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ASCO’s Guideline on Bone-Modifying Drugs for Breas

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    Posted: Feb 23 2011 at 11:43am
Here is the link-


as always, I have no advice as to whether to take the new drug but felt this announcement might be important and something to discuss with your oncologist. There is also information on dental health and a rare condition, osteonecrosis of the jaw. 

all the best,

Steve




Edited by steve - Feb 23 2011 at 12:25pm
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Scott Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 12:18pm
Hey Steve, can you or maybe Donna make it hot....I'm a computer idiot!
Scott
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 12:33pm
Sorry, Scott....made the first link ‘hot’..

I just received permission from ASCO to post the following....please note there is one more link that is blank now but hopefully will be fixed later today and I will post it..

Dear Patient Advocate,

 

The American Society of Clinical Oncology (ASCO) today issued an update to its clinical practice guideline on the use of bone-modifying agents, in particular, osteoclast inhibitors, to prevent and treat skeletal complications from bone metastases in patients with metastatic breast cancer. The new guideline includes recommendations on the use of a new drug option, denosumab (Xgeva), and addresses osteonecrosis of the jaw, an uncommon condition that may occur in association with bone-modifying agents. The updated guideline also provides new recommendations on monitoring of patients who undergo treatment with bone-modifying agents and highlights priorities for future research on these drugs.

Please click here to be directed to the What to Know: ASCO’s Guideline on Bone-Modifying Drugs for Breast Cancer on Cancer.Net (www.cancer.net).  

 

Want more information on breast cancer and bone health?

 

Read the comprehensive Cancer.Net guide and fact sheet on breast cancer. Also, learn more aboutdental and bone health during cancer treatment.


...........


all the best,


Steve


p.s. my mother had mets to her bones/spine 46 years ago....when I wrote the above post I thought back to her agony. Someday, I pray, this nightmare will be over for now....it is what it is...and my tears still flow thinking of her and the marvelous women here fighting so valiantly..





Edited by steve - Feb 23 2011 at 12:38pm
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sstefano Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 4:52pm

Steve,

Is this drug recommended in case of metastatic desease but without bone mets?
 
thank you
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 5:12pm
Steve,

Thanks so much for the ASCO update.

Here's a link on denosumab:

http://forum.tnbcfoundation.org/xgeva-new-denosumab-drug_topic7513.html?KW=denosumab

Donna



DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 5:13pm
Steve,

When I click on the first link, first posting, it says "Page Not Found". 

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 5:28pm
Dear Donna,

ASCO told me they have been having trouble with their site on this today..

please try this-

 "Be sure to read the clinical practice guideline atwww.asco.org/guidelines/bisphosbreast."

all the best,

Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 5:35pm
Dear sstefano,

from the clinical guidelines link I just posted-

"Recommendations: Bone-modifying agent therapy is only recommended for patients with breast cancer with evidence of bone metastases; denosumab 120 mg subcutaneously every 4 weeks, intravenous pamidronate 90 mg over no less than 2 hours, or zoledronic acid 4 mg over no less than 15 minutes every 3 to 4 weeks is recommended. There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another."

so, again, please do not rely on anything I have posted as medical advice but it would seem to me that, according to the ASCO guidelines, denosumab (XGEVA) is only recommended for folks with breast cancer with evidence of bone metastases.

But please speak to your oncologist for clarification. 

all the best,

Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 6:48pm
Thanks Steve, it worked!

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 6:50pm
Personally, I would ignore this guideline and take the drug if possible because it likely prevents bone mets as well as healing existing ones.   (Steve hates when I do this, so I'll put in the disclaimer that I am not an MD nor do I play one on TV so take my advice with a grain of salt.   That said, I think oncology is largely seat of the pants anyways so having an MD doesn't necessarily mean the advice would be any better.)

Peace,

d

DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 7:42pm
Denise,

Love your sense of humor!  Actually how does this differ from the bisphosphonates they were recommending to maybe help prevent recurrence?  Also, with chemo our bone density gets screwed up, so wouldn't this help strengthen our bones after treatment?

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Feb 23 2011 at 8:18pm
I agree on both counts, Donna.  Though the Zometa results that just came in don't seem to support the idea of bisphosphonates preventing recurrence.  We don't know yet about clodronate or the others. 
And of course there are risks, like osteonecrosis of the jaw.  Still on balance I'd do it, at least the once or twice a year dosing, probably not the monthly because of the risks.


DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote suec Quote  Post ReplyReply Direct Link To This Post Posted: Feb 24 2011 at 3:24pm
my case is definitely not definitive but will report i've had 2 shots (month apaet) of xgeva (was on zometa for 18 months) and my monday pet shows a reduction in activity with several areas no longer showing and no new bone mets.  blood work was also encouraging.  OF COURSE, this could be related to methotrexate and 5fu which i've been on since last august.
tnbc 3b: partial mas 5/06; 6 rounds FEC; 36 rad; 05/09-mets to bone; xeloda, avastin, zometa; gemzar & avastin; rads to hips; 8 mo on methotrexate+5fu; 5/11 mets to liver/lung; halevan fails;carb&Abrx
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Feb 24 2011 at 3:33pm
Dear Sue,

whatever the reason...thank you for sharing your encouraging news...

you are in my prayers that positive reaction continues.

all the best,

Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Feb 24 2011 at 6:33pm
Sue, that's great!
love,
d
DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 24 2011 at 6:42pm
Suec,

Great news, very encouraging!

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote zoomommy2 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 24 2011 at 7:21pm
Sue,
Whatever has worked, it's great news!
 
