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Studies Show Clinical Benefits of Gemcitabine in Pancreatic Ca
Published on Cancer Network (http://www.cancernetwork.com)
Studies Show Clinical Benefits of Gemcitabine in Pancreatic
Cancer
January 01, 1996 | Gastrointestinal Cancer [1], Pancreatic Cancer [2]
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.
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 (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
(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.
Gemcitabine was well tolerated, with only 15% of patients experiencing grade 3 or higher
nonhematologic toxicity and 23% experiencing grade 3 or higher neutropenia, Dr. Burris said.
In the second study, a single-arm trial of gemcitabine in 63 patients with fluorouracil-resistant
pancreatic cancer, 27% showed a clinical benefit response, with minimal side effects. Only 9%
developed grade 3 or higher nonhematologic toxicities; 25% had grade 3 or higher neutropenia.
"These studies confirm the positive effect of gemcitabine on tumor-related symptoms in patients
with advanced pancreatic cancer, either as frontline therapy or for fluorouracil-resistant disease," Dr.
Burris said.
He added that other studies have indicated that the agent may be useful in advanced non-small-cell
lung cancers, especially in combination with cisplatin (Platinol), as well as in advanced ovarian and
breast cancers.
Gemcitabine is currently available from Eli Lilly and Company through a Treatment IND program for
selected patients with advanced or metastatic pancreatic cancer. The agent has been recommended
for approval by the FDA's Oncologic Drugs Advisory Committee, and is awaiting further FDA action.
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Studies Show Clinical Benefits of Gemcitabine in Pancreatic Ca
Published on Cancer Network (http://www.cancernetwork.com)
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[1] http://www.cancernetwork.com/gastrointestinal-cancer
[2] http://www.cancernetwork.com/pancreatic-cancer
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