So sorry to hear about the rash. My trial coordinator said that 2/3 of the people she's seen on the trial have gotten a rash. How are you doing now that you're taking a break? Did it go away right away? Can you have a dosage reduction?
The combination of stopping the Alpelisib plus the steroid and antihistamine cleared up the rash quickly. I had 4-5 bad days in total. The first step in the protocol is to re-start at the same dose while continuing the antihistamines for at least 30 days. If the rash comes back, then I think I would try a lower dose. It's been a nice little break, but I'm going to start up again tomorrow. How are you feeling?
Glad your rash cleared up. Which antihistamine did they put you on? My MO wanted me to take Claritin but I know that doesn't work for me so I've been taking Allegra. She told me to take a double dosage. One 24-hour pill every 12 hours.
I've been feeling better. I thought the side effects would just keep building up but my fatigue seems to be letting up a bit. Mouth sores and head aches gone. Knock on wood.
Hi Susan - It appears I may have to abandon Alpelisib. I tried restarting on Sunday but that didn’t go well. No rash, but my skin was crawling (not sure how else to describe it!) and i got a fever. I was out of commission for 2 days. I took it with Reactine/Zyrtec. Tried again on Thursday at my MOs office with a lower dose and the same thing happened (within 10 mins of taking it). Not sure if it is worth trying it one more time. I’m glad it is going well for you
So sorry to hear what you a have gone through. And I will miss having someone who is going through it with me!
I trust that your MO will find you another good treatment. Doesn't look like you've been on Xeloda or the Affinator/Aromasin combo yet. I was on Xeloda for over two years without any terrible side effects.
Wishing you the best.
Big Hugs, Susan
I have officially been removed from the study. It was quite disappointing to have to do this, but I obviously couldn't keep going with the allergic reaction. Thank you for the encouragement, Susan. At this time, I will stay on the Fulvestrant (I had not been on it before the study) and I am likely also going to pursue SBRT. I will keep the other ideas in mind for down the road. I will be interested in following your story. I hope this drug is very effective for you.
Susan, how are you doing?
Just dropped in to ask Susan how she is doing, as well! The data for the Alpelisib SOLAR-1 trial and will be released at ESMO18 next week, so we can finally see how this drug fared for PFS
Daniel86 and Cure-ious,
Thanks so much for checking in! Last night, I got my first CT results since I have been on this trial. I have had a dramatic and positive response to Alpelisib! My one new lung tumor has disappeared and the older ones have all shrunk by a significant amount. No new tumors. Still waiting for my brain MRI results.
After a few bouts with mouth sores and an incident of face swelling (that we think is from the Letrozole), I haven't had any other side effects. Some fatigue but it's hard to say that it is because of the Alpelisib.
Hoping this trial will eventually help a lot of other women!
I will be starting the BYLIEVE trial next week on fulvestrant. I was on an Ibrance/Femera trial for 30 cycles & found it very doable, kept my bone & retinal mets stable, but let in a pesky liver lesion. I am hoping for the same on this one.
I hope to see more than just a couple of us doing this trial. I know at the cancer centre I'm at, there are only 2 of us at the moment.
Whoop, whoop, whoop!!!! Congratulations Susan, I logged on just to see if you had popped back up, was starting to worry!!! And Kudos to Dr. Rugo for fighting SO HARD to get you into the trial (twice!), it might well not have happened if you had an ordinary mortal oncologist.
Have you had any of those reported problems with blood sugar levels? Are you doing anything particular with diet or fasting to prevent blood levels of sugar from going up? And also, other side effects?! Hoping for great results from brain MRI..
PS The numbers for Alpelisib-Faslodex from SOLAR-1 will be released at ESMO18 next week. I looked up the numbers from the much smaller phase 2 trial:
In the PIK3CA-altered population, the disease control rate (ORR plus stable disease) was 80%. The clinical benefit rate (ORR plus stable disease >24 weeks) was 45%. In the PIK3CA wild-type arm (n = 32), no patients experienced a response.
They reported 9 months PFS on the combo compared to 5 mos on the Faslodex alone, and this group of tested patients were pretty heavily treated already, so it will be interesting to see if they get even better numbers. Also they know to monitor the sugar, might not have been doing that in the early trials.
So far, you are the only one I've been in contact with on the trial. Sary, was on for a short time but had to drop out due to side effects. I would guess there are others at UCSF but haven't met any of them. Did your MO introduce you to the others? Looking forward to hearing from you about how you are doing. Please keep us updated.
