Faslodex + Pablociclib(Ibrance) treatment combination -
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Ibrance and Faslodex with ovarian suppression in premenopausal MBC. ASCO abstract on Paloma-3 trial
Palbociclib (PAL) in combination with fulvestrant (F) in pre-/peri-menopausal (PreM) women with metastatic breast cancer (MBC) and prior progression on endocrine therapy – results from Paloma-3.
Sub-category:
ER+Category:
Breast Cancer—HER2/ERMeeting:
2016 ASCO Annual MeetingAbstract No:
524Poster Board Number:
Poster Discussion Session (Board #12)Citation:
J Clin Oncol 34, 2016 (suppl; abstr 524)Author(s): Sibylle Loibl, Nicholas C. Turner, Jungsil Ro, Massimo Cristofanilli, Hiroji Iwata, Seock-Ah Im, Norikazu Masuda, Sherene Loi, Fabrice Andre, Nadia Harbeck, Sunil Verma, Elizabeth Folkerd, Kathy Puyana Theall, Ke Zhang, Cynthia Huang Bartlett, Mitch Dowsett; German Breast Group, Neu-Isenburg, Germany; Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; National Cancer Center, Goyang-Si, South Korea; Robert H Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Chicago, IL; Aichi Cancer Center Hospital, Nagoya, Japan; Department of Medicine, Seoul National University Hospital, Seoul, Korea, The Republic of; Breast Oncology, NHO Osaka National Hospital, Osaka-City, Japan; Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Institut Gustave Roussy, Villejuif, France; Brustzentrum der Universität München (LMU), Munich, Germany; University of Calgary, Tom Baker Cancer Centre, Calgary, AB, Canada; Pfizer Inc, Cambridge, MA; Pfizer Inc, San Diego, CA; Pfizer Inc, Collegeville, PA
Abstract:Background: Standard endocrine therapy options for PreM women with MBC are limited and better options are needed. PALOMA-3 is the first large registrational study to include PreM women with HR+ MBC.
Methods: In this double-blind phase 3 study, patients (pts) with HR+/HER2– MBC were randomized 2:1 to receive PAL (125 mg/d orally for 3 wk followed by 1 wk off) + F (500 mg) (PAL+F) or placebo (PLB)+F. PreM women received ovarian suppression starting ≥ 4 wk before randomization and throughout treatment (trt) with gosrelin. Reproductive biochemistry measurements (estradiol [E2] and FSH) were assessed using blood samples from day 15 of trt.
Results: 108 (21%) of 521 enrolled pts were PreM (72, PAL+F; 36, PLB+F). Age groups were: ≤ 40 yrs (31%), > 40-50 yrs (46%), and > 50-59 yrs (23%). Of the 108 pts: 44 (41%) were Asian, 74 (69%) had ER+/PR+ disease, 27 (25%) were ER+/PR-, 68 (63%) had visceral disease, 55 (51%) had prior tamoxifen (TAM) only, and 50 (46%) had prior TAM + aromatase inhibitors. 27 (25%) of 108 pts had disease progression while on/within 12 mo of endocrine adjuvant trt. 46 (43%) of the PreM pts received one line of prior chemotherapy in the MBC setting. Median progression-free survival (PFS) among PreM women was 9.5 mo for PAL+F and 5.6 mo for PLB+F (HR, 0.50; 95% CI: 0.29-0.87; p = 0.006). Clinical benefit rate was 69% vs 44% (OR, 2.84; p = 0.01). In the PAL+F arm, the safety profile for PreM and PostM women was similar for all grade adverse event (AE) rate (99% each), grade 3/4 AEs (83% and 71%, respectively), and serious AEs (14% and 12%). The discontinuation rate due to AEs for PAL/PLB was 6% and 5%, respectively. E2 and FSH concentrations among PreM women for whom day 15 samples were available showed good suppression in both arms. PAL did not alter ovarian function suppression and plasma E2 levels were not significantly associated with the PFS results.
Conclusions: The combination of PAL+F with goserelin is an effective and well-tolerated trt for PreM women who developed endocrine resistant MBC. The data on PAL plus F/goserelin support its use in HR+ MBC and expands the trt options for PreM women. Clinical trial information: NCT01942135
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My cats don't listen either, and they never pick up after themselves. Every day they get toys out of the toybox, I come home to them strewn all about the floor . Who cleans them up? Me.
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Cats do what they will do.
HLB, the Ibrance label says "IBRANCE should be taken with food [see Clinical Pharmacology (12.3)] in combination with letrozole 2.5 mg once daily given continuously throughout the 28-day cycle. Patients should be encouraged to take their dose at approximately the same time each day."
