How Are You Doing On T-DM1?

[KDR]

Good morning, everyone-
I am considering T-DM1 and would like to know how you are doing on it? How it is administered (weekly), what kind of pre-testing is done, all of the above. Please respond with any information you wish.
Thank you so much,
Karen

[schoonder]

KDR,

In addition to information you seek from participating Board members, on May 18 ASCO will publish abstracts of their early June annual meeting. T-DM1 items of interest will be:

Abstract #TPS102
MARIANNE: A phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzumab (H) plus taxane for first-line treatment of HER2-positive, progressive, or recurrent locally advanced or metastatic breast cancer (MBC).
Paul A. Ellis, MD
Poster: 36D
________________________________________
Abstract #TPS116
EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen.
Sunil Verma, MD
Poster: 38B
________________________________________
Abstract #605
A semi-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC.
Brendan C. Bender, MS
Poster: 9G
________________________________________
Abstract #633
Pharmacokinetic and pathophysiologic covariates influencing treatment outcomes with T-DM1 in patients with HER2-positive metastatic breast cancer (MBC).
Manish Gupta, PhD, FCP
Poster: 13C

Both Emilia and Marianne are worldwide evaluation. Mid 2012 Roche plans to submit Marianne results to FDA for product approval. This then would be latest official status of product.

In closing, I believe that if either phase III trial proofs so superior in performance to current standard of care, Roche would seek to discontinue the evaluation and allow all participants to transfer into the T-DM1 arm; if memory serves me right this is exactly what happened with GSK's Tykerb.

[hutchibk]

I have had two treatments. So far, so good. The things to keep an eye on are 1. LVEF 2. Liver enzymes 3. platelets. Those are the areas of the body that it can really ping on. I know my platelets are taking a hit, I suddenly experience bruising if the wind blows too hard ; ). My liver enzymes are good currently. I do have to exercise, take lisinopril, coQ10, and omega 3s diligently to keep my LVEF/heart strong... as I have been on Herceptin for 5 years leading up to this.

Other than that, so far I just get REALLY fatigued, really easy. But I can tolerate that. The key is recognizing your "down days" (feel achy and fluey) and respect them. Stay in bed and REST. The remaining days in the cycle are much easier if you respect those initial down days. Mine seem to be on day 4 and day 7, so far.

Are you trying to access it through Emilia or Marianne trial? Or compassionate use/EAP? Here's the link to the EAP and locations... http://www.clinicaltrials.gov/ct2/show/NCT01120561

I travel to Denver (from Texas) every 3 weeks to get treatment. I fly in and out the same day. My pretesting was brain MRI, CT, Muga/ECHO. Read the link above to see if you meet the enrollment qualifications. The trial enrollment qualifications for Emilia and Marianne are different from the EAP link that I posted above.

[Kathy T]

I have received T-DM1 for 1 yr and 9 months. So far --so good. My liver enzymes elevate, but the dosage has never needed to be lowered. Platelets also are lowered, but--again- no change in dosage. It has been as easy drug for me to tolerate. Good luck with you decision.
Kathy T