NEW YORK--A novel nucleoside analog has demonstrated clinical benefits measured by reduction in pain, weight gain, and an improvement in performance status in patients with advanced pancreatic cancer.
Gemcitabine(Drug information on gemcitabine) (Gemzar) has shown a broad spectrum of activity against a range of solid tumors in both preclinical and clinical studies, Howard A. Burris III, MD, reported at the 13th annual symposium of the Chemotherapy Foundation.
In phase I and II trials of patients with advanced pancreatic cancer, gemcitabine produced only modest response rates (in the range of 11%), said Dr. Burris, associate professor and director of Drug Development, Brooke Army Medical Center, Cancer Therapy and Research Center, San Antonio.
Improvements in disease-related symptoms, however, have been far greater, Dr. Burris said, as have correlative improvements in performance status, weight gain, and pain control. These observations led to the development of a clinical benefit endpoint to be used in the prospective evaluation of gemcitabine in pancreatic cancer.
Dr. Burris described two trials in which clinical benefit endpoints were assessed in terms of pain (composite of analgesic consumption and pain intensity), performance status (an improvement of 20 or more points on the Karnofsky scale), and weight gain (7% or more over baseline), all over the course of 4 weeks or longer.
In the first trial, 126 patients were randomized to receive gemcitabine (1,000 mg/m²) or fluorouracil(Drug information on fluorouracil) (600 mg/m²) as a 30-minute weekly infusion. Clinical benefit response was 23.8% among gemcitabine patients, compared with 4.8% for those receiving fluorouracil.
Median survival was 5.65 months for patients receiving gemcitabine versus 4.41 months for those on fluorouracil. Among gemcitabine patients, 18% were alive at 1 year, compared with 2% of fluorouracil patients.