To be reported at San Antonio,

[Jean]

http://www.medicalnewstoday.com/releases/270019.php

['lizbeth]

If I am following the latest studies, the combination of neoadjuvant Paclitaxol, Herceptin & Tykerb is likely superior to THP, and likely inferior to neoadjuvant TCHP in randomized studies. It cannot be a direct comparison as the number of treatments are not equivalent.

It is time to stop randomized trials and compare against a standard. The best treatment should be found by functional profiling - like the recent approval for CLL.

The best treatment for a patient's cancer could be Tykerb, Herceptin and Paclitaxel, it could be Perjeta, Tykerb, Carboplatin & Adriamycin or it could simply be Herceptin. It could be that none are needed. It is time to stop using patients like lab rats and accept that using tumor and blood samples when possible best defines the concept of "first do no harm."

This information on Tykerb and Herceptin & Paclitaxel is wonderful, I like the concept of less chemo treatments.

I'm back on the soap box again - saying the system has reached its maximum effectiveness. Imagine if we select the group of women that this combination is most effective for by utilizing functional profiling. Tykerb, Herceptin & Paclitaxel could have a 90% effective rate for this group - until the industry stops trying to work around the best tool we have patients will continue to suffer needless chemotherapy and recurrences.

Stepping off the soap box now. . .

[phil]

my first reaction to these trials was " wow, after all these yrs, we are still looking at nasty chemos like taxotere , and a drug like tykerb, so limited in use because of the gi s/e's , as " advances " . we should be pushing for a " quick " ( whats ' quick ' in the current drug approval system ? - 2 , 3 yrs ? instead of 7 , 10 ? ) trial of neo adj. t dm-1 vs. standard of care, or neo -adj. herc /perj alone vs. herc alone .
What we really need are stage iv activist pt. /caregivers in an advocacy grp. that sits on FDA advisory boards. right now no stage iv advocacy grp gets that . instaed we have a bc action sitting on the FDA board which is so clueless that they wrote the FDA in 2010 asking them to NOT grant early appr. for t dm-1. I think an advoccay grp that has no scientific knowledge and " plays scientist " infuriates me more than the know it all Dr. Pasdur and his t dm-1 team at the FDA !

['lizbeth]

Phil,

I think we are both getting frustrated with the "system".

I appreciate the study on Tykerb, Herceptin & Taxol. I know that when I was making my chemo decision this information would have been golden. I would have loved the opportunity to have neoadjuvant treatment. Better yet - if I had know about Rational Therapeutics in Long Beach I would have insisted on testing instead of agonizing over what chemo would be more effective for me.

The neoadjuvant study is quicker. The NeoAlto study started enrolling in 2008 and just finished it secondary end point mid 2013. They will follow the patients for 10 years.

I was mistaken on less chemo, I see they also have FEC after surgery.

I am with you about the side effects, the taxanes and Tykerb have severe side effects. I've heard Slamon mentioning finding treatments that offer a higher quality of life. I am extremely grateful that he has given this consideration.

I too was shocked that this "bc action" group ask not to grant early approval for TDM1. I do not choose to be represented by this group. Frankly - I would not deprive stage IV women of an opportunity to have life saving treatment. Asking for a delay was morally irresponsible. I am ashamed of them.

Phil, honestly I think the research community is advancing science so rapidly that soon the FDA and medical community will be forced to adapt to a new paradigm. The randomized trial system is becoming obsolete. We all realize that many patients require more than one targeted therapy to overcome their cancer, so the NeoAlto trial is part of the problem of the system. Even if functional profiling showed this combination to be best for a specific population of women - would they be able to receive it, if it were not incorporated into standard of care?

The question that now begs to be answered is specifically who benefits from this treatment. Not how many women out of 100 benefit. But which women in this 100 benefit.

[Rolepaul]

One of the actions that is reported is to use multi-variate testing. This means that side by side testing of only two drugs is going be less, to be replaced exploring the interactions of multiple drugs. This is definitely a shift in how testing is done. To give you an idea on how long it takes for drug development, I worked on the precursors to TDM-1 in the mid-1980s. Now drugs are going from concept, through animal models, and into initial human trials in four to six years. Testing on patients is typically two to three years more. Once a drug is approved, a further indication is another two or three years. The FDA treats a drug for Stage IV Herceptin the same as for a blood pressure medication for 20% of the population. That has got to change! I am a person who benefited from knowing the system better than most, with Nina having Clinical Trial Associate certification and me having 27 years of experience in the pharmaceutical manufacturing system. This is very unique and it should not be necessary to have similar credentials to get treatment. I hope that the medical community and the pharmaceutical industry can get earlier and more effective treatments to patients on this site. I still cannot get acceptance for IT Herceptin after demonstrating with Nina and a few other patients the effectiveness of this dose and method of introduction. But I will not give up.

['lizbeth]

Rolepaul,

For the sake of future patients I seriously hope that multi-variate and side by side testing of drugs in randomized trials become obsolete.

Think about this - with the current knowledge in the research community about genomics, and the functional testing available from Drs Nagourney, Wiesenthal and others - we can leave this antiquated system of drug approval behind.

If Nina would have been able to have her tumor genetically & functionally analyzed - you would have known she was receiving the most effective drugs available for her cancer. Her recurrence could have been stopped or delayed significantly.

The research community is waking up and already doing 2nd biopsies after administering treatment - to see the effect of the treatment. Instead of the wait and see & let the cancer get resistant to treatment strategy that has been so popular in the medical community.

Let us use genomics for those who do not have tumor samples that can not be functionally profiled.

We cannot cure cancer until we accept that each individual should be treated for their own unique cancer. Not grouped into large, randomized trials and forced to take toxic treatments that are unnecessary medically.

Even more important we must push to separate those who do not need treatment from chemotherapy, from those who can benefit from a combination of targeted therapies, from those who only need surgical intervention . . . etc.

As far as the IT Herceptin, You should never give up on this. . The stage IV patient population desperately needs a successful treatment for CNS mets. It is a critical area that could save many, many wonderful lives if a treatment such as IT Herceptin is approved.

I did see a post from Lani recently, but have not followed IT Herceptin as closely. After I saw our dear NEDenise lose her life to brain mets, I don't have the heart to follow the latest developments in this area for a while.