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@article{1447456,
author = {Fazio, N. and Buzzoni, R. and Delle Fave, G. and Tesselaar, M.E. and Wolin, E. and Van Cutsem, E. and Tomassetti, P. and Strosberg, J. and Voi, M. and BubuteishviliandPacaud, L. and Ridolfi, A. and Herbst, F. and Tomášek, Jiří and Singh, S. and Pavel, M. and Kulke, M.H. and Valle, J.W. and Yao, J.C.},
article_location = {HOBOKEN},
article_number = {1},
doi = {http://dx.doi.org/10.1111/cas.13427},
keywords = {everolimus; lung carcinoid; neuroendocrine tumors; progression-free survival; RADIANT-4},
language = {eng},
issn = {1349-7006},
journal = {CANCER SCIENCE},
title = {Everolimus in advanced, progressive, well-differentiated, non-functional neuroendocrine tumors: RADIANT-4 lung subgroup analysis},
volume = {109},
year = {2018}
}
TY - JOUR
ID - 1447456
AU - Fazio, N. - Buzzoni, R. - Delle Fave, G. - Tesselaar, M.E. - Wolin, E. - Van Cutsem, E. - Tomassetti, P. - Strosberg, J. - Voi, M. - Bubuteishvili-Pacaud, L. - Ridolfi, A. - Herbst, F. - Tomášek, Jiří - Singh, S. - Pavel, M. - Kulke, M.H. - Valle, J.W. - Yao, J.C.
PY - 2018
TI - Everolimus in advanced, progressive, well-differentiated, non-functional neuroendocrine tumors: RADIANT-4 lung subgroup analysis
JF - CANCER SCIENCE
VL - 109
IS - 1
SP - 174-181
EP - 174-181
PB - WILEY
SN - 13497006
KW - everolimus
KW - lung carcinoid
KW - neuroendocrine tumors
KW - progression-free survival
KW - RADIANT-4
N2 - 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).
ER -
FAZIO, N., R. BUZZONI, G. DELLE FAVE, M.E. TESSELAAR, E. WOLIN, E. VAN CUTSEM, P. TOMASSETTI, J. STROSBERG, M. VOI, L. BUBUTEISHVILI-PACAUD, A. RIDOLFI, F. HERBST, Jiří TOMÁŠEK, S. SINGH, M. PAVEL, M.H. KULKE, J.W. VALLE and J.C. YAO. Everolimus in advanced, progressive, well-differentiated, non-functional neuroendocrine tumors: RADIANT-4 lung subgroup analysis. \textit{CANCER SCIENCE}. HOBOKEN: WILEY, 2018, vol.~109, No~1, p.~174-181. ISSN~1349-7006. Available from: https://dx.doi.org/10.1111/cas.13427.
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