Oliver's mTOR Atlas Evidence Platform
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Everolimus for advanced pancreatic neuroendocrine tumors (RADIANT-3)

Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Oberg K · 2011 · New England Journal of Medicine · Atlas ID YAO2011

What this study shows

A phase 3 RCT (n=410) that made everolimus a standard treatment for pancreatic neuroendocrine tumors. It more than doubled progression-free survival (11.0 vs 4.6 months, a 65% reduction in risk of progression/death) with mostly mild side effects. Another FDA-approved indication built on blocking mTOR.

Abstract

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Everolimus, an oral inhibitor of mammalian target of rapamycin (mTOR), has shown antitumor activity in patients with advanced pancreatic neuroendocrine tumors, in two phase 2 studies. We evaluated the agent in a prospective, randomized, phase 3 study. We randomly assigned 410 patients who had advanced, low-grade or intermediate-grade pancreatic neuroendocrine tumors with radiologic progression within the previous 12 months to receive everolimus, at a dose of 10 mg once daily (207 patients), or placebo (203 patients), both in conjunction with best supportive care.

Read the full abstract on PubMed →

At a glance

Evidence type H Human study Marked H because it is direct evidence from a human clinical trial or human cohort; the code names the kind of study, not its quality -- a small, well-run trial is still H.
Study type2 - Human Clinical Trial
Model systemHumans, phase 3 RCT (n=410)
JournalNew England Journal of Medicine
Year2011
Peer reviewedYes
Record last updated2026-08-22
SourceDOI 10.1056/NEJMoa1009290 · PMID 21306238 · Free full text (PMC4208619)

Extracted findings

InterventionEverolimus
TargetmTORC1
ModelHuman – phase 3 RCT (RADIANT-3, n=410)
EffectEverolimus prolonged progression-free survival in advanced pancreatic neuroendocrine tumors
DoseEverolimus 10 mg once daily vs placebo; oral; international multicenter double-blind phase 3 (RADIANT-3).
Sample size410 patients, 82 centers, 18 countries (target 392) with advanced pancreatic neuroendocrine tumors.
Effect sizeEverolimus prolonged progression-free survival vs placebo (primary endpoint). Confirmed objective responses 5% (everolimus) vs 2% (placebo).
LimitationsNoninfectious pneumonitis / interstitial lung disease in 7 patients (5 drug-related, ~2%); other cancer therapies debated as comparators.

In the Atlas

Related topics

EverolimusPancreatic neuroendocrine tumormTORC1

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Cite this paper

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Yao, J. C., Shah, M. H., Ito, T., Bohas, C. L., Wolin, E. M., & Oberg, K. (2011). Everolimus for advanced pancreatic neuroendocrine tumors (RADIANT-3). New England Journal of Medicine. https://doi.org/10.1056/NEJMoa1009290

@article{YAO2011,
  author       = {Yao, J. C. and Shah, M. H. and Ito, T. and Bohas, C. L. and Wolin, E. M. and Oberg, K.},
  title        = {{Everolimus for advanced pancreatic neuroendocrine tumors (RADIANT-3)}},
  journal      = {New England Journal of Medicine},
  year         = {2011},
  doi          = {10.1056/NEJMoa1009290},
  note         = {PMID: 21306238},
}

Cite this Atlas record

The record is the Atlas's own work — the evidence label, the extracted findings and the links. It is cited as part of the dataset, not as the paper. 

Barton, O. (2026). Oliver's mTOR Atlas (record YAO2011) [Data set]. https://mtor-atlas.org/study/YAO2011/ · Dataset DOI 10.5281/zenodo.22059963

@misc{atlas_YAO2011,
  author       = {Barton, Oliver},
  title        = {{Oliver's mTOR Atlas}, record YAO2011},
  howpublished = {Data set},
  year         = {2026},
  url          = {https://mtor-atlas.org/study/YAO2011/},
  doi          = {10.5281/zenodo.22059963}
}