Ibrance schedule 5/2 days.

[8576]

Has anyone been put on this Ibrance schedule because of progression of cancer? Or was it strictly due to low neutrophils?

Cheers, June S.

[Timtam56]

I had low neutrophils but my onc just dropped my dose from 125 down to 100 mgs. I’ve never heard of it. But I think someone here mentioned it recently.

[8576 in reply to Timtam56]

Thanks for the reply. It happens often that Ibrance doses need to get lowered because of low neutrophils. I had that problem as well as some slight progression in my left lung. So my oncologist absolutely won't continue on Ibrance because the progression happened over two scans.

I feel we haven't given Ibrance a chance as we have been constantly changing the dosage till now and having weeks off in between for my neutrophils to recover.

I am so disappointed and upset. I feel the 5/2 regimen would have worked. It has been very successful for some people on this forum.

June S.

[Rotagirl in reply to 8576]

Hi June. What exactly do you mean by 5/2? I am on ibrance for 3 weeks and have 10 days off because the neutrophils stagger to get up to 1 in a week. In fact last month I had 13 days off. I am on 100mg. I am awaiting a CT result and if it is still working I think the oncologist will drop my dose to 75mg. If there is progression that will be change all round I think. I have been on ibrance for 26 months. Good luck with it all. Fay

[8576 in reply to Rotagirl]

Thanks Fay. That means 5 days on/2 days off. It is a a new regimen not yet published but trialled by a University School of Medicine in the States and Pfizer because so many of us had to have our doses lowered or discontinued. This regimen does work very well but the results of the trial, which ended last year won't be ready for publication until early next year.

My point was my progression was slight and could have been because of not taking the doses regularly because of low neutrophils.

Hope that makes my position more clear.

Cheers, June S.

[Half-Full]

I would like to know this as well. My wife is showing some new ground glass opacities in her lungs. Her once says she doesn’t think it’s cancer but her usually stable tumor markers are also increasing. Changing the iBrance to 5/2 would certainly preferable over starting an entirely new approach, but I’ve only seen very few anecdotal references to this 5/2 protocol so far. Hope to hear more from others.

[8576 in reply to Half-Full]

Everyone is different and your doctors know best. The trial for 5days on/2 days off was done at the Washington University School of Medicine . The trial finished late last year. The results have to be tabulated and will not be published until 2021. There are some people on trying this regimen and it is working very well for them. I am sure there are people that it doesn't work for. Your doctor has to decide.

Cheers, June S.

[hdhonda]

Did the 5/2 schedule ever leave the earliest studies. There was some question of efficacy

of this dosage. I would call Pfizer and ask them. That way you are getting the answer from the horse's mouth. Best of luck. Blessings, Hannah

[8576 in reply to hdhonda]

Thanks Hannah. I don't think I understand your question.

The trial was completed last year. The results have not been published. Some people are trying it already. The trial information and the thinking behind it are published in ClinicalTrials.gov.

You can look it up. under Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer. See other posts here for the name of the university in collaboration with Pfizer. So it is a legitimate source.

I hope that clarifies the question. Thanks for the good wishes. I am thankful for them.

Cheers, June S.

[hdhonda in reply to 8576]

I am not really asking a question other than if the trials are completed. Once they are completed, then studies have to be done on the efficacy and that takes quite a while. The last step would be FDA approval. I had asked both of my oncologist when this was first talked about on this board, but that was before the trials were completed. Both suggested waiting for FDA approval. I will be seeing the one at Moffitt Cancer Center in Tampa this coming Tuesday and I will try to remember to ask him. He has been involved in some of the Ibrance studies. Will try to remember to post as soon as I get to the car. For some reason it seems to be that the 5/2 would be easier on the blood counts and hopefully still kick the cancer's butt. You have created a popular string of posts. Blessings, Hannah

[8576 in reply to hdhonda]

Hi Hannah. Your oncologist are right the very best thing to do is to wait for FDA approval of any drug dosage. I don't know why some people have already been put on this dosage. For me, it is try this, invalidated as yet, dosage or quit Ibrance. The thinking behind this test makes sense to me in my situation. It may not be appropriate for another person. So many factors have to be taken into consideration.

