Avastin plus chemotherapy improves survival in a large Phase III study -- SOUTH SAN FRANCISCO - May 19, 2003 Genentech Inc. announced that a Phase III study of Avastin plus standard chemotherapy for metastatic colorectal cancer improved survival when compared with patients who only received chemotherapy. In addition, patients randomly receiving Avastin had longer progression-free survival and better response rates. Responses lasted longer.

More than 800 patients were randomized to receive either Avastin or placebo. All patients in the study received 5-FU/Leucovorin and CPT-11, the Saltz regimen.

Avastin is antibody designed to inhibit tumor growth by binding to and inhibiting VEGF, a protein that plays a critical role in tumor angiogenesis (the formation of new blood vessels to the tumor), and maintenance of existing tumor blood vessels.

Read the Genentech: Press Release here.

Rofecoxib (Vioxx) appears not to improve outcomes when combined with 5FU/Leucovorin and has high toxicity in a Phase I trial. (International Journal of Cancer) April 16, 2003 -- A trial of 10 patients with metastatic colon cancer was halted early when 4 patients developed upper gastrointestinal bleeding (Grade III) and other toxicities -- stomatitis, diarrhea, and nausea -- were noted. In addition, there were no partial or complete responses to therapy.

The authors, Carlos R. Becerra and colleagues at the University of Texas Southwestern Medical Center, wrote that "Rofecoxib did not appear to increase antitumor activity and resulted in increased gastrointestinal toxicity when combined with 5-FU/LV. Future studies will need to consider the added gastrointestinal toxicity of Rofecoxib when combined with chemotherapy for the treatment of patients with colorectal cancer."

Read the abstract in the online version of the International Journal of Cancer