TDM-1 results reported @ ASCO annual mtg 2012 now in New England Journal of Medicine

[Mandamoo]

5-7years is a long time but I can understand their reasoning. We need to come up with a way to determine what is the best treatment for each person. There are people for whom TDM1 has had no benefit - it may, in the early BC setting be no better than the current treatments - the only way to test that is to do trials. I know of many girls who did the TYkerb instead of Herceptin trial in EBC only to recur (and the results did show it was less effective) - if this had been rushed into treatment, it is more palatable as it is a tablet not chemo etc... where would many women be?

To me the answer is to support personalised medicine research - these guys should be investing in profiling tumors and cross referencing results to determine who it is working for and why.
Just my 2cents worth...

[Paula O]

Phil,

Can you please copy and paste your list of actions that scrolls through on that final segment of
https://www.youtube.com/watch?v=WyNr69dDKTo
that people can carry through to help get TDM-1 approved?

Thanks for yours and Lorraine's efforts.

With appreciation,

Paula

[bmorr7]

Does this trial mean that Kadcyla is better than Herceptin? Or should stage 1 Her-2 positive patients still start with Herceptin?

[Lani]

welcome--you are new to reading the literature on treatments for her2+ breast cancer. Let me help explain why we can't answer your question.

It (whether herceptin alone is enough, whether TDM1 is better than herceptin as an adjuvant treatment) has not been looked into yet. TDM1 trials may be beginning, but noone yet know that they will or will not be better, how long to treat etc. I believe there may be neoadjuvant trials looking into dual targetted treatment, but since your wife's breast were already removed, she cannot be a candidate.

In breast cancer all clinical trials must test a new agent ADDED to the standard of care (or one of several effective much used treatments) in order that they not claim the participant was cheated from having their best chance at a best response.

In addition, clinical trials are usually started on Stage IVs, where they have the least to lose ( the chance it will be proven to be unnecessarily toxic treatments which might not be effective is not considered so terrible if the person was expected to die anyway than if the person will in all likelihood survive). Later, once they have been proven to be safe (relatively) and more effective, they are introduced into trials of nonmetastatic patients.

Each of these phases has taken around a decade in the past.

From METASTATIC patients we know that adding chemo to herceptin is more effective than herceptin alone. From METASTATIC patients we know that adding lapatinib to herceptin is more effective than herceptin alone. But it will probably be a LONG LONG time before we know who, if anyone, can be effectively treated with herceptin alone, or herceptin+antihormonals alone, or herceptin+lapatinib along, or herceptin+pertuzumab alone, or a triple blockade regimen and how long that regimen will need to be utilized.

When there are no data to support a treatment you will be hard-pressed to find a doctor willing to offer it (they could be found negligent for not treating her with the standard of care) let alone an insurance company willing to pay for it (even if it would be cheaper)

Feel free to lookup clinical trials (NCI website) to see if anything offered fits your wife's case. Obviously since neoadjuvant trials are out, so you won't know if the treatment worked until years later (by whether or not she has an recurrence
rather than within weeks)

Best of luck!