Faslodex + Pablociclib(Ibrance) treatment combination -
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A n encouraging free full text article:
Quality of Life With Palbociclib Plus Fulvestrant in Previously Treated Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer: Patient-Reported Outcomes From the PALOMA-3 Trial
excerpt:…estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group (66.1, 95% confidence interval [CI]: 64.5, 67.7 vs 63.0, 95% CI: 60.6, 65.3; P=0.0313). Significantly greater improvement from baseline in pain was also observed in this group (–3.3, 95% CI: –5.1,–1.5 vs 2.0, 95% CI:–0.6, 4.6; P=0.0011).
No significant differences were observed for other QLQ-BR 23 functioning domains, breast, or arm symptoms.
Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P<0.025) and pain (P <0.001) compared with fulvestrant alone.
http://annonc.oxfordjournals.org/content/early/201...
Still no word on Overall Survival (OS), which is important to numbers folks, but probably not so much to patients.
Loving healing wishes for all, Stephanie
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Hello everyone! I agree with Deanna about the mind-body connection! My minister told me that the mind-body connection is huge in the healing process, and for me not to own the cancer. Let me explain...He said not to label it with the big "C' word and give it life. Does that make sense to anyone? One time someone asked me why I didn't work and I replied "I have breast cancer' but now I will only refer to it as a health issue. Maybe that is silly.... but I really do feel better not uttering that NASTY word!
Hope everyone has a great night!
Robin
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So many oncologists, so little time. Wish we could consult them all!
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Robin, I totally get what you're saying. I think I do that too. But I also feel like it's my own cells that have gone awry and need TLC -- if that makes sense to you. In other words, I do not subscribe to words like "fight" or the feeling it evokes. I work at creating peace within my body so that it can heal.
I'm a huge fan of Dan Buettner's work (The Blue Zones), and your post made me think of this story (link), which is one I literally think about every day. Thought you might enjoy it if you haven't seen it. http://www.nytimes.com/2012/10/28/magazine/the-isl...
PS ~ Just realized that link I pulled is a rather lengthy article. It's the story of Stamatis Moriatis I wanted to share with you.
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Thanks for sharing Deanna great story
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Thanks Deanna, great read! I agree with you on the TLC to our bodies and trying to create peace to heal. That's the main reason I quit my accounting job!! I cut all stress out of my life and learned not to sweat the small stuff. Now I'm working on the stress that comes with the quarterly scans. I will have to say...it is getting much better!
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Quick question, my PET today showed progression at T2 and right pelvis, both small, 9 mm or less. My onc on vacation so I have to wait for her thoughts but in your experience, is any progression viewed as bad in that Ibrance isn't working, OR can it be viewed as good in that it's kept cancer out of my organs? What are your experiences in this regard? I've been on 100 mg Ibrance for 5 months and 125 mg for 2 months for a total of 7 months.
Should I feel grateful I have a very good QOL? Which I am.
Thank you
Amy
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AmyQ, 18 months ago I had a scan. Showed two spots where I'd previously been NED. Onc says to me "you feel ok?" I say "yeah". He says, well let's scan in 4 months. Next scan the spots are the same. "You feel ok?" "Yes." OK, wait four more months.
We waited an entire year before switching treatment! Essentially the scans were always "the same, maybe a little worse". Eventually my tumor markers started to rise higher than we wanted, so we added Ibrance.
It was scary not altering treatment right away, but I bought a year on the same treatment and I would do it again. It feels like an extra year of life. Don't know whether it actually is.
What I realized through all that is that I will never feel as good as I do right now. (I do feel a little worse than last year) So why be so anxious to make my life worse? Each drug is going to add side-effects. Your experience may vary.
Bottom line: You could certainly consider staying the course for a while.
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Sending these abstracts as the issue of response (PFS- progression free survival) for faslodex/fuvestrant with ibrance/palbociclib came up on the femara with ibrance thread. There have to be errors in either abstract #1 or abstract #3...there's quite a gap between (9.5 vs. 4.6 months) as reported in abstract #1 and Median progression-free survival was 95 months (95% CI 92-110) in the fulvestrant plus palbociclib group and 46 months (35-56) in the fulvestrant plus placebo group (hazard ratio 046, 95% CI 036-059, p<00001) as reported in abstract #3.
