Elacestrant (ORSERDU)
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perkey2020,
I remember reading a comment on the private Facebook group by one woman who is on a second drug along with Orserdu. As best as I can remember, she has both the Pik3 and ESR1 mutation. I assume any oncologists who go the route of paired treatments would be pretty independent in their thinking. I don't find the Facebook site very easy to look around in, but if I find her comment again I'll let you know.
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perkey2020,
I'm now aware of one woman in the Facebook group who is on Piqray plus Orserdu and one woman who is on Kisquali plus Orserdu. Makes sense to my limited understanding, but since the drug is only authorized as mono therapy, these oncologists must feel pretty confident to prescribe outside the box. My MO would not do this. If you go on Elacestrant (Orserdu) I'd recommend joining the Facebook group. I prefer the quality of BCO, but the Facebook group is very active.
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@ninetwelve I am wondering when oncologists want to combine other meds with Elacestrant… I have another mutation NF1which (based on my search) alone drives breast cancer.
I am off meds right now, waiting for insurance approval second opinion MO to be my MO.
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A commenter on the private Facebook group posted that she had significant progression after 3 -4 months on Orserdu. Prior to Orserdu, she had been on all the CDK4/6 inhibitors over 12 years for Stage 4. She will move on to chemo. She said her doctor, a PHD breast cancer researcher, said 50% of trial participants experienced progression at 60 days.
I find trial reports confusing and hard to interpret, so not sure the exact failure % that was reported.
This article is a good summary:
"Among these patients, 43% of whom had two prior lines of endocrine therapy, elacestrant significantly reduced the risk of progression or death compared with SOC by 30% in the overall cohort (P = .002) and by 45% in patients with ESR1 mutation (P = .0005)."
"Among the ESR1-mutated population, progression-free survival was also improved with longer prior exposure to CDK4/6 inhibitors. In ESR1-mutated tumors and with at least 18 months of prior exposure to CDK4/6 inhibitors, median progression-free survival was 8.6 months with elacestrant vs 2.1 months with the standard of care, a 53% reduction in the risk for disease progression or death."
“When we start to get to longer than 12 months of CDK4/6 exposure, that’s when you see the benefit of elacestrant, suggesting these tumors are more endocrine-sensitive. This is a crude way of looking at endocrine sensitivity. Unfortunately, we don’t have a more sensitive biologic tool, so we rely on clinical characteristics, one of which is the prior duration of CDK4/6 therapy,”
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@weninwi @cure-ious i have extensive bone met and 2 lung nodules. I’ve been on Kisqali &. Faslodex since 11/2022. Unfortunately I have progressions on bone only, lung is stable, liver is clear. MO wants to change treatment, we will discuss tomorrow. How would I know if Kisqali or Faslodex or both failed? Which do you think is a better choice for me for next treatment: Xeloda, Afinitor, another CDK4/6i, or Oserdu? Appreciate your input.
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anx789,
My understanding is very limited, but offer this: Did you have a genomic test done - like a liquid (i.e. blood) biopsy? If yes, does the report list any treatments relevant to any mutation(s) you have? I have the ESR1 Y537S mutation/variant. From my additional on-line reading I found that this mutation/variant has greater resistance to Fulvestrant and mTOR inhibitors (like Afinitor) in the test tube. But my MO put on these two treatments, even after knowing my mutations. They didn't work and I progressed within 3 months. I was then started on Xeloda and it worked 6 months for me, but I progressed by 9 months. Whatever treatment your doctor recommends I'd suggest asking what his/her rationale is for making the choice. What pathway is being targeted?
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Anx, Its a good question, most MOs say you have developed resistance to both CDK4,6i and Endocrine therapy, where research shows it most often just needs a switch of the endocrine backbone. Your cancer progressed while on AI therapy, so there as WeninWI says, you'd want to look first to see if it was because of an ESR1 mutation (PI3KCA mutations are also common). Liquid biopsies have really changed the game, in terms of seeing if there is something obvious to target next. With an ESR1 mutation, you want a SERD, Elascestrant is so far the only one approved by FDA. Clinical trials are where we go for most SERDs or for combinations that include SERDs.
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@cure-ious my MO will test for Guardant 360. My Pet/Ct report only says “new lesions” never mentioned hypermetabolic or the SUVmax measurement of these new lesions, my MO assumes it’s malignant lesions - is this a correct assumption?
