Objective outcome measures of quality of life.

An objective end point of quality of life-the clinical benefit response-was developed for use in clinical cancer research. This end point was used in two clinical trials of gemcitabine (Gemzar) in the treatment of advanced pancreatic cancer. To qualify as clinical benefit responders, patients had to demonstrate a marked, sustained improvement in pain and performance status; if both parameters were stable, patients could still be considered responders if they showed at least a 7% increase in dry weight. In a phase III trial in 126 patients with advanced pancreatic cancer, gemcitabine was significantly superior to fluorouracil (5-FU) with regard to clinical benefit, and also produced a survival advantage. In a phase II trial involving 63 patients in whom 5-FU had previously failed, gemcitabine also afforded clinical benefit. We conclude that clinical benefit response is an effective means of evaluating the activity of gemcitabine in advanced pancreatic cancer.