Oh well, don't know who's proofreading for Lancet Oncology?!
Also, quite a span in adverse effects or adverse reactions - The most common adverse reactions (>20%) in patients treated with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, and thrombocytopenia (abstract #1). And Grade 3 or 4 adverse events occurred in 251 (73%) of 345 patients in the fulvestrant plus palbociclib group and 38 (22%) of 172 patients in the fulvestrant plus placebo group.
Well, the PALOMA-3 trial reported in abstract #3 supplied the data for the FDA to green light the treatment as described in abstract #1.
confusing for sure, Stephanie
xxx
1. FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Walker AJ1, Wedam S, Amiri-Kordestani L2, Bloomquist E3, Tang S4, Sridhara R3, Chen W5, Palmby TR6, Fourie Zirkelbach J7, Fu W8, Liu Q9, Tilley A10, Kim G11, Kluetz PG12, McKee AE11, Pazdur R13.
Clin Cancer Res. 2016 Jul 12. pii: clincanres.0493.2016. [Epub ahead of print]
Abstract
On February 19th, 2016, the U.S. Food and Drug Administration (FDA) approved palbociclib (Ibrance, Pfizer) for use in combination with fulvestrant (Faslodex, AstraZeneca) for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy. The approval was based on the results of a randomized, double-blind, placebo-controlled trial conducted in 521 pre- and postmenopausal women with HR-positive, HER2-negative advanced or MBC. Patients were randomized (2:1) to receive palbociclib plus fulvestrant (n=347) or placebo plus fulvestrant (n=174). The primary endpoint was investigator assessed progression-free survival (PFS). A statistically significant and clinically meaningful improvement in PFS (9.5 vs. 4.6 months) was observed in patients receiving palbociclib plus fulvestrant [HR 0.46; 95% CI: 0.36-0.59; p<0.0001]. Safety data confirmed the known adverse reaction profile of palbociclib. The most common adverse reactions (>20%) in patients treated with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, and thrombocytopenia. This approval was granted in the context of a prior accelerated approval for palbociclib in combination with letrozole in patients with HR-positive, HER2-negative advanced breast cancer as initial endocrine based therapy.
Copyright ©2016, American Association for Cancer Research.
PMID: 27407089 DOI: 10.1158/1078-0432.CCR-16-0493
[PubMed - as supplied by publisher]
2. Palbociclib in Combination With Fulvestrant in Women With Hormone Receptor-Positive/HER2-Negative Advanced Metastatic Breast Cancer: Detailed Safety Analysis From a Multicenter, Randomized, Placebo-Controlled, Phase III Study (PALOMA-3).
Verma S1, Bartlett CH2, Schnell P3, DeMichele AM4, Loi S5, Ro J6, Colleoni M7, Iwata H8, Harbeck N9, Cristofanilli M10, Zhang K11, Thiele A12, Turner NC13, Rugo HS14.
Author information
Oncologist. 2016 Jul 1. pii: theoncologist.2016-0097. [Epub ahead of print]
Abstract
BACKGROUND: Palbociclib enhances endocrine therapy and improves clinical outcomes in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Because this is a new target, it is clinically important to understand palbociclib's safety profile to effectively manage toxicity and optimize clinical benefit.
MATERIALS AND METHODS: Patients with endocrine-resistant, HR-positive/HER2-negative MBC (n = 521) were randomly assigned 2:1 to receive fulvestrant (500 mg intramuscular injection) with or without goserelin with oral palbociclib (125 mg daily; 3 weeks on/1 week off) or placebo. Safety assessments at baseline and day 1 of each cycle included blood counts on day 15 for the first 2 cycles. Hematologic toxicity was assessed by using laboratory data.
