Are you currently (or have you been) in a Clinical Trial?
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It is great to have a nurse or research team that will assist in navigating the administration of the trials. However, word of caution - they are not doctors nor experts on either the minute details of each trial nor your background. I have had to push back on the research team members at my cancer center on multiple occasions. In one instance, they told me the monthly eye exam required by my trial would need to be covered by my primary insurance. However, I read the trial material and knew it stated the trial would cover it. When I told them it was covered, they disputed me until I told them to check again in the documents. On other occasions, their lack of understanding has resulted in treatment delays for me which is just wrong. I have had to stay on top of them to try minimize the impact of their missteps. My center does some trials and my MO is head of clinical research and is open to bringing new trials that would suit his patients. He came from MSKCC. However, the cancer center does not have the “bench strength” in the clinical trial staff. They don’t have much experience. Very nice and seem interested in doing a good job, just haven’t been trained properly and don’t have the requisite experience.
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NewGardener,
Woo hoo! 16th cycle! That's amazing. I'm towards the end of cycle 8 on Alpelisib+Letrozole and crossing my fingers since I had a small progression on my last scan.
likestobike,
My MO had me start on a double dosage of anithistamines right away, before I started the Alpelisib+Letrozole. A bad skin rash is the most common side effect. She wanted me to take Claritin, but I know that doesn't work for my regular allergies so I convinced her that I needed to take Allegra. Wishing your mom great success on this drug.
Hugs, Susan
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Those of you on Alpelisib have the PI3K mutation, and should know about a recent study
https://www.sciencedaily.com/releases/2019/01/1901...
reporting that Aspirin/NSAID/Celebrex drugs (which inhibit COX-2) improve overall survival, but only for those cancers with a PI3K mutation. So Susan, if you don't already take one of these drugs, they might improve your response to Alpelisib?
Also, there was a report in Lancet Oncology of a successful trial for ovarian cancers that combined PARP injhibitor with PI3K inhibitors - they saw about one-third saw tumors shrink and half stayed on the combo more than six months, with no greater toxicity than they get with Alpelisib alone. That sounds really good, I did not check whether or not they tested each drug alone but these numbers look good- surely they will extend this combo to metastatic breast cancers?
https://www.ncbi.nlm.nih.gov/pubmed/30880072
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Cure-ious thank you so much for all this information. It looks like a number of possibilities might emerge for the future. It sounds more and more likely though that if Ibrance has infact stopped working for me, I will move on to Xeloda or ivy chemo. My cancer did not respond much to chemo (when I was stage 3) except for Halaven where we saw a partial response. This makes me wonder if I'll respond to Xeloda at all..
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No, I have never been on a clinical trial but that is one of the possibilities my new MO mentioned in our first appointment. I think I’ll be lurking on this thread trying to learn a little about them. They all seem so different and so specific for certain types of tumors.
My most recent liver BX pathology said I was 100% + ER, 3% + PR Her2- The report also said something about GATA. My foundation One report said I have ESR1. But she is doing another genomic test on my recent tumor. I don’t know how soon it will come back.
I’m having a PET on April 6 and an appointment on April 11 to discuss results and Treatment options. Ibrance/ Femara failed also AA. She said either Xeloda or Clinical Trial. I have active mets to lung, chest and liver. I also had y90 and my liver mets responded for 18 months I would be very interested to have another one if eligible at some point
I know next to nothing about clinical trials. Except that you have to have a wash out period before you start. I am doing that. No meds in over a month.
If anyone knows anything to help me learn a little more about what to expect that would be helpful. Mine will done at UTSW in Dallas.
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Grannax,
She sounds good- the next big combo is likely to be something being tested in a clinical trial, and if not now, when?! Will be very interested to hear what she suggests...
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BlaineJenner!!
Totally exciting! Today at the AACR meeting in Atlanta they reported on your CAR-T trial using the mesothelin-tracking immune cells at Memorial Sloan Kettering! They don't say how well its working but you can keep us up to date - how great to be among the patients that could make history with this trial!! - here is a write-up:
https://www.dailymail.co.uk/health/article-6869033...
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More from AACR2019. They studied what happens with resistance to PI3K inhibitors. This is an important question, because if you know this, you can add some drug together with the PI3K inhibitor in order to make the treatment last longer.
