Adjuvant XELOX regimen improves disease-free survival in elderly with colorectal cancer

ORLANDO (Reuters Health) - Regardless of their age, patients with stage III colon cancer have better disease-free survival with adjuvant capecitabine plus oxaliplatin (XELOX) than with 5-fluorouracil and leucovorin (5-FU/LV), researchers said this week at the 2010 Gastrointestinal Cancers Symposium in Orlando, Florida.

"An abstract presented last June at ASCO suggested that patients over 70 did not benefit from the addition of oxaliplatin to 5-FU leucovorin," said lead author Dr. Daniel G. Haller of the University of Pennsylvania, Philadelphia. "However, the results from our analysis shed doubt on these findings, and show that these older patients do indeed benefit from XELOX. Eligible patients should not be denied this treatment, just because they are 70 or older. Age is just a number."

Dr. Haller and his colleagues did a sub-group analysis of data from the NO16968 trial, also known as the XELOXA trial, which compared adjuvant treatment with XELOX vs 5-FU/LV in 1886 patients with lymph-node positive colon cancer. In that study, XELOX significantly improved disease free survival compared with 5-FU/LV at 3 years (70.9% vs 66.5%).

Now, in their post-hoc analysis, the investigators evaluated the effect of XELOX on the 409 patients who were 70 years or older. In this subset, the disease-free survival rate was 66% in the XELOX arm and 60% in the standard 5-FU/LV arm (hazard ratio, 0.87).

When the investigators looked only at the 744 patients who were 65 years or older, disease-free survival also favored the XELOX regimen (68%) over 5-FU/LV (62%; HR, 0.81).

"The smaller number of patients over 70 years of age, just 400, although still representing nearly a quarter of the patients entered, accounts for...wider confidence intervals for the hazard ratio in that subgroup," Dr. Haller explained to reporters at a pre-symposium press conference.

Unfortunately, the earlier report of no benefit in elderly patients has discouraged some clinicians from offering XELOX to these patients. Germany has even terminated access of patients over 70 to randomized trials, he commented.

"One of the issues always to remember is that when we try to generalize from clinical trials we're dealing with the fit elderly, so there's always an art form of translating clinical trials research into the typical patient in one's office," Dr. Haller told Reuters Health. "These people are highly eligible for randomized trials, although they represent perhaps a subset of the elderly."

The XELOXA trial was sponsored by Hoffman-La Roche, which manufactures capecitabine (Xeloda).

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