Ibrance (Palbociclib)

zarovka · May 2017

Cure-ious - First, I wanted to check my numbers and terms, as there there are a bunch of Ibrance trials with different PFS. The gold standard was the Paloma-2 Phase III trial, the median PFS for women treated with IBRANCE plus letrozole was 24.8 months (95% CI, 22.1-not estimable) compared with 14.5 months (95% CI, 12.9-17.1) for women treated with letrozole plus placebo (HR=0.58 [95% CI, 0.46-0.72], p<0.001).

So we're talking median PFS and half the women went beyond 24.8 months. We have a ways to go to be exceptional responders and blow the median PFS out of the water, but that's a good thing.

I have seen posts in other forums from people 4 and 5 years into this treatment. Maybe a couple members at 24 months or so in this forum, but not frequent many posters. It came out almost exactly 2 years ago.

Hang in there with the scans. I can only say its great to have them behind you.

>Z<

JoynerL · May 2017

Lillymillie, welcome! This is an amazingly warm, knowledgeable, and supportive group. You will be among friends who understand and wish you the very best. Good luck on your journey. I, too, recently started Ibrance [early March] (and Faslodex and Xgeva) and am just starting my third course with first scans on the 15th. Hoping for the best.

Grannax, well done on getting the medications worked out!

Lynnwood1960 · May 2017

Cure-ious, I am on cycle 24 of Ibrance/ Letrozole/ Xgeva and doing very well. Tumor markers stable, blood counts steady on 100mg since second month. Recent scans show sclerotic lesions on bones and all else clear. Muscle and joint pain and stiffness are a daily occurrence, fatigue comes and goes in phases. Still have all my hair, although it has thinned some. Hoping to get a long time on this combo, to me it's been a miracle drug.

micmel · May 2017

Pfizer has been running this study all around the country for years, the NIH lists official early release before the end of phase three here in the US in early February 2015,due to great successes in the efficacy. But only the U.S. Nothing outside of the US, I believe the project manager told me, when I spoke to him about ibrance for Wendy. The first trial rolled out in late 2009, Paloma 1,Which was super secret and blinded so much even the doctors didn't know what the patient was receiving. That phase went for over two years because it was the first trial set out and they wanted to establish out of the gate a medicine medium time line of success. Which is where the 22-24 month time frame came from, because the initial trial was the proforma and guideline setter for how long the ibrance when effective could possibly work for a patient. When It became clear after phase one that, this was a game changer. They had already had phase two (end of 2011 & 2012) fully booked and starting in tandem with the first ending and moved as fast as they could to compile the data to get FDA approval for accelerated release. Trial Paloma2 ended and the results were staggering and alongside of the ending of phase two, mid 2013-Paloma 3 (phase) was also fully booked (with a waiting list for adverse side effected patients who dropped out because of side effects and tolerances), stopped blinding early (2014) in the trial itself because the results were so overwhelmingly good for ER POSITIVE cancer, that they pushed it to the distribution companies for packaging and immediate release in 2015.The actual phase 3 was still being compiled as they went to file to have it accelerated for release (2014)I know it sounds like a long time, but for drug companies from first phase to distribution into actual patient hands is actually pretty amazing. Slightly after the trials all started to end and was approved here. I started seeing billings of shortened term clinical trials set up in other countries being over seen by the Pfizer corps in let's say U.K. AND Canada, Singapore, Thailand, the only problem that Pfizer faced there was each country had different guidelines and SOP's that they must follow (standard operating procedures) the regulations are what hold up the drugs from being in the patient hands. In other words red tape! Many many women who went on this phase one trial got very sick, they had several things that had to be changed for this pill to be able to be as fully tolerated by us lucky women who take it today. I thank those special ladies that stepped up and took that medicine so we here could have a chance at progression free time frames alongside with the Letrozoles and anastrazoles. The statstics in out lying third world countries and the alarming amount of women who die from MBC, because they don't have any acces to even letrozole no less this amazing medicine we have called ibrance. The only thing I believe that Pfizer needs to regulate, for this medicine now, is the sky rocketing prices. The pharmacies also have a hand in the drugs pricing issues. did you ever notice your prescription labels vary for pricing? If you purchased that same medicine without insurance? The price is lower? Then the insurance pricing for the same medicine if it is covered, is three times the amount charged With insurance coverage to the company's itself . It is so in demand, that they can get away with it. The entire clinical process is really something to behold. How this medicine reaches our front door step is a miracle in itself and it takes years and years! The problem is the pricing when the insurance company and pharma companies try to make the money off of medicine keeping people alive! Always keeping youall in prayer. ~M~

kim1961 · May 2017

Hi all,

I am new to this and still so scared regardless of all the information I have been gathering to prepare myself.