Section 12.3 says:
Food effect: Palbociclib absorption and exposure were very low in approximately 13% of the population under the fasted condition. Food intake increased the palbociclib exposure in this small subset of the population, but did not alter palbociclib exposure in the rest of the population to a clinically relevant extent. Therefore, food intake reduced the intersubject variability of palbociclib exposure, which supports administration of IBRANCE with food. Compared to IBRANCE given under overnight fasted 10 Reference ID: 3696527 conditions, the population average AUCinf and Cmax of palbociclib increased by 21% and 38%, respectively, when given with high-fat, high-calorie food (approximately 800 to 1000 calories with 150, 250, and 500 to 600 calories from protein, carbohydrate and fat, respectively), by 12% and 27%, respectively, when given with low-fat, low-calorie food (approximately 400 to 500 calories with 120, 250, and 28 to 35 calories from protein, carbohydrate and fat, respectively), and by 13% and 24%, respectively, when moderate-fat, standard calorie food (approximately 500 to 700 calories with 75 to 105, 250 to 350 and 175 to 245 calories from protein, carbohydrate and fat, respectively) was given one hour before and two hours after IBRANCE dosing
So you don't need to eat a lot. Just some -- though a little fat seems to help.
The side-effects I had my first cycle have disappeared. I assume there will be new ones.
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My cat has a mind of his own, screams for food even when his bowl is nearly full and I suspect charges toys to my credit card. lol He a black 17 year old persian and still going. meow HLB - I take Ibrance with dinner as that is my largest/most consistent meal. Try what works best for you, but don't panic too early. I started cycle #6 today, no problem with shots - although there are twin lumps lingering from last month's foray. Good news is that since my WBC crashed (enough) - I am moving to #100. I am really glad as fatigue was getting to me and hoping for more energy coming my way. Z - happy for your move, that takes a lot out of anyone, but we are more fragile taking this combo. Hoping you feel better soon. Today's weather in So Cal is sunny and we are in store for a great weekend. I'm getting to my garden tomorrow.
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pajim, thanks for that info, it's very helpful to know that. I really thought a lot about what time I should take it and still didn't really come up with anything I thought would be the bestt time every day. Knowing that I don't need a giant meal will maake that easier. I took it at 8:30 but I figured if I want to change it it would probably be 👌 to do so after the 7 days off.
Lalady my cats bought me a few Christmas gifts last year. I didn't even know they went shopping.
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Do any of you take atragalus? I read in a forum here a while ago that it brings up blood cell counts. I was wondering if it would be good to take on the 7 days off. I use a lot of supplements and I've stopped a lot of them due to not knowing if they will interfere with this treatment. I started my Meriva again today because I'm so achey in my knee joints. It is just a spice so I can't imagine that would be contraindicated. I feel really crappy when I get up.
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Oh hahahaha, that cat scenerio gave me a good laugh! Sorry about the SE's Z. The skin thing sounds very disconcerting.....I got headaches the first time around with Ibrance too, sort of low grade pressure ones which did get better in a few weeks. I never got much better with the fatigue except maybe the last 4 days or so on my week off. I am getting ready to start it up again so we'll see how it goes....
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Started Ibrance cycle 3 yesterday. Does anyone else have trouble getting Ibrance? My pharmacy can't keep it in stock because of the cost but my onc won't order it until the day before I start after she sees my blood work. Well, the pharmacy needs more time to get it! So it's a catch 22! So I end up with 8 days off instead of 7. I know one day isn't going to hurt, but I wish they could come up with a better system. I asked onc if I could do blood work earlier but she said no, she wants it the day before.
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Kay, couldn't your onc put in a standing order for 3 or 4 mos, and just change it if necessary? Also, I think most of us get our Ibrance overnight from a specialty pharmacy for the exact reason you described -- it's much too pricey for local drugstores to inventory in any quantity. Are you getting yours from a specialty pharmacy or a local drugstore?
Also, though not vetted information, there was something quite interesting posted in the CD4/6 inhibitor group on FB by someone who is friends with a microbiologist. That scientist explained why Ibrance actually works better after a break. I'll try to find it for you, in case it eases your mind about waiting a day or two additional, but I found it very reassuring.
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Interesting problem you have Kay - every onc is different. Mine monitors my blood weekly but doesn't care about what day to draw blood. I have been off Ibrance as long as three weeks due to an infection (cellulitis) and neutropenia that was very low. I have stopped fretting over my schedule, as I figure stress is about as troublesome as cancer recurrence.
I get my Rx from Wahlgreens Specialty Pharmacy and they've been wonderful about refilling. They call me the week I'm off and ask a bunch of questions about SE etc then they ship so it arrives the next day. I've never been out of Ibrance since starting in January.
Good luck to you - I hope something can be worked out for you.
Amy
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I get mine from the Cancer Center pharmacy (who always has it in stock), but I get my letrozole from Xpress Scripts (mail order). Most insurance companies have a mail order pharmacy they work with. Try that?
My onc wrote a prescription good for four months [X with 3 refills]. Each time the pharmacy asks when I'm starting the next round. They report it to either the insurance company or Pfizer. Could be Pfizer is keeping track of how many breaks we take.
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I was going to ask if there was a hospital/cancer pharmacy. That's where my mom gets hers.
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Well, ladies, a red letter day and it's not even 10:30am!
I went to the cancer center this morning to get my shots. And to bitch about how they'd forgotten my new Ibrance prescription -- I'd reminded them last week that I needed it but it wasn't there yesterday.
WELL!!
