Good luck with your scans Susan and Dee,
Cure-ious - I’m on GDC-0077 and fulvestrant. My last hbA1C was 7.3, so above normal still. Of course, that was after Christmas and a cruise. I try not to go overboard with desserts/booze, but nor have I given them up entirely. I’m on metformin and januvia.
Susan I admire that you have taken on the keto diet.
Take care everyone,
This is coincidental, but I have scans next week too! I am on fulvestrant plus ribociclib (though only one cycle so far due to low neutrophils). By the way I found out that it was an error that I was kicked off the alpelisib trial and no longer received fulvestrant. I am also struggling with numb lip and chin after my second zometa infusion.
I wish you all the best in your scans. Susan - so glad to hear you are still tolerating the alpelisib!
I don't usually share click bait, but I found this story interesting as it refers to the pik3ca mutation. Has anyone seen the original study or heard of this before?
I have the PI3K CA mutation in my tumor cells. Found it through the UCSF 500 test which is done on a tumor biopsy. Kept the tumor in my breast because it is easy to biopsy. ;-)
Saw a glimpse of my scan results today though I haven't actually received the reports yet. Looks like I had some small progression in some of the small (3mm) nodules in my lung. The rest of my body is unchanged. My MO, Hope Rugo, suggested I stay the course since it was a pretty minor progression and might even just be some kind of inflammation. Not the best news, but not the worst either. Will have another scan in two months.
Hi Susan, I am sorry the scan wasn’t a perfect result, but it sounds pretty good on balance. Most of my scans have somewhat muddy results too. Still something to celebrate
Thanks NewGardener for helping me keep a good perspective on this. Very grateful there is no progression in my brain or eye or any new areas.
Hi Susan, Thanks for sharing your scan results and experience on alpelisib. It's very, very disappointing when we don't see regression on scans, but I've learned that stable-ish scans can also indicate that the drug is still effective. I'll pray for a better scan in two months. I'm in the Bay Area and tried to get onto the BYlieve trial at UCSF. I have a PIK3CA mutation, but was not qualified for the trial because I was on a PARP inhibitor (talazoparib) trial after Ibrance/Faslodex. They wanted patients who had just progressed on Ibrance. My excellent oncologist is at Stanford, but I'm also fortunate to be able to consult with Dr Munster at UCSF to be considered for trials at UCSF. Best wishes! Theresa
Thanks Theresa! Yeah. I don't understand why they are being so particular in this trial. I had a hard time getting in myself and my MO had to really go to bat for me. Not a whole lot of people who have only been on two previous treatments and the second was a CDK4/6 inhibitor. Also, so many people have had to drop out because of terrible side effects. Not sure how many people are currently in the trial. I don't know anyone else.
On a separate topic, I'm in a BC mets group called Mets in the City, in the Bay Area. We have members from all over the Bay and are part of the larger BAYS (Bay Area Young Survivors) group. PM me if you are interested in finding out more.
Congrats, Susan, the important part is being able to stay another round on the drugs and it will be clearer next time.
Hope everyone is following kattysmith's story on the Opodivo-EP4 trial, she is responding to an immunotherapy combo that is designed so that all of us can take this- awesome therapy and she has only a few rashes for side effects! Keep this one on your list- also Keytruda announced in January they will also start up a Keytruda-EP4 inhibitor trial, so it may be coming to more places soon!
And then also that Mayo clinic trial on Alisertib, which sounds really encouraging and would be good before or after Alpelisib..
Cure-ious- I am wondering— is the Alpelisib different than Afinitor? Same pathway? Better than Afinitor? Fewer side effects? Taken with an estrogen? Shown to have longer PFS?
Hi Nkb! It is a different target but same pathway, PI3K/mTOR. The Alpelisib SEs are high blood sugar, can be treated with metformin but some nighttime fasting might allow you to escape that, give extra time for the blood sugar to get metabolised, and people can get very bad rashes. But generally it seems not the hand/feet problems and mouth sores of Affinitor. Both are combined with Faslodex, with the idea that if you can beat back the PI3K pathway, then generally the cancer becomes estrogen-dependent again, and then the faslodex takes care of that. The PFS in the trials are rather similar, Alpelisib a bit better with I think it was 11 months and the Affinitor was 7-8 months, but with both of them are probably better drugs than that, its just that the trials have suffered from a relatively high number of drop-outs because of the side effects.But the docs have gotten better at helping people figure out how to deal with them and be ready for them, with the dexa mouthwash and staying away from sugar, etc. The PI3K is the most common pathway that needs to be hit after the anti-estrogen therapies have failed. They expect Alpelisib to get FDA approval this year, and if so, a lot more people will be going onto it in short order and we should get a lot more input on the threads here to find out what it is like. Supposedly at least one person still on Alpelisib four years out, so that is good.