RESULTS: A total of 517 patients were treated (palbociclib, n = 345; placebo, n = 172); median follow-up was 8.9 months. With palbociclib, neutropenia was the most common grade 3 (55%) and 4 (10%) adverse event; median times to onset and duration of grade ≥3 episodes were 16 and 7 days, respectively. Asian ethnicity and below-median neutrophil counts at baseline were significantly associated with an increased chance of developing grade 3-4 neutropenia with palbociclib. Dose modifications for grade 3-4 neutropenia had no adverse effect on progression-free survival. In the palbociclib arm, febrile neutropenia occurred in 3 (<1%) patients. The percentage of grade 1-2 infections was higher than in the placebo arm. Grade 1 stomatitis occurred in 8% of patients.
CONCLUSION: Palbociclib plus fulvestrant treatment was well-tolerated, and the primary toxicity of asymptomatic neutropenia was effectively managed by dose modification without apparent loss of efficacy. This study appears at ClinicalTrials.gov, NCT01942135.
IMPLICATIONS FOR PRACTICE: Treatment with palbociclib in combination with fulvestrant was generally safe and well-tolerated in patients with hormone receptor (HR)-positive metastatic breast cancer. Consistent with the drug's proposed mechanism of action, palbociclib-related neutropenia differs in its clinical time course, patterns, and consequences from those seen with chemotherapy. Neutropenia can be effectively managed by a dose reduction, interruption, or cycle delay without compromising efficacy. A significant efficacy gain and a favorable safety profile support the consideration of incorporating palbociclib into the routine management of HR-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer.
©AlphaMed Press.
KEYWORDS:cCyclin-dependent kinase 4; Cyclin-dependent kinase 6; Neutropenia; Palbociclib
PMID: 27368881 DOI: 10.1634/theoncologist.2016-0097
[PubMed - as supplied by publisher]
3. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.
Cristofanilli M1, Turner NC2, Bondarenko I3, Ro J4, Im SA5, Masuda N6, Colleoni M7, DeMichele A8, Loi S9, Verma S10, Iwata H11, Harbeck N12, Zhang K13, Theall KP14, Jiang Y13, Bartlett CH15, Koehler M16, Slamon D17.
Lancet Oncol. 2016 Apr;17(4):425-39. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3.
Abstract
BACKGROUND: In the PALOMA-3 study, the combination of the CDK4 and CDK6 inhibitor palbociclib and fulvestrant was associated with significant improvements in progression-free survival compared with fulvestrant plus placebo in patients with metastatic breast cancer. Identification of patients most suitable for the addition of palbociclib to endocrine therapy after tumour recurrence is crucial for treatment optimisation in metastatic breast cancer. We aimed to confirm our earlier findings with this extended follow-up and show our results for subgroup and biomarker analyses.
METHODS: In this multicentre, double-blind, randomised phase 3 study, women aged 18 years or older with hormone-receptor-positive, HER2-negative metastatic breast cancer that had progressed on previous endocrine therapy were stratified by sensitivity to previous hormonal therapy, menopausal status, and presence of visceral metastasis at 144 centres in 17 countries. Eligible patients-ie, any menopausal status, Eastern Cooperative Oncology Group performance status 0-1, measurable disease or bone disease only, and disease relapse or progression after previous endocrine therapy for advanced disease during treatment or within 12 months of completion of adjuvant therapy-were randomly assigned (2:1) via a centralised interactive web-based and voice-based randomisation system to receive oral palbociclib (125 mg daily for 3 weeks followed by a week off over 28-day cycles) plus 500 mg fulvestrant (intramuscular injection on days 1 and 15 of cycle 1; then on day 1 of subsequent 28-day cycles) or placebo plus fulvestrant. The primary endpoint was investigator-assessed progression-free survival. Analysis was by intention to treat. We also assessed endocrine therapy resistance by clinical parameters, quantitative hormone-receptor expression, and tumour PIK3CA mutational status in circulating DNA at baseline. This study is registered with ClinicalTrials.gov, NCT01942135.
