Abemaciclib Verzenio for Stage IV
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Ann273, Do not be disappointed!! ASCO may not impress us, but we set a high bar for that here!!
2019 has (so far) given us a lot of exciting directions and drugs to pursue; we now know that immunotherapy combo with anti-inflammatory drugs is a potentially great thing, and we have this new Pfizer CDK2-CDK4/6 combo drug to follow, plus Alpelisib may yet someday finally be approved (and we know it should work better in a combo with Alisertib, so we can look for that trial), Venetoclax is being tested and they are making noises like they could be the next greatest thing since Ibrance (efficacy with low SEs) and the CDK7 trial is slowly advancing and CDK12 inhibitors may work their way into clinic, with the promise that they could really boost immunotherapy responses too..
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Thanks Cure-ious, I'm trying to keep my head above the water and all of these things do give me hope! I wish we could fast forward all of these trials and figure this whole thing out lol! That being said, thank you so much for patiently answering all of our questions and keeping us up-to-date with whats going on
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Well, Anne you are right to point out, after all these trials and time, they are mostly still touting Ibrance. NO immunotherapy successes to point to for ER-positive cancers- really?! NO clear direction what to do after progression on I-F, still?! And over on onclive, the headline for the meeting "eat low-fat to avoid mets"? Meeting continues to next week, hopefully there's more than Alpelisib leftovers. Double Meh.
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yes, I did see that about eating low fat to avoid mets and groaned out aloud. And touting Ibrance or the other CDK4/6. We get it already, they work! But, what next?
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Thanks for the summaries Cure-ious!
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Can anyone give an update on how they are doing on Verzenio?
I am currently receiving Fulvestrant injections and added Verzenio today due Mets to my abdomen lining and Ascites fluid to my abdomen.
Anyone else in this treatment plan?
I would love to hear from you
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I just put a response where you asked about this on the hormonal therapy site. I am doing well, also using Zometa.
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Rmrbeck- I am on my 6th month of Verzenio. I did 2 with just the Verzenio and then added the Faslodex, soon to add in Zometa after I get my wisdom teeth out next week. I had one stable scan and then one scan with improvement. My tumor markers dropped and now are bouncing around at stable. I have an appointment this friday and hope things are still looking good. I took Ibrance/letrazole at dx back in 2015, and it lasted for 16 months. So my onc is just excited that something similiar is working and that insurance paid for it. Hope everyone else is doing well too!
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from ASCO, via Anne Loeser (only relevant for those lurkers--no offense; i lurk in a xeloda group-- in this group who aren't yet on verzenio yet): Taking Verzenio after Prior Failure on Ibrance or Kisqali:
Ibrance, Kisqali and Verzenio are CDK4/6 inhibitors, although Verzenio works somewhat differently. A small study of 19 evaluable heavily pre-treated HR+ HER2- MBC patients conducted by the Moffitt Cancer Center concluded that Verzenio elicited a response in a significant number of patients who previously took Ibrance in combination with endocrine therapy. The study participants had previously received a mean of 5.6 prior therapies, and 73.6% had visceral involvement (including brain metastasis in 26%). 15 of the study patients were given Verzenio in combination with endocrine therapy and 4 patients received Verzenio as a single agent. The median Progression Free Survival (PFS) on Verzenio was 7.0 months, and although no partial or complete responses were observed, 33% of the patients had stable disease. From: https://meetinglibrary.asco.org/record/177494/abstract
From Feb. 2015 to Jan. 2019, a somewhat larger study evaluated clinical outcomes in patients with HR+/HER2- MBC who received Verzenio after progressing on Ibrance or Kisqali. 20 (34%) of the patients on Verzenio had disease progression in less than 3 months, while 21 patients (36%) had a treatment duration exceeding 6 months - including 10 patients who remained on treatment at interim analysis (range 181-413 days). The median PFS on Verzenio following a prior CDK4/6 inhibitor was 5.8 months. Interestingly, a preliminary analysis of circulating free DNA revealed RB1 and FGFR1 alterations in patients who exhibited progressive disease. From: https://meetinglibrary.asco.org/record/175766/abstract
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again, via anne, but possibly relevant in future if one is currently on verzenio:
Phase 1 study of Lenvatinib and Letrozole: Lenvatinib, an approved drug that is used to treat liver, thyroid, and kidney cancer, is currently being studied against other types of cancer. It works by inhibiting vascular endothelial growth factor (VEGF), which is a signal protein produced by cells that stimulates the formation of blood vessels that in turn promote tumor growth. In a very small study that included 12 MBC patients (8 of whom had prior therapy with a CDK4/6 inhibitor and endocrine therapy), lenvatinib combined with letrozole elicited an overall disease control rate (DCR) of 92% after 12 weeks. (Anne's note: Although not explicitly stated in the abstract, it is assumed that all 12 patients had hormone receptor positive disease, although it is unclear whether they were also HER2 negative). From: https://meetinglibrary.asco.org/record/175824/abstract
