Poniard cancer drug safer than FOLFOX

26 January 2009

The USA's Poniard Pharmaceuticals presented data from a randomized, controlled Phase II trial of its picoplatin in patients with metastatic  colorectal cancer, suggesting it is associated with less-frequent and  less-severe neurotoxicity than a modified FOLFOX-6 regimen, at the  American Society of Clinical Oncology Gastro-intestinal Cancers  Symposium (ASCO GI) in California, USA.

The randomized, controlled Phase II trial is evaluating picoplatin as a  neuropathy-sparing alternative to oxaliplatin for the first-line  treatment of metastatic CRC in 101 patients who have not received prior  chemotherapy. The trial is comparing the safety, including neuropathy,  and efficacy of intravenous picoplatin given once every four weeks in  combination with bi-weekly FOLPI regimen with oxaliplatin given in  combination with the FOLFOX regimen, which is the current standard of  care. Severe neuropathy is commonly seen in CRC patients treated on  FOLFOX at cumulative doses above 800mg/M2.

65% of evaluable FOLFOX-treated patients showed evidence of  neurotoxicity compared with 28% of those given FOLPI. 10% of  FOLFOX-treated patients exhibited severe (Grade 3/4) neuropathy compared  with no FOLPI-treated patients. Non-hematologic adverse events,  including acute gastrointestinal toxicity, were similar between the  treatment groups. Thrombocytopenia and neutropenia were more frequent  and severe with the FOLPI regimen, but manageable, the firm says.

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