I was diagnosed with stage IV breast cancer, metasticized to my spine, femurs, and hip bones.

Small lesion on my skull, tiny masses in my liver. It has been tested to be ER+ / HER2-

I am on round 3 out of 5 radiation therapy for my femur/hip/spine. The pain in my leg is bad enough that I am currently wheelchair bound. The pain is still the same after 3 rounds so far, I just want the pain in my leg to be gone so I can start walking again!

Once this radiation therapy session is over, they asked if I wanted to participate in a trial with letrozole (already prescribed and taking) with a new clinical trial called Ribociclib.

I did some reading and found that this drug is "not so new" as it has been approved by the FDA, but the problem is I live in Canada and it is still seeking approval from Health Canada. My family prefers I go on Ibrance which has approval from both FDA and Canada but I believe Ibrance is not covered by any drug programs in Canada.

Has anybody have experience with Ribociclib or have any suggestions/recommendations?

Thank you so much, prayers to all.

Hee

cure-ious · May 2017

Lynwood, Wonderful to hear you are still chugging away at two years, and completely stable on the 100mg dose! It's one thing to know the trial averages, but so much better to have someone here showing us that it can be done- you must have started on Ibrance right after the FDA approved it!

MicMel1 thanks so much for that incredible history. I know Ibrance went through in record pace, and so if there are any more blockbuster drugs coming down the pike, we know what to watch for in terms of how quickly they can race through the clinical trials. You should write a book...

Welcome to Lillymille and Hee, you will learn everything you need to know about Ibrance (and life) on these forums

Well said as always, Z, scans are a poop

Scwilly · May 2017

Welcome to all new members. I'm only on my third round but am very happy so far. I would say I don't have too much side effects. (which strangely can sometimes feel worrying!) My white blood cells have gone down, but not too far and so not (yet) a concern. I have less stamina because of that but make sure I rest when I over do it. I have felt indigestion if I take Ibrance with my food - so usually do so after I have finished my meal. My aches and pains I put that down to the Arimidex, though I do have arthritis. My tumor markers have never been a good indicator for me, but my liver markers have gone back to normal so I am trusting this is a great sign I am stable, and xing fingers my CT Scan next Monday confirms this. All in all, I am very happy to be on this regime - and hope to continue as long as I can.

Lynnewood - you give me inspiration to feel positive about the future knowing you have been on Ibrance for so many cycles.

Lillymille: so happy to hear that a fellow brit has access, albeit through private care. I am from Bristol but now in SoCal. I was not happy to hear NICE had not yet included it in their recommend treatments. I am hoping this will change as time goes on and as other similar treatments, eg Ribociclib, become available.

zarovka · May 2017

Kim - ribociclib and palbociclib (Ibrance) are almost exactly the same. If you can get ribociclib through a trial, and not any other way, i would go for it. somewhere in here i have posted an ibrance vs ribociclib comparison as far as side effects go. With ribociblib you get more gastric distress, with ibrance you get a slam to your immune system. Efficacy is very similar.

We don't have a lot of people on ribociclib on this forum, but you are welcome to hang out here. We are very interested in how you do.

>Z<

nbnotes · May 2017

Just had my petscan on Friday after about 4 months on Faslodex and Ibrance. My markers are down and I've had some regression. There was about 1 1/2 months between my last petscan and actually getting on the meds during which my markers rose so pretty sure there was progression just not sure exactly what. So, being smaller and with less uptake than on that November scan feels like a win!

Nanaof5 · May 2017

Thanks for your feedback. The tumor marker bloodwork is a blessing and a curse! I'm having a hard time finding people who have lung mets as bone and liver seem to be the more common locations. After two rounds on Ibrance I'd hoped to stop coughing but that hasn't happened yet and with the rising CA tumor marker bloodwork I can't help but ask "is Ibrance working for me." Onc says its way to early to think that way and that it does work for 80% of patients.

faith-840 · May 2017

Hi Nana of 5, I'm also a Nana but of 10. I also have lung mets only. You're right that most here have bone or liver mets but there are a few of us here. It takes awhile for the Ibrance to show some results, sometimes as long as 5-6 months. So, for you it might be a little early to see results. I was coughing a lot too and my MO really wanted to get that under control so he prescribed a cough medicine, cheritussin. That stopped it pretty well but constipation was a problem. I'm not sure why he was so anxious to get the cough stopped.

