Everolimus in Neuroendocrine Tumors of the Gastrointestinal
Tract and Unknown Primary

J 2018

Everolimus in Neuroendocrine Tumors of the Gastrointestinal Tract and Unknown Primary

SINGH, S., C. CARNAGHI, R. BUZZONI, R.F. POMMIER, M. RADERER et. al.

Basic information

Original name

Everolimus in Neuroendocrine Tumors of the Gastrointestinal Tract and Unknown Primary

Authors

SINGH, S. (124 Canada, guarantor), C. CARNAGHI (380 Italy), R. BUZZONI (380 Italy), R.F. POMMIER (840 United States of America), M. RADERER (40 Austria), Jiří TOMÁŠEK (203 Czech Republic, belonging to the institution), H. LAHNER (276 Germany), J.W. VALLE (826 United Kingdom of Great Britain and Northern Ireland), M. VOI (840 United States of America), L. BUBUTEISHVILI-PACAUD (756 Switzerland), J. LINCY (756 Switzerland), E. WOLIN (840 United States of America), N. OKITA (392 Japan), S.K. LIBUTTI (840 United States of America), D.Y. OH (410 Republic of Korea), M. KULKE (840 United States of America), J. STROSBERG (840 United States of America), J.C. YAO (840 United States of America), M.E. PAVEL (276 Germany) and N. FAZIO (380 Italy)

Edition

NEUROENDOCRINOLOGY, BASEL, KARGER, 2018, 0028-3835

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30202 Endocrinology and metabolism

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 6.804

RIV identification code

RIV/00216224:14110/18:00104045

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1159/000477585

UT WoS

000430216600002

Keywords in English

Everolimus; Neuroendocrine tumors; RADIANT-4 study; Gastrointestinal tract

Abstract

V originále

Purpose: The RADIANT-4 randomized phase 3 study demonstrated significant prolongation of median progression-free survival (PFS) with everolimus compared to placebo (11.0 [95% CI 9.2-13.3] vs. 3.9 [95% CI 3.6-7.4] months) in patients with advanced, progressive, nonfunctional gastrointestinal (GI) and lung neuroendocrine tumors (NET). This analysis specifically evaluated NET patients with GI and unknown primary origin. Methods: Patients in the RADIANT-4 trial were randomized 2: 1 to everolimus 10 mg/day or placebo. The effect of everolimus on PFS was evaluated in patients with NET of the GI tract or unknown primary site. Results: Of the 302 patients enrolled, 175 had GI NET (everolimus, 118; placebo, 57) and 36 had unknown primary (everolimus, 23; placebo, 13). In the GI subset, the median PFS by central review was 13.1 months (95% CI 9.2-17.3) in the everolimus arm versus 5.4 months (95% CI 3.6-9.3) in the placebo arm; the hazard ratio (HR) was 0.56 (95% CI 0.37-0.84). In the unknown primary patients, the median PFS was 13.6 months (95% CI 4.1-not evaluable) for everolimus versus 7.5 months (95% CI 1.9-18.5) for placebo; the HR was 0.60 (95% CI 0.24-1.51). Everolimus efficacy was also demonstrated in both midgut and non-midgut populations; a 40-46% reduction in the risk of progression or death was reported for patients in the combined GI and unknown primary subgroup. Everolimus had a benefit regardless of prior somatostatin analog therapy. Conclusions: Everolimus showed a clinically meaningful PFS benefit in patients with advanced progressive nonfunctional NET of GI and unknown primary, consistent with the overall RADIANT-4 results, providing an effective new standard treatment option in this patient population and filling an unmet treatment need for these patients. (c) 2017 S. Karger AG, Basel

Citovat

SINGH, S., C. CARNAGHI, R. BUZZONI, R.F. POMMIER, M. RADERER, Jiří TOMÁŠEK, H. LAHNER, J.W. VALLE, M. VOI, L. BUBUTEISHVILI-PACAUD, J. LINCY, E. WOLIN, N. OKITA, S.K. LIBUTTI, D.Y. OH, M. KULKE, J. STROSBERG, J.C. YAO, M.E. PAVEL and N. FAZIO. Everolimus in Neuroendocrine Tumors of the Gastrointestinal Tract and Unknown Primary. NEUROENDOCRINOLOGY. BASEL: KARGER, 2018, vol. 106, No 3, p. 211-220. ISSN 0028-3835. Available from: https://dx.doi.org/10.1159/000477585.