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cure-ious,
I just read this about the Guardent360 test:
"The concentration of ctDNA within the blood is very low. Standard sequencing techniques are not specific and sensitive enough to detect mutations of the ctDNA correctly. The secured digital sequencing method of Guardant360® is 1000x more accurate than standard sequencing methods and results in a 99.9999% specificity."
Would the low concentration of ctDNA in blood possibly explain why some women have ESR1 percentages <1% based on the Guardent360 test, but I have 30%…..based on a solid tumor (liver) specimen?
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anx,
There are more comments/questions on the Orserdu Facebook group expressing interest about Orserdu paired with a targeted therapy. The women can obviously see the possible advantage of paired treatment. One woman has confirmed her oncologist has ordered Orserdu in combination with Kisqali and her scans show good improvement. Another commenter asked…..since Orserdu is only FDA approved as mono therapy, how does Medicare (or private insurance) pay for both drugs? No one has answered that question yet. Perhaps ask about the possibility of paired treatment with your oncologist and the second opinion doctors and please let us know what they say.
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weninWI, Oh, you probably are right!!
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anx789,
Thanks for the update. I hope your next treatment goes well, whatever it is.
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@weninwi thanks for sharing this, it is disappointing to learn that this new med is not as effective as it should be, ref: your post about progression on Elacestrant after 12 years on CDK…. my former MO didn't want me to start Elacestrant, she said the results are not satisfying. I am worry if the trial was a sham! what other options do we have?
anyway, my insurance approved it and now I am waiting for biologics to call me(!) for scheduling delivery, seems they work very slowly.
do we need blood test before starting it? what time of the day is best to take it?
Thanks
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snow-drop,
On the Facebook group, one of the site managers stated 50% good response vs progression. Members are of course reporting scans results and informally reports seem about 50/50. Some women who have reported progression go on to say they are still grateful for the time on the drug since they were mostly side-effect free.
I found this statement about the Emerald study: "Among these patients, 43% of whom had two prior lines of endocrine therapy, elacestrant significantly reduced the risk of progression or death compared with SOC by 30% in the overall cohort (P = .002) and by 45% in patients with ESR1 mutation (P = .0005)." I'm not skilled at reading studies, but to me that says 45% had no progression….so that leaves 55% had progression.
Re tips on taking the medication: the most important thing is to take it with your largest meal, with plenty of fat, and plenty of fluids. About same time each day, but I think which meal you choose is less important. Read the package insert that comes with the drug. Under Pharmacokinetics - Effects of Food: a "high fat meal (800-1000 calories, 50% fat)" provides the highest absorption rate. The FB women also emphasize plenty of fluids (i.e. water). Those that skimp on this guidance get into trouble with reflux, nausea, etc. I take mine at the end of breakfast, which is my biggest and highest fat meal. It's a large pill. I bury it in mashed-up avocado (I buy avocado mini cups) and it goes down fine.
Labs: Baseline before starting - the usual CMP, CBC, and now Lipid Panel, because the drug can raise lipids. My MO will repeat lipid panel after I finish bottle #2. Some of the FB women get monthly lipids and some of the women are put on a statin if their lipids go up. If my lipids go up I may decline statins. The lipid issue suggests focusing on non-saturated fat sources (nuts and nut butters, avocado, olive oil, coconut butter, etc) and low-fat saturated choices.
The drug can also slightly raise liver enzymes, so a reason for the CMP. Read the package insert to learn the percent seen in the study. My ALT and AST went up slightly after my first bottle, but my bilirubin went down to normal (it had been up slightly above normal).
Many of the FB women have tumor markers done and see a rise after they start. One of the FB site managers says this is to be expected and not to panic and don't scan too early…i.e. before 3 months. My MO does not do tumor markers.
I've started bottle #2. Mostly side-effect free, but just started having a slight intermittent headache. I reported it to my MO and was told to monitor. Can't help but worry.
The big positive for this drug is it's tolerability. The big negative is it's limited efficacy. If ORSERDU works for you, your 12 years on a CDK4/6i is in your favor. The study reported a longer time on CDK4/6i gave a longer progression free time on ORSERDU.
The best to you. I'd like to see this discussion board more active, but since it's not, I go the FB group most every day.
