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  • helena67
    helena67 Member Posts: 357
    edited December 2009

    [2103] Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women with Primary Breast Cancer (BC) Undergoing Adjuvant Aromatase Inhibitor (AI) Therapy.

    Hines SL, Sloan JA, Atherton PJ, Perez EA, Dakhil SR, Johnson DB, Reddy PS, Dalton RJ, Mattar BI, Loprinzi CL Mayo Clinic Florida, Jacksonville, FL; Mayo Clinic Rochester, Rochester, MN; Wichita Community Clinical Oncology, Wichita, KS; Immanuel-St. Joseph Hospital Mayo Health System, Mankato, MN

    Background: Postmenopausal women with significant osteopenia/osteoporosis are at increased risk of fracture, a risk that is exacerbated by the use of Aromatase Inhibitors (AIs). Bisphosphonates may be used for these patients because there is no known interaction with estrogen and/or progesterone receptors (ER, PR). This study evaluated the concurrent use of zoledronic acid in patients with significant osteopenia or osteoporosis who received initial adjuvant letrozole therapy for primary BC, to determine if further bone mineral density (BMD) loss could be prevented.
    Methods: Postmenopausal women with Stage I-IIIa, ER and/or PR + BC, no evidence of metastatic disease, and a BMD T-score < -2.0 were treated with daily letrozole 2.5 mg/d, vitamin D 400 international units/d, calcium 500 mg twice daily, and 4 mg I.V. zoledronic acid every 6 months (for 5 years). The BMD was measured at baseline and at one year. Kruskall-Wallis p-value methodology was used as the method of statistical analysis. Since this was a single-arm study, the analysis plan was primarily descriptive. The primary endpoint was the mean change in lumbar spine (LS) BMD at 1 year.
    Results: 60 patients were enrolled; 46 completed 1 year of treatment. Mean patient age was 67 years, with 44% having taken prior tamoxifen. At 1 year (see figure 1), LS BMD increased 2.66% (p=0.01), femoral neck (FN) BMD increased 4.81% (p=0.01), and any measured endpoint (within the LS or FN) increased 4.55% (p=0.0052). 7% of patients experienced a fracture vs.13% with a pre-existing history of fracture before enrollment. No patients had disease recurrence during year 1. Toxicity was minimal with arthralgia as the most common complaint. There were no reports of osteonecrosis of the jaw.

    Conclusion: Zoledronic acid prevents additional bone loss in postmenopausal women with significant osteopenia or osteoporosis initiating letrozole. Treatment with zoledronic acid was associated with an improvement in BMD.

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  • helena67
    helena67 Member Posts: 357
    edited December 2009
    [4083] The Effect of Zoledronic Acid on Aromatase Inhibitor-Associated Bone Loss in Postmenopausal Women with Early Breast Cancer Receiving Adjuvant Letrozole: The Z-FAST Study 5-Year Final Follow-Up.

    Brufsky A, Harker G, Beck JT, Carroll R, Jin L, Warsi G, Argonza-Aviles E, Ericson S, Perez EA University of Pittsburgh Cancer Institute, Pittsburgh, PA; Utah Cancer Specialists, Salt Lake City, UT; Highlands Oncology Group, Fayetteville, AR; Robert R. Carroll, MD, PA, Gainesville, FL; Mayo Clinic, Jacksonville, FL; Novartis Pharmaceuticals Corp., East Hanover, NJ

