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

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!

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

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