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| |  Xeloda Shows Promise in Treatment of Advanced Colorectal Cancer DENVER, May 20, 1997 -- Xeloda(TM) (capecitabine), a new investigational anticancer agent, showed activity in the treatment of patients with advanced colorectal cancer, according to the results of a Phase II study presented today at the annual meeting of the American Society of Clinical Oncology (ASCO). The study revealed a response rate of 25 percent and improved time to disease progression in patients receiving Xeloda therapy. Typically, monotherapy yields response rates in the range of 14 percent to 20 percent. The study, an international effort, was conducted at 21 cancer centers worldwide and was presented by Dr. Michael Findlay from the Sydney Cancer Centre in Australia. M. D. Anderson Cancer Center in Houston is one of the U.S. sites for the study. "The potential of Xeloda is exciting because of its tumor selectivity, which may ensure treatment efficacy while reducing side effects for patients," said Dr. Richard Pazdur, Professor of Medicine, Division of Medicine, M. D. Anderson Cancer Center. "We're hopeful that the positive results seen with the agent as a monotherapy can be replicated in large, comprehensive Phase III trials." In the U.S., an estimated 131,200 cases of colon and rectal cancers will be diagnosed in 1997, while an estimated 54,900 deaths will occur from these cancer types. Three dosing schedules of Xeloda were evaluated in this randomized trial as first-line treatment in outpatients with advanced colorectal cancer: a dose of 1331 mg/m2/day continuous (A), 2510 mg/m2/day intermittent (B), or 1657 mg/m2/day + oral Leucovorin 60 mg/day intermittent (C). The aim was to evaluate the efficacy and safety of each schedule. With 38 evaluable patients in group A, 32 in group B and 33 in group C, confirmed tumor response was shown in 8 patients in A, 8 in B and 8 in C; responses were seen after 6 weeks, frequently in liver sites. The median times to tumor progression were 17 weeks in A, 30 weeks in B and 24 weeks in C. Side effects seen by some patients in the trial included hand-foot syndrome (redness and discomfort of palms and soles), stomatitis (inflammation of the mouth) and diarrhea. Grade three toxicity was seen in 5 patients in group A, 10 in group B, and 18 in group C. Unlike most cancer-killing chemicals, Xeloda has a disease-fighting mechanism activated by enzymes found predominantly in tumors themselves. This allows the drug to target cancer cells or tumors more directly, affecting fewer healthy cells. This disease-fighting mechanism could ensure treatment efficacy with fewer side effects. Xeloda is currently being evaluated in 18 clinical trials worldwide for its effects on numerous tumor types, including colon, breast, and gastric cancers, by Hoffmann-La Roche Inc. of Nutley, NJ. Additionally, it is being tested in combination therapies with agents such as Taxol(R) and Taxotere(R). M. D. Anderson is one of the world's preeminent cancer research facilities. It is one of 26 federally designated Comprehensive Cancer Centers in the country devoted exclusively to cancer patient care, research, education and prevention. Hoffmann-La Roche Inc., a U.S. affiliate of Roche Holding Ltd of Basel, Switzerland, is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets prescription drugs in key therapeutic areas including virology, infectious diseases, cardiology, oncology, transplantation and obesity.
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