how are you doing?
I've had a lot of nausea the last week since starting. Lost about 3 lbs this week unfortunately. They finally put me on an anti nausea drug which is helping a tiny bit, but certainly not keeping it at bay. I bought some ginger, it's just not my thing I'm afraid. I am trying club soda with bitters which is helping a little bit. I'm hating this drug already....
GG27, I’m sorry you’re having unpleasant side effects. My mom gets pretty bad nausea on ibrance and she finds that alka seltzer gives her some relief
So sorry to hear about the nausea. Hopefully, your body will get used to it so you can stay in the trial. Have you ever made Rebecca Katz's Magic Mineral Broth? I lived off of that when I was going through Whole Brain Radiation and didn't want to eat anything. Here's a link to the recipe: Magic Mineral Broth
I had mouth sores on and off but not lately. Have had diarrhea if I eat anything spicy or greasy. But I love spicy, greasy food so keep trying it and having a bad reaction. Already can't drink alcohol or eat sugar and carbs and was losing too much weight.
thanks for the suggestion, I will try that.
Interesting looking recipe, I do make lots of homemade soups but that one is a bit different. I tried homemade chicken veg soup tonight & ended up with such bad stomach cramps, I'm not sure what to eat. I only had a small amount, I'm hungry now, but scared to eat.
It's hard when you have mouth sores or diarrhea or nausea. I told my MO yesterday that I know I'm a cancer patient but I don't want to feel like one! She gets it and is trying to help but there were so many restrictions on which anti nausea meds she could prescribe on this trial. I had given up carbs & sugar a long time ago, the glass of wine once in a while has now gone too. Ironically I had been trying to lose 5 lbs, don't have to try anymore. Thanks for the tips, take care of yourself,
Well if I didn't hate this drug already, now it's official. Was told to hold the drug for 3 days because I wasn't getting any better, worse in fact, then got hives all over my body. After holding, I was feeling better within 36 hours, felt like myself again. Saw MO on Tuesday was put back on 300mg. Within 20 minutes I had hives again, projectile vomiting, diarrhea, headache, lightheadedness, heart racing, had a horrible night. I've been taken off the drug for 2 weeks til my next appt. I think they will want to dose reduce me, maybe giving me 2 weeks to forget this horrific event?
Hope you're ok Susan.
Hey GG & Susan, I am sorry this new drug is so hard, but all of your detailed updates and info are very appreciated!. What do they say about the options for dose reductions, lots of us will need this drug and we all need a good QOL. Hope there will be info on Alpelisib at San Antonio next month.
I've had intermittent diarrhea but it's controllable if I stay away from greasy, spicy foods and take an occasional 1/2 an Imodium tablet. Have you tried Allegra? I know you said antihistamines upset your stomach. I think that has kept me clear of the skin rash. The mouth sores haven't come back so I haven't been using the mouth wash. So far, my side effects have been controllable and I've been able to live my "normal" life. Just worried about becoming diabetic.
Your reaction sounds very scary and it doesn't sound like a lower dosage would help. So sad this trial has been so hard on you. Looks like you haven't been on Xeloda. I was able to stay on Xeloda for more than two years with minimal side effects, just the super-sensitive hand and foot thing most people get, controllable by some simple regimens.
Good to hear from you!
Dee - I’m just catching up on this post. Not sure if you read back, but my experience was similar to yours (minus the nausea). Once I started getting the rash (which came with fever and just a terrible feeling) it became instant with taking the drug even at a lower dose. I had to leave the trial. I find it interesting that 2 of the 3 on this thread that have been on this trial had the same experience but Novartis claimed they had never seen anything like it.
That's interesting that you say Novartis hasn't heard of this reaction because I had 9 of the 10 "most common" SE's on the trial papers, I think I just had them to the nth degree. When were you on this trial? Did you get a copy of your trial agreement?
I am seeing my MO on Tuesday to discuss my next option which could be just a dose reduction. After what you are saying, I'm really scared of dose reduction.
