New developments in chemotherapy for patients with advanced pancreatic cancer.

Alleviation of tumor-related symptoms may be a more appropriate basis for judging drug efficacy in pancreatic cancer than is tumor shrinkage. Clinical benefit response (CBR), a new way to assess clinical efficacy based on marked, sustained improvement in pain intensity, analgesic consumption, and performance status, was used to evaluate a new chemotherapeutic agent, gemcitabine (2',2'-difluorodeoxycytidine [Gemzar]). A phase III study of newly diagnosed pancreatic cancer patients treated with either gemcitabine or fluorouracil (5-FU) and a phase II trial of gemcitabine in patients whose disease had progressed despite prior treatment with 5-FU both demonstrated that a significant number of patients achieved a CBR with gemcitabine. Prolonged survival was a secondary benefit demonstrated in the phase III trial. In both studies, gemcitabine was well tolerated, with a relatively mild toxicity profile. These results suggest that gemcitabine may serve as a prototype for the development of more effective therapies for pancreatic cancer patients.