(HealthDay) -- For elderly patients with colon cancer or those with stage II disease, the addition of oxaliplatin to fluorouracil with leucovorin (FL) does not seem to offer any survival benefit, according to a study published online Aug. 20 in the Journal of Clinical Oncology.
Christophe Tournigand, M.D., Ph.D., from the Hôpital Saint-Antoine in Paris, and colleagues conducted subgroup analyses of stage II colon cancer and elderly patients with colon cancer, who were randomly assigned to FL with or without oxaliplatin (FOLFOX4).
The researchers found that 889 patients had stage II disease, including 569 high-risk and 330 low-risk patients, and 315 patients were aged 70 to 75 years. Comparing FOLFOX4 with FL, the hazard ratios (HRs) for stage II patients were not significant for disease-free survival (DFS) or overall survival (OS), and no interaction was noted between treatment and age or stage. There was no benefit seen for low-risk stage II patients. For high-risk stage II patients and for elderly patients, the HRs comparing FOLFOX4 with FL were not significant for DFS or OS.
"The addition of oxaliplatin to infusional fluorouracil/leucovorin has not been shown to be beneficial in low-risk or high-risk stage II patients or for patients between 70 and 75 years," the authors write. "The identification of a patient population for which adjuvant therapy is necessary, safe, and effective continues to be challenging, especially for high-risk stage II patients and for elderly patients."
Several authors disclosed financial ties to the pharmaceutical industry.
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