The Truth about Cancer

specialK: I thought all 4 arms were receiving the GM-CSF vaccine. I realize the two different arms received a possible second drug. But even just getting the vaccine would be a plus in my view.

1. disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone
2. disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone
3. disease recurrence rates between all four arms of the trial

Umm, yes it is. Not a sweeping statement. Avistin is a good example. It helped very few bc patients, many more colo-rectal patients. Didn't feel so good for the bc patients benefiting when they were told it could no longer be used for bc unless they funded the drug themselves. May not be the case for enzyme replacement therapies...don't know, not my area, but cancer drugs? C'mon, you know how important profit is right? You're just messing with me. It's a pretty hard sell to get an investor to be charitable. Can't find the smiley, seems to have disappeared, but there would be one here if I could. I don't really want to get confrontational with you either, but that little remark if I'm taking it the way I think it was intended,  turned me off. I made it pretty clear earlier how I feel about the researchers. Enjoy the debate.

kay,

Could you elaborate a bit on the concept that it is more ethical for treatment guidelines to continue for years (and more years) to recommend extensive treatment that includes routine severe immunosuppressive effects, severe cardiac effects for some, and documented significant extended adverse economic effects for some, based on inadequate documentation of efficacy due to original trial design?

I appreciate the open admission noted above that a lack of documented proof of efficacy continues to exist for very early stage bc patients in regard to recommending the chemo/trastuzumab therapy, which supports the points I outlined in earlier posts advocating acknowledgement and genuine informed consent for those patients by providers at time of application of guideline recommendations.

I'm one of those who understands already that the reason we continue with the standard recommendations for early stage HER2 positive bc for chemo + trastuzumab is that we have no proof one way or other about the benefit.

Therefore we would rather recommend treatment that is known to cause some damage to some early stage HER2 positive bc patients and may in fact have worse results for more of this group of patients than if chemo + trastuzumab were not recommended for this group of patients, just in case it might be true that giving chemo + trastuzumab might be more beneficial to this group of patients.

Voracious: Why is it ethical to have a trial of herceptin without chemo for women over 70? Why not 68 or 69? Why is 70 the cut-off date? How is that justifiable?

granny - the GM-CSF is not the vaccine, it is the "placebo" if you will, even though it is a drug - it is similar to Neulasta - a granulocyte colony stimulating factor.  The vaccine is the GP2 or the AE37.  There are two arms, each split into two sections - GP2 (the arm I am in) is given to tissue types A2+ and within that arm it is split between those who get the GP2 and GM-CSF, or two injections of the GM-CSF.  Those who are tissue typed A2- get the AE37 vaccine plus GM-CSF, or two injections of the GM-CSF.

SpecialK: Thank you for that information. I don't want a placebo. Perhaps if they find it works, we can all have it.

granny - that is certainly the goal of this trial, and all of the data so far points to both the GP2 and AE37 vaccines having recurrence prevention effect, but all of us who participate in a trial take the risk of getting the placebo - part of figuring out what works is having a parameter specific placebo to compare it to.  I believe in the GP2 arm there were 190 participants and 89 received the vaccine, 91 the placebo (GM-CSF only).  Here is a recent article that discusses the GP2 arm:

http://blog.dslrf.org/?p=2161

Kayb,

I understand that my views may differ at times for various logical reasons, but not this time.

I understand that a substance may show a percentage of value (such as chemo) when used alone. The addition of other substances can chemically 1) reduce that percentage, 2) increase that percentage, or 3) leave that percentage unchanged. I think you could agree with that basic chemistry fact, but I won't assume that you do.

The use of chemo, along with whatever percentage of success it may have, also reduces the known and as-yet-any-unknown benefits of the immune system, whereas the use of trastuzumab is not considered to have that major adverse effect. All patients exposed to standard recommended chemo have major immunity deficit that patients who receive trastuzumab alone do not, and in addition some of these patients do have immunity complications due to the chemo that they otherwise would not have if trastuzumab were used alone. While that may not reduce the established benefit of chemo (in that the benefit of chemo used alone in addition to the detriment with chemo alone would not change), it may reduce the benefit of trastuzumab that otherwise could show greater effect in conjunction with an intact immune system if used alone.

Could you review your statement in consideration of that information, and provide evidence to the contrary? "There was no indication that Herceptin alone might be a miracle drug that would provide an equal or better outcome than the chemo. If most of the HER2+ patients had suddenly been cured by the addition of Herceptin then maybe the researchers might have decided Herceptin was effective enough to devise trials of it alone - but they had no logical reason to think that!"

No logical reason?

"Do you know that it isn't up to the researchers to make those decisions alone? "

Yes, certainly. I never said it was.

"AA - I already know my explanation will not sway you in the slightest."

If researchers ever do provide accurately documented evidence for early stage bc for the risk vs benefits of adding chemo to trastuzumab, that would sway me. Basing recommendations on "assumptions" does not.

VR, as long as there is a nonscientific bias favoring the undocumented optimistic "guess" by research that drugs that work only in 1 out of 5 patients to begin with, that will remain the status quo. But as we well know already, what works for postmenopausal patients differs often from what works for pre- and/or perimenopausal patients, and there is reason to believe that a high percentage of those over the age of 70 are postmenopausal.

One major effect of chemo that has nothing to do with "killing cancer cells" is that it generally speeds the onset of menopause. Therefore, some form of ovarian ablation in conjunction with trastuzumab might be necessary, and that is not included in the present trial for those over 70.

AA.....the results of the SOFT sand TEXT trials are around the corner.....can we shelve the ovarian suppression debate for a few weeks? The annual San Antonio Breast Cancer commences the first week in December and it is likely that we will be knowing more once those preliminary results are announced.

VR,

We most certainly would have been able to shelve that argument until the results of SOFT and TEXT would be available, but for the major failure of our gallant advocates (researchers) to allow HER2 positive patients to have their own arm in those studies. HER2 positive patients were banned from being included in those studies.

Didn't they know any better?

AA....you know why they were excluded! ETHICS. They DID know better!

AA...logical rationales???? Hmmmmmm.....I didn't make up or define the bioethics used in medical science. I think you go to great lengths to redefine bioethics to justify your reasoning. Very sad.

kayb,

So is that why HER2 positive patients were excluded from the SOFT and TEXT trials? Or did they find some other convenient excuse for excluding HER2 positive patients from those trials?

Given that "success" is so minimal and generally lousy with chemo (1 out of 5 benefit, even if for many only for an additional day of life) and the awareness that the addition of trastuzumab has improved the picture to a far greater degree, the definition of the ethics being used as an excuse is far from adequate.