There is no effective therapy for North American patients with progressive metastatic colorectal cancer, after frontline treatment with irinotecan, bolus fluorouracil (FU), and leucovorin (IFL).
In this study, researchers assessed patients with metastatic colorectal cancer who progressed after IFL therapy. Patients were randomly assigned to bolus and infusional FU and leucovorin (LV5FU2), single-agent oxaliplatin, or the combination (FOLFOX4).
The team evaluated objective response rate (RR), time to tumor progression (TTP), and alleviation of tumor-related symptoms (TRS).
The researchers randomized 463 patients from 120 sites, between 2000 and 2001
|Single-agent oxaliplatin was not superior to leucovorin in any measure of efficacy.|
|Journal of Clinical Oncology|
The team determined that FOLFOX4 was superior to LV5FU2 in all measures of clinical efficacy.
The RRs, which were determined by an independent radiology panel, were found to be10% for FOLFOX4, compared with 0% for LV5FU2.
In addition, median TTP was 4.6 months for FOLFOX4, versus 2.7 months for LV5FU2.
Furthermore, the relief of TRS occurred in 33% of patients treated with FOLFOX4, compared with 12% in those treated with LVFU2.
The researchers also determined that single-agent oxaliplatin was not superior to LV5FU2 in any measure of efficacy.
The team also found that patients treated with FOLFOX4 experienced a higher incidence of clinically significant toxicities than patients treated with LV5FU2. However, these toxicities were predictable, and they did not result in a higher rate of treatment discontinuation or 60-day mortality rate.
Dr Mace Rothenberg's team concluded, "For patients with metastatic colorectal cancer, second-line treatment with FOLFOX4 is superior to treatment with LVFU2 in terms of RR, TTP, and relief of TRS".