Are you currently (or have you been) in a Clinical Trial?
Comments
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cure-ious,
I'm still on Elacestrant and have watched some of the YouTube presentations on the drug and the Emerald study outcomes. I have just realized that on the charts displayed by the speakers, Progression Free Survival PFS is sometimes a measurement of Time (i.e. Months) and sometimes a measurement of Rate %. Can you elaborate on this at bit for me? Many women on the Facebook site for Elacestrant are confused, like me, trying to figure out what to expect from this drug.
N = 115. If there is a 45% reduction in risk of progression or death for those with the ESR1 mutation….does that mean 51.75 women will respond to treatment? How many women will be progression free at the medium of 3.8 months? And if 6 month PFS % is 40.8%…..does that mean of those 51.75 women ~20 will still be progression free at 6 months? Or is there an easier way to read the charts? Should I just read the two stacked lines: Elacestrant/SOC? At 3 months 46 were still progression free; at 6 months were 26 were progression free, etc? These numbers just confuse me.
Here is a slide of two of the charts.
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WeninWI, It seems they prefer to use those percent PFS when the median PFS number itself is not so impressive; so in the 115 patient example, 46 women were stable or better for 6 months, and 30 made it at least a year. I wish they would give us the range, mostly so we could get a sense if people are still responding and therefore the final numbers might end up even better. And I don't know how they correct for the fact that different people are starting at different times, so some may have been on treatment less than 6 months, maybe those aren't counted? Hoping somebody who knows more about this stuff will weigh in!!
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PS Oh, I had not seen the recent update on elascestrant at SABCS, it's sounding better now!!!
Among all patients with an ESR1 mutation, median PFS in the treatment arm was 8.61 months (95% CI, 4.14-10.84) vs 1.91 months in the control arm (HR, 0.410; 95% CI, 0.262-0.634).
That is for monotherapy, post CDK4,6i- that's good, unless you also have a PI3KCA mutation (see below)
"In the ESR1 mutation group, 159 patients (out of 259) were treated with prior CDK4/6 inhibitors for 12 months, 71% had liver and or lung metastases, 39% had a PIK3CA mutation, 38% had a TP53 mutation, and 48% had HER2-low expression."
Liver/lung mets PFS= 7.26 mos
PI3KCA= 5.35mos
Her2low=9 mos
so does it mean its better to fix the PI3KCA mutation before treating the ESR1mutation? Ideally one would want to do both, so hopefully there will be a push to test PI3KCA inhibitors in combination w/elascestrant
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cure-ious,
Oh, thank you for the explanation and the link! I'm going to post the link on the Elacestrant discussion board and also with the facebook group.
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Weninwi, I find the "risk of progression or death" type metric to be unhelpful when thinking about the benefit (it means that according to their statistic calculation, at a given time point, a patient in the elacestrant arm had a risk of progression or death that was 45% lower than the risk of progression or death for a patient in the SOC arm). The company cares about these things because they are trying to show how they are better than the SOC, but as a patient, I don't really care how much better off I am vs. SOC, I care about my chances to get to 6 months, 1 year, etc. without progression. So, disregard the risk of progression or death.
You also cannot just look at the two stacked lines of numbers below the graph, because they also reflect people who just didn't yet reach a certain time point, or who were lost to follow-up. Those are called "censored" events, and they are counted in the lines of numbers, but disregarded in the graph. For example, you see 9 patients at ~14 months, but 0 at 25 months, and you may think "Gosh, nobody made it to two years". But if you look at the blue line in the graph, it's straight, which means that none of those 9 "missing" patients had progression. They just didn't reach the later timepoint yet. For this reason, it's very hard to interpret those "tail" portion of the curves, because we do not know what happens to those 9 patients (and 9 patients is not a lot anyway).
The median PFS represents the time it took half of the patients to progress. In other words, a patient has a 50/50 chance of making it to that time point. So, in this study, only half of the patients they followed for at least 3.8 months were still progression free. That's disappointing, and it shows that a pretty big proportion of patients just don't respond to this drug (you can see how the curve is pretty steep in the beginning, meaning a big chunk of patients progress right away).