Denise,
I'd love to quote you to my oncologist at times!
Lee in  Denver
dx6/09,stageII,gr3,(L)mastectomy 7/09,ACx4,Taxolx7,Avastin study,gall bladder surgery 1/10,4/11 Stage 4, mets to lung, 4/11 Started Taxotere and Xeloda, 5/11 Taxotere stopped, off Xeloda
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 25 2011 at 8:02am

http:///www.medicalnewstoday.com/articles/217267.php

Quote from the link:

ASCO's Bisphosphonates in Breast Cancer Panel conducted a systematic review of the medical literature to develop the new recommendations. The updated guideline, American Society of Clinical Oncology Clinical Practice Guideline Update on the Role of Bone-Modifying Agents in Metastatic Breast Cancer, was published online today in the Journal of Clinical Oncology.

The guideline recommends that patients with breast cancer who have evidence of bone metastases be given one of three agents - denosumab, pamidronate or zoledronic acid - approved by the U.S. Food and Drug Administration. It does not support use of any one drug over the others. These drugs are all considered osteoclast inhibitors, but they belong to different drug families: pamidronate and zoledronic acid are part of a class of drugs called bisphosphonates, while denosumab is a monoclonal antibody that targets receptor activator of nuclear factor-kappa beta ligand (RANKL).
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Mar 02 2011 at 2:34pm
This is from OncologyStat.com

http://www.oncologystat.com/news/ASCO_Revises_Guideline_on_Bone_Metastases_in_Metastatic_Breast_Cancer_US.html

ASCO Revises Guideline on Bone Metastases in Metastatic Breast Cancer

Elsevier Global Medical News. 2011 Feb 22, S Boschert

The American Society of Clinical Oncology has revised its guidelines on care of bone metastases in metastatic breast cancer to reflect expanded treatment options as well as concern about osteonecrosis of the jaw, a rare but serious side effect.

The new guideline, released Feb. 22, on the role of "bone modifying agents" are the first to include denosumab (Xgeva), a monoclonal antibody approved in 2010 that targets the receptor activator of nuclear factor-kappa beta ligand (RANKL). They also address use of the bisphosphonates pamidronate (Aredia) and zoledronic acid (Zometa), two other agents previously available in the United States.

"There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another," according to the expert panel that updated the guidelines. It noted that two other bisphosphonates, ibandronate (Boniva) and clodronate, are not approved in the United States for patients with breast cancer that has metastasized to the bone, and therefore not addressed in the new guidelines.

The panel said it replaced the term bisphosphonates with "bone-modifying agents" in the name of the guidelines in order to be able to incorporate data on new types of agents, including osteoclast inhibitors, in future updates.

The "Updated Guideline on the Role of Bone-Modifying Agents in the Prevention and Treatment of Bone Metastases in Patients with Metastatic Breast Cancer" will be published soon in the Journal of Clinical Oncology, but is available for free online.

The recommendations include, also for the first time, advice regarding osteonecrosis of the jaw, a rare but potentially disastrous complication of therapy with bone-modifying agents that was recognized after publication of the 2003 guidelines (J. of Clin. Oncol. 2003;21:4042-4057). Before starting a bone-modifying agent, a patient should get a dental examination and receive preventive dentistry care, the panel recommends.

Bone-modifying agents should be used only in patients with breast cancer with evidence of bone metastases, the updated guideline states. Patients without bone metastases should not receive the drugs unless they are in a clinical trial. Diagnoses of bone metastases must by confirmed by X-ray, CT or MRI, and not rely on an abnormal bone scan to qualify for treatment.

Clinicians should start bone-modifying agents as soon as patients with metastatic breast cancer develop cancer bone pain, and should provide pain management.

There wasn't enough evidence to recommend one agent over another. Two are given by IV and one subcutaneously. Recommended dosages are 120 mg subcutaneous denosumab every 4 weeks, or IV pamidronate 90 mg over no less than 2 hours every 3-4 weeks, or IV zoledronic acid 4 mg over no less than 15 minutes every 3-4 weeks, with no new data to support any changes from the last guideline.

Biochemical markers should not be used to monitor the effectiveness of bone-modifying agents except in clinical trials, the guideline states.

The new recommendations reflect recent progress in controlling potential bone damage in metastatic breast cancer, guidelines panel co-chair Dr. Catherine H. Van Poznak said in a prepared statement released by ASCO. A "growing number" of osteoclast inhibitors can be helpful in preventing or treating skeletal-related events in these patients, said Dr. Van Poznak of the University of Michigan, Ann Arbor.

"Because many factors - including medical and economic - must be considered when selecting a therapy for an individual, it's good to have several effective choices," she said.

The new data since 2003 showed that denosumab is equally as effective as the previously available drug therapies, panel co-chair Dr. Jamie H. Von Roenn said in the statement. Osteonecrosis of the jaw is a rare but significant complication seen with use of bone-modifying therapy, added Dr. Von Roenn, professor of medicine at Northwestern University, Chicago,

Data since 2003 on the effects of bisphosphonates on kidney function led to new recommendations on monitoring patients. No change in dosage, infusion time, or interval is needed for patients with creatinine clearance greater than 60 mL/minute. Clinicians should monitor the creatinine level with each IV bisphosphonate dose. When giving denosumab to patients with creatinine clearance less than 30 mL/minute or who are on dialysis, closely monitor for hypocalcemia, the guideline states.

Amgen, which markets denosumab, has provided payments for consulting, advising, or research to Dr. Catherine Van Poznak, co-chair of the guidelines panel, and to two other panelists. Dr. Van Poznak has received payments for consulting, advising, or research for Amgen, which markets denosumab and has received research funding from Novartis, which markets pamidronate and zoledronic acid. Dr. Von Roenn, co-chair of the guidelines panel, declared having no conflicts of interest. Two other panelists have been consultants, advisors, or recipients of honoraria from Roche or Abraxis BioScience.


DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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