From a part of the notes of the University it says: investigators hypothesize that 5days on/2days off schedule is more tolerable with less frequent high grade neutropenia and dose interruption/reduction. (end of quote).

I have been told that others in Canada are on this dosage and doing very well. In fact everyone, I have heard from is doing well on this dosage! So very encouraging. Also, I feel that I have nothing to lose in trying it for 6 wks. or two months and then repeating the scans.

BUT my oncologist will have none of it.! Darn!!

Cheers, June S.

[Smokeyd in reply to 8576]

I know this is an old post that I just happened across, but I am in the same train of thought as you and my Onc would have none of it either! ( even though now in 2023 I believe it might even be FDA approved in US!) Onc said after 1st line treatment had progression to liver (3 small spots, originally mainly just bone mets, on Letrozole+ Ibrance for 18 nths 1st line), the standard of care 2nd line treatment is Taxol IV chemo! It seems worth a try to do 5/2 schedule before bringing out the ' big guns' chemo?! I'm so confused as it seems alot of women on this forum from US are offered other oral meds/targeted drugs +hormone therapy before chemo?! I feel like the treatment in US is very different than here in Canada? Another difference is they seem to be offered more trials, the thibgs that make you go hmmmmm!

[Canchondo]

Good morning, as always I wish the best of luck to everyone on this forum. My opinion: I’m not sure why Oncologist continue to keep their patients with breast cancer on Ibrance. There are two other medication that can be used that will not drop neutrophils as low as Ibrance does. Verzenio is one. Yes it does have a side effect which is diarrhea. Imodium will help adjust that side effect. Going down to 75 mg is not a good choice if you’re having progression. I just hope to God that it’s not for kickbacks. Best of luck.

[Hidden in reply to Canchondo]

Hi Canchondo -

I hear what you're saying (although I think kickbacks are less of an issue than they used to be?), but it does raise a question in my mind...

Like you, I understand that there are two drugs that are similar to Ibrance/CDK4/6 inhibitors. One of them (the one that's *not* Verzenio) is completely interchangeable/same thing as Ibrance, but the Verzenio operates somewhat differently can be effective after Ibrance or the one I can't remember fails. So I plan to ride out the Ibrance as long as possible and then will do the Verzenio a couple of treatments down the road. I feel like this gives me full mileage with both?

Re: reducing dosage of Ibrance, there was at least one credible study which shows that reduced dosage doesn't affect the efficacy of the drug. I have a mental reflex against this fact, and have sometimes fought to remain on the highest dosage as a result, but at the end of the day, I have to believe the science. Bestbird, on this site, has done a lot of work advocating for enabling lower doses when appropriate. If I understand correctly, the phase I testing of these drugs is about finding the maximum tolerable dose (or similar) which can often exceed what's actually needed and bring on challenging side effects, unnecessarily..

My best to you...

Lynn

[Canchondo in reply to Canchondo]

This is a link to your doctors kickbacks from pharmaceutical companies

openpaymentsdata.cms.gov/se...

[Hidden in reply to Canchondo]

Ah, yes, I was going to point you to this site but couldn't remember the name.

Maybe I'm using the search function incorrectly, but I searched on Palbo, entire US, and no docs came up as having received any type of compensation... ?

Are you saying that you're in another country where perhaps the laws/oversight are less stringent?

[Hidden in reply to Hidden]

Okay, I wasn't using it correctly. Just figured it out....I entered the names of my two docs. One has received something of value = $28 (the price of a decent lunch?) over past five years and the other, more active in clinical trials, etc, has received $18k in general payments, including food/travel (conferences, I imagine) and $27k in research funding - so, e.g., I can imagine that this this doc's clinic - not him personally - received funding for something mundane related to a study, e.g. perhaps a piece of equipment or similar?

Personally, I'm not viewing this as anything nefarious? This amounts are pretty insignificant, unlikely to sway most people?