My first scan after three months showed improvement and I'm still improving and am now on rd.#17. So, hang in there it will most probably get better soon. Good luck!

It would help all of us to answer your questions better if you fill out your profile and make it public. That puts things in context.

Keeping all in prayer.

Lillymillie · May 2017

thank you for the warm welcome. This is a really interesting thread. So much information on it. I have been more of a lurker with nothing much to add but feel like I really need to keep up to date and learn from you ladies.

Pat - yes my onc has me on monthly xgeva with 4 ad-cal tablets a day. Zoladex for my ovaries. I would really love to have a 'remarkable' response after 3 months. That is encouraging to hear.

Micmel - thanks and yes scanxiety is the worse. We are all familiar which how hideous it feels but hopefully you will have positive results.

Zarovka - you are a fountain of knowledge! Amazing results on your scans. I start on paloma 3 version I suppose. I have bone mets and a small amount of fluid causing my no issues in my pluera. The median time on this is 9 months I think which doesn't seem long compared to the 22 months on your combo. I hope for longer.

Joyner- good to have someone on same combo. Best of luck for the 15th. Hoping for a positive response!

Cure-ious- thanks for the support, lotshirt of good advice here.

Scwilly - I'm annoyed it took so long to get ibrance approved here but grateful if can start it. It would have been good to have it as a first line treatment when I have limited bone mets. I have had a little progression since. After a couple of failed hormone treatments chemo did the trick.

Nbnotes- that is great news. My onc ignore tumour markers. He has found themy too unreliable so he just scans.

Faith - good to hear u are still approving. Hoping it dries you my pluera situation!

You guys all seem to know a bit more than they tell us in UK. We don't do tumour markers. My onc says they are unreliable so he scans every 3 months for actual images to tell the story. I don't know how much er I am. I was 8/8 originally but now I have failed arimidex and aromain I wonder am I weaker in er for such a crappy response??? Will this determine my response to ibrance? Hard to know. Side effects day 2 were rash on feet now gone and today day 5 was very stingy lips...better now. Also I'm so worried to plan my summer holiday with all this uncertainly. I live for my travel adventures.it would be sad if I didn't get at least an a stable scan at 3 months. I live for my travels with my family.

micmel · May 2017

Hee~ if you go to the Pfizer website itself,they have a co pay coupon for ibrance for people who cannot afford it. My medicine costs 11383.00 a month supply so it is incredibly expensive. But Pfizer does have programs that assist patients. You just have to have a prescription. When I worked for the distribution company that dealt with some of the blistering and packaging of the medicine,. They always advertised the financial help that they had. It helped a lot of people. They also have it in the U.K. I am sure. Hope you get on the treatment you would want to be on! ~M~

dancingdiva · May 2017

Kim I'm from Canada. My onc /hospital dealt with Pfizer directly ( they had to fill out paperwork) and then Pfizer called me. They worked it out with my work insurance. It had to be my 1st line of treatment for MBC though.

I have finally read all these pages and am astonished at the knowledge in here. I have just put my 2 kids to bed and just want to hit the sack. I still work full time, although I question why I do. It's more of a distraction than anything else.

How many of u have had ur ovaries removed? Ovary suppression? My onc says I don't need it but then why do people do it?

carpe_diem · May 2017

Kim,

Ribociclib (Kisqali) is another CDK 4/6 inhibitor like Palbociclib (Ibrance). I recently progressed on Abraxane after multiple other regimens since 2011 and my oncologist recommended Ibrance plus letrozole. However, I'd been following the progress of Ribociclib since my husband was employed by Novartis before he retired and our retiree insurance (BC/BS) covers Novartis drugs for free. My cost for Ibrance would have been about $75 for 21 days through Accredo pharmacy, so my doc checked to see if I'd be approved for Kisqali even though it's only approved as a first line treatment. I started last week so I can't tell if it's working, but so far I'm feeling fine - certainly a lot easier than Abraxane and incredibly superior to Xeloda.

The stats for Ribociclib really look a lot like Ibrance, so go for it if the price is right.

singlemom1 · May 2017

Hi Nano5, my mets are to my lungs as well. I have been on Ibrance for 19 months and am doing well. Give the ibrance some time.

