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Old 08-14-2012, 04:27 PM   #1
Lani
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denosumab superior to Zoledronic acid in Stage IVs with bone mets

study NOT her2 specific


Public release date: 14-Aug-2012

Contact: Jeremy Moore
Jeremy.Moore@aacr.org
215-446-7109
American Association for Cancer Research
Denosumab superior to zoledronic acid for breast cancer patients with bone metastases

PHILADELPHIA — Treatment with denosumab resulted in a greater reduction in skeletal-related events in patients with breast cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a phase III study published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

"Our data indicate that denosumab should be the treatment of choice for the prevention of skeletal-related events and hypercalcemia in patients with breast cancer that has metastasized to the bone," said Miguel Martin, M.D., Ph.D., professor of medicine and head of the Medical Oncology Service at Hospital General Universitario Gregorio Marañón in Madrid, Spain.

Bone metastases can have devastating consequences for breast cancer patients including hypercalcemia, bone fractures, spinal cord compression and more, according to Martin. The introduction of bisphosphonates, such as zoledronic acid, into the clinic has delayed the onset of these skeletal-related events. However, the use of these drugs is associated with acute reactions and kidney toxicity. Denosumab has a mechanism of action that is more specific than zoledronic acid, and it does not cause these adverse events.

Martin and colleagues have previously reported the phase III study results indicating that denosumab is superior to zoledronic acid in preventing skeletal-related events in women with breast cancer and bone metastases. In the study, they randomly assigned 2,046 patients with breast cancer to receive subcutaneous denosumab and intravenous placebo, or intravenous zoledronic acid and subcutaneous placebo. In their current analysis, the researchers further analyzed the data from that study to get more information about bone-related complications and quality of life.

The data indicated that only 31 percent of patients on denosumab experienced a skeletal-related event compared with 36 percent assigned to zoledronic acid. Among those who experienced a skeletal-related event, few patients assigned denosumab experienced a second event while enrolled in the study.

Treatment with denosumab reduced the need for radiation therapy to the bone by 26 percent, and those patients also had an 18 percent lower risk for developing a skeletal-related event or hypercalcemia of malignancy. Quality of life also improved. In addition, patients assigned to denosumab had fewer acute phase reactions associated with a flu-like syndrome and fewer adverse events related to kidney dysfunction compared with those assigned to zoledronic acid.

"This analysis provides additional evidence of the superiority of denosumab over zoledronic acid," Martin said. "The clinical implication of this analysis is clear: Denosumab offers an improved therapeutic index with respect to the prior standard."

Martin and colleagues plan to continue to evaluate the use of denosumab to prevent bone-related issues in cancer patients. Due to the drug's ability control the bone microenvironment and to curb the growth of breast cancer cells, they are also testing denosumab as a preventive adjuvant therapy for early breast cancer patients.

###
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About the AACR

Founded in 1907, the American Association for Cancer Research (AACR) is the world's first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR's membership includes 34,000 laboratory, translational and clinical researchers; population scientists; other health care professionals; and cancer advocates residing in more than 90 countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis and treatment of cancer by annually convening more than 20 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 17,000 attendees. In addition, the AACR publishes seven peer-reviewed scientific journals and a magazine for cancer survivors, patients and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration and scientific oversight of individual and team science grants in cancer research that have the potential for near-term patient benefit. The AACR actively communicates with legislators and policymakers about the value of cancer research and related biomedical science in saving lives from cancer.

For more information about the AACR, visit www.AACR.org.
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Old 08-14-2012, 05:17 PM   #2
JennyB
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Re: denosumab superior to Zoledronic acid in Stage IVs with bone mets

Very interesting I am on Zoladex at the moment but my new onc wants to stop. Looking forward to the adjuvant studies on denosumab.

Thanks

Jenny
__________________
Diagnosed Nov '10 IDC whilst pregnant with 2nd child
Her 2 ++ ER/PR + but weak and patchy 50% + 5%
Left mastectomy Dec '10, 6cm tumour 1 of 2 lymph (micro mets)
Clear margins but lymphovasculer invasion
Stage 3a Grade 3
Fec 100 x 3 Jan '11 Taxotere X 3 and Herceptin X 1yr
Staging scans - CT brain & body and bone - May '11 - NED!!
Start Femara - in chemo induced menapause
25 Rads June '11
Dec '11 Menstruation resumed - zoladex inj monthly and Tamoxifen
Feb '12 Back on Femera and Zoladex
March '12 CT brain & body & bone scan all clear
Zometa x2/yearly
April '12 - Oopherectomy

Praying the Herceptin is as good as its hype!!
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Old 08-15-2012, 12:43 AM   #3
Pamelamary
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Re: denosumab superior to Zoledronic acid in Stage IVs with bone mets

Lani,
I had heard of these results, but the oncologist said there hadn't been results for people who had already started Zoledronic acid and then transferred to denosumab. I don't know whether my info related to the same study, as I heard maybe 12 weeks ago. He suggested that i might as well stick with Zometa; perhaps i should revisit the issue?
Thanks for your info..... Pam
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Old 08-15-2012, 09:35 PM   #4
hutchibk
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Re: denosumab superior to Zoledronic acid in Stage IVs with bone mets

I have been told that if Zometa is working, then it should not be changed. If it stops working, then try denosumab.

I have been on Zometa for over 3 years and it is working great.
__________________
Brenda

NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)

Nov'03~ dX stage 2B
Dec'03~
Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~
Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~
micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~
micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg

Apr'07~
MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~
Started Tykerb/Xeloda, no WBR for now
June'07~
MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~
MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~
PET/CT & MRI show NED
Apr'08~
scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~
MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~
dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~
Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~
new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~
new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~
25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.

"I would rather be anecdotally alive than statistically dead."
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Old 08-15-2012, 11:19 PM   #5
Pamelamary
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Re: denosumab superior to Zoledronic acid in Stage IVs with bone mets

Hi Brenda,
Just wondering why not a change? if results are so much better with denosumab, fewer SREs?
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Old 08-20-2012, 10:51 AM   #6
hutchibk
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Re: denosumab superior to Zoledronic acid in Stage IVs with bone mets

Because Zometa is working. The grass might be green on the other side, but it is just as green here... we don't change until the former stops working and we need to. I have no side effects at all from the Zometa.
__________________
Brenda

NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)

Nov'03~ dX stage 2B
Dec'03~
Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~
Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~
micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~
micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg

Apr'07~
MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~
Started Tykerb/Xeloda, no WBR for now
June'07~
MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~
MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~
PET/CT & MRI show NED
Apr'08~
scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~
MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~
dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~
Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~
new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~
new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~
25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.

"I would rather be anecdotally alive than statistically dead."
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