FINDINGS: Between Oct 7, 2013, and Aug 26, 2014, 521 patients were randomly assigned, 347 to fulvestrant plus palbociclib and 174 to fulvestrant plus placebo. Study enrolment is closed and overall survival follow-up is in progress. By March 16, 2015, 259 progression-free-survival events had occurred (145 in the fulvestrant plus palbociclib group and 114 in the fulvestrant plus placebo group); median follow-up was 89 months (IQR 87-92). Median progression-free survival was 95 months (95% CI 92-110) in the fulvestrant plus palbociclib group and 46 months (35-56) in the fulvestrant plus placebo group (hazard ratio 046, 95% CI 036-059, p<00001). Grade 3 or 4 adverse events occurred in 251 (73%) of 345 patients in the fulvestrant plus palbociclib group and 38 (22%) of 172 patients in the fulvestrant plus placebo group. The most common grade 3 or 4 adverse events were neutropenia (223 [65%] in the fulvestrant plus palbociclib group and one [1%] in the fulvestrant plus placebo group), anaemia (ten [3%] and three [2%]), and leucopenia (95 [28%] and two [1%]). Serious adverse events (all causalities) occurred in 44 patients (13%) of 345 in the fulvestrant plus palbociclib group and 30 (17%) of 172 patients in the fulvestrant plus placebo group. PIK3CA mutation was detected in the plasma DNA of 129 (33%) of 395 patients for whom these data were available. Neither PIK3CA status nor hormone-receptor expression level significantly affected treatment response.
INTERPRETATION: Fulvestrant plus palbociclib was associated with significant and consistent improvement in progression-free survival compared with fulvestrant plus placebo, irrespective of the degree of endocrine resistance, hormone-receptor expression level, and PIK3CA mutational status. The combination could be considered as a therapeutic option for patients with recurrent hormone-receptor-positive, HER2-negative metastatic breast cancer that has progressed on previous endocrine therapy.
FUNDING: Pfizer.
Copyright © 2016 Elsevier Ltd. All rights reserved.
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Very interesting read once I could unglaze my eyes and really concentrated - so Stephanie and pajim, I think my onc will recommend staying the course and I would be comfortable with that. Who know what my outcome may have been without Ibrance?
Btw, whenever I write Ibrance, I want to write it iBrance - as in all the apple products...I find myself doing it over and over - talk about indoctrination.
Have a great weekend all -
Amy
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Steph - I understand the Pfizer study was 9.5 months median progression free survival, not 95. But I wish!
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Here's an article on Ibrance and other inhibitors.
http://www.targetedonc.com/conference/IBC-2016/cdk...
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Have a question for you ladies, I recently joined a Facebook page on fighting breast cancer with alternative methods interesting stuff. Anyway I was told in no uncertain terms that Ibrance in a chemo drug.. It's not is it? I'm totally naive regarding this I wondered what you ladies think as I trust your judgement a lot more. Thanks
Wendy
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Wendy, chemotherapy kills all fast growing cells and in the process damages our immune systems. Ibrance is a targeted therapy that inhibits the manufacture of CDK 4/6. That said, it does have some mild but similar SEs to chemo, such as lowered wbcs and thinning hair. But it is not chemo. There is added confusion because some oncs don't seem to know the difference. And drug providers stick a "Warning Chemotherapy Drug" label on the bottle to ensure it's recognized as a potent cancer drug to avoid missuse and ensure proper disposal, further murkying it's true identity. But, no...it is in a new class of drugs technically called targeted therapies because it shuts down a mechanism necessary for cancer cells to reproduce.
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Thanks so much Deanna I will pass this info along you so rock
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Wendy I agree with Deanna but the definition of "chemotherapy" is murky. In the old days it meant intravenous treatment. Dictionary says "cytotoxic". :-)
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Wendy, I confess to occasionally even using the term "chemo" or "chemo-like" when trying to explain not feeling up to par to someone -- like, "My chemo-like meds are taking a toll on me this week." And I can see how some women would just prefer to call it chemo and be done with it, especially if it hits them hard, as it does some. So probably no real harm in calling it chemo. It's just technically not accurate.
