Ibrance (Palbociclib)
Comments
-
This abstract is unusual- it is embargoed until Saturday June 2, and may be part of a planned press release? If so, maybe good results? Might be a good secondline treatment after Ibrance-Femara, if one has PI3K mutation? Time will tell...
Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA-mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER.
0 -
I apologize for all these posts.
Here is one showing premenopausal/perimenopausal respond well to CDKinhibitor plus faslodex with GnRH agonist for ovaries..
Background: Abemaciclib is a selective inhibitor of CDK4 & 6 that is dosed on a continuous schedule and is approved for the treatment of HR+, HER2- advanced breast cancer (ABC) as monotherapy and in combination with fulvestrant (F). In the intent-to-treat (ITT) population in the MONARCH 2 study, abemaciclib in combination with F demonstrated improved progression-free survival (PFS) and objective response rate (ORR) compared to placebo (P) + F (16.4 vs 9.3 months; hazard ratio [HR] .553; 95% CI: .449, .681; p < .0000001; ORR in measurable disease 48.1% vs 21.3%; p < .001). Here, we compare the efficacy and safety of abemaciclib + F vs P + F in the pre/peri-menopausal subgroup. Methods: MONARCH 2 was a Phase 3 randomized, double-blind, placebo-controlled study of abemaciclib + F vs P + F in pts with HR+, HER2- ABC that progressed on ET. Key eligibility criteria were: pre/peri- and post-menopausal women with HR+, HER2- ABC (pre/peri-menopausal pts received a GnRH agonist); ECOG PS ≤ 1; progression on (neo)adjuvant ET, ≤12 months from end of adjuvant ET, or on first line ET for metastatic disease; ≤1 line of ET; no prior chemotherapy for metastatic disease. Pts received orally administered abemaciclib 150 mg twice daily + 500 mg F (per label) or P + F. Primary objective was investigator-assessed PFS. Secondary objectives included ORR, clinical benefit rate, disease control rate, duration of response, safety and tolerability. Results: 114 pre/peri-menopausal pts were randomized 2:1 to abemaciclib + F (N = 72) and P + F (N = 42) arms. 57 PFS events were observed. Median PFS was not reached for the abemaciclib + F arm and was 10.5 months for the P + F arm (HR, .446; 95% CI: .264, .754; p = .002). In pts with measurable disease (n = 79, 69.3%), ORR was significantly higher in the abemaciclib + F arm: 60.8% (3.9% complete response [CR]) vs 28.6% (0% CR; p = .006). The most frequent adverse events (any grade) for abemaciclib + F vs P + F were diarrhea (87.3% vs 23.8%), neutropenia (59.2% vs 7.1%) and leukopenia (43.7% vs 4.8%). Conclusions: Abemaciclib + F in combination with a GnRH agonist significantly improved PFS and ORR, and had a generally tolerable safety profile in pre/peri-menopausal women with HR+, HER2- ABC. Clinical trial information: NCT02107703
0 -
some notes from abstracts
Resistance: Breast cancer driver mutation landscapes are largely similar after treatment with Ibrance+Fulvestrant and with Fulvestrant alone, with acquired PIK3CA and ESR1 Y537S mutations that likely contribute to fulvestrant resistance. Acquired RB1 mutations are selected infrequently by P + F. These findings may inform future treatment strategies to address resistance to palbociclib and fulvestrant.
Another CDK4,6 inhibitor has entered trials: CDK4/6 inhibition has demonstrated significant improvements in PFS when combined with fulvestrant (F) in patients with breast cancer (BC). G1T38 (38) is a potent, selective oral CDK4/6 inhibitor with best-in-class potential. Continuous daily dosing in preclinical models inhibits tumor growth and leads to a dose-dependent ANC decline and subsequent plateau. A completed Phase 1 trial supports this Phase 1b/2a trial (NCT02983071) in BC patients.
0 -
Thank you Cure-ious.
0 -
Cure-ious-I appreciate these posts. They give us all hope that we are moving towards a cure or at least hope for other alternatives after Ibrance. Thank you!
0 -
Thank you cureious!
0 -
Well, we all in the same boat! What to take next? It seems that one strategy is either to move to PI3Kinhibitor (if you have an activating mutation, but they are common) or Affinitor/Aromasin (to block mTORC1), with the idea that either inhibitor is pushing down that pathway and restoring estrogen dependence on the cancer. And probably keep a CDKinhibitor? Anyway, keep an eye out for news from ASCO first week in June.
