Monday, November 28, 2011 (Last Updated: 11/29/2011)
MONDAY, Nov. 28 (HealthDay News) -- For patients with low- or intermediate-grade advanced neuroendocrine tumors (carcinoids), everolimus plus octreotide long-acting repeatable (LAR) improves progression-free survival versus placebo plus octreotide LAR, according to a study published online Nov. 25 in The Lancet.
Marianne E. Pavel, M.D., from the Charité-Universitätsmedizin Berlin, and colleagues evaluated the combination of everolimus plus octreotide LAR in patients with low- or intermediate-grade advanced neuroendocrine tumors. Participants were aged 18 years or older, and had disease progression established by radiological assessment within the previous 12 months. A total of 429 patients were randomly assigned to receive either everolimus plus octreotide LAR or placebo plus octreotide LAR every 28 days. Treatment was discontinued by 357 patients, and one was lost to follow-up. Progression-free survival was the primary end point of the study.
The investigators found that the median progression-free survival was 16.4 and 11.3 months in the everolimus and placebo groups, respectively (hazard ratio, 0.77). Most adverse events associated with everolimus versus placebo treatment were grade 1 or 2. The most common adverse events of all grades were more prevalent in the everolimus plus ocreotide LAR versus placebo group, and included stomatitis (62 versus 14 percent), rash (37 versus 12 percent), fatigue (31 versus 23 percent), and diarrhea (27 versus 16 percent).
"Everolimus plus octreotide LAR, compared with placebo plus octreotide LAR, improved progression-free survival in patients with advanced neuroendocrine tumors associated with carcinoid syndrome," the authors write.
One author disclosed financial relationships with pharmaceutical companies, including Novartis; several authors disclosed financial ties to Novartis, which funded the study and manufactures everolimus.
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