    Background: Aromatase inhibitor (AI) therapy effectively increases disease-free survival in postmenopausal women (PMW) with ER+ and/or PR+ breast cancer (BCa). However, the use of AIs results in nearly complete ablation of estrogen production which can lead to accelerated bone loss and increased fracture risk. The Z-FAST study evaluated the efficacy and safety of zoledronic acid (ZOL) in preventing AI associated bone loss in PMW with early breast cancer (EBC) who received adjuvant letrozole (LET).
    Material and Methods: 602 PMW with stage I-IIIa ER+ and/or PR+ BCa starting LET (2.5 mg qd x 5 yrs) were randomized (1:1) to upfront ZOL (4 mg IV q 6 mos) vs delayed ZOL. The delayed arm (D) received ZOL when either the post-baseline T-score decreased to <-2 or a clinical fracture occurred. All patients (pts) were treated with calcium and vitamin D. The primary endpoint, the percent change in lumbar spine (LS) bone mineral density (BMD) at 12 mos, was previously reported (JCO; 25:829, 2007). The 5 year (5y) final study results are reported here.
    Discussion: Baseline characteristics were similar between groups. 180 pts in upfront ZOL arm (U) and 175 pts in D completed full 5y study. Of pts with BMD data available, U (n=140) showed a mean increase of 6.2% in LS BMD while D (n=132) showed a mean decrease of 2.4%, resulting in an absolute difference of 8.6% (p<0.001). U (n=141) showed a mean increase of 2.6% in total hip (TH) BMD while D (n=132) showed a mean decrease of 4.1%, resulting in an absolute difference of 6.7% (p<0.001). When BMD data in D was excluded after pts started ZOL (censored analysis), the absolute difference in LS and TH BMD between the two arms was 11.3% and 8.7%, respectively. Among pts with baseline LS T-score between -1 and -2, 27.9% (19) U pts [8.6% (7) D pts] returned to normal T-score (T-score >-1), and no U pts as compared to 4.9%(4) D pts became severely osteopenic (T <-2). 17.7% (53) D pts met criteria that required initiation of ZOL. Although the study was not designed to detect a significant difference in the fracture rate between treatment arms, fractures occurred in 10.7% (29) U pts and 12.4% (33) D pts. Administration of ZOL q 6 mos for up to 5y was safe and well tolerated. No serious renal adverse events suspected related to ZOL and no confirmed osteonecrosis of the jaw cases (ONJ) were reported. Disease recurrence including death due to disease progression was reported in 7.0%, 95% C.I. (3.7%-10.3%) from K-M (16) pts in U, and 8.8%, 95% C.I. (5.2%-12.5%) (21) pts in D.
    Conclusion: The 5y follow-up of the Z-FAST trial show that the overall difference in the percentage change in BMD between U and D, at both LS and TH, progressively increased from baseline through 5y. These data demonstrate that ZOL 4mg IV q 6 mos is effective in preventing bone loss associated with adjuvant AI therapy in PMW with EBC.

    Saturday, December 12, 2009 7:00 AM
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  • helena67
    helena67 Member Posts: 357
    edited December 2009
    [1111] Economic Evaluation of Zoledronic Acid for the Prevention of Osteoporotic Fractures in Post-Menopausal Women with Early Breast Cancer Receiving Aromatase Inhibitors in the United Kingdom.

    Logman F, Heeg B, Botteman M, Kaura S, van Hout B Pharmerit International, Rotterdam, The Netherlands; Pharmerit International, Bethesda, MD; Novartis Oncology, Florham Park

    Background: Aromatase inhibitors (AIs) are increasingly used as adjuvant therapy in early-stage breast cancer (EBC) and are associated with accelerated bone-loss. Adjuvant therapy with zoledronic acid (ZOL) has been shown to prevent aromatase inhibitor-associated bone loss (AIBL) in postmenopausal women (PMW) with EBC. This analysis assessed, via a model projecting lifetime incidence of osteoporotic fractures as a function of BMD, the cost-effectiveness of adjuvant ZOL for the prevention of fractures in PMW with hormone receptor positive breast cancer (stage I-IIIa) who receive adjuvant letrozole 2.5 mg daily for 5 years and who had a baseline bone mineral density (BMD) T score of ≥-2. Methods: A Markov model was developed to project the lifetime incidence of osteoporotic fractures, quality-adjusted life years (QALY), and healthcare costs as a function of BMD for women with EBC (aged 60 years) receiving adjuvant AIs (for up to 5 years) alone or with ZOL upfront or delayed. Two strategies of adjuvant ZOL therapy compared to no treatment were modelled: starting ZOL treatment only when BMD levels decreased ("delayed ZOL") and starting ZOL 4mg i.v. q 6mo simultaneously with AI therapy ("upfront ZOL"). ZOL efficacy was derived from the ZO-FAST study (N=1,060) which reported a 5.41% (p<0.0001) difference in percentage BMD change between both strategies after 3 years. Data for the no-treatment arm came from a separate trial of AI in which patients did not receive ZOL. The model runs in annual cycles, over a lifetime horizon. Future costs and effects were discounted at 3.5% annually. Results: Compared to no treatment, delayed ZOL therapy was associated with an estimated QALY gain of 0.026 (CI95%:0.007 - 0.045) and an additional cost of £ 419 (CI95%: £ 367 - £ 473). Delayed ZOL therapy vs. no treatment was estimated to cost £ 16,069 per QALY. Compared to no treatment, upfront ZOL was associated with a gain of 0.079 QALY (CI95%: 0.059 - 0.100), at an additional cost of £ 1,742 (CI95%: £ 1,676 - £ 1,810). The corresponding cost per QALY gained was therefore estimated at £ 21,973. Compared to delayed ZOL therapy, upfront ZOL resulted in a gain of 0.053 QALY (CI95%: 0.039 - 0.062) and additional costs of £ 1,323 (CI95%: £ 1,280 - £ 1,366). The cost-effectiveness ratio for upfront vs. delayed therapy was therefore £ 24,868 per QALY gained. Conclusions: Based on this analysis, upfront ZOL is shown to result in better health outcomes (QALYs) than either delayed ZOL or no therapy. Both ZOL therapy strategies were shown to result in highly acceptable cost-effectiveness ratios compared to no treatment.

