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Old 12-17-2007, 05:42 PM   #1
micheleu
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any news about Herceptin clinical trials?

does any know if there has been any information out from San antonio about the Herceptin trials for early breast cancer? There must have been something noted about them.
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Old 12-17-2007, 06:38 PM   #2
Lani
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the big news was from the trial which compared anthracycline with nonanthracycline

combos with herceptin in the adjuvant setting...

TCH was AT LEAST AS GOOD as AC, then TH but without the cardiac side-effects. Dr. Slamon pointed out that he thinks that only those who overexpress both her2 AND topoIIa benefit from Anthracyclines (and they benefit equally from being given TCH), and that they constitute about 30% of her2+ bc patients which constitute about 25% of breast cancer patients...ie, 8% of ALL breast cancer patients and recommended that his colleagues consider whether the 82% of breast cancer patients who do not even benefit from anthracyclines and are only susceptible to its cardiotoxic effects (and in his opinion without hope of any benefit) should continue to be treated that way.

The problem is that his views have still not been tested out in a large prospective randomized trial with topoIIa testing and that accurate topoIIa testing is only being done in one lab at USC (others who claim to test it apparently are not providing an equivalent service or not in a reproducible or accurate way) and that lab is not geared for commercial use of the test and thus, patients do not have access to this test yet unless they have been seen by Dr Slamon or others at UCLA ordering the test (JEAN has!)

This will probably speed up the change by ordering physicians of TCH rather than AC and then T, but those who wait for large randomized trials will change much slower and EU protocols are determined yearly at the St Gallen conference and there may not be enough time until that conference for Dr. Slamon's findings to be debated nor conservative opinions changed.

Whether the change is warranted will be much debated in the next months and years. Dr. Slamon feels it is--he seems to be proud of the fact he "invented herceptin" but concerned about the cardiac dysfunction it is causing in those who might not even die of breast cancer if they were not given it (depending on their tumor characteristics, whether it was caught
before micrometastases occured, how active the patient's immune system is, etc) and trying to minimize the chance of cardiac side effects by asking that it be combined with a drug combination which appears to be at least equally effective and associated with far fewer cardiac side effects as it seems to be that herceptin worsens the kind of cardiac damage that anthracycline causes (or at least keeps it from being repaired).

I think you are referring to the HERA 1 vs 2 year herceptin results. Dr. Piccart, head of the HERA trial announced that it now will not be until 2009 (she originally said 2008 last year) that some results might be announced.

There were updates on the TCH trial (see above), updates of a small Italian trial, updates on some neoadjuvant chemo plus herceptin trials, and update on an aspect of the HERA trial unrelated to 1 vs 2 years (given the last day as one of the last talks--would have to check my notes, but nothing monumental)

The big news on the No American trials was that the improvement with AC then TH given concurrently or sequentially held up when looked at another year further out. It does not appear that the result peters out with time!

The posters and abstracts and talks should all appear online, so you are welcome to look at them. Just google "SABCS 2008"
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