I forgot to put the link to the abstracts, if anyone wants to check them out: http://abstracts.asco.org/214S/search.php?zoom_que...0 -
I am grateful to you Cure-ious for combing through these and sharing them. Will check out the link.
0 -
Thanks so much, Cure-ious. I wish that I better understood the language. G1T38 (38) sounded promising. I assume that it will have another and likely unrecognizable name if it makes it through the trials and becomes available as a treatment option?
0 -
Thanks Cure-ious. I wish I understood it better. Ibrance May not be working for me and the MO is talking about weekly chemo but I’m wondering why not just switch to verzenio?
0 -
Gracie- If you do have progression, it would be reasonable to move from Ibrance-Femara to Abemaciclib-Faslodex or even Ibrance-Faslodex (since the abstracts indicate that progression on Ibrance-Femara is most often due to the same reasons one gets for progression on Femara alone, ie mutation of estrogen receptor or PI3K or upregulation of mTORC)- unless there is significant progression in the liver to the point where they want to do some chemo that can act faster. The Sandpiper phase 3 trial that seems like it is going to be one of the handful of abstracts that ASCO is saving for a press release (presumably because of good news) is adding a PI3K inhibitor (taselisib) along with Faslodex if the cancer has a PI3K mutation, so that could be an option as well, if you have progression and liver is not at risk. And I'd say can I get some Ibrance along with that?! These trials always lack some obvious arms, I guess its too expensive to do the different combinations you'd like to see.
Anyway, I think some people on these boards have been on Sandpiper, there might be a thread about that..
0 -
Cure-ious: thank you so much for all those abstracts. It is great to have you taking the time to screen the ASCO abstracts for relevant ones.
0 -
Thanks Cureious. Lets hope that some great news comes out at ASCO.
0 -
Netta, Congratulations on the good results. Ibrance is working for you and I am sooo happy for you! I just came back from the МО office. He said my results from the PET/ CT scan were good, nothing new, but he was not sure about a spot on my arm and he sent me for a X-RAY . I'll find out tomorrow and will try not to worry.
Prayers and hugs
0 -
Jaycee, I am second day on Cepro for UTI and I am hoping to do it at least 5 days, because of the nausea. Ordered the D Mannose and after the antibiotic I am going to try it. I read very good rewews. Bath with apple vinegar helped, but not enough to clear it. I hope you feel better
0 -
Vilma65: I still owe you an reply to your question on primary tumor surgery. I am de novo stage 4 (i.e. my mets were already there at original breast cancer dx), which is somewhat unusual. We had some discussion on the pros and cons of surgery/no surgery for de novo stage 4 at mid of march (e.g. relate to my posting from march 18th, but there are also several postings from met sisters on this topic). Certainly, a case like the one of Lakewoman is a completely different story, in this case surgery is mandatory.
0 -
My wife is getting her blood tests done tomorrow to check how her body is handling her Ibrance dosage. Here's hoping everything will show up fine. I have my doubts and fears. Also she has started hurting around her shoulder and arm again as before the start of hormonal therapy.
This might be of interest for someone, her psychiatrist switched her antidepressant medication from Zoloft to Celexa because by European standards SSNIs tweak CYP3A levels, therefore should be avoided while taking Ibrance. I haven't found this information to be acknowledged by FDA.
0 -
Blueshine, my culture results were posted on my hospital portal today. Positive, of course. (>100,000 CFU, whatever that is [colony forming units like that explains it]) It is a different bacteria than last time three weeks ago. No call from uro office yet. I like to get sensitivity data before taking an antibiotic anyway. That was not on the portal yet. Good (sort of) news is I stopped taking Letrozole on Sunday and the symptoms have become much less. I can wait for uro NP to let me know what she wants to do. It takes them forever to do anything. The sample got to the hospital lab on Monday. I took it myself. No usable results on Thurs. I may call them in the AM. I see MO on Wed. See what she thinks. I think I need to take a month off Ibrance to get my white count up and stay off Letrozole, too. What a huge difference that makes.
Hope the Cipro works for you.
0 -
NettaGER
TY for your response regarding my surgery being mandatory..Always appreciate a positive comment..much appreciated..Nite to you all...