    Thursday, December 10, 2009 5:30 PM
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  • kim40
    kim40 Member Posts: 904
    edited January 2010

    OH!!!! HAPPY DAY!!!!

    My onc has FINALLY given me his ok to do Zometa!!!  I am so happy!!!!  (Who would have ever thought that one could get so excited over an infusion!!!  Come a long way in a year!!!)

    He was on the fence about it at first, but I convinced him.  Just got to call my insurance company for him to fill out the required paperwork and get the ball moving. 

    Thanks ladies for all of the great ammuntion I had when I went to see him this morning!  He was totally amazed at my knowledge of this subject!!

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  • kimber3006
    kimber3006 Member Posts: 586
    edited January 2010

    Hooray!  I'm so happy for you!

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  • KerryMac
    KerryMac Member Posts: 3,529
    edited January 2010

    Oh, Kim, I was hoping you would have good news. I am thrilled for you!

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  • Let-It-Be
    Let-It-Be Member Posts: 325
    edited January 2010

    Awesome news!!

    Maybe we'll both have our first infusions on the same day :)

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  • Anonymous
    Anonymous Member Posts: 1,376
    edited January 2010

    Hi Let-It-Be,

     I just PM'd you, can you read that please?

    Thanks!

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  • Flamin_nora
    Flamin_nora Member Posts: 52
    edited January 2010

    Hey Ladies,  It's my first post, but I have been reading you all for some time now........anyways big thanks to all of you for the Zometa info...I too discussed with my onco prior to the holidays.  He was hesitant because it is not standard of care (ie. not currently covered by provincial health care program).  When I persisted as to what his opinion was on its anti-tumour effectiveness, he acknowledged that he thought it likely was helpful, but that it unfortunately could take a few years before it was approved as SOC..... 

    I told him that I was concerned about future mets and was very willing to pay if not covered by gov't program.....he eventually relented and agreed to the prescription.  I'm scheduled for my first infusion next week!!!   The added bonus, my private insurance company has agreed to pay for 80% !!

    Again big thanks to all of you for providing the Zometa "low down"...since my onc has agreed I feel like my stress levels have come down dramatically (was dreading having to find a second onc for the prescription)....for that alone, I'm sure that my outcome will be better! 

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  • Gitane
    Gitane Member Posts: 1,885
    edited January 2010

    Kim40,  What fantastic news. (Ya, I agree, getting excited about an infusion is kind of strange, but I'm right there with you.)

    Flamin_nora,  Welcome to the site and the Stage III forum.  Great news that you were able to get the oncologist on your side with the Zometa.  It's a good feeling to know something might help; it helped my stress level, also.  My husband has family in Montreal, and we go to visit with them.  Great place!!! 

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  • everyminute
    everyminute Member Posts: 1,805
    edited January 2010

    It is my sincere hope that we are the Zometa trailblazers. 

    Welcome FlaminNora

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  • kim40
    kim40 Member Posts: 904
    edited January 2010

    Kerry - I just sent you a message on FB, but in case you don't get there, could you send me all of the phone numbers you have for the Zometa people?  Thanks in advance!  (((HUGS)))

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  • KerryMac
    KerryMac Member Posts: 3,529
    edited January 2010

    Just done it!

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  • kim40
    kim40 Member Posts: 904
    edited January 2010

    Got it!!!  Thanks again!!

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  • Let-It-Be
    Let-It-Be Member Posts: 325
    edited January 2010

    Kerry, can you copy me on those numbers as well...?  Guess what, drug access is not returning my calls!!  I will have to be a bit more squeaky!

    Thanks in advance!!

