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Old 12-16-2015, 11:45 AM   #1
Lani
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Thumbs up SABCS denosumab increases disease-free survival & reduces fractures 50% for er+s,

on AIs, especially postmenopausals...and with very few side effects compared to bisphosphonates

ABCSG 18: monoclonal antibody increases disease-free survival in breast cancer


(Vienna, 9 December 2015) Giving a monoclonal antibody (denosumab) as adjuvant therapy with aromatase inhibitors in postmenopausal, hormone-receptor-positive breast cancer patients reduces the relapse rate by 18%. This is the central finding of the ABCSG 18 breast cancer study regarding disease-free survival. Michael Gnant, Head of the University Department of Surgery at MedUni Vienna, Deputy Head of the Comprehensive Cancer Center (CCC) and President of the Austrian Breast & Colorectal Cancer Study Group (ABCSG) presented the paper on Wednesday at the San Antonio Breast Cancer Symposium (SABCS), one of the largest and most important breast cancer conferences in the world.

Today, lead investigator Michael Gnant presented the results of the placebo-controlled, adjuvant study ABCSG 18, involving 3,425 postmenopausal breast cancer patients, to thousands of breast cancer experts in the general session of one of the largest and most important international symposia on breast cancer, the San Antonio Breast Cancer Symposium in San Antonio/Texas (8 -12 December 2015). The results indicate a further important benefit of treatment with the monoclonal antibody denosumab, which was administered as an adjuvant therapy to aromatase inhibitors within the framework of the ABCSG 18 study. The results of the primary study endpoint – the effect of denosumab on bone health – were published in "The Lancet" at the beginning of June 2015 and showed that drug-related osteoporosis and bone fractures can be reduced by a remarkable 50% as a side-effect of the adjuvant therapy, without any additional toxicity.

50% fewer bone fractures, 18% fewer relapses
The data have now been determined for an additional study endpoint, the impact of denosumab on disease-free survival (DFS). A total of 370 DFS events were recorded during the four-year period, 203 of these in the placebo group and 167 in the denosumab arm. This reduction in the recurrence rate of breast cancer is barely at the statistical significance threshold (HR=0.816, p=0.051).

"This result is very pleasing, because it shows that adjuvant denosumab not only halves the number of bone fractures but also reduces the rate of recurrence of breast cancer," says Gnant in his assessment of the results. "We have long dreamed of being able to positively influence the recovery rate by changing the micro-environment and we have succeeded once again with ABCSG 18," he adds.

Clear reduction in recurrences in certain subgroups
Explorative subgroup analyses indicate that some patients in particular benefit from the practically side-effect-free administration of denosumab in addition to the standard aromatase inhibitor treatment: There is a clearly significant result, especially in the case of tumours of more than 2 cm in size and early start of treatment and in tumours with a particularly high receptor density.

Gnant is now expecting that there will be changes in clinical practice before too long: "This means that denosumab, which hardly has any side-effects, is generally superior to bisphosphonates as an adjuvant therapy and, in my opinion, should be offered to all postmenopausal, hormone-receptor-positive breast cancer patients." We know that bisphosphonates, which are used for treating osteoporosis, can have a positive impact upon disease-free survival. Denosumab acts in a similar way to bisphosphonates but is more effective and less toxic and can easily be given as a subcutaneous injection (60 mg subcutaneously 2xyear).
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Old 12-16-2015, 07:23 PM   #2
KathyT
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Re: SABCS denosumab increases disease-free survival & reduces fractures 50% for er+s,

Thank you for posting this Lani!

Kathy
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Kathy
38 years old!

