Metastasis to the brain is hard to treat because many chemotherapies do not pass the blood-brain barrier. The blood-brain barrier is a natural filter within the body. It only allows certain substances through from the blood to the brain tissues. This is a natural defense mechanism. It is designed to keep harmful substances out of the brain. Only a few chemotherapy drugs get across the blood-brain barrier.
One drug that can pass the blood-brain barrier is called Temodar. A clinical trial was done from researchers at MD Anderson Cancer Center to evaluate the combination of Xeloda and Temodar in the treatment of metastatic breast cancer to the brain. The trial included 48 patients who were either newly diagnosed brain metastasis patients, patients with multiple areas spread to the brain and those that had recurred to the brain following prior therapies.
The study showed that 18 percent of patients have regression of the cancer in the brain, half of the patients had continued anti-cancer responses at eight weeks and half of the patients did not have cancer progression in the brain after three months.
The researches concluded that the treatment combination of Temodar and Xeloda provided anticancer response in metastatic breast cancer to the brain.
21. So we say that cell culture assays haven't been proven "efficacious." So what? No one ever represented that the assay had been proven to be "efficacious" in randomized trials. They are just claimed to be "accurate" and that "accuracy" is the standard always before used to evaluate tests. A scientist that had based his career on Her2/neu and E.R., which neither has been tested in clinical trials to show "efficacy," should realize that he works in a "glass" institution. If an oncologist doesn't want to use the test, that's their privilege, though the patient should certainly have a say in the final decision.
ASCO should at least be consistent. They should honestly evaluate and report the "accuracy." They should correctly note the lack of proof of "efficacy," but at least evaluate and report the "accuracy." The tests have been proven "accurate." And there are obviously lots of situations where a rational oncologist and patient would conclude that the evidence from an accurate test would be of help to guide treatment.
No other lab test in history has anything other than evidence of "accuracy" to either commend it or condemn it. But ASCO won't even look at the "accuracy" and only looks for "efficacy" and finds four out of four preliminary trials which show that the assay-treated group actually did better, but because these are non-randomized studies, they conclude that "efficacy" hasn't been proven.
They should perhaps say something like "the assays shouldn't be used routinely" (as they said for chemotherapy in Stage II colon cancer). But they should also say "in the end, the decision is up to the oncologist and the patient" (as it is in Stage II colon cancer). But this is not what was said. They said it's okay to give chemo in Stage II colon cancer, even though the trials don't show benefit, but it is not okay to use cell culture assays because the trials have never been done. That's a classic example of hypocracy.
So-called scientists that have done more over the past 20 years to keep the cell-death assay technology under a bushel basket and out of the light should be spotlighted and rebuked. It has ultimately hurt literally hundreds of thousands of patients. We'd be much further along and technology would have improved sooner, even more accurate. New treatments would have been discovered earlier and targeted immediately to the people who could most benefit from them. This has been one great lost of opportunity in clinical research, and that's what it is.
I do this in memory of my dearly beloved wife. "She" is the true hero.
Posted at 10:47AM on Sep 27th 2006 by Gregory D. Pawelski