So appreciate your continued support! I have had diabetic levels of Hemoglobin A1c. 6.5 where anything over 6.4 is considered diabetic. At the same time, my fasting glucose levels have been well within normal ranges. I try my best to reduce my sugar and carb intake but find it difficult to follow too strict a regimen. I suspect I will soon be put on Metformin. Other side effects have been mouth sores and swelling in my face. I woke up one morning and it looked like I had been given massive doses of lip injections! Scary but temporary. Right now I don't have any side effects besides a moderately loose stool. I take a double dosage of 24-hour Allegra, one pill every 12 hours and use a dental paste, steroid mouth wash, and antiviral medication for mouth sores as needed. Can't wait to see the stats from SOLAR-1.
thanks for posting your SE's, it helps me to know what to ask for as far as remedies. I am 6 hours each way from my cancer centre, so I can't exactly pop in. My trial nurse was the one who told me there was only 2 of us so far, but I think the trial only just opened here in Canada.
Tomorrow is when I kind of find out everything. They are doing an ECG, Muga scan, first fasting labs etc. Fulvestrant shots in a week.
Cure-ious, thanks for all the info, I too look forward to the report. My MO says it's very encouraging.
Susan- There are studies showing that just with eating a regular diet but stop eating everything except water at 6:30 so you have a prolonged nighttime fasting is in tests good for as much as a 1.5 point drop in A1C levels. Don't restrict regular eating and fill up at 6:30 so you aren't hungry and that part is really not a problem. I have done it sporadically in the past, and drink fizzy water instead and go to bed early if you get hungry, it is a manageable thing (well, unless you have to make dinner for kids etc). The occassional dinner out is fine, but keep with the schedule on weekends otherwise.
Also, metformin might synergize with this drug for reasons that go beyond the blood glucose control, and it has had intself anti-cancer properties, so I would not hesitate to take it, if that is necessary. A report in the literature says that metformin works literally 1000 times better in a fasted cell than in the presence of high sugar, so adding it in combinatino with nighttime fasting would be the most effective.
The main thing to remember is that this attempt by your body to re-wire its metabolism is because it is seeing what the drug is doing and trying to counteract it by bumping up the sugar, and if it succeeds then the drug will become ineffective. So fight the sugar off, and I would prioritize trying the nightime fasting before worrying about the diet too much, just avoid obvious sugary foods and otherwise eat normal, see if that can work.
The other side effects, rash? and all the rest, we are curious what the docs say they are seeing with other patients as well, and whether they ease up with time on the drug.. thanks for all the info!!!
Do you have anymore information on metformin and fasting? My mom has been taking it pre-diagnosis.
Metformin is complicated because you have to take with food, esp at the beginning, to avoid the side effects- however, in the petri dish it works way better on a fasted cell than a fed cell- so, some people who already are adjusted to metformin have found that they can move their after-dinner pill to a bedtime pill and get better blood sugar numbers. But I think you'll see a much bigger effect by limiting the number of hours per day that you eat food (not dieting or changing diet, just eating whatever you need to be full but then stopping and burning it all off for a 12-14h fast every day).
Below are some links about the time-restricted feeding- the main thing is to do a fast for 12 or more hours in a 24 h cycle. Our bodies were designed for a strong circadian rhythm that is reinforced with food. When mice were kept in cages and given the same number of calories (a high-fat diet where each mouse ate the same amount of food, but in one cage the food was available 24 hr vs the other cage it was available only during their normal nocturnally active time period, then the mouse had to fast until food was available again)- and the 24h feeding led to diabetes and obesity and bunch of other problems versus int he other cage the mice were normal and lean, no problems, despite eating the high fat diet, because they had the chance to burn off what they did not use!! So if you want better sugar control a scheduled fasting every night can do miracles. Like I mentioned they have been testing this clinically now and its good for a reduction in A1C that is as good or better than drugs, and that will make the metformin work really well too.
The first numbers on Alpelisib in the phase III SOLAR-1 trial came out at ESMO2018!
In brief, the PFS nearly doubled from 5.7 months to 11 months for patients with PI3K mutations (which is very common in advanced breast cancers)
Note that as more time goes by and more of the people who responded very well progress on the trial, that PFS difference may go even higher
The trial did not allow for prior fulvestrant use or prior chemo in metastatic setting, so these patients were probably mostly first or secondline
I start on Tuesday. Fasting labs, ECG, appt with trial RN & Dr, then loading doses of fulvestrant. Not sure when they will give me the alpelisib, but I am to have it with food. At this point there are only 2 of us on the trial at Vancouver but I'm sure more will join.