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Update on the following statement from a summary article on the Emerald Study:
"Among these patients, 43% of whom had two prior lines of endocrine therapy, elacestrant significantly reduced the risk of progression or death compared with SOC by 30% in the overall cohort (
P= .002) and by 45% in patients with ESR1 mutation (P= .0005)."One of the Facebook site managers responded to the above statement. She said…"The Trial scanned every participant every 8 weeks. Any progression counted as progression no matter what else it showed/even if there was improvement in other lesions. Trials are very strict, so the % that showed No progression showed absolutely No progression. This drug takes longer than 8 weeks/really closer to 5-6 months to really see what it's doing…."
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Hi, everyone. This is my first time writing on this forum. I am due to start Orserdu, and I didn't realize it was going to be approved so quickly. I had planned to start it after I went to see my grandson from October 13th-16th because I didn't want to have to deal with new side effects. I have been on no meds since my last faslodex shots on August 8th. They're getting me the medication Tuesday, October 3rd, and now I'm having second thoughts on waiting. Can anyone tell me what side effects you've had, especially the first few weeks after starting. It will help me decide whether to wait or not. It's been a while since I saw my grandson, and I certainly don't want it spoiled by me not feeling well.
Thank you,
Kris(KBL)
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kbl,
Not many people on this thread…yet. There are over 300 member on the Orserdu private Facebook group. So if you want more info quickly that's the place to go. You have to request to join….any woman who started or is starting the drug can join…..may take a day or two for them to respond. I'm not a fan of FB, but I did join. https://www.facebook.com/groups/1577378016092625
Based on my daily perusal of the FB site, the most common early side effect seems to be acid reflux, nausea. Some women get pretty uncomfortable and end up taking antacids or anti nausea meds. But it's my opinion this side effect can be avoided by following the instructions on the package insert….i.e. take with "800-1000 calorie meal, 50% fat"….and the FB women add "plenty of fluids".
So plan to take it with your biggest meal and with plenty of fat. What "plenty of fat" means differs with each woman. Some women follow the pill with a dixie cup of ice cream, or peanut butter on toast, or avocado, or cheese. I take mine at the end of breakfast (2 eggs, Greek yogurt, walnuts, berries, toast with almond butter, kefir, milk 2%, hot tea. The pill is big, so I bury it in mashed up avocado and it slides down easily. I've not had any GI symptoms so far.
The drug can cause lipids to increase so to me this suggests focusing on non-saturated fats (nut butters, avocado, coconut milk, olive oil) or low fat saturated fats. It's only the meal you take the pill with that needs plenty of fat - your other meals can be lower fat.
Some women have also reported bone pain, skin rash, sleep disturbances (insomnia), plus more, but these symptoms seems to start with bottle #2 or beyond.
The drug can cause slight increase in liver enzymes and also raise lipids. Most women get monthly CBC, CMP, and baseline lipid panel. Lipids get repeated either monthly or periodically. Some women have been put on statins.
When you get your first bottle, your may get a welcome package with assorted gifts and a glossy page booklet. Most important is to read the package insert carefully - it's folded up, small print, attached to top of the bottle. The best to you.
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Thank you, Weninwi. I’ve missed you at our Monday meetings. I already have high cholesterol and had started on Lipitor but haven’t been taking it so as to see what is ahead. I see that Lipitor may not be the best choice to take with Orserdu, so I’m going to ask my doc at my appointment.
I also already suffer with gastritis and nausea from my stomach Mets, so it won’t be anything new. I just hope it doesn’t get worse.
Thank you for all of the information.
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Hi kbl!
Several FB women have mentioned the statin that they're on: Rosuvastatin, Crestor, Lipitor, Simvastatin (the commenter added - because some studies show it reduced recurrence).
Just today several women posted about taking the drug with their largest meal (several mentioned dinner), and peanut butter, ice cream, yogurt, dairy, avocado, etc for the fat to avoid GI symptoms.
Yes, I miss seeing everyone on Monday. I've been busy trying to finish genealogy projects and also getting my affairs in order. If the drug works for me (first scans in late Nov), then my husband and I may go to AZ for a few months. I'd like to have my projects mostly done by then. If the drug fails, then Erhertu may be next - not an easy drug for many women, and we won't go to AZ. I've exchanged personal messages with one Monday member and she told me Jane passed. So sad.
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To All:
Would you like me to post some articles I've found on Elacestrant or would you rather do your own research?
Dr Aditya Bardia was one of the Emerald Trial researchers in the US. Virginia Kaklamani, MD is another. There are several discussions on elacestrant (ORDERSU) on YouTube.
