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Original Research: Lung Cancer |

Everolimus Plus Octreotide Long-Acting Repeatable in Patients With Advanced Lung Neuroendocrine TumorsNeuroendocrine Tumors of the Lung: Analysis of the Phase 3, Randomized, Placebo-Controlled RADIANT-2 Study

Nicola Fazio, MD; Dan Granberg, MD, PhD; Ashley Grossman, MD; Stephen Saletan, MD; Judith Klimovsky, MD; Ashok Panneerselvam, PhD; Edward M. Wolin, MD
Author and Funding Information

From the European Institute of Oncology (Dr Fazio), Milan, Italy; Departments of Medical Sciences and Endocrine Oncology (Dr Granberg), Uppsala University, Uppsala, Sweden; Oxford Centre for Diabetes, Endocrinology and Metabolism (Dr Grossman), Churchill Hospital University of Oxford, Oxford, England; Novartis Pharmaceuticals Corp (Drs Saletan, Klimovsky, and Panneerselvam), Florham Park, NJ; and Cedars-Sinai Medical Center (Dr Wolin), Los Angeles, CA.

Correspondence to: Nicola Fazio, MD, Upper Gastrointestinal and Neuroendocrine Tumors Unit, Department of Medicine, Via Ripamonti, 435-20141 Milan, Italy; e-mail: nicola.fazio@ieo.it.


For editorial comment see page 884

Funding/Support: This study was funded by Novartis Pharmaceuticals Corp.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2013;143(4):955-962. doi:10.1378/chest.12-1108
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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 = 33) or placebo plus octreotide LAR (n = 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 = .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; URL: www.clinicaltrials.gov

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