Thursday, May 12, 2011 (Last Updated: 05/16/2011)
THURSDAY, May 12 (HealthDay News) -- Elderly and frail patients with colorectal cancer can participate in randomized controlled trials with appropriate design, including reduced drug dosing, according to a study published online May 12 in The Lancet.
In the FOCUS2 study, Matthew T. Seymour, M.D., of the University of Leeds in the United Kingdom, and colleagues randomized 459 frail and elderly patients with advanced colorectal cancer to 48-h intravenous fluorouracil with levofolinate; oxaliplatin and fluorouracil; capecitabine; or oxaliplatin and capecitabine. The investigators started treatment at 80 percent of standard doses, but could increase to full standard doses after six weeks if treatment was well tolerated.
Although the primary end point of progression-free survival (PFS) was not met, the investigators found that patients most likely to benefit from chemotherapy were more active, had less widespread cancer, and had fewer symptoms. The investigators also found that oxaliplatin produced less benefit in frail and elderly patients than in younger and fitter patients; however, the drug significantly improved overall treatment utility, a measure of cancer shrinkage and survival time as well as patients' own assessment of treatment effectiveness and quality of life. The researchers also found that the use of tablet chemotherapy as opposed to intravenous infusion resulted in more side effects and did not have any clear benefits.
"With use of reduced starting drug doses, adapted for this population, combination chemotherapy including oxaliplatin seems, on balance, preferable to single-agent fluoropyrimidines, although the primary end point of PFS was not met. We did not, however, detect any advantage of capecitabine compared with fluorouracil," the authors write.
Two authors disclosed financial relationships with Roche; one author disclosed a financial relationship with Sanofi-Aventis.
Hematology & Oncology
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