0 -
Jaycee, I think too , it's a good idea to wait for the sensitivity data before taking antibiotic. My just came today and it turns out the bacteria is resistant to Cipro. I am stopping it and I'll ask them to change. skipping tonight Famera too. Thank you for sharing your experience. Get well fast
0 -
Hi all. Been on 100 mg Ibrance for two weeks. Saw my oncologist yesterday - WBC count was down but still within "normal" range". He did not get tumor markers yesterday but will when I see him again in two weeks. I haven't had much in the way of side effects - I do run out of gas a bit quicker than before but that is probably normal. Have a pretty hectic schedule right now - including hitting a deer on my way home from the doctor yesterday. Nothing serious but just a "pain" having to deal with the insurance company and getting the car repaired. Hosting a dinner tomorrow night for 15 people so lots to do. I am trying to be aware of how I feel and if here are any changes. Love this site - first time I have found "soul sisters" with similar illness as me and similar treatments. Thanks for the input.
0 -
Leapfrog--sorry for the delay in responding. It sounds similar. My spot is about the size of 2 ping-pong balls side by side, on my right hip. It didn't itch or hurt for a while. Then it got itchy. I was using benadryl and hydrocortisone on it, but found that Bio Oil I had for skin and scars has been working. It's starting to fade and shrink. My Onc thought it was rash that is common with Ibrance. We'll see it it finally goes away.
0 -
Welcome Seaway! I'm only in my 3rd cycle of Ibrance, and new within the last month or so to the site. The ladies here have a lot good support, experience and knowledge.
0 -
SandiBeach--I live at about 7400 ft in Central New Mexico. No issues with altitude, but I'm used to it. Have a great time camping!
0 -
Wow! I was away from this site for a week and so much has been posted! I will all you ladies luck with upcoming scans and tests! I'm sending lots of light to all of you to ease your journeys. May we all do well and continue to thrive!
0 -
Welcome, Wandering! And what a great place to wander....Montana! But stay away from those bears....!
There is wonderful support here from caring, knowledgeable, generous fellow Ibrance "dancers". Fire away with questions. I hope that your dinner last night went well. We have 30 for brunch on Sunday, and it has been raining in VA for DAYS. We are well hydrated, though my garden looks sodden. It's so nice to do "normal" things and move on with life. Ibrance tends to let you do that. We are blessed that it is available to us.
You may want to fill in your diagnosis and treatment information under "My Profile". It helps for others to be able to see your history and treatment(s) in BC.
Hugs to all...I'm slogging out into the downpour to pick up food and flowers....wish you were all here to join us!
0 -
Wow Wandering and Lynn. I can't imagine doing dinners or brunch for so many any more. My mind simply wouldn't remember all the details and exhaustion would overcome me. Congratulations and I hope you both had lots of help lol.
I am wondering what the difference is if you PR+ or PR-? Does it make any difference to the treatment or effect of Ibrance or Letrozole?
Wishing you all good results,
Cathy
0 -
Cathy, I don’t think there’s any solid clinical data regarding the response to Ibrance based on PR status. I seem to remember a study suggesting that the proportion of patients responding to letrozole was highest in patients with moderate PR positivity and lower for no PR or very high PR. They didn’t go into differences in length or quality of response in the patients that did respond. There’s been a relatively recent article suggesting that PR negative cancers could be more aggressive, as the PR receptors can act as a break on the tumors, but right now doctors don’t make treatment decisions based on PR status and some labs don’t even report it
0 -
I did update my profile about a week ago but it hasn't shown up on my posts. I'll try it again and see if it shows up. Nothing very exciting like lots of you ladies. PS: Got a shipment of Ibrance today. It was sent UPS next day air. We were gone (drs appointment of course), so I left a note and asked the delivery man to leave it in the grill under the front porch. I assume there is no danger with getting the pills wet even if they are not under cover. The packaging seems pretty waterproof. We are very remote so I'm not concerned about having someone borrow them- just wet if it's raining or snowing starting pretty soon - ugh.
0 -
Wandering;
I believe I had the same problem as you initially. Once you entered the data about diagnosis, treatment etc. you need to go to the setting area on the left side of the main page and change private settings to public. Also, since I was diagnosed with ovarian cancer and you don't have any way to enter the data I had to use my signature option to enter the data. Hope that helps.
Best wishes,
Cathy
0