They identified some mutations that accompany resistant to PI3K drugs, like RB loss was one of them, and then they did a big screen to identify what would kill those cells- and it showed that you want to inhibit MCL1! and there is a drug that can be added, so future trials may include that- so, overall, progress!!
Thanks very much to the StandUp2Cancer team!!!
https://www.cancertherapyadvisor.com/home/news/con...
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Cure-ious,
I'm reading up on this trial and the CAR-T process, so thank you very much for the new information. The Daily Fail got some details wrong - I think. I am not aware of mesothelin expressing patients with solid tumors from the phase 1 trials needing to be on immunosuppressants. Granted, I can only think of three people, of which Judy Perkins is one. The trial she was on had three people with durable remissions, Judy, someone with colorectal cancer, and someone with bile duct cancer.
I do know that they want us to have as little cancer burden as possible before the T-cell infusion, and are very keen to have you go back onto treatment after the T-cell harvest in the six weeks before they infuse the ninja cells back. This is due to the solid tumor conundrum. Keep the mets small so that the T-cells have every possible chance.
When speaking to the trial nurse, I mentioned that one of the nurses in my infusion center had experience doing CAR-T with myeloma patients. He mentioned that they are not seeing the same neurotoxic problems with the solid tumor cohort as with the blood cancer folk. It's probably because they are getting very familiar with how to control the adverse side effects. After the infusion, you have to stay within 2 hours of the trial center, for six weeks, with a caregiver or family member keeping a beady eye on you in case of a cytokine storm or brain silliness.
Speaking of which, I have to get a brain MRI as part of the trial entrance requirements. I have no symptoms, yet I am scared that they will find something. I haven't had scanxiety since the first year I was diagnosed. I always figured it was best to know what was going on, as the ostrich approach never helped anything. But I've never had my head examined before, so fear/worry/doubt/anxiety/stress.
Again, thank you for all your insightful and pertinent information!
Jennifer
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interesting stuff- I have been reading its very uncommon for ER-positive cancers to express mesothelin, but I cannot find data indicating whether its is more commonly over-expressed at later stages of MBC, ie could mesothelin expression get upregulated as cancer cells mutate to escape drugs? Or is it just fortuitous that you have mesothelin expression and therefore can be helped by this approach? Also I see there is CAR-T for HER2 positive MBC, including a trial at City of Hope for HER2-positive MBC brain mets. They are looking for other proteins that might be used to target CAR-T, and I would think CD47 might be useful..
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Thanks Cure-ious and Jennifer for sharing information on the CAR-T trial!
I also looked for the frequency of mesothelin expression in ER+ breast cancer, but didn't find any data. I did read in an earlier MSK presentation that 35% of triple negative breast cancers express mesothelin.
Thanks also for the link to the information on resistance to PI3K inhibitors. I have RB1 loss found on Foundation1 tumor analysis, so this is VERY relevant information for me!
FYI for others with RB1 loss: RB1 loss predicts that CDK4/6 inhibitors will not work (Ibrance/Faslodex did not work for me). Apparently RB1 loss is not all or nothing. Foundation1 will now report the percentage of RB1 loss. If you have an older (>2 years) Foundation1 report that mentions RB1 loss, you can go back to Foundation1 and they will provide you the percentage of RB1 loss for free. If your RB1 loss is not 100%, then it's possible that CDK4/6 inhibitors could work. The good news is that very few ER+ breast cancers have RB1 loss (approximately 5%). Unfortunately, RB loss is "frequent" in triple negative breast cancers.
Jennifer, I am praying that your brain scan will be clean and that you will be the next patient put into remission by CAR-T therapy!!!
Much appreciation! Theresa
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Apparently 30-40% triple-negative cancers express mesothelin, but for ER-positive or HER2-positive, only like 1 in 25-30 patients express the gene (which is better odds than winning a lotto, but still). For this reason they are developing other CAR-T approaches, and have to find proteins that are highly expressed on ER-positive cells but not well expressed in other cells in our body. For HER2, they are using HER2 CAR-T. For the rest of us, they are still trying to figure that out.
But Teresa you raise a good question, what to do for cancers lacking RB (which is rather common way for cancers to escape CDK4,6 inhibitors).
I just quick-checked, and here is a link to a recent paper where they took MBC cells lacking RB and checked what drugs would block their growth, and guess what? the number one hit- Aurora A kinase!