The hives showed up almost instantly & the skin on my torso sloughed off after 5 days.
thank you for your input into this, I so appreciate it. cheers, dee
Hi Dee - The rash is common, but they had not heard of the allergic type reaction that I developed. I was fine for about 2 weeks and then got the rash. After that, I tried to start again 2 more times and the reaction was almost instantaneous. I didn't get a rash again (that I could see), but it was like my body went crazy (skin felt like it was crawling) and fever. The last try I did in the cancer centre so they could monitor me. They also loaded me with antihistamines. Nothing helped. My skin pealed off afterwards too.
I started on the trial at the same time as Susan (end of August). Yes, I had a paper copy of the trial agreement.
Just a warning, if you end up having too bad of side effects and have to stop the trial, they stop paying for the fulvestrant. My trial coordinator told them I had to stop the day before my fulvestrant injection and they refused to pay for it. I felt that was pretty poor patient support. Thankfully my hospital had a compassionate dose on hand while I worked out the insurance coverage.
I too feel like I had an allergic reaction, not just SE's. I took for about 10 days, then started feeling really bad, stopped for 4 days, then restarted & had the same immediate skin reaction as you but with the hives and then the vomiting started.
Did you dose reduce down to 200 or 100? Sorry for all the questions, I'm just trying to get all the info I can before Tuesday. I had asked about still getting fulvestrant and was told I would, but that sounded weird to me, I tend to think your experience is more truthful.
thank you so much for responding. cheers, dee
I don't mind the questions at all! I am happy if my experience can be helpful.
I reduced down to 200. We considered trying again with another dose reduction, but in the end my MO didn't think it would be any different. Also, even if we found a combination of drugs to manage the side effects, she didn't feel like that was sustainable for something you have to take daily (indefinitely). I really hope you have a better experience with the dose reduction.
My doctor and trial coordinator thought that Novartis would pay for the fulvestrant too and were surprised at the result. They felt terrible.
I just read over my trial papers again & the language they use is very confusing & I suspect I will have your same problem of them not funding fulvestrant. My MO said she would apply for funding from either the drug company or BCCA because I have done so well on antihormonals before.
I will post on the end result on Tuesday, but I have to say that I am terrified to restart the drug even at a lower dosage.
Last time they gave me an anti nausea drug which gave me nausea & diarrhea. When I called the trial RN, she said "oh yes, that can happen" ???? seriously? the SE's of an anti nausea is nausea? I feel like a lab rat.
Took the lowest dosage drug today & within 20 minutes, my skin feels like fireants are biting every single part of my body.
I think i'm done with this drug.
edited to add. I am off the alpelisib, but my trial nurse feels that I am allowed to stay on the trial just hold the alpelisib meanwhile still getting the fulvestrant injections which would be great as it's not funded here in Canada
Fireants … that is exactly what I experienced! What a great way to describe it. I thought I was going crazy. It's so interesting that we had the exact same reaction. Hopefully they take notice now that there are at least 2 of us
Sary, I was thinking of you today as my trial RN was telling me that she reread the entire trial & she has underlined the part where my MO has discretion to hold the apelisib indefinitely due to severe SE's while saying that I am getting benefit from the fulvestrant. She is meeting with my MO tomorrow at a conference & going to talk to her about it.
It would be great if that was the case, otherwise my DH & I have to figure out where we will get $1,000 a month from our budget, because we both believe that it's a good drug for me.
Ya, the fire ants thing, I experienced it before in Hawaii, horrible. I was hoping now that I was 7 hours out, they would be subsiding, but the half life of alpelisib is 7 1/2 hours which means about 35 hours til it's out of my system. It's too bad that I didn't throw it up today!!
GG27, I’m so sorry that is a really tough situation. It’s really lousy that youe physical side effects are compounded by this needless potential financial burden. I’m angry that the Canadian health system doesn’t fund fulvesteant. It’s been around for 15 years; it’s not a brand new treatment! Well, I’m glad you and your MO are finding a way to make sure you get the appropriate treatment
So sad you both had such horrible experiences. I asked the RN and trial coordinator about these side effects and she said they haven't seen them. Two out of the other three patients they have on Alpelisib (SOLAR-1 + BYlieve) had the skin rash. I think my MO said she has one woman who's been on it for four years! I am on cycle 4, 300 mgs/day. The mouth sores and diarrhea haven't returned. Knock on wood. Next scans December 6th.