Potential Impact of Being on a CDK4/6 Inhibitor before Moving on to Afinitor: A small study examined the medical records of 33 patients who underwent therapy with Afinitor and Aromasin (A/A). 17 of the patients had prior CDK4/6 inhibitor therapy combined with endocrine therapy and 16 had taken either letrozole or arimidex alone. In patients who had previously received a CDK4/6 inhibitor, the PFS was 5.7 months vs. 4.7 months in patients who had taken letrozole or arimidex alone. The median overall survival of patients who'd had a prior CDK4/6 inhibitor was 17.8 months vs. 11.4 months for those who had only taken letrozole or arimidex. The study concluded that A/A was effective for patients who had previously received CDK4/6 inhibitor therapy and for those who had received prior therapy with an aromatase inhibitor alone. From: https://meetinglibrary.asco.org/record/177375/abstract
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i am on verzenio monotherapy, started january 2018. my tumor markers had been going up since last fall, after an initial period of falling at the beginning of therapy, then stability for a few months. so three months ago, with cure_ious's help (she sent me an abstract that i used to make the case with my oncologist. thanks again, cure_ious!) i decided to go up in dose, back to the regular monotherapy dose of 200 mg, which i had been started on but did not tolerate well back then (grade 4 diarrhea). so for most of last year, i had been on 150mg, which i did fine on. a year in, diarrhea turned into constipation. going back up tp 200 has not given me any noticeable side effects, and this month, two of three TMs are down a bit and the other stable. so upping the dose is currently working for me. who knows how many more months i can carve out on verzenio that way; probably not all that many. who knows what'll happen once verzenio quits on me on this higher dose--maybe pushing the tumor like that'll make it more aggressive. but the abstract had shown that in mice, going off verzenio MONOTHERAPY from a higher dose, the mice did better: more tumor cells stayed in senescence. (on monotherapy, cells tend to return to rapid cycling once verzenio is withdrawn.) no idea if that 50mg dose-increase is enough to effect that in humans. but here's my point: for those who had to have a dose reduction due to side effects, or simply chose to start at a lower dose for whatever reason, it might be worth bringing up a dose increase with your oncologist when verzenio starts quitting on you, which it inevitably will, for all we know (although some combining it with antiestrogen therapy can have as long as 5 years on that combo, from what i have heard so far). just an idea; i am pretty sure this is not SOC, and my oncologist had been ready to take me off verzenio when i proposed upping the dose. now he is pleased to see it work for now.
(here's the bummer: i am unable to be happy about this reprieve. my cat, pierre, was killed by some predator the night after my oncology appointment. i tried to keep him in but didn't always succeed. he didn't start out as my cat, but a neighbor left him behind when she moved, so he had ingrained habits. he was my best friend.)
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It truly is sad when we lose a pet who was like a family member so condolences to luce over Pierre's death.
Regarding the group of CDK 4/6 inhibitors and the idea that abemaciclib works differently from the other two, I picked this statement out of the lengthy summary which serves as the initial post on this thread: ”Verzenio is more specific in inhibiting CDK4, that is it is CDK4-selective, and myelotoxicity including neutropenia is primarily associated with CDK6”. I try to keep that in mind.
When I was requesting a decrease due to intolerance of 150mg, one option presented was to switch to Ibrance! It was apparent to me that V has better stats overall and I really didn't want to drive my blood counts down therefore was happy to settle at 100mg twice a day with diarrhea controlled by FiberCon (loperamide worked too well). Once, when my package was a day late in arriving, I took one of the stronger tablets and within hours got pure liquid instead of loosely formed stool. That's why I'm not planning to rechallenge at the higher dose anytime soon...
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Thanks for your kind words regarding Pierre.
To be clear, I'm not suggesting going up in dose until/unless one is starting to fail on Verzenio, after first doing well on it, and one is looking to extend one's time on Verzenio. Then it may be worth a try, in my experience. By that time, diarrhea probably has settled down for many. It seems common in the CDK 4/6 inhibitor group for diarrhea from Verzenio to stop a year in (if not sooner). I had diarrhea about as bad as it gets on the higher dose a year ago, and loose stools with weekly bouts of diarrhea for a year after reducing thedose. Now, I'm constipated on even 200mg.
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That is wonderful news. I am so happy to hear that you are doing so well.
