Ibrance (Palbociclib)
Comments
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Well dang, Grannax, I'm sorry to hear your news. When AA works, it can work for a long time. Sending hugs as you digest the news and cheering you on for a smooth transition onto AA and that it beats the %*&! out of your cancer. Xeloda also seems to work well on the liver. We're with you friend.
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Grannax, once an Ibrance dancer, always an Ibrance dancer! Don't even think of leaving this thread! You are one of us and we need you. When I think of you, I think of my friend and fellow artist, Colleen Newport Stevens, a 13 year survivor. She lived for 8 of those years with liver and bone mets during a time when there was nothing but hard chemo for MBC. I also think of my friend, Julie, who is still with us after more than 20 years with liver and bone mets. She had the old standard chemos and everything new that's been invented. You will find your next plan and you will handle it well. I don't doubt that for a minute. "Til then just know that you are loved and admired by friends who know how hard it is to pick yourself up after bad news. Let us help you carry that load with our prayers. God bless you, Grannax.
Love from PatGMc
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Grannax- So sorry to hear your news. Effective treatments are available and AA can work well with minimal SEs. Hope you can enjoy your project runway event. Stick with us! Ibrance is recyclable and you may be on it again after AA does its job. We are pulling for you
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Another interesting development:
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Grannax...sorry to hear about progression BUT there's something unique about being on everolimus, ( I found out today) apparently it's one of those medications that should be able to stop angiogenesis, thus, who knows you might benefit in more ways than one...my best wishes for a long run on AA
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Grannax; I'm so sorry to hear of your progression. I don't know what AA is but hope it is hugely successful for you. Please keep posting. Plus I am so looking forward to pictures of your next fashion show. New York, New York.
Pat; Love, love your artwork.
I have been reading but not posting and I am sure to have forgotten lots of news I wanted to respond to. So sorry about that. Have had a terrible cold for about the last month and have been really under the weather. I just finished some antibiotics and am on two inhalers, both a nasal and a lung inhaler which seems to help. Crazy what a simple cold will do to us.
I hope everyone is getting ready for a nice holiday season this year. Bless you all.
Cathy
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Hoping you got my PM from earlier Grannax....hang in there, precious girl! We've got a date to go surf-rolling....(I prefer a bit warmer weather).....
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Grannax lifting you up in prayer this evening.
Tanya
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Grannax the biggest hugs being sent to you my friend. Holding you in my heart and in light as you navigate these news oceans of treatment.
I found this article and thought that perhaps folks would find it calming and soothing...it basically talks about how we are not to blame for our disease. That we did not cause our cancers...hope it brings some mental strength to those who are in need of it at this time:
http://www.simmsmanncenter.ucla.edu/index.php/reso... (scroll down to the "Myths" section)
with love
Brenda
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Grannax- so very sorry to hear about the progression hopefully the AA works for you. ((Hugs)) -Randy
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Bubblebeard, I'll started my 4th round of Ibrance today but I take it with Faslodex. I had nothing except some itching and I'm fatigue. The fatigue is combo I think of that they found mets in the brain 3 weeks ago. That mets are going to be removed with the Gamma knife jsut waiting to get my appointment.
I'm taking a Desloratadine every day since I got sick I think that helping against the itching. The time it itches I skipped the pills a couple of days. I'm using Desloratadine after reading about it and it will not hurt :-D. See the about antihistamines and breast cancer, just one link http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e125270 -
grannax- so sorry to hear about the progression. i will be praying that AA works to kick your cancers tail!
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Good Morning Ladies.
Need advice/encouragement. (Best advice Lynn J gave me few weeks ago , 2nd Opinion, that's in the works) Started Ful/Ibrance Oct.15th, barely 2 months. Started Xgeva Nov 12
Mon. Went to Onc. for , Ful injections, lab work,Xgeva. I was so full of hope for this treatment because of you ladies. Well, my Onc was a real "buzz kill". She said that the combo was not working! I grasped but it's only been like 7 weeks , how can you tell? She said there should be NO progression once the treatment starts. So, progression to her is, every part of my body that can hurt, does hurt. Esp. my back, (but I have compression fractures, Low bone density, arthritis that might explain that) Onc. wanted immediate scans next week. So increased pain PLUS skin mets increased on my breast (tumor never removed) indicated to her progression which = combo not working. I pleaded, please just give me this Christmas season with my family then all the scans you want. She didn't like that but did agree. She also suggested another biopsy to determine which treatments could help. That I readily agreed to.