Cure-ious This will be my second line, first line was arimidex alone, then I joined a trial of Ibrance/Femera, still considered first line because I did not have progression, we just changed things up.
Hey Dee- Good luck!! This is definitely the trial to join if you have a PI3K mutation- I guess the question is when will the FDA approve it so that (at least here) we can get it without being on a trial. However, in the meantime you and Susan there can bring up the averages by stretching out the time to progression! Do keep in mind that on this drug you want to be careful about the blood sugar and it sounds like just careful overall about the side effects, main thing is to keep them in check if possible (things like rash are obviously not under your control!)- but regardless even a short time on Alpelisib should push down the PI3K pathway and make the cancer ER-driven again (and therefore sensitive to Faslodex)...
Thanks for the tips on lowering my blood sugar levels. My Hemoglobin A1c went up to 6.7 last week but my fasting glucose level was still low so Hope said to hold off on metformin. 12 hours of fasting is easy for me. I sleep 9-10 hours a day! I wasn't eating between roughly 7pm to 7am but started eating more, smaller meals because they told me that that would stabilize my glucose levels. The more, smaller meals thing definitely isn't working so I will go back to a 12 hour fast.
You might want to start on antihistamines now. I've been taking one 24-hour Allegra twice a day, so a double dosage. My MO had me start as soon as it was clear I would be on the trial. Haven't any rash issues. Steroid mouthwash once a day might help prophylactically as well.
Thanks for the tips Susan.
I'm going to hold off on the antihistamine for the moment as they don't sit well with my tummy. But I will definitely take my magic mouthwash with me.
I already eat low carb, was paleo for a long time but eased up a tiny bit on eating potatoes once in a while as a treat, like half a baked potato or homemade pasta once a month or so. A friend of mine is a diabetic RN & she said as long as I have these as a treat & eaten with good fat, it shouldn't affect my blood sugar too much.
Here's a link to Hope Rugo's summary of breakthrough trial results presented at ESMO 2018. She talks about the SOLAR-1 Phase II trial of Alpelisib.
You can also watch the actual presentation at ESMO by the primary researcher, Fabrice Andre, here:
Very exciting results!!!
So I had my first shots of fulvestrant yesterday & first 300mg dose of Alpelisib. Within an hour of eating & taking A, I was very nauseous & couldn't eat dinner last night. This morning I felt a little bit better til I ate some oatmeal & a half a banana, then the nausea started again. I got permission from the trial today to try gravol which is having a limited success. I need to be able to eat dinner as I have to take a blood thinner for a clot. I missed it last night because food turned my stomach even more. Any advice other than prescription meds which they may prescribe tomorrow.
So sorry to hear this. So far, I've only been nauseous during one meal. But my appetite has been very low. I've lost 10 pounds since I started the trial just a little over two months ago which is a pretty significant percentage of my body weight. 122 to 112. My MO told me to try to stabilize my weight but with a reduced intake of carbs and sugar I'm finding it hard to gain weight. My Hemoglobin A1c has been very high, 67 at the last reading. Strangely, my fasting glucose levels have been normal.
My go to for nausea is ginger. Pickled ginger, fresh ginger, ginger tea. Doesn't really matter what form. Have you tried it?
I tried ginger gravol which helped for about 1 hour. The package says up to 6 per day, starting with 2, I was able to eat a bit of chicken soup & a piece of bread with butter on it, enough to get my blood thinner down. I'm just about to go to bed, but the nausea has kicked up again, hopefully I'll sleep through it. I hope this is just a temporary thing til my body gets used to things. thanks for the suggestion, I'll pick some up tomorrow.
Had some diarrhea today and realized that I don't know what to eat that is low carb and easy on the digestion. Did a Google search of "BRAT diet for diabetics" and it basically said 1 serving of banana and/or heavily boiled vegetables. And I'm supposed to stop losing weight at the same time?
Any tips would be appreciated!
I've had a lot of luck controlling the big D with soluble fiber. I use inulin powder in my beverages because it takes the loose contents of one's large bowel and turns it into a kind of gelatinous plodge. That same hydrophilic nature makes it good for constipation as well.
Avoid insoluble fiber. In our house, we call it "colon blow". I'd list the different foods and what kind of fiber they have, but google does it so much better.
don't know if you eat dairy or not, but I eat some cheddar at lunch almost everyday, it provides "stopping" power as well as some fat & protein.
Thanks Jennifer and Dee! Learning so much through this thread!