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| |  Xeloda (Capecitabine) Shows Benefits in Metastatic Pancreatic Cancer OCALA, FL -- January 22, 2002 -- Data published by a Florida physician affiliated with US Oncology, Inc. in a January issue of the Journal of Clinical Oncology reveals that the oral chemotherapy agent Xeloda® (capecitabine), recently approved for the treatment of metastatic colorectal and breast cancer, provides significant clinical benefit response and tumor response for patients with previously untreated advanced or metastatic pancreatic cancer. The data, from a Phase II trial involving 42 patients, with Thomas Cartwright, MD, of Ocola Oncology and US Oncology, Inc. as the Principal Investigator, shows clinical benefit response of 24 percent and an overall tumor response rate of 9.5 percent for patients treated with Xeloda. Last year, the U.S. Food and Drug Administration (FDA) approved Xeloda (capecitabine) in combination with Taxotere® (docetaxel) for the treatment of metastatic breast cancer after failure of anthracyline therapy. Xeloda also is indicated as first-line treatment of patients with metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred, as well as for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated. "Identifying new therapy options to treat pancreatic cancer is critical as current options are very limited and success is generally poor," said Dr. Cartwright. "Patients respond differently to different therapies; therefore, physicians need multiple options to consider. Our research suggests that Xeloda deserves more consideration and advanced study in pancreatic cancer." Currently, the only product approved by the FDA for the treatment of pancreatic cancer is Gemzar® (gemcitabine). Results of Dr. Cartwright’s Phase II study show that treatment with Xeloda provides a clinical benefit response of 24 percent and an overall tumor response rate of 9.5 percent (CI: 90 percent), with the median time to objective response of 85 days (range 47-91 days). Of the 41 patients with measurable disease, three had a partial response, for an objective response rate of 7.3 percent. One patient with assessable (nonmeasurable) disease showed improved residual disease, with a positive clinical benefit response. Thus there were a total of four responders among the 42 patients treated, for an overall response rate of 9.5 percent (90 percent CI). The median survival was 182 days (six months) (95 percent CI, 85-274 days) and duration of response ranged from 208 - 566 days. All patients (22 men and 20 women) were treated with Xeloda 1250mg/m˛/BID days one-14 followed by a one-week rest period. Xeloda was generally well tolerated in this study. The most common treatment-related adverse events were hand-foot syndrome and nausea, each occurring in approximately 50 percent of patients. The majority of adverse events were grade 1 or 2. The predominant grade 3 toxicities were hand-foot syndrome (17 percent), diarrhea (12 percent), and nausea (10 percent). Two patients (5 percent) experienced grade 4 diarrhea. There was no other grade 4 toxicities and there were no toxicity-related deaths. Xeloda is the first oral drug that is enzymatically converted into the cancer-fighting substance 5-fluorouracil (FU). The enzyme thymidine phosphorylase (TP), is higher at the site of the tumor than surrounding normal tissue. This finding has not been adequately studied in the clinical setting. SOURCE: U.S. Oncology, Inc.
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