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  • kim40
    kim40 Member Posts: 904
    edited January 2010

    I called and they are working on it.  Only problem now is that they may not have any nurses in Nova Scotia to give it to me!  They are going to call me back.

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  • KerryMac
    KerryMac Member Posts: 3,529
    edited January 2010

    AccessZometa # is 1-866-281-4765. All you need is a prescription from your onc, they will do the rest.

    Kim - oh, no, that sucks. Come to TO, stay with me, they'll get you a nurse here! Can you get a private nurse to do it?? Oh, that is so frustrating. 

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  • Flamin_nora
    Flamin_nora Member Posts: 52
    edited January 2010

    the process I had to follow was a bit different (different health care systems in different provinces???)  The prescription had to be sent a special pharmacy, one that handles "IV-type" medications---not your standard Shoppers drug mart etc.  I had to pay for it over the phone (credit card) and they then sent it to me by courrier.  In the meantime the hospital where I had chemo arranged for me to have it administered in a local medical centre (gov't paid).  Am scheduled for next Wed

    If Novartis (AccessZometa) is having trouble finding you a nurse, maybe see if the hospital where you had chemo is willing to administer it or perhaps refer you to a local medical centre---just a thought

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  • victoriasecret
    victoriasecret Member Posts: 333
    edited January 2010

    Hi girls

     Just got the call from Juravinski and all my paper work has been sent to Access  Zometa...thx Kerry for your info or  I would have been paying 250.00 per infusion...still have to talk to them tho because Juravinski says I have to have my 1st infusion there and now it is only 100.00 yikes ...I just dont think thay have done this very often .... LIB... where are you having yours done ?

    I think I will call now ...get back to you all

    ml

    Cheryl

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  • KerryMac
    KerryMac Member Posts: 3,529
    edited January 2010

    Cheryl - if you are being charged an "infusion fee" from your Cancer Centre, remember that Norvatis will send a nurse to your house for free.....

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  • Let-It-Be
    Let-It-Be Member Posts: 325
    edited January 2010

    Hey Cheryl, great news!  I just got the call from my onc's office today after drug access had sent her 2 emails about a prescription.  I go in for details on Monday.  I agree, I don't think they have done this often as it's not "Standard care".  So, not sure yet, I'll let you know details.  Yay for us though!

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  • victoriasecret
    victoriasecret Member Posts: 333
    edited January 2010

    Good Morning Girls!

    SO..I called yesterday to AZ...someone is returning my call today so I will find out more.

    Here are my concerns.. 1st my hubby says to me ..if this is promising why did your onc not bring it up ? why are all of you having to be your own advocats ?..tried to explain..he is just concerned about being  me being a guinea pig ..so please give me some answers for him.

    Second ...I have had extensive dental work my teeth look great ...but lots of crowns ,veneers,actually broke a tooth just after last chemo( its fixed)...Is it not the jaw ??

    Third renal problems ...did you have a test for that before infusion ?

    One more thought ..was your infusion given slowly as I have read that can combat SEs ?

    Tomorrow my rads start for 25 rounds . I also see my onc for the 1st time since finishing up chemo Dec 7th  is there anything I should be asking her that you all can think of ..of course I have my own questions but maybe some I have not thought of.I then have an appt. to see a lymph specialist ...no real problems but just some insurance and question as my node arm is still healing..have good mobility , numb still in areas .

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  • Flamin_nora
    Flamin_nora Member Posts: 52
    edited January 2010

    My understanding is that the Zometa studies showing reduction of mets have not totally been wrapped up yet---the findings were so promising though, the researchers announced their findings.

    My onc did not proactively suggest Zometa to me...I was the one that asked his opinion (based on what I had read here on the board).  At first he was hesitant because "it's  not covered", but when I insisted on his expert opinion, he opined that it "is probably a very effective anti-tumour medication.....but that it was currently not covered/not standard of care" and that he didn't know how long it could possibly take to become covered/standard of care, but would likely take a couple of years to complete all the studies and administrative steps etc. 

