I thought that everyone on MOL-Cancer would like to see the following news release announcing new findings about Camptosar (CPT-11)
May 20, 1998
Source: PR Newswire
New Data Demonstrates That CPT-11 Extends Survival in People With Advanced Colorectal Cancer - CPT-11 Provides Improved Survival as Compared to 5-FU -
LOS ANGELES, May 19 /PRNewswire/ via NewsEdge Corporation -- Data presented today at the American Society of Clinical Oncology (ASCO) meeting demonstrates for the first time that people with advanced colorectal cancer who receive CPT-11 (irinotecan hydrochloride; Campto(R)/Camptosar(R)) monotherapy as second-line therapy have better survival rates compared to patients treated with 5-fluorouracil (5-FU).
"CPT-11 has been shown to be the most active drug in advanced colorectal cancer as second-line treatment," said Professor Eric Van Cutsem, M.D., PhD (University Hospital Gasthuisberg, Leuven, Belgium). "The study shows that CPT-11 is a better therapeutic option than 5-FU for patients who receive second-line chemotherapy, and establishes a new reference for treatment."
The study, presented at ASCO, is the first randomized Phase III study ever conducted in advanced colorectal cancer comparing CPT-11 with high dose infusional 5-FU following 5-FU failure. Researchers demonstrated that at one year, the overall survival rate was 38 percent higher in patients who received CPT-11 than with 5-FU (44.8 percent, compared to 32.4 percent).
Trial Methodology
This multicenter trial enrolled 256 patients with advanced colorectal cancer who had previously failed standard first line therapy with 5-FU. The study was designed to compare overall survival with CPT-11 monotherapy compared to best estimated regimens of 5-FU. Patients were divided into two treatment arms: Patients in arm A received CPT-11 (350 mg/m(2) every three weeks), and patients in arm B received one of three best estimated regimens of infusional 5-FU (5-FU 400 mg/m(2) per day (d) i.v. bolus + 600 mg/m(2) per day i.v. continuous infusion + folinic acid; 5-FU 250-300 mg(2) per day i.v. continuous infusion until toxicity; or 5-FU 2.6-3/m(2) per day over 24 hours (folinic acid weekly x6 w+2 with rest). At one year, the overall incidence of survival was 44.8 percent in the CPT-11 arm compared to 32.4 percent in the 5-FU arm (p=0.035).
Quality of life analysis did not show a difference between the CPT-11 and 5-FU arms measured by the frequency of symptoms, such as pain, nausea, weight/appetite loss and emotional functioning. Diarrhea and vomiting were slightly less prevalent in the 5-FU arm.
The most common adverse effects with CPT-11 observed in this study were diarrhea, neutropenia and vomiting.
Colorectal cancer is cancer involving the lining of the large intestine or the rectum. In the past, colorectal cancer was known as the "one drug disease " because the only effective drug therapy was 5-fluorouracil (5-FU).
SOURCE Interel Marien
/CONTACT: Eveline Goossens, or Caroline Verschaffel, of Interel Marien, +32-2-761-66-52, or fax, +32-2-777-05-25/
William J. Comcowich, President, UltiTech, Inc. / Medicine OnLine
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