Also, keep us posted on anything good you learn in that group. If you think it's valuable, I'd be interested in joining too, although I'm not into battling with people who are totally anti-conventional meds, LOL.
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Agree Deanna I think there is a sweet spot in combining conventional and alternative therapies. So far a lot of talk about clove oil and what not I will let you know if something good comes up. I feel really bad for a lot of these woman because they are getting diagnosed stage two then doing only the super flakey protocols and they end up stage four. One even has her breast tumour opening up on the outside of her skin. I think a lot can't afford insurance it's heart breaking
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Ladies, my feet are burning. I'm about to start my 6th cycle of Ibrance (3+ yrs on Faslodex).
I'm not kidding. The soles are hot to the touch and they feel like they're sunburned. I keep looking for a cool tiled floor to stand on. The feeling comes and goes. Started Sunday morning.
This could just be exercise, or the heat, etc. but I'm wondering whether this is due to Ibrance and it's going to get worse. A couple of months ago my feet bothered me during the off week but it was really hot out and I blew it off. Anyone hear about something like this? If it is drug, any idea what to do to prevent/alleviate this?
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I had my first Faslodex shots last week, and so far so good. All the advice I read on these boards was followed. My next shots are scheduled for next week. Medicare has approved Ibrance, but my onc's office and the specialty pharmacy have been unable to secure any copayment assistance. The usual foundations have already committed all their funds for this year. They are applying to Pfizer now, but I think our income was too high last year. It was our first year of retirement. I am anxious to get started and will have to bite the bullet and pay the huge copay. It strikes me as odd that people who are not on Medicare are eligible for a $10 per month copay through Pfizer regardless of income, but people on Medicare are not eligible for the program. I know why it is that way, but it still stinks I know that you are probably thinking that you can't put a price on the value of something that might prolong life, but I cannot continue to pay thousands and thousand of dollars for one medication every year because I feel that my dh will need that money years from now. This is really upsetting. Sorry for the whining.
Lynne
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Hi Pajim,
I have never heard of burning feet being an se of Ibrance, although peripheral neuropathy is listed . Does the skin look okay? Sorry I have nothing to offer except the cold tile floor! I will say Ibrance se's seem to come and go and change a little each month. These last 2 cycles I have been itching like crazy and am back to the little red bumps I had early on. Maybe make the same post on the Ibrance thread and see if anyone there has had experience with this.
Wishing you relief!
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Thanks! I asked my onc this morning and got the "look". "New one on me," he said. I decided not to remind him that I only get the weird side-effects.
Skin looks OK. Not red or inflamed. Just hot. OTH it's 90+ degrees outside with 90% humidity and has been for weeks it seems. And I've been trying to step up my exercise. (I do have air-con at work and home.) Could be this isn't drug related at all. Maybe it will fade away.
Great suggestion to ask the letrozole/palbo ladies.
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I don't get the burning feet sensation but my scalp feels sort of burn-y when I haven't washed my hair in 2 days or so. Never happened before Ibrance. I also occasionally feel itchy and get red spots - that was a real mystery, so I'm glad to hear it might be an Ibrance SE and not something more sinister. My only other SEs are some hair thinning and fatigue, with the latter fairly manageable if I'm diligent about exercise and generous with naps.
I've been on the Ibrance + Faslodex + Zometa combo since early June, so 3 cycles of Ibrance in. My tumor markers have gone down from 950 or so in late May to low 400s last week. Best of all, I'm nearly free of the terrible pain I was in, except for strong aches that come in the week or so after the monthly Faslodex injections. I'm hoping all of that points to the treatments working, but we won't know for sure until I'm re-scanned in mid-September.
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I for one have been getting the warmth/burning feeling in my left foot around the ball of my big toe - just started about a week ago. Almost feels like athletes foot but I know it's not.
