Oxaliplatin Approved for Metastatic Colorectal Cancer

Oxaliplatin for injection (Eloxatin™, Sanofi-Synthelabo/Debiopharm SA), in combination with 5-fluorouracil/leuco-vorin (5-FU/LV), has been approved by the FDA for the first-line treatment of advanced colorectal cancer. Eloxatin™ was approved in 2002 for the second-line treatment of patients with metastatic carcinoma of the colon or rectum.

In a study sponsored by the National Cancer Institute and coordinated by the North Central Cancer Treatment Group (NCCTG), patients treated first with Eloxatin™, combined with infusional 5-FU/LV (the FOLFOX regimen), experienced an overall median survival time of 19.4 months after starting therapy. Patients taking a standard combination of irinotecan (Camptosar®, Pharmacia & Upjohn) plus 5-FU/LV (the IFL regimen) had a median survival time of 14.6 months; therefore, the median survival advantage for the FOLFOX patients was 4.8 months (a 35% improvement). The FOLFOX group reported less severe, more manageable, and more reversible side effects than the IFL group did.)