Now, my ONC is retiring end of this mo. (Dec) and I just don't think she's kept up with latest research. The following are some statements that she made which I THINK are contrary to what I've read on this board.
-----Xgeva does nothing for cancer mets, it just strengthens your bones to prevent fractures.
-----I failed my first anit-hormonal, Arinatase, and now the Onc has said failure on Fulversant, so therefore, anti-hormals won't work for me.. No need to try another one.
-------I asked about the two other meds in same class as IBRANCE, she said "they are all the same, if one does not work, the others won't either.
She gave me absolutely no hope. I asked about surgery to primary tumor in breast, she said oh, absolutely not. THEN went on to say you know that tumor will grow and ulcerate, the skin mets on your breast will ulcerate and proceeded to tell me the hell that that would incur.
Before the nighmare was over she said "lets do chemo" (same voice as one would say lets do lunch) Just 4 weeks ago, her Nurse Practioner said that she thought the treatment might be working because of of pain and pulling in original tumor. (sign of dying cells) (Same Nur. Prac. said Chemo WOULD Not work for me) This Onc said no, it means tumor is growing. (The pain pulling, tingling, zingers)
So, I did manage to start just my third cycle this past Mon. on Ful/Ibrance. The day of the apt. my Spirit was so comforted by My Lord. But then late last night and this am. my emotions/feelings OCD got in the way. So ladies, Please brutally honest with me. If my Onc is right, then so be it.
Thanks You and Blessings for All of you for reading such a long post.
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hi Snooky...I'm sorry about what you’re currently going through, hopefully your situation will improve soon as you get the necessary tests to ascertain the current hormonal status of your cancer.
The good news is your rude MO will be leaving in Dec, that means you will have a new one that maybe will be more sensitive and patient in explaining your options of treatments. She's is however right about xgeva....it's prescribed to strengthen bones, but there are warnings about its potential to actually break femurs and jaws, and to release high amounts of calcium in the blood causing hypercalcemia, a potentially deadly occurrence when it's withdrawned.
If it turns out you need chemotherapy, there's something called Capecitabine, it's taken as a pill one week on and one off. It has some SE but it's relatively manageable. For some people it works for many years, I hope to be one of them.
Hopefully your new MO will try other hormonals and targeted therapies for you that will match your current genetic profile. Pray that if there's a change, you can get on Herceptin, that's the only medication that actually work for 50% of the people for a very long time.
I send you many wishes for a peaceful holidays to you and your family...
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Snooky I'm not a Dr. But I do believe it takes longer than six weeks for Ibrance to work. Some docs say six months. For me at three months the scan showed it had stopped the growth of lung and chest mets. Every scan since then they have gotten smaller and now down to almost nothing 20months.💞
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Reply Grannax, that's is exactly what I thought. Up to 6 mos. But my Onc. said there could be no progression. That's the part I"m not sure about. Thank You so much for replying.
Miaomix, thank you for your reply and encouragement. I will check out the medicine you mentioned. I know, I need to keep my emotions at bay until a) see new ONC b) scans c) a biopsy is done. The original biopsy showed 80% E pos. But, I learning that can change. Thank you so for replying.
Both of you have given me encouragement.
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Grannax...sending lots of strength your way....stay positive. Snooky....don't let this Onc get you down. She will be retiring soon. In the beginning of my treatment my Onc never said anything about progression. She wanted to give Ibrance a chance. My first Onc moved and the one I have now said when and if progression starts she will move me up to 100mg Ibrance and go from there. I am on 75mg now. I don't know what the answer is for you right now but enjoy this wonderful season and try not to worry. God bless
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Dear snooky, It's very hard and seems like a cliche to ask that you take this one day at a time. We all do this...We start leaping ahead trying to figure out whether the doctor knows what he's doing, whether we're going to mess up and not do this the right way. I hope you're able to decide to put the treatment anxieties aside until you see the doctor next.
