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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