January 17th 2014-mammo, ultrasound, biopsy
January 20th 2014- diagnosed, ER/PR+, Her2+++, Stage 2A
January 21st 2014-MRI, right breast only plus lymph nodes
January 23rd 2014- Pet scan-2 cm tumor, 3 lymph nodes
February 4th 2014-port insertion
February 12th 2014-first chemo treatment(TCHP x6 cycles)
May 28th 2014-LAST chemo treatment!!
July 10th 2014-double mastectomy
July 29th 2014-start radiation(30)
Sept. 11th 2014last radiation treatment!!!
November 12 2014-started Tamoxifen
January 20 2015-reconstruction begins, lat flap
February 4 2015-last Herceptin treatment!!
April 24, 2015- pet scan-NED!!
June 3 2015- exchange surgery, port removed!!
September 8 2015-hysterectomy/oophorectomy
September 15 2015-Revision of lat flap reconstruction
December 23 2015-nipple reconstruction
May 9th 2016-Mets to pituitary gland, liver and C7 vertebrae
May 10th-port put back in:(
May 17th- biopsy of mass on back
May 19th-started Herceptin/Perjeta
May 20th-5 treatments Cyberknife to pituitary gland tumor
June 9th-Started THP (will have 6 cycles)
August 17th-MRI of brain, significant reduction in tumor
😃, repeat MRI in 3 months. Received first Zometa
infusion.
June 24th 2019- Thoracic spine Mets, leptomeningeal Mets , 10 radiation treatments
Aug 1st- Ommaya Reservoir implanted
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Old 12-17-2015, 08:28 AM   #3
Carol Ann
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Re: SABCS denosumab increases disease-free survival & reduces fractures 50% for er+s,

Thanks Lani! I am going to bring this up at my next onc visit in March.

Carol Ann
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July 24, 2013: "Infected" Right Nipple and benign cyst removed, pathology report revealed Paget's, DCIS, and ILC 1.25 cm, ER+/Pro+/HER2 equivocal, Grade 2 under benign cyst, previous diagnostic mammo/ultrasound said I was perfectly healthy in both breasts.

Aug 18, 2013: MRI report says Left breast is perfectly healthy "consistent with previous studies".

Sept 2013: I insist on a bilateral mastectomy anyway. Too nervewracking to let left breast remain with higher risk after 3 cancers in right, nipple in right is already gone anyhow.

Sept 18, 2013: Bilateral mastectomy, 11 right nodes removed, ALL negative BUT -- ER+/PRO+/HER2+ tumor, 1.0 cm, Grade 2 found in a piece of "grossly unremarkable" breast tissue from prophylactic mastectomy of left breast, no nodes removed.

Oct 25, 2013: 13 left side nodes removed, ALL negative, Stage 1 across the board, NO RADS needed, YAAAAY! Port also installed.

Nov 25, 2013 Begin 6 rounds TCH.

March 10, 2014 Just finished 6th and LAST Chemo today, YAAAAAY!

March 24, 2014 Echocardiogram to make sure I'm still good for Herceptin every 3 weeks.

March 31, 2014 Echo results NORMAL, first Herceptin all by itself. Now if only my eyes would stop streaming from the Taxotere ... :)

April 21, 2014 Started Arimidex and therapy for "mild" lymphedema in left hand and arm

May 2014 Therapy completed, I have sleeves and gloves for both arms, a Flexi touch lymph pump to hook up to for an hour every day, and I've become an arm bandaging expert. :)

June 2014 Begin Fosamax to prevent osteoporosis; bone scan revealed osteopenia

Nov 17, 2014 FINAL Herceptin!

Dec 4, 2014 My right thigh muscle has been extra achy for days ... I discover a blister rash cluster on the side of my right thigh while taking a shower. Port appointment cancelled until Dec 17, my doc is working me in tomorrow afternoon to see me and the rash. My muscle at least feels less achy.

Dec 5, 2014 Yep, I have shingles. Boo! I start acyclovir and also have a prescription for a painkiller just in case for over the weekend.

Dec 17, 2014 Port is OUT!

January 2016 Shingles again and this time it started where my left breast (where the hidden HER2+++ tumor was!) used to be. My onc nurse got me a same day appointment to see my doc when I called and told her I had a rash on the site. The antiviral meds are working once again, though, so that is good news. :)
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Old 12-17-2015, 01:13 PM   #4
Donna H
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Re: SABCS denosumab increases disease-free survival & reduces fractures 50% for er+s,

So this would be an alternative to Fosamax or Prolia or the like? Without potential side effects? Sounds very promising!
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Old 12-17-2015, 11:20 PM   #5
Lani
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Re: SABCS denosumab increases disease-free survival & reduces fractures 50% for er+s,

Donna--denosumab for breast cancer is the same thing as prolia for osteoporosis, just in a different dosage.

Hope this helps!
Lani
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Old 02-04-2016, 11:23 AM   #6
Juls
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Re: SABCS denosumab increases disease-free survival & reduces fractures 50% for er+s,

I asked for this instead of zometa but told I don't fit UK criteria (too young, no kidney problems) & expensive. Think the main reason is expense! Really disappointed as I have read that it is superior.
Have also read that it can cause a rash with xeloda so maybe would still be excluded anyway.
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