Study affirms safety of Oxaliplatin (Eloxatin) in advanced colorectal cancer

Results of a study confirm that heavily pretreated advanced colorectal cancer patients can safely receive oxaliplatin alone or in combination with fluorouracil (FU)-based regimens with manageable toxicity.

In August 2002, the U.S. Food and Drug Administration approved oxaliplatin (Eloxatin: Sanofi-Synthelabo, New York, New York) in combination with infusional FU and leucovorin (LV), a regimen known as FOLFOX4, as second-line therapy for advanced colorectal cancer patients failing first-line therapy.Prior to approval, more than 5000 patients who had failed one-to-three prior chemotherapy regimens were treated with oxaliplatin alone or with FU, with or without LV as part of a compassionate use treatment program. In the August 1st issue of the Journal of Clinical Oncology, Dr. Ramesh K. Ramanathan of the University of Pittsburgh Cancer Institute and colleagues present safety and toxicity data from these protocols.Overall, oxaliplatin alone or in combination with FU, with or without leucovorin (LV) was well tolerated, with a relatively low incidence of grade 3 to 4 hematologic (25%) and gastrointestinal toxicity (24%), they report. The incidence of grade 3 and 4 GI toxicities was lowest (18%) in patients receiving FOLFOX4.The prescribed dose of oxaliplatin was maintained at 80% to 94% in all arms of the study, even in patients thought to be at high risk for treatment-related complications. The incidence of death due to treatment-related adverse events was less than 1%.”Our results are encouraging because they affirm that oxaliplatin is safe for patients with advanced colorectal cancer,” Dr. Ramanathan said in a statement.Studies currently underway are evaluating the safety, efficacy, and optimal regimens of oxaliplatin with FU, irinotecan, and capecitabine as front-line or salvage therapy for advanced colorectal cancer.(Source: J Clin Oncol 2003;21:2904-2911: Reuters Health: Oncolink: August 4, 2003)