I'm always very concerned about the effect that hyper-capitalism/politicians who support this have had on our society. But I feel like concerns about "kickbacks" (I really don't think that's the right word?) aren't necessarily justified?

If anyone doesn't trust their doc then clearly they should change, regardless of whatever things of value might have been exchanged. No one would want a doc who put a few bucks ahead of their well-being...but I haven't encountered one like that and I think they're few and far between?

My two-cents...

Lynn

[diamags in reply to Hidden]

I'm with you on the kick-backs Lynn. I have a big time research onc for my doc and he got about the same amount as yours. Frankly, if people want him to speak at a conference, I do feel he's entitled to compensation as well as travel expenses. $28K is not what I would call a number that would sway an opinion in the cancer research world.

[Bettybuckets in reply to Canchondo]

That list of Doctors is there for transparency.... And is not a naughty list. I proudly worked for as Pharma rep for Pfizer Oncology for 15 years. I can assure you that working in both USA and NZ, Pfizer has been completely ethical. Also most Oncolgists too! Drs do of course get paid to give scholarly presentations and must note those contacts....-also some drs participate in lunch/ dinners provided by Pharma companies while getting updated on new drug info. In the 10 years, Drs have been required to sign into these kind of interactions with drug reps and then their names go onto lists of people accepting something of value from a drug company. It does not indicate nefarious behavior....just my own opinion But, I would be more worried about the Oncolgists who rarely if ever make times for quick updates from knowledgeable reps who try to make busy Drs lives easier by reminding them briefly about dosing, side effects and efficacy and answering any questions they may have.

[8576 in reply to Canchondo]

No, in this case it is not kickbacks. My oncology unit is above that for sure. We have just discovered the slight increase in the lungs over two scans 2 months apart. Now I would like to stay on Ibrance as I have no side affects. Just low neutrophils. I think the progression is due to several months of adjusting the doses and having extra weeks off so my immune system could recover. No consistent medicine. My oncologist does not agree and will not prescribe it. A second opinion didn't help either.

Cheers, June S.

[Julie2233]

As soon as I had progression I was taken off ibrance. I have heard of others being put on a 5/2 schedule because of low neutrophils.

[BayG in reply to Julie2233]

Hi, Julie, were you put on Verzenio? I’m looking into that as I have shown some progression on Ibrance. Many thanks and best.

[Julie2233 in reply to BayG]

No, I was put on exemestane and afinitor for 3 months, then cabazitaxel for 3 months, then capecitabine (xeloda) for 3 months - had progression on each. I was then off treatment for 10 weeks while a liver biopsy was done and processed. I started on eribulin (Havelon) in September and have just had first scan but don’t get results for 3 weeks, not very hopeful though. Fingers are crossed 😊. Please don’t be worried by all this, sometimes it takes time to find the right drugs. Ibrance and faslodex worked well for me for 18 months.

[BayG in reply to Julie2233]

You have really been through it. All my best and many thanks

[Canchondo]

This is a link to your doctors kickbacks from pharmaceutical companies

openpaymentsdata.cms.gov/se...

[Nursewithcancer]

This schedule is very unusual. It is not the recommendation. If a person has a problem with low neutrophils you would decrease the dose but not do a 5/2 schedule. Pushing out the days off is also commonly used so giving a few extra days off every month but not ideal and only if already at 75mg dosing.

[Half-Full]

Nursewithcancer: I would appreciate it if you could clarify your above post advising against a 5/2 protocol beyond “it is not the recommendation”. You’re correct that it’s not the FDA approved prescribing recommendation, but at the end of the day the recommendation for 3 weeks on and 1 week off is simply due to the fact that this is what what the manufacturer tested so this is what was ultimately FDA approved. It stands to reason that iBrance serum levels will remain somewhat more stable in the body on a 5/2 protocol, which could improve efficacy for some, while also potentially minimizing some side effects that might be triggered by the more widely varying serum levels. Our oncologist does not disagree with this rationale, but like most in her position she’s obviously much more comfortable with the FDA approved prescribing recommendation. She did say that different prescribing frequencies was still being studied but she does not have access to any info on them as they have not been finalized. Have you heard anything about any of these ongoing studies?

