Alpelisib
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Hi everyone,
Just wanted to let you know my mom started her trial today taking alpelisib + letrozole. She is taking 300mg of the alpelisib. Fingers crossed!
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Thanks Theresa!
Looking through the qualifications, it looks like I would qualify. Trying to stay off of IV treatments for as long as possible.
Hugs, Susan
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I just listened to a medical oncology podcast with Dr Neil Love who was interviewing Drs Sarah Talany and Charles Geyer (not sure if spelling correct in either.). Among other things they talked about whether they would use Alpelisib after progression with q CDK4/6 inhibitor In someone with a PI3K mutation once it was approved. They said that they would and mentioned that a few of the patients in Solar 1 had failed a CDK4/6 drug- they said that they better start testing these drugs in people who failed Palbo etc in the first line, because these drugs were going to be second line drugs- they were not going to be given instead of a CDK 4/6 as a first line drug. Makes sense.
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In the trial literature I was given, one of the qualifications was that you had to have failed on a CDK4/6 & have the PIK3CA mutation. That is the BYLIEVE or whatever it's called now (they changed the name partway through) So that is what this new trial seems to be partly testing for. Also dosage & SE's.
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When I was at my appt on Thursday, I had to resign my trial paperwork because there was an amendment to the Alpelisib trial. There is now a 3rd arm. You still have to have the PIK3CA mutation but you can have had chemo prior. It may open up the trial to more women.
I don't know if this applies just in Canada but if you weren't able to access the trial previously because of prior chemo, you may want to ask about this.
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GG27, SusaninSF, and others who have taken apelisib..... What was the specific mouthwash that you took to manage the mouth sores? The MO has prescribed Magic Mouthwash which worked 1 week, but then the mouth sores came back once my mom stopped rinsing w/ the mouthwash. When she got the 2nd prescription of the Magic Mouthwash, it has not taken the mouth sores away.
in other SE: My mom is 6 weeks in and has managed the rash by taking Claritin in AM & PM and occasionally using a creme. She also has had to start taking metformin to bring her fasting glucose down. (before apelisib it was 99, then after 1st week up to 154, and now down to 119 after taking metformin consistantly)
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likestobike, I've never been on Alpelisib, but have been on Afinitor for 3 years. Mouth sores are a very common side effect of Afinitor as well and I was able to control them using a daily probiotic. Maybe you could try that out?
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likestobike,
mouth sores were the only side effect i didnt get on alpelisib. But I did get them on Ibrance. I used magic mouthwash whenever I could feel one coming on and used it for a few days after it was gone. Sorry I don't have more info for you.
GG
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likestobike,
Has your Mom used a dental paste? That worked the best for me. There are several different formulations of what is called "Magic Mouthwash". I tried two. One is basically Lidocaine and Pepto-bismol. The other has a steroid. Neither worked for me, mainly because I couldn't keep it in my mouth for the 10 minutes or whatever that was required.
I saw a Dermato Oncologist, someone who specializes on skin problems for cancer patients. She said that Zyrtec works best for skin problems. I was taking Allegra when I was on Alpelisib and didn't get a rash while was on the trial but got a horrible itch and rash a few days after I got off of it. My MO says she hasn't heard of anything like that happening after getting off the trial. The dermatologist thought it was an immuno response after getting off of Alpelisib.
I was able to control my blood sugar by greatly reducing the carbs and sugar in my diet. My MO said that Alpelisib won't give you diabetes. Once you are off the drug, your blood sugar will come back down. That has been the case for me. I'm back to eating carbs and some sugar and my blood sugar is back to normal.
Wishing the best for your Mom.
Hugs, Susan
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Thanks SusaninSF and GG! Appreciate the info
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FDA OKs Novartis' alpelisib for certain type of breast cancer; shares up 4%
May 24, 2019 3:54 PM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor
The FDA approves Novartis' (NVS +3.7%) Piqray (alpelisib), a PI3K inhibitor, for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative PIK3CA-mutated advanced or metastatic breast cancer in patients who have progressed after receiving endocrine-based therapy.
The approval is the FDA's first under its Real-Time Oncology Review pilot program.
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Wow, this is great Susan! Thanks for posting it! There are so many of us on here that have the P13k mutation and this can hopefully buy us some time.
Hope you are doing well!
