***Lack of patients to test drugs hinders research***

[RhondaH]

http://www.kansascity.com/mld/kansas...n/15109728.htm

Rhonda

[Lani]

"Any time a new drug comes out, there's a chance that an existing trial could be derailed."

Once Lapatinib becomes more generally available it will throw the "monkeywrench" in discovering whether Herceptin just prolongs recurrence or prevents it. Since patients are not guinea pigs, you cannot refuse to let them try the latest drugs. There will be few "virgin/untouched by lapatinib" patients who only got Herceptin (unless countries/insurance companies refuse to pay for it) with which to continue out the study statistics to discover what herceptin alone does.

Also those patients who take flaxseed oil, vitamin D or NSAIDs (or bisphosphonates or statins) on their own who are in clinical trials are botching up the results for statisticians as these (hopefully) may alter the results of what adding herceptin to chemo does.

This is also why we may never get a trial of what herceptin alone does. In order to get people to participate and the government and ethics counsels of cancer centers to permit clinical trials, they must provide all participants with the "gold standard or standard of care treatment" and then just add on what the new treatment is. That way, noone suffers (in theory) should the treatment prove ineffective (that doesn't help if the treatment proves harmful or harmful when combined with the standard treatment).

This has held back the clinical trial of less radiation therapy, metronomic chemotherapy, etc. leaving us not knowing if less treatment would do. We can only infer from trials of TCH that their numbers are occasionally not as good as AC, then TH for example that tht either it is better when AC is added OR, as is likely the case, there is a subgroup of patients within the group of patients for whom AC added to TH improves the results. It is not always easy to figure that out, and what makes that subgroup do better with AC, for example (topoII positivity)

In addition we are finding breast cancer is of many subtypes. When we still lump together subtypes with different cancer types with different natural histories and behaviors needing different treatments it is difficult to discover whether any one treatment is better for the sum of them vs for the subgroups themselves.

Using multigene arrays on FRESH FROZEN biopsy samples (important to advise new patients to get this done on a portion of their tumor instead of it being entirely embedded in paraffin) and studying breast cancer stem cells so that we can identify the subtypes and look for appropriate markers for targetted therapies on each subtype looks to be the way of the future.

Clinical trials will become harder and harder to do...for many reasons including the lack of available patients for the statistics.

I hope advocates like Cynthia, work to keep the laws which require insurance companies to keep paying for patients on them, or they (clinical trials) may become an " endangered species"

Off the soapbox again!

Lani

[Christine MH-UK]

The sheer need for bodies. There are, after all, lots of places in the world where hardly anybody gets herceptin, but the internationalization has its own problems as well. I wouldn't want phase I trials moving into countries where bad results could be hushed up (not after the whole TeGenero debacle, in which six men ended up in hospital. All six men have long since recovered, although one who had been a plumber lost some figures and toes and there are concerns about long-term effects). On the other hand, I want patients to receive the best care possible, which means that some phase III trials might not be able to recruit in the US (for example, when the control arm's treatment suddenly becomes substandard).

It's not just what cancer patients deliberately take that can throw off a trial. What if it's true that oleic acid actually does make her2 positive cancer more sensitive to treatment (so far only shown at the cell level)? That could really affect how generalizable results were from countries where people use alot of olive oil or other foods high in oleic acid.

[R.B.]

And once it gets a "gold standard" stamp and integrated into the system who will question the applicabilty efficacy good or bad for sub groups etc. The drugs companies ? - the health authorities? - the medical profession?.....

Thought provoking posts.

Thank you.

RB

[mindersue]

I would gladly take part in a clinical trial, if I could pick which treatment arm to be in. Would it be wrong to join a study and then drop out if I got the treatment arm I didn't want?

Thanks for the post. It reflects what I'm going through right now.

Mindy

[CLTann]

I always felt that in clinical trials, the patient should be allowed to choose the arm she wants to be in. What is purpose for the individual that after 2 or 3 years of a trial and discovered that she was only taking sugar pills. Meanwhile she may have progressed to a worse condition.

Of course, I realize that for a scientific study, controls are necessary to validate the new drug's efficacy.

Ann