitter sweet ... because it was good - and I don't want it to be my last.
And so we wait until the new year to find out if this is working ... or maybe 12/31 ... to get a glimpse of whether or not it's working before I "officially" meet with the doctors. And truthfully - I'm terrified. Part of me doesn't want to even see the results because can't we just pretend? If I don't know the results then - at least for a little while - I can pretend all will stay the same. And at least for a little while ... I'm still around.
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