But now we can consider yet another drug on the horizon for this step, its not really in the same pathway but was reported to strongly synergize with either Alpelisib or Affinitor, and that one is Alisertib, the Aurora A kinase inhibitor, for now just in a tiny Mayo-Clinic-Only clinical trial, being tested by itself or with Faslodex. But that is one mighty phase 1 trial, in terms of very high response rates and one woman still on the drug three years later, just in phase 1!!! And tho maybe they would be good in combination, it should also great to take them back-to-back. And amazingly sounds like Alisertib side effects are mostly neutropenia, like Ibrance? So it might be in sort-of the same category and better than either Affinitor or Alpelisib in terms of side effects. The thing with Alisertib is it hasn't been amazing in trials with other cancers, so we don't have any idea for PFS, and probably there won't be an Alisertib-Alpelisib or Alisertib-Affinitor combo trial for a long time, so hopefully we just keep hearing from the people in these trials, to get an idea of what is happening on the ground..
And now we get to hope that maybe the EP4 inhibitor - immunotherapy trials might be a thing that works for us, too- gee, 2019 is shaping up to be pretty exciting, and its just February!!
Cure-ious ... just saw the Alisertib trial is open at Dana Farber too! I thought is was open at a couple more sites I sawon a clinical trial site I saw last week - but need to double check before I speak too soon..
so here a couple more sites for the Alisertib trial https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/alisertib. Seems they are opening up pretty fast
Cure-ious- Ann 1999 and others- have you ever listened to Breast Cancer podcast narrated by Dr Neil Love? They are quite fascinating although they are geared towards practicing oncologists and only the generic names of drugs are used. There are 15 episodes available currently and several new ones were available from Dec 2018. I especially like the information from Dr Joyce O'Shaughnessy who does like the anti PIK3 drugs although says there is a lot of toxicity.
She also has addressed many topics about Lobular (ILC) and I am really hopeful that we will get more information about how to treat it, since clearly it responds differently to certain drugs. I hope that my UCSF doctor will have a lot of knowledge about ILC and also about Afinitor and Alpelisib. Dr O'shaughnessy says that many of the hormonals are inferior in ILC, that CDKs work well in ILC. I have not heard if she thinks Afinitor or Alpelisib works as well in ILC. She has been a big researcher in Xeloda as well.
I am very excited about the EP4 inhibitor.
Hi Susan- hope you are feeling well.
NKb- I’m not familiar with Dr Love but have followed Dr O’Shaughnessy a little. I try to follow as much as I can about lobular research like the trial for Crizotinib and some researchers like Dr Riggins and Oesterreich. Finally there is some focus on lobular. Yes the EP4 inhibitor is exciting!
ann1999- are you taking any hormonals currently? Dr O’Shaughnessy said that tamoxifen, exemestane and fulvestrant were inferior in ILC- wonder if she would use Arimidex with Afinitor in someone with ILC?
NKb- I’m on the Alisertib trial right now and only taking the Alisertib. When there is progression I can add Fulvestrant. I was on I/F for 3 months but had progression then went to Halaven but also had progression. Alisertib has kept things stable for six months.
Ann- great news that you are stable for 6 months! The Solar 1 study was good news also.
My UCSF appt has to be rescheduled 2 weeks further out- so am not sure what I will change to yet. Will keep learning and making my list of questions.
Thanks, Ann- How interesting!! When we looked at this just a couple of weeks ago, your trial was only available at the Mayo Clinic. My sister has a summer house on a lake in Minnesota, so I was already figuring I'd have to go stay with her to get on this trial. But now, the official NCI website has it listed as being available also at Dana-Farber (Boston):
Moreover, at another NCI site, it says you can also get the trial also at MD Anderson, or at two places in Washington DC ( but does not mention Dana Farber - go figure!)
It is phase 2 trial, so anyone on the trial will know exactly what they are getting in the way of drugs. To be eligible, you have to have had no more than two prior chemotherapy regimens in the metastatic setting, and you need to have already been treated with fulvestrant (so you would not go on it straight after Ibrance-Femara, but you could go onto it right after Ibrance-Faslodex), plus also you need to have "measurable disease", which I think means you need liver or lung mets, ie the cancer cannot still be bone-only mets? (If anyone knows about this, please chime in!). And for some reason they do not want anybody needing constant proton pump treatment (ie, you have to get off Prilosec for indigestion before getting into the trial).
But wow, not too many requirements! you don't need to test positive for Aurora A kinase over-expression or a PI3K mutation, so that's really great!!