Dancing diva, I had to have my ovaries removed before I could start on letrozole and ibrance. My MO said i had to be in menopause before i could start the current treatment. Is your doctor suppressing your ovaries?

nextmoondance · May 2017

Hi group, decided to introduce myself. I'm at the end of my second week of my second cycle of Ibrance and lotrozole. I was stage IV de novo on 3/17 and started one week later on this treatment. At first I was scared because my surgeon had been telling me to be aggressive about mastectomies, chemo and radiation, but after I met my MO and started researching, I'm glad I decided on this route. My Ibrance is $10,960 a month, but I have BCBS and they pay 100% now that I have met my out of pocket maximum for the year.

In the first cycle, I had really bad fatigue, sleeping up to 16 hours a day, while trying to work full time and care for my adopted 13 yo girl. This last week, I ran out of my Paxil and decided just to deal with things until I could see what difference it made. Wow, my energy has returned with a passion, but so has my crying jags! I may ask about starting Effexor 37.5 next visit with my MO. He is amazing, but he is just a baby (but soooooo intelligent and plugged in). He just started with the group last July and did his residency studies on Ibrance. I know its the lotrozole causing the mood swings, crying and hot flashes, so I hope Effexor might help. Just unsure about when it's time to stop it.

I supplement with a probiotic, L-Lysine, Spirulilna, Zantac, Zyrtec and Flonase. I only had N and V one night and I think I did not eat enough when I took the Ibrance, so they called in enough Compazine and Pherergan to choke a horse! I only take that at night now along with Valium 10 mg so I get a good night's sleep. Vertigo has been a big issue with me going back to an ear infection when I was 18, so the Compazine and Valium go a long way in helping me function every day.

I have three large tumors in my right breast, three nodes in my axilla, several nodes in my hilum, lots of mets in both lungs and two small skin mets. The amazing thing is my cough has completely cleared and my first skin mets has shrunk by half just after my first cycle. My BW is great even after the first round, so my MO moved me to once a month checks until he is ready to scan me in about six weeks. Other than my fatigue, I feel great. If I feel tired, I take a nap. Since I work from home, that helps a lot

I adopted my granddaughter in 2010 and this is hitting her hard, but I'm lucky we are very close and she trusts me to be honest with her and protect her in whatever is going to happen. I've been through the grief and anger cycles and now I'm in acceptance, so that helps her deal with things better too. She is enrolled in a therapeutic riding stable and has great emotional and spiritual support there too.

I really do appreciate all the info you ladies have shared. You have NO idea how helpful this group has been in helping me work through this diagnosis. I was given a prognosis of 2-3 years, but Kristina graduates in five years. This damn drug better give me that time, haha! If not there are other things in the works and I believe in Him and where he wants me to be.

Carol

zarovka · May 2017

Gracie - I believe that you reported awesome scans .. wahoo. You are right that is an impressive response in just a short time.

Lilly - Tumor markers are challenging. For some people a consistent rise over time seems to predict progression; however for others they mean nothing. It takes a while to figure out if and how to use them. Let's compare my last TM results and with my scan results.

My scan results from the end of April suggest significant improvement since my last scan in December. However, he TMs from the blood work I did the same week of my scan showed that CEA (4ng/mL) and CA 27.29 (53 U/mL) are up more than 30%. Although my TM's have never been super high, they are now the highest they have been. So I just had great scans and increased tumor markers .... unless you look at CA 15-3.

CA 15-3 was 47 in December and is now down to 32 U/mL and within normal range. So we must be measuring different things ... well no. The CA 27.29 and CA 15-3 tests are different methods of measuring the levels of the SAME antibody. Labs do not recommend having both CA 15-3 and CA 27.29 done because they supposedly measure the same thing, yet my results from these tests are the opposite.

TM's are hard to interpret. I understand doctors who do not use them.

DancingDiva - you must have ovarian suppression for Ibrance to work unless you are already in menopause and your ovaries are no longer producing estrogen. We've had a couple situations on this forum where doctors thought a woman was in menopause and did not order ovarian suppression but in fact they were not. Ibrance does not work without hormone suppression ... the first clinical trial of this drug failed. It's very important to make sure your estrogen levels get to non-detect one way or another.

Carpe Diem - free is good and little difference between the two drugs. let us know how you do.

>Z<

Lillymillie · May 2017