But for now, there's this: I don't know everything about Ibrance but what I've seen here on this board is that it very often takes many months to stop progression. Your doctor, like all our doctors, doesn't know exactly what Ibrance is going to do because its history is so short. I'm glad he's retiring because he doesn't sound like someone with enough hope to share. You may have to gather your hope from the stories of the people here. Tell the next doctor you very much want to give Ibrance a bigger try. I'd also have a talk with him about how important hope is when you wake up every day to a hard diagnosis.
About surgery: I would go and see a surgeon, perhaps a new one and let that person in that specialty advise you. I'd also see a radiation oncologist...a new one...and see what he/she has to say about your current circumstances.
About failure: I hate when they use that word! You didn't fail the hormone treatment. It may have just been the wrong drug for you but you didn't fail. I'm pretty sure one of the newer drugs similar to Ibrance was effective in trials without hormone treatment. I'm thinking it's Verzenia.
Now back to that first advice....letting it go. The Lord was there to comfort you before that doctor came at you with his hope-stealing ways. Just call out to Him right now. He's not going to let you go. If I sound like a broken record on this it's because I know it in my soul.
Much love from PatGMc
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I'm already on plan B and I only found out about progression 48 hours ago.
I now have rescheduled PET and MO appointment so that we can get this plan rolling sooner than plan A. PET is Friday, MO Monday. On Monday I'm sure we will discuss PET results but mostly I want her to schedule a liver BX. A few months ago she told me if I ever had progression she would want a new BX. It could show that the cancer has changed/mutated as many do. That could mean a different drug would be more effective. I've heard of some cancers changing from ERPR+HER2- to HER 2 +. If so I would be eligible for Hercepton. And there are others. I'm not talking about genomic testing although it would be great if she would do that too.
Basically this cancer has been untreated for four months. My liver mets never responded to Ibrance even though my lung and chest mets have responded beautifully. Go figure?!?! My liver mets responded to the y90 for 18 months. My IR said a microwave ablation is not an option because of the location in my left lobe. Y90 is not an option yet. At some point it might be. So for now, systemic TX is best. Aromasin/ Afinitor is what my MO is leaning towards but a new receptor study on this new tumor could guide her to choose a different one, a better one.
Yes, I don't want to miss my NYC modeling gig. It's February 16. Another reason to get this show on the road. And I will post pics and updates. 💞
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Grannax, you have grabbed MBC by the horns once again and you will turn this baby around!! I have the utmost faith in you!
Love from PatGMc
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One thing I have been wondering for a while is about my impression that when you are diagnosed with stage 4 doctors don't seem to surgically remove the primary tumour. Snooky, like yours for instance. I was always told and saw in older research that it was better to remove it. When I was originally diagnosed my 3 cm breast tumour was removed prior to them finding an inoperable tumour in my supraclavicalar node. That was blasted with radiation. It seems like a straight forward operation and a logical one.
Cathy
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I like the visual of little plump me at a rodeo grabbing a bull by the horns. Pretty funny. PatG that could be the name of your next painting!?!?! For today, I will keep that image in my head. Hahaha
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If Hot Flashes are bothering you, there's this from the San Antonio BC conference:
"In a randomized, double-blind, placebo-controlled clinical trial, investigators tested whether oxybutynin, an anticholinergic agent commonly used to treat urinary incontinence, could lower hot flashes in breast cancer survivors taking tamoxifen or an aromatase inhibitor and those who could not take hormone replacement. Besides impacting quality of life, hot flashes are also associated with discontinuation of breast cancer treatment, which could increase the risk of breast cancer recurrence and death.
The study showed that patients who took oxybutynin experienced decreases in their hot flashes scores compared with those who took placebo. Women who took oxybutynin also reported improvement in work, social activities, leisure activities, sleep, and overall quality of life."