    My perception was that he felt some "moral" or "ethical" obligation to only prescribe what is standard of care so that I could have it for free.  I insisted that II didn't mind paying any costs if need be, and really, really wanted to take the extra step (I'm still a bit freaked out about all my positive nodes).

    the SE are very low, and there is the added bonus that the treatment will strengthen bones (and hopefully ward off osteoporosis).  Regarding necrosis of the jaw, apparently that affect very few people.  I did however advise my dentist. He didn't seem to think that dental history was much of a factor---it just happens to a very few people

    from what I have read here on the boards, people are recommending an infusion time closer to 30min instead of the minimum 15minutes....I can't tell you from personal experience though as I will only be having my first treatment next Wed.  I will however be asking the nurse for a 30 min time (and be drinking a ton of water before and after to reduce any potential renal issues)

    personally,  I am thrilled to have my prescription, and don't at all feel like a guinea pig....I would have hated to wait a few more years while they are "dotting the i's and crossing the t's"...just having the prescription has brought my stress levels down and I'm feeling a lot more confident that I'm going to beat this cancer beast

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  • KerryMac
    KerryMac Member Posts: 3,529
    edited January 2010

    Cheryl - it has not yet been approved as "standard of care" for early (ie not stage 4) BC.....soooo, they can't offer it to you. But as many of us are finding out, they can give it to us if we ask.

    It is currently in Phase 3 trials - so very close to hopefully being approved.....but not soon enough for us to get any benefit.(it will be 3 or 5 years before results are in, i think, then all the approval process....)

    The way I see it, it is a drug that has been used for other things - mainly osteoporosis -  for a few years. So they know the risks - and they are not huge. It is not some new thing where they are going to uncover unknown SE's a few years down the track.

    At the very least you will get stronger bones - which is good. And hopefully it will prevent mets as well.....the more things I have to throw at the beast, the better.

    Certainly no-one knows "for sure" yet if it will one day be the standard of care, but who knows - It may just be the one thing that saves me.  I am willing to take that chance.

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  • kim40
    kim40 Member Posts: 904
    edited January 2010

    Well, Thank God!  Access Zometa has a nurse in Halifax that can give me the infusion.  I'm so thrilled.  Just got to get the paperwork filled out and we are good to go!!

    My onc also told me that this isn't the standard of care.  If it was, it would have been offered a while ago and paid by provincial insurance.  He also told me that it will only make a marginal difference and I am happy to take all the marginals difference I can take.  A marginal differnece here and there all add up at the end of the day and I feel better knowing that I am doing what I can to stay on this side of the grass.

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  • claude1944
    claude1944 Member Posts: 63
    edited January 2010

    HI GALS, i AM NEW TO THIS TRHREAD...HAD MY FIRST I FUSION OF ZOMETA IN NOV....TOOK 30 MINS. BUT WILL HAVE ANOTHER ONE IN 6 MONTHS AND WAS TOLD IT WILL ONLY TAKE 15 MIN. FOR ALL THE REST...I HAVE AN ONC. FROM THE U OF MN WHO IS REALLY UP TO DATE...SOLELY TREATS BREAST CANCER...SHE IS GIVING IT TO ME TO PREVENT OSTEO. AND SHE SAID THEY FEEL THAT IT DOES PREVENT METS..  I HAD NO SE FROM THE INFUSION...MY INS. PAID 100%.  A NEWBEE FROM MN>>CLAUDIA

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  • KerryMac
    KerryMac Member Posts: 3,529
    edited January 2010

    Kim - fabulous news. Let us know when you get a date.

    Yep, I am with you - even if it only helps 1%, if I am that 1, then it is worth it.

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  • victoriasecret
    victoriasecret Member Posts: 333
    edited January 2010

    Thanks all !!Yes that is what I told my hubby ...I will try anything ...think he is just worried about me thats all.

    He is coming with me to my appt. tomorrow so he will hear it from her.

    Kerry I agree 1% is worth it !!

    Rads start tomorrow girls off I go !!

    much love C

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  • Anonymous
    Anonymous Member Posts: 1,376
    edited January 2010

    Got the approval from the onc to switch to Zometa from Aredia today!

    Thanks for help, Kerry and Christine.

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  • Gitane
    Gitane Member Posts: 1,885
    edited January 2010

    Hello Claudia,  So nice to meet another BC friend.  I'll be getting my Zometa infusion in February, I've had others, this isn't the first.  I am so hopeful that this drug will help us.  My mother's side of the family is in Minnesota and Iowa.  Boy you guys are having a really bad winter.  How are you holding up under it?

    FlaminNora,  Good news, hope the infusion goes well.  Interesting comment about health care systems being different in different provinces.  I've wondered about that, too.

    kim40, I agree with you totally.  That "marginal difference" could mean a lot when we are talking about breast cancer.  How can our doctors throw phrases like that around, knowing how important all this is to us?  I'll take that "marginal difference" and be very glad to get it. 

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