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

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.

Základní údaje

Originální název

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

Autoři

FAZIO, N. (380 Itálie, garant), R. BUZZONI (380 Itálie), G. DELLE FAVE (380 Itálie), M.E. TESSELAAR (528 Nizozemské království), E. WOLIN (840 Spojené státy), E. VAN CUTSEM (56 Belgie), P. TOMASSETTI (380 Itálie), J. STROSBERG (840 Spojené státy), M. VOI (840 Spojené státy), L. BUBUTEISHVILI-PACAUD (756 Švýcarsko), A. RIDOLFI (250 Francie), F. HERBST (756 Švýcarsko), Jiří TOMÁŠEK (203 Česká republika, domácí), S. SINGH (124 Kanada), M. PAVEL (276 Německo), M.H. KULKE (840 Spojené státy), J.W. VALLE (826 Velká Británie a Severní Irsko) a J.C. YAO (840 Spojené státy)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Itálie

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 4.751

Kód RIV

RIV/00216224:14110/18:00103985

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1111/cas.13427

UT WoS

000419892200018

Klíčová slova anglicky

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

Štítky

14110811, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 9. 2. 2019 22:56, Soňa Böhmová

Anotace

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).

Citovat

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 a J.C. YAO. Everolimus in advanced, progressive, well-differentiated, non-functional neuroendocrine tumors: RADIANT-4 lung subgroup analysis. CANCER SCIENCE. HOBOKEN: WILEY, 2018, roč. 109, č. 1, s. 174-181. ISSN 1349-7006. Dostupné z: https://dx.doi.org/10.1111/cas.13427.

@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 a J.C. YAO. Everolimus in advanced, progressive, well-differentiated, non-functional neuroendocrine tumors: RADIANT-4 lung subgroup analysis. \textit{CANCER SCIENCE}. HOBOKEN: WILEY, 2018, roč.~109, č.~1, s.~174-181. ISSN~1349-7006. Dostupné z: https://dx.doi.org/10.1111/cas.13427.

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