The women on the FB group repeatedly say the drug works slowly so don't scan too early (no sooner than 90 days). It isn't until after 2 months that a positive effect starts to occur (if it's going to occur). Those with the ESR1 mutation in the trial got a somewhat better response than those without the mutation. Several FB women report progression (on first scan) and stop the treatment, often on the advice of their oncologist. Others stick it out longer and gradually see a good response (by 6 months). One detail that's encouraging - longer PF time on a CDK4/6i (12 months or more) is associated with longer median PF time on elacestrant (> 8 months).
The percent of mutation doesn't seem to matter for drug efficacy. If your genomic test was a blood biopsy your percentage will be low. Many of the FB women report <1%. But if your biopsy was solid tumor then your percent will be higher (one FB woman reported 47%). My liver biopsy showed 30%.
Hope we can get some sharing/discussion going on this site.
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I'm not taking this med, but am reading along to keep it in mind for when I do show progression. One of my peers in my local support group is taking this med. I appreciate folks sharing their experience, and any links to research articles are appreciated, thank you weninwi!
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Hi weninwi,
Thank you so much for sharing such valuable information, it is like having a team of physicians onco, nutritionists, hematologists, which we usually do not have all of those expertise in our care team, so this is helpful for connecting the dots that might otherwise be missed during our treatment. please continue sharing your experience and knowledge. also thank you for mentioning that the % for ESR1 mutation in liquid biopsy is low, mine is around 1.4, I have been on CDK about 47-48 cycles ( 2 breaks for the covid vaccine, 2 breaks for taking antibiotics). but realistically I should deduct 3 cycles as the meds stopped working at least 3 months before I switched.
I have started Elacestrant, I know it is too soon to notice any se but I feel sleepy after taking it, I think it will be helpful to take it at evening with supper, helping night sleep!
I have a liver biopsy scheduled for mid October, I am concerned if using Elacestrant might have any impact on the liver biopsy results?
I hope this new med works its magic for all of us and you are able to keep your travel plans.
I have been busy with adjusting to the new clinic, sorting out insurance paperwork etc. but I promise to be more active here.
Hello everyone
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Weninwei, It sure sounds like you’re very busy. I hope you get to go away.
I also like all of the information you post. It’s helpful. And if I see something about what you post, I can go and look for more info.
I’m not sure you knew Jaimee, but we lost her too. Jane and Jaimee passed two days apart. It’s so sad.
I’ll be behind snow-drop on starting, but I will make sure not to scan too soon and not to panic if markers go up for a little while.
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To All,
Here's an article by Dr. Aditya Bardia…"Updated Emerald Data Support Oral SERD Elecestrant…." Dec 14, 2022.
The article refers to the Kaplan-Meier curves that show an initial drop in PFS (not good) in the trial, but at about the 2-3 month mark, patients on Elacestrant with the ESR1 mutation start to show greater benefit than those on Standard of Care. (I do not understand Kaplan-Meier curves). Patients with longer time on CDK4/6 inhibitors (12 months or more) also showed greater PFS. One of the moderators on the Facebook group for Orserdu explained that trial participants were scanned every 2 months, which she said explains the drop in PFS in the first two months because Orserdu works slowly.
On the Facebook group women are reporting very mixed results. Many feel pretty good on the drug with minimal side effects, but scan results at 3 months, 6 months are very mixed. Some report significant progression. Not very encouraging to me.
I start month 3 next week and have had no obvious side effects. Will have labs CBC, CMP, and lipids next week. My MO does not do tumor markers.
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I just started this drug today. I will post in about a week to let you know how I’m feeling. I took it during lunch because that will be my highest fat meal. Do any of you switch between lunch and dinner due to when you know you’ll have more fat?
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kbl,
I do not switch the time of day that I take my dose, and don't recommend doing that. If the amount of fat varies at your preferred meal, some of the ideas from the Facebook group include: add Brie cheese on crackers, or a tablespoon of peanut butter, or a slice of cheese cake, or a dixie cup of ice cream to the meal. The best to you and keep us posted on how it goes.
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Thank you, weninwi. I kept it at lunch and will take the advice.
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I start bottle #3 in two days. I've started to have dull pain over my liver (right upper quadrant) and into my back. It started out intermittent and short lasting, but is now continuous day and night. I had significant progression in my liver before starting ORSERDU and suspect it is not working. I have labs and see NP early next week. I will probably ask for scans sooner rather than wait the full 3 months. Concerned and disappointed as it's been an easy drug - no side effects,
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