So, at least in the lab, these cells are sensitive to Alisertib! I guess this is why they say move to Alisertib after progression on Alpelisib/PI3K inhibitors, or even after progression on Ibrance if the cancer lacks RB
http://cancerdiscovery.aacrjournals.org/content/ca...
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Jennifer, good luck with the brain scan.
Cure-ious thanks for posting the various links. I agree that the combo of alisertib (or future related drugs) and PI3K inhibitors sounds promising from an efficacy standpoint. The biggest challenge may be the toxicity of this and other similar cocktails of multiple drugs but let's hope they can find some tolerable combination drugs. It sounds like adding an FGFR inhibitor to PI3K inhibitors may be a promising combo as well. They are thought to be synergistic. FGFR1 can drive PI3K resistance through upregulating the Aurora A kinase. FGFR inhibitors serve to downregulate the Aurora A kinase. I wish I were on FGFR inhibitor erdafitinib in combination with another target therapy but I only qualified for the trial using it as a solo medication.
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So, does it work the other way as well? Does Alisertib inhibit FGFR-amplified cancers?
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Cure-ious,
I can't find any source for mesothelin expression in ER+ MBC. Frustrating. I'll have another go tomorrow.
I have been told by a medical professional that it is less than 5% of the cohort, but until I can find a reputable primary source, I'm not going to fully trust the data.
Jennifer
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I'm learning so much by lurking here. Thanks ladies.
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I noticed on my pathology for my most recent liver BX that it says ER+100%, PR+3%, HER2-, Ki-67intermediate(12%positive cells).
Also, it says tumor cells are strongly and diffusely positive for CK7 and GATA -1 and negative for CK 20.
Cure ious What does all that mean? I understand the top paragraph but the second paragraph, I'm not sure I get. Except maybe I would be a candidate for CK7 inhibitors? What are their names and are they still in trials?
There are also several other things mentioned: CPT: (A) 88313-TRix(1), (A) 88360-K67x(1), (A) 88342-CK7x(1), (A) 8831-GA3x(1). And about ten more, are these clinical trials I might be eligible for?
If so, I'm surprised to see them listed on a pathology report. I thought they were only on Genomic testing reports. If they are trials, I would be interested in reading about them. I haven't learned how to find that info yet. I hope my new Genomic testing comes back before in time for MO to use it to make decisions for TX.
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Grannax, I am the last one to know about these reports, no familiarity with them at all, but I can tell you CK7 (a cytokeratin), is totally different from CDK7 (a kinase). It is common to have high CK7 and GATA3, but I don't know any specific treatments about them..
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Thanks, anyway Cure ious. See, I just assumed you knew everything. Lol
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Just a quick note to report that my latest scan (3/29) shows NO progression and continuing decrease of tumor load (overall decrease of 37% since trial started in mid-December and tumor markers are still going down, too), so I will start on cycle 5 of this trial tomorrow!!! I don't have results of the genomic testing yet, but my doctor did say that I am a "low" positive and that could be a contributing factor in my great response!
HOT DIGGETY DAWG!
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Thats great news katty, congratulations! I hope things continue to get better! When your doctor says "low positive" do you mean for PDL1?
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Ann, I honestly don't know. I thought he meant my ER/PR positive status. I'll have to ask him next month.
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Kattysmith, rock on!!!
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Thanks Katty!
JFL, I was reading the clinical paper Cure-ious posted about Alpesilib and how it does not respond to FGFR amplified cancers. And at least in lab settings when an FGFR inhibitor was added, the resistance to Alpesilib went down and it started responding to it. All of this sounds so logical in theory and its frustrating to read about it all and still feel helpless in our respective situations. I wish you good luck with your trial!
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Katty, that's great! Thank you so much for posting.
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Katty! Fantastic news. Thanks for sharing with all of us
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YES!!! Thanks for sharing
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Katty Awesome news. What is the name of the clinical trial you are on? Do you know what drug you are taking? Are you at MDA?
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Katty!!! Howl as loud as you like, we are howling along with you!!! Dances with wolves!!!
How terrific, you are boosting their numbers for when they have to report phase 1 results!!
I assume your doc means you do have low (but some) PDL-1 expression, which is helping your response- however, Ibrance will also boost PDL-1 expression, so it might have helped that you were treated with it before. And maybe future iterations of this trial will include a CDK4,6 inhibitor.
Awesome, may the tumors shrink and shrink! Can you tell the difference, in terms of how you feel, and what are the side effects?
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