I was exactly 60 minutes in the building -- maybe an all-time record
Saw my favorite nurse -- who gives totally pain-free shots
The Ibrance was at the pharmacy waiting for me to pick it up and
Tumor markers were down again!!!! 20% more. Not sure "how low can we go" but we'll see. . .
Now off to get some work done. I feel like I should play the lottery.
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pajim, congratulations! That's awesome results. I'm in the same protocol and my tumor markers have gone down to normal range in the 3 months I've on it. Tomorrow I have a PET scan which should give me even more good news I hope. It seems this is a winning combination all around, a lot of people having good results on it.
Aurora
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Yea Pam! That's what we like to hear! Congrats on record short time at docs. Now on with your life, and maybe a lottery ticket, ha ha!
Aurora, Hoping you get great news after your scan tomorrow. TMs in normal range has to be a good sign! Please share when you get your results.
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Way to rock those markers, Pajim!
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Pam, fabulous news on the TMs! And YaY for getting the painless shots nurse! And I hope you bought a lottery ticket!
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That is Great news! I spent 4 hrs at the cancer yesterday. Other than that it went well. Glad I had my knitting.
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Heading out to the oncologists to get results from my last ct scan ...yikes...hate this every time. I guess it will never get easier . Pam great news always gives the rest of us so much hope😊.
Wendy
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Hi Wendy! Haven't "seen" you around here in a while. Hope you get great news too! Please let us know how it went. I think it gets to be more routine as time goes on, but not a lot easier. Best wishes!
HLB, That's a long damn time at the cancer center, yuck! What are you knitting? In 4 hours I bet you got a lot done.
Aurora, did you get your PET results yet?
My turn for PET next week. Waited 5 months this time and I am a little more nervous than usual. Fingers crossed.
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Jobur, no I haven't, I always wait until my doctor gives them to me, I'm afraid if I read them myself I'll get paranoid about details that I can't explain so I just trust my doctors. So far they've been right on the money. I'll see my oncologist Friday next week. I had an appointment for Wednesday but I had to move it to Friday because my daughter will be out of town. I'll let you know what they say.
Aurora
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Jobur, I'm knitting a neckwarmer. I buy thrift store sweaters and unravel them for knitting yarn. Cheap way to get nicer materials, even cashmere. I make a lot of hats and slippers. Four hrs was way too long. All I needed was blood tested, talk to onc then get my shots. He is so busy and runs hours behind sometimes. Then at checkout they tried to give me an appt in 5 weeks instead of 4. I said I'm pretty sure it has to be exactly 4 weeks for these shots. He said they were overbooked already so they will call me today. Have I gotten a call? Of course not. Dumb
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Wendy, how was the scan?
HLB, 4 hours, ugh. I've been there. Many times. I never go to the cancer center without my computer and my book. Knitting sounds excellent.
Aurora, may the scan show "no evidence of metabolically active disease". . .
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Thank you Pajim, same for you and everyone.
Aurora
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HLB
I think you and I have the same problem. I spent 3 hours at my MO office today for bloodwork, a brief visit and my Faslodex and Xgeva shots. He was being shadowed by a 2nd yr med student, so things were taking twice as long. Ugh. My doc isn't even in for my 4 week appt, so I'm going to see the PA, get shots and labs, and I have to go back the following week to see him! Crazy.
Debie
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Debie I am assuming I have to have the bloodwork and have him look at it to approve getting the shot. If I can get the shots without being seen by him every time things would go a lot faster! I noticed that I do have an appt for xgeva on that day that was made in advance before I started faslosex/ibrance. If they could just add the fas shots to that appt everything will be great! I get so irritated when they do things the hard way. I wish I would have noticed that appt at checkout and had him add those shots. Then I would not have to think about it and let THEM call ME about seeing the Dr! The way it is I t looks like I will have to call to remind them to do their job.
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Debie I would think when you see the PA that would be good enough. Unless the doc sees something in the bloodwork that's worth talking about. Then he should just call you instead of making you go in there again. Nothing better as a mets patient than wasting time!!
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I agree the visit with the PA should be enough, but I have to go for myHerceptin infusion that day as well, so I guess it won't be a waste. Since we're sorta doing the Herceptin as a "just in case", he mentioned we might move it to once a month and not every 3 weeks. That would be wonderful, except I would surely (and sorely) leave the office feeling like a pin cushion, getting 3 injections, bloodwork and an IV! So glad I don't mind needles...😳
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That is interesting about the herceptin if you are her2-. I have often wondered if more of us shouldn't be getting it because I read that most if not all breast cancer has her2+stem cells. We sure do get stuck a lot. I'm used to it to the point that the blood draws are actually relaxing because they're so good at it and I get relaxed when someone gets close to me and is being gentle. I doubt the bett shots will ever be relaxing though lol!
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So second ct scan done and dusted. No progression only shrinkage most of my lesions are slerotic. Breast tumour down another .5 cm . Faslodex shots are not fun I wanted to ask in Canada we get them on the hip I've read on these threads that in the states they inject them on the backside is this true and if so have any of you had difficulty with your sciatic nerve? Anyway good report for now yeah.
Wendy
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