Love from PatGMc
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Dear Pat and all who've offered encouragement. Yes, one day at a time. No, it's not a cliché at all. I know this for a fact, during my years of depression, that is how I made it. One day, sometimes one hour. (And is that not what Jesus said? That he gives us grace for one for day at a time and not to worry about tomorrow) I too know that my Lord is with me and will never let me go. This is how I survive. It's just that I do not know about/understand breast cancer. Learning though. And yes hope. One has to have hope. Pat you stated the following, "I don't know everything about Ibrance but what I've seen here on this board is that it very often takes many months to stop progression. " Many months to STOP progression. That's what I needed to hear. Cause my ONC's reason for saying this combo isn't working is because my skin mets have not STOPPED.
Pat, I can sure see why you were the leader of a support group for many years, you know just the right thing to say. And yes, I can and I will put this worry behind me and enjoy the Christmas season with my dear three boys. And I know, my Lord will not let me go. You're also in my heart and my prayers. Thanks you so much.
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I would like to point out another option for those progressing while on AI+CDK4,6 inhibitor. About 70% of ER-positive cancers also express a protein called BCL-2, and may respond to Venetoclax. A phase 2 trial was initiated (VERONICA) to test Venetoclax with Faslodex for those progressing on Ibrance-Femara. Here is a link to the stats from the phase 1 trial, I am not the best at sussing out these numbers and how they might compare to other Faslodex combinations, so hopefully somebody else can chime in! How promising does this new drug sound?
https://www.onclive.com/conference-coverage/sabcs-...
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More details about venetoclax:
https://www.onclive.com/conference-coverage/sabcs-...
Combining the BCL-2 inhibitor venetoclax (Venclexta) with endocrine therapy elicited notable activity with a tolerable safety profile in patients with estrogen receptor (ER)–positive and BCL-2–positive metastatic breast cancer.
Geoffrey J. Lindeman, MD, presented data from a phase Ib dose-escalation and expansion study, the first clinical study evaluating venetoclax in a solid tumor, at the 2018 San Antonio Breast Cancer Symposium.
Among 33 evaluable patients who received the combination of venetoclax and tamoxifen, the median progression-free survival (PFS) was 36 weeks in 15 patients treated in the dose escalation phase, 48 weeks in 18 patients treated in the expansion phase, and 36 weeks overall. Median PFS was 23 weeks in those who received doses of venetoclax <800 mg versus 51 weeks in those who received 800 mg of venetoclax, the maximum dose in the study.
The overall response rate (ORR) was 27% and the clinical benefit rate (CBR) was 67% in the dose escalation phase. No patient had a complete response (CR), and the median duration of response (DOR) was 61 weeks.
In the dose expansion phase, the ORR was 61% and the clinical benefit rate was 72%, with 1 CR. The median DOR was 39 weeks.
In the 24 patients who received 800 mg of venetoclax, the ORR was 54% and the CBR was 75%, with 1 CR (4%) and 12 partial responses (50%). The median DOR was 42 weeks. Eight patients from the 800-mg cohort remain on study treatment; the DOR reported here is until the cutoff date.
"In the primary setting, about 80% of ER-positive tumors prove to be BCL-2–positive," said Lindeman, from the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia. "What we found from this study is that about 70% of tumors remain BCL-2–positive in patients who undergo a biopsy of their metastases."
In preclinical models of ER-positive breast cancer, venetoclax synergized with endocrine therapy.
The 3+3 dose escalation study included 15 patients who received daily venetoclax at 200 mg (n = 3), 400 mg (n = 3), 600 (n = 3), or 800 mg (n = 6) along with 20 mg of daily tamoxifen. Treatment continued until progression.
The primary endpoint was to determine the maximum tolerated dose, define dose-limiting toxicities, and identify the recommended phase II dose. In the dose-expansion phase at the recommended phase 2 dose, secondary endpoints including safety and tolerability, response at 24 weeks per RECIST v1.1, the clinical benefit rate, and PFS.
Overall, 88% of patients were strongly ER-positive and 85% were strongly BCL-2–positive. Some 79% of patients had bone metastases and 61% had visceral metastases. The mean number of prior regimens was 2 (range, 0-8), with 45% having <2 prior lines. Thirty-nine percent had prior tamoxifen exposure in the adjuvant setting, 12% in the metastatic setting only, and 36% had no prior tamoxifen exposure. Twenty-seven percent of patients had prior chemotherapy in the adjuvant setting only and 15% in the metastatic setting only; 36% did not receive prior chemotherapy.