I think you are right, the trial is doing really well and word is starting to spread and now the bigger cancer centers want to have it on-site. This will increase enrollment, so we will learn much quicker if it is as good as it seems right now! It will be fascinating to watch how fast a positive trial can move through the system. There is such a strong need for something to go onto after Ibrance-Faslodex, and it seems like this drug may work very well with few side effects or at the least, not nearly as bad as those one gets with Affinitor or other mTOR inhibitors?!
Side effects are mostly neutropenia, as with Ibrance, is that right? Plus, you mentioned hair loss? How bad is that, like do you completely lose all your hair- do you thiink its worse than Ibrance in that area?
yes - those new trial sites were a surprise to me. I lost all of my hair so bought myself a new wig. Had lost it all five years ago when DX with stage 3B so thought I deserved a new one! I had lost a little with I/F and cold capping helped a little bit with the Halaven but all of it went with the Alisertib. Interestingly I’m noticing a little growth which does worry me the drug isn’t working as well. I don’t really know if there is a correlation or not. I do miss my Prilosec but am able to get by with Tums or Rolaids. I have had a little increase in neuropathy in my fingers and toes...but nothing overly worrying. I’ll try to remember to ask about “measurable mets” - liver, lung , etc at my next appointment and report back. I sure wish we could get some written update on how the trial is working out - such a wait and see process.
Argh, its always something!
However, out of a total of nine patients who completed the phase 1 trial, they had three stay on treatment a long time (PFS of 25.9, 31.2, and 32.5 months, one of which was still in treatment at the end of the trial) and one patient quit after 14 cycles (unrelated to side effects), but she remained stable just on Faslodex alone at the end of the trial, and remember she had previously progressed on Faslodex alone, so the drug has some ability to carry-over.
Are you on 50 mg or 40 mg? And the phase 1 trial was doing a pulse regimen, taking the drug on Days 1-3, 8-10, and 15-17 of each cycle, in order to reduce side effects..
Hi all - Alisertib seems to be effective for a long time for some! Hopefully more can benefit soon.
Just dropped to 40 mg and the same schedule u mentioned three days a week for three weeks then one off. Pretty easy and doable! My neutrophils were too low so had to lower the dose.
My MO mentioned Alisertib has an effect that reawakens the tumor cells to Faslodex again (pretty layman terms🧐) So that isalso reassuring!
Just more information.
Thanks SandiBeach! I started an Alpelisib thread if anyone is interested in checking that out. I've so far been really happy with the drug. I'm on the BYLieve trial. Almost done with cycle 7.
Cycle Seven, already?!! What do you think of Alpelisib at this point, side effects, etc?
So far, it's been very tolerable. Would love to be on it for years. At this point, the hardest part is keeping my blood sugar down. At least that is something I can control, unlike low immunity that is a side effect of so many other treatments. No real side effects except for hair loss which I think is the Letrozole.
Thanks for checking in!
Susan- I am curious about what you are doing to keep your blood sugar down? Low carb diet? Increased fasting overnight? I am going to be starting Everolimus (afintor) which also has an elevated blood sugar side effect. Are you using a glucometer to check your fasting blood sugars? Were you given any guidelines about when (I assume Metformin) would be added to your regimen?
Have you had any cholesterol problems with Apelisib?
Sounds very encouraging so far!
I went on a semi Keto Diet. By semi, I mean that I wanted to do the Keto Diet but cheated some so I was only in ketosis about half the time (measured by using urine test strips every morning). Even so, my blood sugar as measured by my monthly Hemoglobin A1c test went down from 7.0 to 6.5 to 6.2. Have tests tomorrow. My fasting glucose level has been low the whole time so they are not worried that I am becoming diabetic. Apparently, once I am off the Alpelisib, my blood sugar should return to normal. They have not suggested that I get on metformin.
Depending on how you define intermittent fasting, I do try not to eat after dinner, so in general, I don't eat for 12-14 hours every day.
Yes, a long fast overnight is probably the easiest way to get sugar levels low and keep them there! A friend of mine studies this in detail, and has documented incredible benefits that can be achieved. Apparently, during the day you burn sugar, but after about an hour of water-only fast, you move to burning fat. And if you eat even a grape, you break that fast and go back to burning sugar and its an hour before you get to fat-burning again. The fast establishes the lowest sugar level of your body in a 24-hr period, and also the lowest cholesterol, etc, and apparently the body wants to get those numbers as low as possible in order to prevent the levels from going sky-high during the day. The lower you can drive down your nighttime sugar levels, then the more buffering or protection you have from them going up too high during the day, since both the drug and food will cause sugar levels to increase..
And yes, the Affinitor and Alpelisib are both hitting the same pathway, at different steps and hitting different targets, so they have somewhat different but related side effects. And I guess it means if you can't tolerate one drug you might try the other one, or if you get progression on one, you can still move to the other...