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| |  ASCO MEETING: Xeloda Shows Promise For Metastatic Breast Cancer Patients ATLANTA, GA -- May 17, 1999 -- Data presented this weekend at the American Society of Clinical Oncology (ASCO) meeting demonstrates that Hoffmann-La Roche, Inc.’s Xeloda (capecitabine) is effective for treatment of metastatic breast cancer patients for whom paclitaxel or docetaxel therapy has failed. Twenty-five percent of patients with measurable disease treated with Xeloda showed a positive response to therapy. Median duration of response was eight months and median time to progression was 3.7 months. The multicentre phase II study was conducted under the auspices of the Physician Reliance Network (PRN) Research, Inc. and Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, TX. The study's authors concluded that Xeloda is an active drug in the treatment of taxane-refractory breast cancer with a favourable side effect profile. "This study is encouraging, in that it supports previous findings that even patients with tough-to-treat tumours who have failed first-line chemotherapy may experience a positive response with Xeloda," said Joanne Blum, M.D., Ph.D. of PRN Research, Inc., the principal investigator of the study. Data from the eight-month multicentre phase II trial examined the efficacy and safety of twice daily oral Xeloda at 2,500 mg/sqm/day given for two weeks followed by a week of rest, and repeated in three-week cycles. Seventy-five patients were entered at five centres in the United States and France. The primary objective was tumour response in patients with measurable disease. Xeloda requires only two daily oral doses compared to other more complex chemotherapy regimens. Reduced serious side effects seen in this trial may help improve the quality of life of patients. Xeloda is the first oral anticancer drug indicated for patients with metastatic breast cancer whose tumours are resistant to standard chemotherapy with paclitaxel and an anthracycline-containing regimen. The adverse events associated with Xeloda in the trial were predictable and manageable. No treatment-related deaths were seen. Hand-foot syndrome, diarrhea, stomatitis and nausea were the only grade ¾ treatment related adverse events that occurred in more than 10 percent of patients. Only four percent of patients had a grade IV treatment related adverse event. The majority of all treatment related adverse events were rated as mild or moderate in intensity (grade I or II). These side effects were manageable and generally reversible after dosage adjustment. Significant hair loss was not observed.
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