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Title: Gefitinib (Iressa) Active Against Advanced Colorectal Cancer: Presented at CFS

"Gefitinib (Iressa) Active Against Advanced Colorectal Cancer: Presented at CFS"

By Charlene Laino NEW YORK, NY -- November 12, 2004 -- Gefitinib (Iressa) plus a standard chemotherapy cocktail of oxaliplatin, leucovorin, and 5-fluorouracil (5-FU; FOLFOX-4) is a highly active treatment for patients with advanced colorectal cancer, reported Branimir I. Sikic, MD, professor of medicine, Stanford University School of Medicine, Stanford, California. "In an uncontrolled setting, IFOX [gefitinib, oxaliplatin, leucovorin, and 5-FU] may be more effective than FOLFOX-4, but it is associated with more diarrhea," he told colleagues here on November 10th at the Chemotherapy FOUNDATIONS Symposium XXII: Innovative Cancer Therapy for Tomorrow. The primary objective of the study was to compare the antitumor complete response plus partial response of IFOX and that of standard FOLFOX therapy, Dr. Sikic said. For the study, 72 patients were stratified according to prior colorectal cancer therapy. Group A consisted of 45 patients who had received no prior treatment for metastatic disease and had received adjuvant therapy more than 6 months prior to enrolment. Group B consisted of 27 patients who had received prior treatment for metastatic disease and had received adjuvant therapy within the past 6 months. Adjuvant therapy consisted of either a 5-FU and leucovorin combination or the 5-FU and leucovorin combination as well as irinotecan. For this study, subjects underwent 14-day treatment cycles. In the first cycle, they received oxaliplatin 85 mg/m[² in a 2-hour intravenous installation on the first day. On the first and second days, they also received leucovorin 200 mg/m² intravenously, as well as 5-FU 400 mg/m² in an intravenous push. On those days, patients also received 5-FU 600 mg/m² for hours 2 to 24. In the second and subsequent cycles, patients received 500 mg of gefitinib orally once daily, along with the combination chemotherapy regimen.

Among patients who did not have a history of previous metastasis, median overall survival has not yet been reached. Among the patients with previous metastases, median overall survival was 12 months, Dr. Sikic said.

In group A, 73% of patients had a complete or partial response. "Eleven of these patients went on to liver resection, so are now disease-free," he said. In group B, the overall response rate was 36%. Historically, FOLFOX-4 has been associated with a 10% response rate in such patients, Dr. Sikic said, although "the patient populations may have been different."

There was significantly more diarrhea associated with the gefitinib regimen -- 49% versus the 14% observed in studies of FOLFOX-4, he said.

Research funding for the study was received from AstraZeneca. Gefitinib is a tyrosine kinase inhibitor of epidermal growth factor receptor-1.

[Presentation title: A Phase II Study of the IFOX Regimen (Gefitinib, 5-Fluorouracil, Leucovorin, and Oxaliplatin) for Metastatic Colorectal Cancer. Abstract 20]

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