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Old 06-13-2015, 09:03 PM   #1
Lani
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Join Date: Mar 2006
Posts: 4,778
Phase II MARIANNE trial results--T-DM1 treatment not superior to herceptin+taxane in

Stage IVs/locally advanced bc

T-DM1 treatment resulted in noninferior, but not superior, progression-free survival (PFS) compared with trastuzumab plus a taxane (HT) in patients with locally advanced or metastatic HER2-positive breast cancer.

from ASCO 2015:

https://am.asco.org/phase-iii-marianne-trial-results
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Old 06-14-2015, 03:36 PM   #2
annettchen
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Join Date: Mar 2014
Posts: 95
Re: Phase II MARIANNE trial results--T-DM1 treatment not superior to herceptin+taxane

But, you do not loose your hair and Taxanes (I had Docetaxel every three weeks) can be quite vicious in terms of side effects. So not sure if I'd had the choice I would not have opted for TDM-1. On the other hand, as it currently is second line it's a good thing to have once first line fails, I guess...
Thanks for the info, Lani!
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Annette
----------------------------------------
03/2014: Diagnosed with ER/PR-, HER2+++ MBC (bone mets, oligometastatic)
04/2014: Started 6 cycles of "PHD" (Perjeta, Herceptin, Docetaxol)
07/2014: Finished 6 cycles of PHD; restaging; 2 bone mets are sclerotic - looks like Herceptin and Perjeta is working
10/2014: STABLE!
01/2015: STABLE!
04/2015: STABLE!
08/2015: STABLE!
12/2015: BRAIN METS. BODY STABLE.
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Old 06-15-2015, 11:23 AM   #3
kk1
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Join Date: Sep 2005
Posts: 182
Re: Phase II MARIANNE trial results--T-DM1 treatment not superior to herceptin+taxane

Lani,

I am bit confused about these stage III Marianne trial results, and was really hoping for a clearer picture.

By progression free survival they report no difference between the arms. Yet they also showed an almost doubling in the duration of response for TDM-1 and P. That is pretty significant in my book.

To me, this would suggest that if a tumor responds to TDM-1 and P then you get a much better bang for your effort than just using H&T.

That is to say, I am wondering if the PFS data is impacted by cases where those tumors are resistant or have a lower affinity for Herceptin in the first place. For those patients, whether or not it is bound with TDM-1 would then be mote.

Definitions (as as I understand them):
PFS- time from trial enrollment to the time of tumor progression.
DOR- time from tumor response to the time of tumor progression.


k
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KK1
April 2004 de novo metastatic left breast 1.5cm her2++,er+/pr+ with 2 small liver mets
weekly taxotere,herceptin, xeloda
Sept 2004 NED-3 herceptin, zoladex,aromasin
Dec 2006 recurrence in liver
Feb. 2007 liver resection left lobe removed-herceptin, zoladex, switch to Arimidex
NED 16 months added zometa
May 2008 new lesion in liver 15mm Tykerb/Xeloda/Herceptin
July 2008 stable...yeah!
Sept 2008 NED again !!!
Jan 2009 fell off the wagon again spot back in the liver and fell out of menopause.
Feb 2009 RFA and 2nd liver resection to remove spot ---back on the NED wagon again continue Tykerb, Herceptin.
March 2009- oophrectomy added Femara and bi-annual Zometa
May 2009- scans clear but suspect lung nodule
June 2009- Lung VAT wedge resection to remove nodule---fungus ball not cancer!! phew
Aug 2009- NED
Nov 2009-scans again clear YAHOO!
March 2010- scans clear continue Tykerb, Herceptin, Femara, Zometa Q6mo
Nov 2009-Nov 2019 scans clear done every 6 months


Feb 2020 - Fell out of the NED wagon hard! single liver lesions and large infect cyst. 3 weeks in ICU.
March 2021- 5 cycles perjeta, herceptin, navelbine. lesion stable.
June 2021 - 3rd liver resection to remove single liver lesion. Continued perjeta, herceptin.
Nov. 2021- PET scan show 5 hot nodes near liver. 9 cycles Kadcyla
June 2021- PET scan shows progression. nodes size unchanged but even more SUV uptake.

July 2021- start ENHERTU
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Old 06-15-2015, 12:12 PM   #4
schoonder
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Join Date: Jul 2008
Posts: 186
Re: Phase II MARIANNE trial results--T-DM1 treatment not superior to herceptin+taxane

Yes, I was disappointed by the results of the Marianne trial between the T-DM1 arm and T-DM1+Perjeta arm, which came in with a median PFS of 14.1 vs 15.2, and a median DOR of 20.7 vs 21.2 months. The difference in these figures failed to show the SIGNIFICANT synergy between these compounds that was reported by I-SPY2 investigators in preclinic work with both agents. I wonder if administering of the drugs at Marianne sites somehow did impact these numbers.
http://cancerres.aacrjournals.org/co...S6-07.abstract

http://meetinglibrary.asco.org/content/147990-156
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