I am new to the Verzenio and in Wednesday will have my abdomen lining drained again due to Ascites fluid. Praying this new treatment will stop the fluid all together.
Thank you for responding. Have a great weekend
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Luce, You are making it work, all while eschewing any endocrine therapy- that's some amazing results w/Verzenio monotherapy!
Thanks so much for the cogent distillation of ASCO abstracts- AA is not attractive (5.7 mos vs 4.7 mos, are they kidding?!) They need to define the molecular subset of cancers that really respond well to AA!!!!
Seven months on Abemaciclib sounds better, tho they don't say what the placebo group got. Has anyone in this thread taken Abemaciclib-Faslodex following I-F and gotten longer than 7 months?
For comparison, the newly approved PiqRay got PFS= 11 months (for PI3K mutant cancers only), so by comparison that is looking like a good option. But this is something that could also be tried after Abemaciclib-Faslodex.
Now let's see what PFS numbers come out with other Faslodex combinations:
1) with Alisertib; 2) with Lenvantib; 3) with Venetoclax; 4) the Super-Duper-CDK4,6+CDK2 inhibitor that Miaomix is starting on Friday (drug needs a name!); 5) CDK7 inhibitor
PS In an early report of a phase 1 trial with just ten patients, Alisertib-Faslodex combo reported a PFS of 12.4 months, where 77.8% of the cancers responded for at least six-months (clinical benefit rate)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC58422...
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rmrbeck: I had ascites and a large pleural effusion when I started Verzenio. It took three or four months but they dried up on it and have been dry since. But I’m always keeping an eye out for other meds that dry up ascites, effusions, edema (which are all related to VEGF). Losartan, an anti hypertensive, does. It also has other anticancer properties. It breaks up fibrosis so that cancer drugs can reach their target, for example.
Anthelmintics dried up a FB friends ascites and kept them away for a year without any other treatment (she then became resistant). They also have anticancer properties besides: they are microtubule disrupters. You can get mebendazole prescribed (doses 100mg to 1.5 g), or buy albendazole online from abroad, or go with the animal version, fenbendazole. There are certain supplements that may boost the effect, so you’ll want to dig deeper. For now, you can wait for Verzenio to kick in , and keep those others in your back pocket
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it’ll be interesting to see what my TMs do next month. I fear they may spike because of Pierre’s death. He was my entire joy.
In case anyone’s wondering what else I’m currently taking, I’m on 1g slow release metformin; 81mg aspirin; 40 mg propranolol (too low a dose to have much anticancer actIvity); and 5 mg desloratadine plus 10 mg loratadine (loratadine is cheaper), spread out; 10mg melatonin. My oncologist wanted me to add something else this month (my choice; we’d agreed on disulfiram) that we could test against TMs in a month but I didn’t because of Pierre. I just didn’t care enough about my protocol without him. Still don’t. I may add indole-3-carbinol 400mg, though, because of recent news. It needs to be taken away from antacids and proton pump inhibitors, I believe, so I may quit propranolol.
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Luce - I’m so sorry to hear about Pierre. It is so hard to lose a companion thatmeans so much to us.
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thanks, moissy. i am a total freak loner catlady who has neither family nearby nor close friends, and pierre was the best cat. and best friend. i had never had a purebred before(don't believe in breeding animals) but he was a flame-point birman (and still from the humane society). runt of the litter, i think, so maybe got dumped at the shelter because of that? always stayed smaller than a regular birman, but gorgeous and ultra-friendly and with a great sense of humor. the entire neighborhood loved him; people would come by from a nearby housing project for the disabled in their wheelchairs and call him. he made everyone feel special and loved, although he was most closely bonded to me, i like to think. incredibly bright spirit that at least a dozen folks relied on for their bright spot of their day. so a real loss. he was only six. impossible to keep indoors every night, sadly. he also had a siamese cat friend who now seems despondent.
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Luke, I'm so very sorry for your loss of Pierre. I know how much it hurts. I decided at one point not to have any more cats because my grief reaction is so profound. I have two 5 year old sister's because I missed having them around and it was in the back of my mind that I might die before them. Love them to pieces. I too live alone as a cat lady but my parents and sister's family all Live in town, which is nice. Pierre sounds like a really special cat. RIP.
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Luce, I am so sorry about Pierre.
Many thanks to you and Cure-ious. I am so incredibly grateful for what you do for us. I get overwhelmed, but knowledge is power for sure, yet frustrating at times.
And thanks for letting us know your current regime....wishing you and all of us the very best of course.
I am still currently on Verzenio 100mg after dose reduction from 150 mg because ofside effects several months ago...also still on Faslodex and Zometa. Getting new scans in 2 weeks....
