Eloxatin with fluorouracil-leucovorin effective for progressive colon cancer

Treatment with Eloxatin (oxaliplatin) and fluorouracil-leucovorin (FOLFOX4) is more effective than either therapy alone for metastatic colorectal therapy that has progressed after first-line therapy, new findings indicate.

In North America, no effective therapy has been available for patients with metastatic colorectal cancer who experience disease progression after being treated with irinotecan, bolus fluorouracil and leucovorin–the favored first-line therapy. As a result of the current study, however, the US Food and Drug Administration granted accelerated approval to the FOLFOX4 regimen for this indication last year.In the new study, 463 patients with disease progression after first-line therapy were randomized to receive bolus and infusional fluoruracil-leucovorin (LV5FU2), Eloxatin monotherapy, or FOLFOX4.FOLFOX4 outperformed the other regimens in all measures of clinical efficacy, lead author Dr. Mace L. Rothenberg, from the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, and colleagues note. Given that Eloxatin monotherapy was not better than LV5FU2 in any efficacy measure and sometimes inferior, the researchers focused on comparing FOLFOX4 with LV5FU2.FOLFOX4 lead to an objective response rate of 9.9%, while the rate for LV5FU2 was 0% (p < 0.0001), according to the findings, published in the June 1st issue of the Journal of Clinical Oncology.The median time to tumor progression with FOLFOX4 was 4.6 months, significantly longer than the period seen with LV5FU2-2.7 months (p < 0.0001). Thirty-three percent of FOLFOX4-treated patients experienced relief of tumor-related symptoms, compared with only 12% of LV5FU2-treated patients (p < 0.001).FOLFOX4 did appear to be more toxic than LV5FU2, but the adverse events that occurred were predictable and did not negatively influence treatment compliance or survival, the investigators note.'Oxaliplatin has been licensed in Europe since 1999, but it only gained FDA approval in the US in August of 2002,' Drs. Ian Chau and David Cunningham, from the Royal Marsden Hospital in London, note in a related editorial. 'Further efforts to harmonize the new drug-approval process globally may allow active new drugs to be available to cancer patients in a more timely fashion.'(Source: J Clin Oncol 2003;21:2049-2051,2059-2069: Reuters Health: July 11, 2003: Oncolink)