This is the first chemotherapeutic agent since 5-FU to be approved for use in patients with pancreatic cancer in nearly 35 years. These trials introduced the concept of clinical benefit response. Pancreatic cancer patients almost always have devastating symptoms including pain and weight loss. These patients also experience declining performance status.
Objective responses are also frequently difficult to assess non-invasively.
Investigators combined changes in pain control, weight loss and performance status to create clinical benefit response. The FDA accepted this patient-centered endpoint for testing of gemcitabine in pancreas cancer. In addition, patients achieving symptomatic relief did so within six weeks of initiating therapy. Symptomatic benefit lasted an average of 12 weeks. Treatment was with gemcitabine at the same dose and schedule.