Not sure how long I'll continue Ibrance - my TM's are creeping up and with the latest progression, 2 spots, right hip and T-2 I think Ibrance will be history. Now who knows if it has kept my BC from coming back with vengeance or if it's just not working at all. I've been in the hospital twice this year; once from SE's of Ibrance and once cancer related. My body was unable to fight the infection I had, which is a big deal so if there's no positive gain, why risk it? I'll be calling my MO and see what she thinks.
Be well all -
Amy
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Well, it looks like I'm going to be joining you ladies. My TM numbers have been going up since this past April. I had a scan then which showed no progression, but when they were up again at my appt in July, I had another CT/Pet scan yesterday and the results report said that the lesions had not increased in number or size, but they had become more active. I got a call from my onc's NP today and she said that while it's not a big change, or as she put it, "anything to write home about," that my onc thinks it's time to change treatment, to stay on top of things. We had already talked last April that the next treatment would probably be Faslodex/Ibrance. So, on Friday, I go in for my first Faslodex shots and will start the Ibrance then too.
I've been stable on Arimidex since I was diagnosed stage IV in the Spring of 2013, so this will be my first change in treatment. I'm glad that it hadn't spread and that we're staying on top of it, but there's still something hard, emotionally and psychologically about the first treatment change. It pulls me right out of denial land and really drives home the fact that I can't just stay in a holding pattern forever.
Also, the Arimidex was a very easy one for me - the only side effectts I had were hot flashes and maybe making my arthritis a little worse. My NP said most do fairly well on Faslodex/Ibrance, but I have a feeling it won't be as easy as the Arimidex.
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AmyJM I haven't been on Arimidex yet but I have been on this therapy six months now. No SE at all and my tumour in my breast is almost gone last CT scan in July said stable no new growth have another CT scan in September we shall see but so far so good. Wish you all the best of luck.
Wendy
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Welcome seagan, we're almost neighbors! I live about an hour east of St. Paul. I get itchy red bumps that look like zits and bleed if scratched. I have no doubt this is an Ibrance se, never had them before. Lately, certain parts of my scalp itch terribly, I would swear I have cooties, but it is isolated to only the back of my head. Weird. Hair is thinner but noticeable only to me so far. So glad you are feeling so much better after only a few months in to tx - it's a good sign! Best wishes on the Sept scan.
AmyJM, I know what you mean about that 1st little sign of progression. Arimidex was my 1st tx too, and my 1st progression was not huge either. But since I have been on this combo I have gone from stable/little progression to complete metabolic response. Not bragging, just trying to throw a little hope your way. This tx may be a little more difficult than Arimidex, but I think you will still find it very tolerable. I hope it works great for you too.
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Amy, I was on Arimidex (Anastrozole) for 18 mos, and yes, it's not only a rude awakening to realize you're chalking one off the list, but I know I was also shocked to learn I wasn't simply going to Aromasin or Letrozole, but something that sounded a lot tougher. But after being on Faslodex + Ibrance now for a year, I can honestly say I love it. Aside from an occasional weird, fleeting SE, it's been a relatively easy combination -- especially in view of the results gained. It's different than Anastrozole, but I honestly can't say it's worse - just different.
Welcome, Seagan! I can't imagine that your TMs and pain would have decreased that much if this combo wasn't working for you big time! I'll bet your next scans will show a huge improvement! Mine did, and there have been a recent slew of NEDs and NEADs scans in a FB group I'm in for Ibrance.
Pam, are you getting any peeling skin with the burning you described? It's probably a form of neuropathy, but hand & foot syndrome also came to mind, although that's really not a recognized SE for palbo. Anyway, here's a link I posted in the FB Ibrance group today that got into a discussion about neuropathy. Just thought it might help you figure out if that's what you have, as well as giving some helpful suggestions to treat it. http://www.drweil.com/health-wellness/body-mind-sp...
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Thank you Wendy, Jobur and dlb for the encouraging words - it does give me hope that this combo will hopefully be very tolerable AND hopefully as successful as it has been for all of you! Jobur and dlb, your situations both seem fairly similar to mine - it's always nice to hear from someone else who "gets it" about the first progression/treatment change and that have had such good results with this tx!
Thanks all,
Amy
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