Quality-of-life assessment in phase III clinical trials of gemcitabine in non-small-cell lung cancer.

Health-related quality-of-life (QOL) endpoints in clinical trials provide decision makers with a more comprehensive picture of a specific treatment than activity-related endpoints alone. Such endpoints are increasingly being reported in cancer clinical trials. We reviewed phase III clinical trials that involved gemcitabine in the treatment of unresectable non-small-cell lung cancer. A systematic literature search was undertaken and 16 phase III clinical trials were found in which gemcitabine therapy was included in a treatment arm and QOL was an endpoint. Twelve of the 16 trials compared a gemcitabine-based treatment with a non-gemcitabine-based treatment. Not all data were reported in the trials, and the findings are mixed. However, a review of these 12 trials generally shows that gemcitabine-containing chemotherapy treatments had either no different or more favourable QOL outcomes than non-gemcitabine-containing chemotherapy treatments. Ten of the 16 trials that were reviewed had a primary endpoint or objective that was not QOL. Of these ten trials, only four concluded that one treatment arm could be therapeutically favoured over another in terms of the non-QOL primary endpoint. Two of the trials reported no difference in QOL and two reported that QOL favoured the arm that was therapeutically favoured. Many more trials will need to be conducted in order to conclude that gemcitabine-containing arms are associated with a more desirable QOL than non-gemcitabine-containing arms and that QOL necessarily favours the therapeutically favoured arm in the treatment of non-small-cell lung cancer.