Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study.

Fazio, N; Granberg, D; Grossman, A; Saletan, S; Klimovsky, J; Panneerselvam, A; Wolin, E

Journal article

Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study.

Abstract:: BACKGROUND: The incidence of neuroendocrine tumors (NETs) has increased approximately fivefold since the 1980s. A similar increase in the incidence of lung NETs has been reported, but therapy has not been optimized. METHODS: This exploratory subanalysis evaluated the efficacy and safety of everolimus plus octreotide long-acting repeatable (LAR) in a cohort of patients with low- to intermediate-grade advanced lung NET from the phase 3, randomized, placebo-controlled RADIANT-2 (RAD001 in Advanced Neuroendocrine Tumors) study. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate, overall survival, change from baseline in biomarker levels, and safety outcomes. RESULTS: Patients were randomly assigned to everolimus plus octreotide LAR (n 5 33) or placebo plus octreotide LAR (n 5 11). Median PFS was 13.63 months in the everolimus plus octreotide LAR arm compared with 5.59 months in the placebo plus octreotide LAR arm (relative risk for progression: HR, 0.72; 95% CI, 0.31–1.68; P 5 .228). More patients receiving everolimus plus octreotide LAR (67%) experienced minor tumor shrinkage (not partial response as per RECIST [Response Evaluation Criteria in Solid Tumors]) than those receiving placebo plus octreotide LAR (27%). Most frequently reported adverse events (AEs) included stomatitis, rash, diarrhea, and asthenia. This was consistent with the overall RADIANT-2 trial and the safety profile of everolimus. CONCLUSIONS: This exploratory subgroup analysis of the RADIANT-2 trial indicates that in patients with advanced lung NET, the addition of everolimus to octreotide LAR improves median PFS by 2.4-fold compared with placebo plus octreotide LAR. These clinically significant observations support the continued evaluation of everolimus treatment regimens in this patient population. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00412061

Publication status:: Published

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APA Style

Fazio, N., Granberg, D., Grossman, A., Saletan, S., Klimovsky, J., Panneerselvam, A., & Wolin, E. (2013). Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest, 143(4), 955–962.

MLA Style

Fazio, N., et al. “Everolimus plus Octreotide Long-Acting Repeatable in Patients with Advanced Lung Neuroendocrine Tumors: Analysis of the Phase 3, Randomized, Placebo-Controlled RADIANT-2 Study.” Chest, vol. 143, no. 4, 2013, pp. 955–62.

Chicago Style

Fazio, N, D Granberg, A Grossman, S Saletan, J Klimovsky, A Panneerselvam, and E Wolin. 2013. “Everolimus plus Octreotide Long-Acting Repeatable in Patients with Advanced Lung Neuroendocrine Tumors: Analysis of the Phase 3, Randomized, Placebo-Controlled RADIANT-2 Study.” Chest 143 (4): 955–62.
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