Ann
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I did well on Alpelisib but started progressing after five months. Stayed on it for another scan and when that showed more progression. Got off. A few days after getting off of Alpelisib I became terribly itchy and broke out in rashes on the sides of my hips, my knees, my forearms and my neck. My back was very itchy but didn't have a rash. Steroid pak didn't help. Tried all sorts of creams. Finally, on the advice of a Dermato Oncologist, Bernice Kwong, at Stanford, I switched from Allegra to Zyrtec and started using Triamcinolone cream and it went away that same day. My MO said she'd never seen a skin rash after stopping treatment. Many people get a rash just after commencing treatment. The Dermato Oncology doctor said she thought it was an immuno response to getting off of Alpelisib.
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Sorry to hear that. I was following your journey with Alpelisib during the trial and remember you mentioning the progression and rash. I actually have the FGFR1 amplification so I think the chances of Alpelisib working for me might even be slimmer. Hopefully there are some of us here that can benefit more from it. Always happy to see a drug come through and getting approved because it offers some hope and ease of access to the medication.
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SusaninSF, how are you doing on the Paclitaxel?
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Thanks to YOU, susan, and everyone else who was part of the trial, its because of you guys directly they were able to make this available to everyone! And the advice and information on the rash and blood sugar issues is invaluable!!! after spending literally a BILLION dollars trying to get something, anything, for treating PI3K, pharma can take a big breath of relief, but for us, I'm just hoping this means they will finally get busy and start designing combo trials, with Alisertib for one, and see if dose reductions can help. I guess it won't change the blood sugar problems, because those are due to direct effect of the drug hitting its target.
Anyway, Susan, who knows, you may come back to Alisertib in some type of combination. At least you know how to handle it!
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Just found out that my first scan after getting on Paclitaxel showed progression. Strangely, my pleural effusion went away but several of my nodules are larger. Guess it doesn't matter too much that I got the IV instead of the oral Taxol. For some reason, Taxol didn't work for me.
Thanks Cure-ious, for your kind words! Back, again, looking for my next treatment...
Hugs, Susan
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Susan - So sorry to hear about your progression. That is hard news.
Just wondering, how long do you give a treatment before you know it isn't working vs progression still from the previous one that didn't work? I guess said another way, how long did you wait for your scan? Since my alpelisb fail, I haven't found stability yet. On afinitor now, but lots of delays (rads then mouth sores) so not sure what next scan will really tell me. (I’m also curious to see if my sensitivity to alpelisib will also translate into bad side effects with afinitor ... I will report back!)
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I too am sorry to hear of your progression Susan. Good luck on your next treatment. Let us know what that us.
Sary, I would be very interested to hear how you do on afinitor. I have had 9 months on faslodex without the alpelisib but I based on my last scans I may be heading for a new trial or afinitor/aromasin. MO wants me in the new oral faslodex which is paired with Ibrance after first progression even though I've had ibrance before.
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Sary- are you doing the alcohol free steroid mouth wash with the afinitor? The protocol is to use it four times per day for the first 8 weeks. I did that and got no mouth sores. No longer using it for month 3 and no mouth sores.
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Hi Susan,
Thank you for the update, though I really really wish it was better news for you.
I just had another scan and while there's been some progression, it's below the threshold so I'm still in the trial with the pik3ca inhibitor (gdc-0077 in my case). I just started cycle 19. For my next treatment, I have been wondering about trying abemaciclib (which is finally available in Canada), a repeat of a cdk4/6 inhibitor. My oncologist and I also discussed whether I should have another biopsy. What ideas are you and your oncologist thinking over - another chemo or have you thought about repeating a cdk4/6 inhibitor?
Fingers crossed that something good comes up for you.
Heather
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Nkb - Yes, I was swishing 4 times a day. The problem was that I had just finished radiation to my jaw, so the inside of my mouth was damaged - the sores were only on the side of my mouth that had radiation. It was definitely a mistake to start the afinitor right after finishing rads. Live and learn! I am taking a 2 week break (after only being on it a little over a week).
FYI - I repeated a CDK4-6. I had been on Letrozole/Palbo, then when that stopped working I switched to fulvestrant/alpelisib. When I had the bad reaction to alpelisib, I stayed on fulvestrant alone. At my next scan I had bone mets (healing or progression?). Rather than switch treatment completely, I decided to add in Ribo (no studies to back the decision ... just a hunch). I guess the Ribo bought me 4 or so months. Now I've had more progression, so on to affinitor/aromasin. I feel like a lab rat.
