[AlaskaAngel]

I believe that many of the people involved in bringing trastuzumab to us are to be admired and appreciated for their initiative and hard work.

To the degree that they have no control over the unfortunate blanket application for the various patients for whom the the mandated combination of drugs do not provide benefit and yet is the only option authorized, they should not be blamed.

The firsthand, anecdotal information and explanations I think are very helpful for anyone to consider. That includes my own anecdote.

Since the original trials led to blanket use of therapies, and since I did not have trastuzumab and yet I remain NED, it is reasonable to continue to question just exactly what therapy or combination of therapies did the trick for any of us. Can we know for absolute certain which therapy given made the difference for each person? Is it proof?

For some, it is possible that becoming menopausal through the use of the required addition of chemotherapy is what then slowed their rate of metabolism and would be enough without the other drugs.

Since I had a very aggressive, strongly HER2 positive 1.9 cm tumor (grade 3) and yet I never had any trastuzumab and continue to remain NED at 12 years out, what we DO know is that trastuzumab is not the reason that I remain NED.

It also especially poor practice to continue to pressure patients and the doctors treating early stage patients to push their patients to include chemo in order to receive trastuzumab, since the trials done for this group were done largely only for those who had positive nodes or tumors at least 2 cm in size. We cannot say who benefits from which therapies.

If it is true that becoming menopausal is adequate treatment for some to be able to remain NED, there are less invasive ways to accomplish that, which should be offered as alternatives instead of pushing chemo as the ONLY way to do it (in combination with trastuzumab).

It is true that chemo MAY also reduce the number of cancer cells when the type of cancer cells one has happen to be very responsive to the particular chemotherapy being given. At the same time, we do not know what mechanisms of the immune system are being suppressed by the chemo that otherwise could provide significant benefit to patients for whom other therapies (such as trastuzumab) when used alone would have been more effective. For early stage patients, this may be especially true in that therapies are often more successful when the tumor burden is less -- which is the case with early stage patients. We cannot know because the evidence was not obtained for this group.

These is is all pertinent information that should be provided to early stage patients. Instead the sledgehammer approach continues for this group, even though these patients have not had the opportunity to base the conclusions on carefully trialed evidence.

I do understand that trials cost a lot of money, and that the financial bias against providing money for any trial for this group exists, and that trial results could reduce the present policy of over-use of very expensive drugs. The bias is significant because the drugs are so expensive and revenues from blanket application are not insignificant. Who would fund such trials just because that is a more ethical, less harmful thing to do?