The other trials she talked about before I got on BYlieve were for Gedatolisib (PI3K+mTOR) and NKTR-102 (targets brain mets). Hope you will both find the right next treatment soon.
I'm sorry to read about these allergic reactions. I'm still in the trial for the GDC-0077 (another pi3k inhibitor) plus fulvestrant after 11 months. My biggest SE seems to be from the metformin I'm on (diarrhea)
GG27 - I wanted to mention that in Alberta I knew of several people who have received fulvestrant through Astra Zeneca's compassionate care program. There were rumours that the program had stopped, but I hope it's a route that you can pursue. I was fortunate that on my first time with fulvestrant back in 2012 my private insurance covered it. Good luck.
All the best
NewGardener, AZ does have a compassionate program but it is for first line only, you cannot have been on any hormonal treatment since mets. My MO says that she was using this program, just fibbing about her patients being first line, but AZ is now requesting records and she is unable to get it for me under that program.
I'm not giving up yet, I will push to see if I can stay on the trial, but I sure cannot take the alpelisib. More than 24 hours later I still have the very itchy rash. Half life of the drug is 7.5 hours, so it will be close to 36 hours before it goes away.
Susan, I'm glad that you are able to take it. I have always been extremely sensitive to drugs & we thought I might have a bit of a problem with it, but never imagined it would be this bad. The only other person on the trial in Vancouver has been dose reduced because of the rash, but she is now doing fine on it at 250mg.
The GDC-0077 trial sounds very interesting. I hadn't heard of it before so appreciate your post. Looks like the two drugs, Alpelisib and GDC-0077 are very similar, both alpha-specific PI3KCA inhibitors. What were the factors that persuaded your MO to put you on metformin? My Hemoglobin A1c is 6.8 but she said as long as my fasting glucose level is normal, last was 87, she would not put me on metformin. My brother and mother are diabetic and I had gestational diabetes so I'm worried. The nurse told me that even if the drug put me into a diabetic state, that should go away as soon as I'm off the drug. Have you heard anything like that? I thought once you are diabetic, that's it.
I'm not sure I would believe that about diabetes going away. Also, a lot of people are taking metformin because it might help fight the cancer. There's a clinical trial but some oncologist are just prescribing it because it's a pretty safe and cheap drug.
Of course as long as it would not interfere with your trial. I just follow this thread for info on what might be coming along so if I'm way off base sorry.
They put me on metformin once my fasting blood sugar climbed above 8, after about 2 months , I think the units might be different.
But as HLB noted, there are thoughts that metformin itself might have anti cancer properties, thus my onc wasn't really unhappy about adding it.
Even on metformin my blood sugar is still over 7, and they added a secnd diabetes drug whose name escapes me right now. I have to admit that I have not rid my diet of added sugars as much as I should/could.
I think we are technically just hyperglycemic not diabetic because it is drug induced. My blood sugar rose to diabetic levels while I was on everolimus/affinitor and dropped as soon as I stopped.
NewGardener, you are correct, the reason the blood sugar goes up on the drug is because the body thinks the blood sugar is aberrantly low and is pumping it up through normal channels to 'compensate'. And if it gets the blood sugar high enough, then the drug actually cannot work, so you really don't want the sugars to get high. But off of the drug then the whole cycle goes away, this is nothing to do with getting diabetes. Just that for the duration of this particular treatment, you want to use all strategies to keep the sugar down so the drug can work.
Susan, how long have you been on this now- 3 or 4 months or so? How do you find it? obviously a more difficult treatment than I/F, however historically once we became endocrine therapy-resistant, our time was limited. Here you have the chance to reverse that resistance and potentially get back onto the anti-hormonals. So I wonder what your doctor says about whether you could go back onto something like Abemaciclib-Faslodex after this? It is so new, I guess its not clear what's next, and hopefully your body gets used to the therapy and you get years benefits from it...
PS Also, onclive put out a video interview talking about Alpelisib today- we know most of it, but there is going to be a lot of interest in it as it hopefully moves to FDA approval:
HLB, Not out of line at all. Appreciate your comment. Looks like you've been on only two treatments in six years. That's amazing! How are you doing on the Aromasin?
New Gardener, Thanks for letting me know at what level they started you on metformin. Would love to learn the name of the second diabetes drug.