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Thanks Sary! I'm hoping a repeat might work for me too when it comes time.
When I was on afinitor/everolimus my oncologist just reduced my dose to keep the mouth sores at bay (I started it the month it was approved for funding in Canada - back in 2013!...they hadn't sorted out the mouth washes). Hopefully your mouth will heal up quickly (it tends to) and you can start up and it will last awhile for you!!
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Sary,
Sorry about your recent progression. Good to know that you were able to buy an additional 4 months by adding Ribo to your Fulvestrant. As you probably already know, on trials they normally have a threshold amount of progression based on the RECIST measurement protocol. With this protocol, I believe they choose the largest non-radiated, measurable tumor and base progression on that percentage change since the trial start. Surprisingly, though my CT scan showed a mixture of progression (larger pleural nodules in my lungs) and regression (disappearance of pleural effusion) versus my last scan two months ago , my RECIST report, that came out today, showed minimal progression, within the limits of the trial. This is the oral taxane trial where I got randomized to the control group, IV paclitaxel. I got on this trial after progressing on Alpelisib.
As I was writing this, a revised CT scan report came out saying "The extent of pleural involvement has decreased compared to prior study." So they completely flipped their findings after being questioned by my MO! Good news but I was already skeptical about my radiology reports, now I have zero confidence in them.
Heather,
Cycle 19! That's fantastic! To answer your question, I'm having another lung biopsy. My brain, eye, breast and bone sites of mets have all been stable so I'm wondering if my lung tumors have morphed into something different. Not scheduled yet. My last one was in 2016.
Though I technically don't have to get off the trial, she wants me to switch to Abraxane. 2 weeks on/2 weeks off. No Affinitor/Aromasin until my tumors shrink. She is also hopeful that some new ADC (Antibody Drug Conjugate) trials will be coming out in July.
Hugs, Susan
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Hi Susan, that's a hard scan report to navigate:( Good luck with the biopsy and also with the new treatment.
Heather
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All-- 2 weeks ago my mom's 2 month CT (with contrast) showed that her liver and lung lesions had decreased, but she possibly had drug induced pneumonitis. The MO recommended stopping the alpelisib for 12 days , continue taking the letrozole and then come back for another CT (without contrast) to see if the pneumonitis cleared up. She didn't have any physical signs, no coughing or shortness of breath, just pneumonitis indication on the CT scan.
We saw the MO yesterday and the new CT scan (without contrast ) showed the pneumonitis had cleared up, but 2 of her liver lesions had grown by 1 cm just in the course of these 14 days she's been off alpelisib!
So my mom is off the alpelisib/ letrozole trial and MO is recommending Xeloda 1500mg 2x day. He may put her back on alpelisib at a later time once the Xeloda has gotten the liver lesions under control.
Are CT scans with contrast and CT scans without contrast comparable? MO said he talked to radioligiost and discussed it and they all agree that mom should stop the alpelisib for now and start the Xeloda. It's just odd that she had that much growth in such a short time..
In good news her glucose and creatinine went back down to normal levels after stopping the alpelsib. She's continued to have a skin rash, but it's been manageable taking Claritin 2x day and using the prescribed creme.
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Wow ... that is really bizarre. I'm sorry to hear it. Thanks for sharing your experiences. I don't know if there is a difference between CT with and without contrast, so I'm not able to help you with that. I can say that I don't have a lot of confidence in the way radiologists read scans, so hopefully your MO took a look at the scan as well.
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Hi All,
Monday's PET showed more progression for me on A/A, so mo wants to try Alpelisib and Faslodex next. I can't thank those of you on this thread (and especially SusaninSF) enough for all of the great info. It makes this tx change much less scary that it would have been without your input. Thank you!!
Jo
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Jobur- i am sorry to hear of your progression!- I wondered how you were doing.. I am very interested to hear how this combo goes for you. will you take the shots of faslodex or can you get the oral - outside of a trial?
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Hi nkb! I have been wondering how you were doing too. The A/A thread has been quiet lately. I will keep you posted on how this new tx goes once I start it in 3 weeks or so. Looks like we have been on exactly the same treatments so far. Hope you get a longer run on A/A if it has continued to be tolerable for you. Have you had a scan yet? I assume it will be back to shots for me. Do you know if oral Fas is available outside of trials? It wouldn't break my heart to take a pill instead of those 2 big needles! Hope you are feeling well and enjoying summer. Jo
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