J 2018

Everolimus in advanced, progressive, well-differentiated, non-functional neuroendocrine tumors: RADIANT-4 lung subgroup analysis

FAZIO, N., R. BUZZONI, G. DELLE FAVE, M.E. TESSELAAR, E. WOLIN et. al.

Basic information

Original name

Everolimus in advanced, progressive, well-differentiated, non-functional neuroendocrine tumors: RADIANT-4 lung subgroup analysis

Authors

FAZIO, N. (380 Italy, guarantor), R. BUZZONI (380 Italy), G. DELLE FAVE (380 Italy), M.E. TESSELAAR (528 Netherlands), E. WOLIN (840 United States of America), E. VAN CUTSEM (56 Belgium), P. TOMASSETTI (380 Italy), J. STROSBERG (840 United States of America), M. VOI (840 United States of America), L. BUBUTEISHVILI-PACAUD (756 Switzerland), A. RIDOLFI (250 France), F. HERBST (756 Switzerland), Jiří TOMÁŠEK (203 Czech Republic, belonging to the institution), S. SINGH (124 Canada), M. PAVEL (276 Germany), M.H. KULKE (840 United States of America), J.W. VALLE (826 United Kingdom of Great Britain and Northern Ireland) and J.C. YAO (840 United States of America)

Edition

CANCER SCIENCE, HOBOKEN, WILEY, 2018, 1349-7006

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

Italy

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 4.751

RIV identification code

RIV/00216224:14110/18:00103985

Organization unit

Faculty of Medicine

DOI

UT WoS

000419892200018

Keywords in English

everolimus; lung carcinoid; neuroendocrine tumors; progression-free survival; RADIANT-4

Tags

Tags

International impact, Reviewed
Změněno: 9/2/2019 22:56, Soňa Böhmová

Abstract

V originále

In the phase III RADIANT-4 study, everolimus improved median progression-free survival (PFS) by 7.1 months in patients with advanced, progressive, well-differentiated (grade 1 or grade 2), non-functional lung or gastrointestinal neuroendocrine tumors (NETs) vs placebo (hazard ratio, 0.48; 95% confidence interval [CI], 0.35-0.67; P < .00001). This exploratory analysis reports the outcomes of the subgroup of patients with lung NETs. In RADIANT-4, patients were randomized (2:1) to everolimus 10 mg/d or placebo, both with best supportive care. This is a post hoc analysis of the lung subgroup with PFS, by central radiology review, as the primary endpoint; secondary endpoints included objective response rate and safety measures. Ninety of the 302 patients enrolled in the study had primary lung NET (everolimus, n = 63; placebo, n = 27). Median PFS (95% CI) by central review was 9.2 (6.8-10.9) months in the everolimus arm vs 3.6 (1.9-5.1) months in the placebo arm (hazard ratio, 0.50; 95% CI, 0.28-0.88). More patients who received everolimus (58%) experienced tumor shrinkage compared with placebo (13%). Most frequently reported (5% incidence) grade 3-4 drug-related adverse events (everolimus vs. placebo) included stomatitis (11% vs. 0%), hyperglycemia (10% vs. 0%), and any infections (8% vs. 0%). In patients with advanced, progressive, well-differentiated, non-functional lung NET, treatment with everolimus was associated with a median PFS improvement of 5.6 months, with a safety profile similar to that of the overall RADIANT-4 cohort. These results support the use of everolimus in patients with advanced, non-functional lung NET. The trial is registered with ClinicalTrials.gov (no. NCT01524783).