Terminal cancer patients may benefit from phase I trials, study says

A new study from The University of Texas M.D. Anderson Cancer Center in Houston may lead to more physicians referring terminally ill patients to undergo experimental treatments, Reuters Health reports.

Led by Dr. Ignacio Garrido-Laguna, researchers tracked 61 patients with advanced head and neck cancer who had participated in phase I trials at their center over a five-year period. Fifty-nine of those patients had been on FDA-approved drugs before the start of the trials. Patients survived an average of 12 weeks on FDA-approved treatments and 10.7 weeks on experimental drugs before their cancer progressed--outcomes that were not statistically different.

Although the purpose of phase I trials is to determine whether a drug is safe and at what dose, newer tools to match patients with the right drug for their type of cancer may improve the odds that patients will benefit from the treatment, the authors wrote in Clinical Cancer Research.

Nonetheless, ethicists still warn that very ill patients may derive false hope from trials or even be unable to give informed consent. For researchers who are explaining drug trials to patients, "you have to be very careful," said Dr. Franklin Miller, a bioethicist at the National Institutes of Health in Bethesda, Md.

In addition, without a control group, it might not be possible to tell whether a patient truly benefits from being in a trial.

But Miller did not indicate that patients are taken advantage of with the lure of trials. "They've exhausted all the [treatments] that are available and standard," he said. If they want to keep fighting the cancer, he said, "there really isn't any better option for them. I think this is genuinely what many people want to do."

To learn more:
- read this Reuters story
- here's the abstract from Clinical Cancer Research