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
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.
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
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
"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
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.)
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
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.
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
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
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
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
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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