[8576 in reply to Half-Full]

Can I interject here to say the trial for this dosage has finished but the results will not be ready until 2021. However, you can find a good explanation of the trial and thinking behind it at ClinicalTrials.gov It explains the trial in detail.

A lot of people are already trying this. It makes sense to me. BUT I WANT TO MAKE CLEAR I HAVE NO MEDICAL BACKGROUND. JUST MY OWN EXPERIENCE WITH THIS DISEASE AND MY GUT FEELING.

Cheers, June S.

[8576 in reply to Half-Full]

You have exactly hit the idea behind the study. The dosage works out the same. The same number of days on/days off on the 5/2 schedule. Only more consistency of the drug to the patient. Again there are people on this and it is working very well for them when other schedules failed! I haven't heard from anyone yet who failed on this schedule. The info on the reasoning for the trial is explained at ClinicalTrials.gov See other post for info. The trial is finished. Just waiting for results.

Cheers, June S

[Epinto]

I have been on ibrance 125mg for 4 and a half years with faslodex injections one a month. I take the ibrance for 21 days and off for seven days. My white blood cell count is low but u guess not low enough to alter the dose. Same with my platelet drop to 93-96 on average. If it should go lower my doctor said she would lower the dose which she says is effective. Every month I watch my blood counts and hope for the best. I was redusgnosef to stage 4 in 2016 with mets to the bone but have been stable, I am always prepared for the worst but hope for the best.

[viennagirl]

Hi, I have never been on that protocol. I think it might have something to do with neutrophils. You need to ask your Oncologist. Because I think most women on Ibrance are on a 21 day ON with 7 days OFF. Marlene

[8576]

Hi Marlene: It does have to do with Neutrophils and more even dosing of the Ibrance. See the other replies I have posted. It does work for some people very well. If you read the posts here under Ibrance dosing you will see quite a few women are on lower doses and even down to one week on/one week off. I personally went down to 2 wks. on/one week off

which wasn't bad but I did have slight progression over the last 6 months.

Cheers, June S.

[OceanBreeze3]

USA - Diagnosed in May 2019, started 75mg of Ibrance/Letrozole in August 2019 to March 2020, although I was "off" more than "on". Went off Ibrance completely for 8 months (surgery & low neutrophils) - still NED after being on Letrozole ONLY for the last 8 months. My NEW Oncologist wants me to go back on Ibrance, but I said "why", when so far the Letrozole alone is working. He said because the combo of the two is better for long term. The only thing I have done differently is I take CBD Oil daily. I'm very suspicious of the drug pushing. My insurance company gets billed a one month supply of Ibrance for $50,000!

[8576 in reply to OceanBreeze3]

Thanks for your reply. Not sure what the billing is about. I guess it is for patients who are on Ibarance. Given the cost of Ibrance that is not high. It is good to watch out for drug pushing. It is my understanding that once you go off Ibrance you cannot get it back. So perhaps your oncologist doesn't want you to lose that opportunity.

Nice that you are doing so well.

Cheers, June S.

[Suzierox]

Hello! Has anyone seen the published results of Palbo (Ibrance) 5 days on-2 days off clinical trial? I read above that they were to be made available in 2021, but I haven’t found anything. Thank you 😊

[Dragonfly2 in reply to Suzierox]

I just did a post about trying the 5/2 schedule…and included this link to the results on the three year study for this alternative schedule. Here it is for you at long last.practiceupdate.com/content/...

The reason I am trying is because of borderline neutropenia and extreme fatigue…I had to tried two weeks off between cycles in order to recover. My onc did not want to reduce the mg dosage…so we’re trying this. Wishing you.the best!

[Suzierox in reply to Dragonfly2]

That's awesome! Thank you! Best Wishes to you!!

[8576]

I haven't seen anything but I would say it doesn't matter how you take the drug as long as it works. What is wrong with trying? They take you off the drug for weeks at a time for operations, radiation, etc. so what could be the harm.