@article{1449736,
   author = {Singh, S. and Carnaghi, C. and Buzzoni, R. and Pommier, R.F. and Raderer, M. and Tomášek, Jiří and Lahner, H. and Valle, J.W. and Voi, M. and BubuteishviliandPacaud, L. and Lincy, J. and Wolin, E. and Okita, N. and Libutti, S.K. and Oh, D.Y. and Kulke, M. and Strosberg, J. and Yao, J.C. and Pavel, M.E. and Fazio, N.},
   article_location = {BASEL},
   article_number = {3},
   doi = {http://dx.doi.org/10.1159/000477585},
   keywords = {Everolimus; Neuroendocrine tumors; RADIANT-4 study; Gastrointestinal tract},
   language = {eng},
   issn = {0028-3835},
   journal = {NEUROENDOCRINOLOGY},
   title = {Everolimus in Neuroendocrine Tumors of the Gastrointestinal Tract and Unknown Primary},
   volume = {106},
   year = {2018}
}

TY  - JOUR
ID  - 1449736
AU  - Singh, S. - Carnaghi, C. - Buzzoni, R. - Pommier, R.F. - Raderer, M. - Tomášek, Jiří - Lahner, H. - Valle, J.W. - Voi, M. - Bubuteishvili-Pacaud, L. - Lincy, J. - Wolin, E. - Okita, N. - Libutti, S.K. - Oh, D.Y. - Kulke, M. - Strosberg, J. - Yao, J.C. - Pavel, M.E. - Fazio, N.
PY  - 2018
TI  - Everolimus in Neuroendocrine Tumors of the Gastrointestinal Tract and Unknown Primary
JF  - NEUROENDOCRINOLOGY
VL  - 106
IS  - 3
SP  - 211-220
EP  - 211-220
PB  - KARGER
SN  - 00283835
KW  - Everolimus
KW  - Neuroendocrine tumors
KW  - RADIANT-4 study
KW  - Gastrointestinal tract
N2  - Purpose: The RADIANT-4 randomized phase 3 study demonstrated significant prolongation of median progression-free survival (PFS) with everolimus compared to placebo (11.0 [95% CI 9.2-13.3] vs. 3.9 [95% CI 3.6-7.4] months) in patients with advanced, progressive, nonfunctional gastrointestinal (GI) and lung neuroendocrine tumors (NET). This analysis specifically evaluated NET patients with GI and unknown primary origin. Methods: Patients in the RADIANT-4 trial were randomized 2: 1 to everolimus 10 mg/day or placebo. The effect of everolimus on PFS was evaluated in patients with NET of the GI tract or unknown primary site. Results: Of the 302 patients enrolled, 175 had GI NET (everolimus, 118; placebo, 57) and 36 had unknown primary (everolimus, 23; placebo, 13). In the GI subset, the median PFS by central review was 13.1 months (95% CI 9.2-17.3) in the everolimus arm versus 5.4 months (95% CI 3.6-9.3) in the placebo arm; the hazard ratio (HR) was 0.56 (95% CI 0.37-0.84). In the unknown primary patients, the median PFS was 13.6 months (95% CI 4.1-not evaluable) for everolimus versus 7.5 months (95% CI 1.9-18.5) for placebo; the HR was 0.60 (95% CI 0.24-1.51). Everolimus efficacy was also demonstrated in both midgut and non-midgut populations; a 40-46% reduction in the risk of progression or death was reported for patients in the combined GI and unknown primary subgroup. Everolimus had a benefit regardless of prior somatostatin analog therapy. Conclusions: Everolimus showed a clinically meaningful PFS benefit in patients with advanced progressive nonfunctional NET of GI and unknown primary, consistent with the overall RADIANT-4 results, providing an effective new standard treatment option in this patient population and filling an unmet treatment need for these patients. (c) 2017 S. Karger AG, Basel
ER  -

SINGH, S., C. CARNAGHI, R. BUZZONI, R.F. POMMIER, M. RADERER, Jiří TOMÁŠEK, H. LAHNER, J.W. VALLE, M. VOI, L. BUBUTEISHVILI-PACAUD, J. LINCY, E. WOLIN, N. OKITA, S.K. LIBUTTI, D.Y. OH, M. KULKE, J. STROSBERG, J.C. YAO, M.E. PAVEL and N. FAZIO. Everolimus in Neuroendocrine Tumors of the Gastrointestinal Tract and Unknown Primary. \textit{NEUROENDOCRINOLOGY}. BASEL: KARGER, 2018, vol.~106, No~3, p.~211-220. ISSN~0028-3835. Available from: https://dx.doi.org/10.1159/000477585.

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