Cure-ious, This is great information about why the drug causes high Hemoglobin A1c levels. Wonder why my fasting glucose is normal? I'm in the middle of Cycle 4. I haven't found it to be difficult. Had a few mouth sores, occasional diarrhea, swollen face for half a day. Nothing terrible. If I can stay on it for years, that would be fabulous. Will ask Hope what she thinks about reversing my endocrine resistance. I/F kept me stable but never shrank anything the way Alpelisib and Tamoxifen did. Will take a look at the Onclive video. Thanks for sending the link.
Susan, I have been on more treatment but cannot figure out how to add them! Here are my treatment so far:
Letrozole, aromasin (refused affinitor), sbrt to two spinal areas during aromasin, ibrance/faslodex, Xeloda, and now starting yesterday abraxane. I've had XGEVA every month since the beginning.
I appreciate the info from everyone about the a1c, had no idea. That was one reason I didn't take affinitor, that and pneumonitis. I was feeling so normal on my first treatment and it pissed me off they wanted to put me on that for only the 2nd one because I was so afraid of it. I was like "diabetes! No thank you" !! At the time ibrance was not approved yet and my oncologist will not use anything until it's approved.
Susan, I was reading some of the early data (which will probably be updated next week at SABCS), and thought this was interesting:
The combination of letrozole and alpelisib showed sustained clinical activity: 35% of patients remained on treatment ≥6 months and 31% remained on treatment ≥12 months.
To me, that suggests that the vast majority of those that respond to the combo (defined as stable or shrinking at 6 months) are still doing well at one year (35% vs 31%), and that is super-encouraging given that you already have some signs of it working! On the other hand, a significant number of people are dropping out at the start, presumably because its not working (altho because of the side effects also)
So why would it not work? For one, some of those early patients did not have the PI3K mutation, which at this point is clearly required for response to the drug. In addition the literature says Alpelisib (when taken with Femara or Faslodex) works well even if the cancer has both the PI3K and ESR1 mutations, but will not work if the cancer instead has TP53, BRCA1 or KRAS mutations, or amplification of FGFR1. The PI3K and ESR1 mutations, alone or in combination, are rarely seen in primary tumors but commonly appear in the cancer that has managed to escape the effects of the Ibrance-Femara.
Thanks for the periodic updates, very interested in this drug combo and whether it will get approved by the FDA anytime soon.
I now know of 3 people who have had to drop out before the end of the first cycle because of the brutal SE's. I got in 10 days. The last dose I took was the lowest dose, one only, took 5 days to recover from not including the day that my skin peeled off after rash.
GG27/Dee- Ouch!! Those trial numbers are consistent with your experience and what you are hearing. It seems like they are losing like 65% of their patients right up front- at least within the first six months, and for or all we know within the first three weeks. Surely that is unusually high (?), and for too many people the side effects are way too harsh.
Of course, it's a new drug (first in class) targeting the PI3K mutation, and the pharma companies have spent (llterally) a billion dollars trying to develop drugs to this target, its really a common way cancer escapes estrogen inhibitors. They must know they need to improve on this trial, find a better formulation, I forget what the PFS for Alpelisib-Faslodex combo is, but it was longer than what was reported for Affinitor-Aromasin, which is the only other drug we have to hit that particular pathway right now.
The CDK7 and CDK12 inhibitors may have some overlapping molecular targets to the PI3K/mTOR targets so I'm hoping they will get some promising results, which might provide an alternate way to go...
Also, mutations of CDK12 were recently shown to make cancer immunogenic and respond to immunotherapy, Its not a common mutation but still worth having any new biopsy tested specifically for a CDK12 mutation, because there is a basket clinical trial that will treat any type of cancer that has a CDK12 mutation with a duo combo immunotherapy (Opodivo-Yervoy). Don;t know how well (or not) it works, but worth watching. And if it does work, will a CDK12 inhibitor make MBC respond to immunotherapy?
Do you know yet what will move to next?!
The sustainability of Alpelisib+Letrozole is very heartening. Thanks for sharing that info.
I actually have the TP53 mutation. Here's a screenshot of my UCSF 500 results:
Would love to hear your opinion about this.