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Study Supports Safety & Efficacy of FOLFOX4 in Older Pts

Study Supports Safety & Efficacy of FOLFOX4 in Older Pts

SAN FRANCISCO—Age alone should not be a contraindication to FOLFOX4 chemotherapy in older adults with colorectal cancer, researchers reported at the 2006 Gastrointestinal Cancers Symposium (abstract 228). Data from a pooled analysis of trials showed that, compared with their younger counterparts, patients aged 70 years or older had similar improvements in clinical outcomes with FOLFOX4—fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (Eloxatin)—without clinically meaningful increases in toxicity.

"The average patient with colorectal cancer in the United States is 68 years of age when diagnosed," said lead author Richard M. Goldberg, MD, chief of the Division of Hematology/Oncology, University of North Carolina at Chapel Hill. This fact, he said, as well as the increasing addition of more drugs to combination chemotherapy for colorectal cancer, highlights the need to determine if such regimens are as safe and efficacious in older patients as in younger ones.

Dr. Goldberg's research team conducted a pooled analysis of four trials that tested the FOLFOX4 regimen against other regimens in various populations with colorectal cancer: These trials were:

MOSAIC (Andre et al, N Engl J Med 2004), conducted in the adjuvant setting and using 5-FU/LV as the control.

N9741 (Goldberg et al, J Clin Oncol 2004), conducted in the first-line advanced-disease setting and using IFL—5-FU/LV/irinotecan [Camptosar]—as the control.

A trial by de Gramont and colleagues (J Clin Oncol 2004), conducted in the first-line advanced-disease setting and using 5-FU/LV as the control.

A trial by Rothenberg and colleagues (J Clin Oncol 2003), conducted in the second-line advanced- disease setting and using 5-FU/LV as the control.

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