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Yes luce, I did realize you were talking about upping the V dose when treatment seems to be failing. I was just referring to my experience with reverting back to 150mg on an “emergency" basis for anyone else thinking about it.
You made mention of the other things you are taking but I did not see a proton pump inhibitor on your list - do you use one, along with or instead of, antacids on an as needed basis? Propranolol, of course, is a beta blocker (probably the oldest one around, first on the market as Inderal): I would think 40mg daily might be doing a good job of keeping blood pressure down by decreasing heart rate!
My internist took me off both the antihypertensive and cholesterol therapies I was using when metastatic disease was diagnosed. Goal numbers for otherwise healthy adult populations are even lower now than they were a few years ago so I'm sort of glad she's not pushing the issue...
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yes, you are of course right, propranolol (my prescription is for 120mg; the 40 I’m actually taking is probably too low for anticancer benefits. May help a bit with anxiety, though, but not good for my breathing)isn’t a ppp, protonix is.
Any repurposed drug I’m on I’m using solely for purported anticancer benefits, and possible anticancer synergy with verzenio. I don’t have any of the health issues these drugs get commonly prescribed for, and if I did, I’d modify diet or lifestyle or take herbs instead. My anti-pharmaceutical roots are so deep, they are getting in the way of prolonging my life, as some of the repurposed drugs that are showing the strongest anticancer effects are anathema to my holistic conditioning: antibiotics and statins, for example. But had i been on statins before cancer, I’d certainly be on them now.
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Well, antibiotics are certainly overused in mainstream medicine, setting the stage for all kinds of ‘superbugs’. I suppose I could resume my statin as well as coenzyme Q which was required to keep muscle cramps at bay.
It’s true that beta blockade is helpful especially in cases of performance anxiety. I’ve heard they can be shared like candy among conservatory students at critical times like recitals and/or auditions although, as you imply, are counter-productive for those with asthma.
The pharmacy school dean at Purdue when I was there, Varro Tyler, was known as the godfather of herbology. My faculty advisor was one of his disciples. At least a few the common oncology agents in our armamentarium are derived from natural sources. Many a Pacific yew went into the development of Taxol for example while the Madagascar periwinkle gave us vincristine.
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of course antibiotics are greatly overused. this is a specific use in a specific population. coQ10 negates the anticancer benefits of statins, unfortunately. anyway, all this belongs under a different header, repuposed drugs for cancer, which is a science onto itself. (jane mclleland's "how to starve cancer without starving yourself", available on amazon, is a good start for those interested.) the only reason i mention some of these meds in this group is because i am hoping/testing that they are synergistic with verzenio, and letting me milk more time from it. metformin, for example, may inhibit mtor. aspirin is supposed to help with pi3k mutation. etc.
yes, of course practically every drug known to man is based on a a substance found in nature. but i haven't seen many advanced patients having success with the pacific yew (which i think may be endangered besides) instead of taxol. although my naturopathic oncologist certainly offers those plant extract alternatives.
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This is huge news! We could potentially take a pill instead of Faslodex shots
https://www.apnews.com/Globe%20Newswire/dadddbe318d9cc0a8c29c996af78889f
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Another amazing contribution by Constantine!
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pcollier we welcome you to our BCO community. Tell us a bit about yourself when you get a chance.
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Hi
New to this forum. Long story short, I have metastatic Primary Neuroendocrine Breast cancer which has presented in the liver after 5.5 years. I am a candidate for liver resection but MD Anderson wanted me to start on meds first to verify response before surgery. I have been on faslodex and verzenio for 8 weeks. Very few side effects thankfully. Follow up on Aug 8
Just starting to get some heartburn and stomach ache. Treating with Pepcid.
I am fascinated with the research and options you are watching and pursuing. I will be hanging around.
FYI my tag is not correct- trying to update it.
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Another Update, and I need a little bit of help!!!!
hi beautiful ladies I received the results of my newest CT scan and this time there is no shrinkage(last time i had 25 percent shrinkage on both liver and chest wall after being on letrozole and verzenio and my LY research med for 8 weeks) my new results shows there is No changes in size or numbers of tumors and they are all stable. even though i would have liked to see some shrinkage this time too, i think its still good news but what makes me nervous is my elevated levels of lactate dehydrogenase (LDH) in my recent blood test. it came out at 307 ( normal range is 125-256).my last month test showed 165(within the normal range and 150 lower than my current numbers). i have read that it could possibly show progression of my liver mets and therefore cell damage caused by that. i need your guidance and thoughts please! MO tells me that my results are amazing and they couldn't be any better but she is usually like that. so i want to hear your experience with LDH .
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