You may have friends, as I do, who have been fighting late-stage cancer with the help of an experimental drug, and wondered if venturing into unchartered pharmaceutical territory versus conventional treatment routes was actually worth the risk.

Based on this latest study that tracked the outcomes of 61 patients (median age 55) with metastatic head and neck tumors who participated in 36 phase I clinical trials (59 of them first received FDA-approved drugs), the statistical difference in duration between the two options was slight at best. Overall, the period of survival with the help of experimental drugs lasted 10.7 weeks on average, compared to 12 weeks for FDA-approved drug regimens.

In phase 1 drug trials, researchers are testing treatments or drugs for the first time on patients to determine the best dosage range, safety concerns and any side effects.

The majority of patients (34) monitored for this study experienced no change in their battle against cancer, only one patient died as a result of an experimental treatment and the health of four patients actually improved.

Despite these results, there's still a wariness among health professionals about giving sick patients false hope. And, because a phase 1 trial doesn't compare the efficacy of an experimental treatment or drug with a control group receiving a placebo, there is great uncertainty as to whether patients derive any actual benefit, particularly when the only positive outcome being considered is stability, according to a National Institutes of Health bioethicist.

So, would the numbers, as presented in this study, make you consider an experimental drug or thinking twice about taking one?

I choose hope. Once in a great while, you may actually find a bit of it along the road less travelled.

Clinical Cancer Research, Vol. 16, No. 15, pp. 4031-4037, August 1, 2010

Yahoo News August 13, 2010

drugwatch.com August 13, 2010