Colorectal Cancer (CRC) Colorectal Cancer (CRC) is the third most common cancer in both American men and women, and the third leading cause of cancer death in the U.S. In 2009, an estimated 146,970 new cases of colon and rectal cancer were expected to be diagnosed in the U.S., with an estimated 49,920 deaths.1 A FOLFOX-containing regimen is the current standard of care but is associated with a high incidence of peripheral sensory neuropathy. Discontinuation of oxaliplatin from FOLFOX is recommended by the National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology (v.2.2010) after three months of therapy or sooner for unacceptable neurotoxicity, with other drugs maintained until the time of tumor progression. During the American Society of Clinical Oncology 2010 Gastrointestinal Cancers Symposium, Poniard presented final results from a randomized, controlled Phase 2 trial evaluating picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC. The 101 patient study met its primary objective, as picoplatin in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, produced a statistically significant reduction in neurotoxicity, p <0.004, compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin, in the FOLFOX regimen. Neuropathy was 2.5 times more frequent for FOLFOX- treated patients compared to FOLPI-treated patients, and no Grade 3/4 neuropathy occurred in the FOLPI treated patients. Results suggest that FOLPI had anti-tumor activity comparable to FOLFOX, as measured by disease control, PFS and overall survival. Hematologic toxicity was the most frequent adverse event in the FOLPI regimen, but was manageable. Poniard, in collaboration with its advisory board and the FDA, will leverage insights from its Phase 2 trial to develop a registration strategy for picoplatin in colorectal cancer. More information on picoplatin in colorectal cancer » 1American Cancer Society, Cancer Facts and Figures 2009