"In our dose escalation study, we went beyond the recommended phase II dose for chronic lymphocytic leukemia, which is 400 mg/day. We got to 800 mg/day without getting to a maximum tolerated dose, so we elected to us the recommended phase 2 dose of 800 mg/day. The reason we didn't go higher is simply that the pill burden would be too high [8 tablets a day]," said Lindeman.
Patients who achieved a metabolic response on FDG-positron emission tomography at 28 days had a significantly longer PFS than those with metabolic progression or stable metabolic disease (P = .004).
"It's hard to know with a study of this size, but we seemed to be achieving clinical responses at the 400- to 800-mg doses, but we have more experience now with the 800-mg dose," he said. "It certainly would be predicted to give higher levels of BCL-2 in the blood, probably about double the levels of BCL-2 in the blood than the 400-mg dose."
No patient had to discontinue on the basis of toxicity. The main side effects with venetoclax were on-target effects, including grade 1-3 lymphopenia, "which didn't cause any other adverse events of infections to our knowledge," Lindeman said.
Lymphopenia occurred in 100% at venetoclax doses <800 mg and in 83% at the 800-mg dose. Neutropenia occurred in 56% at doses <800 mg and in 79% in those dosed at 800 mg. Thirty-eight percent had an infection at the 800-mg dose compared with none at lower doses.
"The other side effect we see is low-grade nausea, which occurs a couple of hours after taking the tablets and is often ameliorated by giving antiemetic tablets like metoclopramide," he said. "Otherwise, we saw very few side effects with venetoclax in this small phase Ib study."
Sixty-seven percent of patients experienced nausea at the <800-mg dose.0 -
Thanks Cure ious and husband 11. I'm definitely in that boat right now. Although I don't know what my new BX will show.I've never heard of BCL2. I had my PET today, results Monday and schedule a new liver BX.
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So, this Venetoclax report is as good of an example as any we get to try to understand the terminology they use and how to evaluate an early phase 1 trial update- for one thing, it seems we should focus on the results they report for the so-called "dose expansion phase" of the trial, because it seems that is the part of the trial where they had already determined the amount of drug they want to use, and the other (overall) results look worse because they include the early under-medicated patients?
So, if we just focus on the dose-expansion phase they say the PFS of the Venetoclax drug plus tamoxifen was 51 weeks, which is almost a year (why are they reporting in weeks, anyway? that's confusing). The clinical benefit was 67%, meaning 67% of the patients had some kind of good response to the drug combo (shrinking or stable), during the dose-expansion phase of the trial, so that is good- but remember they had already pre-selected for patients who were both ER-positive and BCL2 positive (which they say about 70% of metastatic patients are positive for BCL2 expression), so that sounds good too.
Now, regarding the rest:They say that 24 patients got the high dose (800 mg) of venetoclax, and one had a complete response (NED) where 12 had partial responses (50%), which sounds high/good. The median duration of response for these patients was 42 weeks, but 8 of the 12 were still taking the drug at the time they stopped to make the report.
So I am confused, can someone explain what is the difference between the duration of response (DOR, 42 weeks) versus the progression-free survival PFS (51 weeks)?
Side effects look to be neutropenia (like everything) and nausea- they should have good anti-nausea meds to use? This drug is used for leukemias but at half the dose, so we can't rely on those reports for side effects. But overall this sounds promising, no? Especially if some of the patients remain on the drug, so the PFS numbers may go higher? And I don;t see where they report what tamoxifen alone would do in this group, but it may be they know it would just be neglible and so didn't test it? But then, how would they know that they need to include tamoxifen, versus just Venetoclax on its own?
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Apparently it is a 20 year old drug invented in Australia. Would be nice if it went off patent and became available at an affordable price. Here in our province, they are limiting targeted therapies to one for the lifetime of the patient. So, switching to this drug from say a cdk4/6 inhibitor wouldn't be covered.
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Snooky this type of treatment is widely known to work slowly. Chemo is the choice if a quick response is needed. Often in the early weeks and months the picture does look worse not better. Don't lose hope! Do find a new MO!
Cure-ious/Husband I did see something about that trial a few months ago. I recall it sounded promising. Thanks so much for sharing
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