Once you make it past your first scan without progression, so you know you're a responder, the most useful metric in this slide is the 6 months PFS and 12 months PFS. This is a bit of a simplification, but essentially, they mean that of the people who were followed for 6 months, 40.8% were still stable. Of the people who were followed for 12 months 26.8% were still stable. I think only ~41 of the total 115 patients were followed for 12 months, and 11 were progression-free, so these numbers are starting to get a bit less reliable.
I like to also do a quick-and-dirty "conditional survival" analysis, and in this case it looks like a patient who made it to 6 months without progression has a 65% chance of making it to 12 months (26.8/40.8), assuming that the PFS rates hold once they have data for more patients.
If the shape of that PFS curve holds with more data, it seems that this treatment may be one of those that work for less than half of the patients, but for a good portion of those in the lucky half it could work for a decent length of time.
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Wondering if anyone has experience with the Vaxinia clinical trial. My wife has a chance to participate in the arm that also gets Keytruda. She also has an opportunity to get Histotripsy to one of her liver mets.
We are just trying to choose the most meaningful potential treatment as she is running out of options having failed AI, Faslodex, Ibrance, Verzenio, Xeloda, Enhertu, Orserdu, and now on cycle 2 of Trodelvy.
Thanks
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piggy99,
Thank you for your explanation of the Elacestrant trail graph!
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Piggy99- Yes, thanks a lot!! I had not noticed they do provide the numbers of patients at the bottom of the graph, so you can see how one patient there did manage 2 years on elascestrant monotherapy! Awesome, but it could have been someone with just a few mets who was on secondline, etc. Comparing the two graphs, it would seem that someone made it 23 months, but that person did not have an ESR1 mutation, which is interesting (unless the data were not available or something)
So otherwise, how would you know how many people made to six months vs how many made it six months without progression?
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Well it has been an eventful week. My cough was getting progressively worse and I was getting SOB on exertion so I went into urgent care to get some cough medicine. My heart rate was 40 so they did an ekg and it was off not sure why? Then my heart rate was high. So they took me to the ER where they did a chest CT. The ER doctors came out and told me I had a new 8mm nodule on my lungs that was not on my last pet scan. I was devastated. But I know comparing PET to CT is apples to oranges but I didn’t want to tell the ER doctor that. They told me to follow up with my oncologist on Monday. So I cried all weekend and followed up on Monday. My oncologist got back to me yesterday afternoon after comparing Fridays CT to my last trial CT on 11/21. She said it did state on my report on 11/21 and 9/12 small nodularity in lungs but that it had improved. So it was likely there but no measurement was listed. It was a huge relief. But I’ll find out for sure in January when I have my trial CT. However, she said I have ground glass opacities consistent with pneumonitis. She took me off Everolimus permanently and said she recommended me continuing on the trial with ARV-471 as a monotherapy. Some people have done well with it as a monotherapy. So I will try that. I was so disheartened that I spent the weekend freaking out about progression and that the ER radiologist and doctors said nothing about pneumonitis. I’m sure glad I wrote my oncologist in a panic. Does anyone have experience with pneumonitis? She said it should resolve off the drug but I’m just wondering how long this cough will last and if I’ve done permanent damage. I’m bummed to not be on an mTor inhibitor but maybe I’ll add some celebrex and see if that helps. It gives me reflux but if it helps?
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Merry Christmas, Everybody!!!
Here's a new target identified for immunotherapy!
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That's exciting news, Cureious.
Thanks. And happy new year.
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Happy New Year, GailMary!!!
Well in my house we all got Covid, so we'll be celebrating Christmas this weekend.. Gave me a few extra days to wrap presents, finally done!
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mommacj, I got pneumonitis from Enhertu, a known side effect, and I took prednisone for a month . and it went away on a follow up CT. and then I had a month of titrating off of prednisone and no chemo during this time. I am about to start chemo at a reduced dosage hoping this was a one off from the Chemo and I will be able to continue at the reduced dose. Enhertu was so good to me, that my MO and I will continue to try and make it work. You might consider the prednisone to get rid of the coughing and pneumonitis. I was fortunate and did not have symptoms before a routine PET discovered it. Nina
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Cure-ious and others who knew NKB on this website, it is with a heavy heart I have to tell you she passed on December 29. I met her on breastcancer.org and discovered she lived close by so we had many visits as we both investigated and tried the many possible therapies. She was a good friend and contributed much to this community, mostly giving good advice and helping others as well as getting good advice and support from all of you. She was a fighter to the end. She is missed.
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Ninaca-Thank you for the update on NKB. I have been wondering how she was doing and of course, hoping that she would get more time out of hospice. May she rest in peace.
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I am so sorry to hear about NKB, may her soul be at peace and her loved ones comforted. Thank you, ninaca, for letting us know.
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Oh, no, no, no!!! Not Nanci!!! This is ridiculous, she was doing fine, bone-only, and then gets a rare and dangerous SE of hemolysis, apparently from Xeloda (can happen w/ other chemos too) and its a mad rush for transfusions and in and out of hospital- her doctor warned her she could die quickly. So it seems this is a death not from the cancer,but from the stupid drugs we have to take…
She made incredibly lovely quilts, pierce work like lasers and highly technical, and was waiting for 3 of them to get back from the long arm, that's how engaged in life she was at the time this all went down. Massively unfair. Love in buckets to her family & Friends.. Thanks NinaCA, its good to know you guys were able to meet up…
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Oh no, nkb… so difficult to say something:/ Saulius
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I am saddened to hear of nkb’s passing. Sending prayers and love to her family and friends.
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It is sad to read about the passing of nkb. my condolences to her loved ones and friends.
curious thanks for informing us about the cause which is a se of C drugs.
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A new phase 2 trial has opened to examine Elascestrant plus CDK7 inhibitor:
Secondline only, requires prior AI plus CDK4,6 inhibitor
In addition to US, there are multiple sites in the UK, France, and Spain
Bone-only MBC is allowed
This will be quick, recruitment stops Dec 2024
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@cure-ious I just wrote them today. I was wondering if they would say I qualify if I’m already on Orserdu. I’ve been on it three months. I have it in bones and stomach. I’m not sure, but I haven’t heard back.
I don’t think I will qualify, as Orserdu is my third line.
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Oh, KBL, you are so close! since you haven't progressed on Orserdu, you could argue that you should qualify. There is already a secondline trial for CDK7i with fulvestrant, so moving to Orserdu thirdline makes sense!
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Some interesting recent data appeared about Zotatifin an eIF4A inhibitor, that controls a key node for cancers driven by PI3KCA and RAS as well as CDK4,6 and CycD1. The latest trial data presented at SABCS showed a promising 7.4months PFS for Zotatifin in combination with Fulvestrant and Verzenio, in ER+ MBC patients with a median of four prior lines treatment. Impressive that 5 of 19 patients got partial response (tumor shrinkage).
These are small numbers of patients but the results are encouraging. Mostly grade 1/2 AEs. Hopefully future trials are larger and replace the fulvestrant with an oral SERD.
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@cure-ious Thank you. I will keep you posted.
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@cure-ious I just heard back. I do not qualify because I already started. Sad but true.
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kbl, Well hopefully the Orserdu works for a long time; but we just need some more SERD combination trials to open up, there are a number of interesting targeted drugs out there…
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Cure-ious fantastic news!
hopefully it will be effective and added to the treatment lines soon, I see that it is on fast track fda approval. do you have any ideas about how long it takes from trial to approval as a line of treatment? I hope they open more trail arms to accommodate more patients like KBL and myself.
KBL, thanks for sharing the response from them. as we both have already started Elacestrant, and myself having liver involvement, my best guess is that they may disqualify me as well. but it brings hope.
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