Evidence map›Paper›PMID 26626617›Full record

Trial reportEuropean urology2016

Everolimus Versus Sunitinib Prospective Evaluation in Metastatic Non-Clear Cell Renal Cell Carcinoma (ESPN): A Randomized Multicenter Phase 2 Trial.

Nizar M Tannir, Eric Jonasch, Laurence Albiges, Emre Altinmakas, Chaan S Ng, Surena F Matin, Xuemei Wang, Wei Qiao, Zita Dubauskas Lim, Pheroze Tamboli and 6 more

Open access · greenAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 172 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
172citing papers in PubMed, 14 pooled it
26.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

172 citing papers in PubMed, 14 syntheses or guidelines pooled it, 358 citations in OpenAlex.

  1. Treatments for renal cell carcinoma: NICE Pilot Treatment Pathways Appraisal.Health technology assessment (Winchester, England) · 2026
    Pooled it
  2. Pooled it
  3. SEOM SOGUG clinical guideline for treatment of kidney cancer (2022).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Guideline
  4. Pooled it
  5. Pooled it
  6. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
  7. Pooled it
  8. Pooled it
  9. Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020
    Pooled it
  10. Pooled it
  11. Pooled it
  12. SEOM clinical guideline for treatment of kidney cancer (2017).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Guideline
  13. Pooled it
  14. Pooled it
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Phase II Trial of Cabozantinib Plus Nivolumab in Patients With Non-Clear-Cell Renal Cell Carcinoma and Genomic Correlates.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  20. Trial

112 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 1 country.

Nizar M TannirDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ntannir@mdanderson.org.
Eric JonaschDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Laurence AlbigesDana-Farber Cancer Institute/Harvard Medical School, Boston, MA, USA.
Emre AltinmakasDiagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Chaan S NgDiagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Surena F MatinDepartment of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Xuemei WangDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Wei QiaoDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Zita Dubauskas LimDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Pheroze TamboliPathology Department, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Priya RaoPathology Department, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Kanishka SircarPathology Department, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jose A KaramDepartment of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
David F McDermottBeth-Israel Deaconess Medical Center, Boston, MA, USA.
Christopher G WoodDepartment of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Toni K ChoueiriDana-Farber Cancer Institute/Harvard Medical School, Boston, MA, USA.
The University of Texas MD Anderson Cancer Center · USBeth Israel Deaconess Medical Center · USDana-Farber Cancer Institute · USHarvard University · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundSunitinib and everolimus are standard first-line and second-line therapies, respectively, in clear cell renal cell carcinoma (ccRCC).

objectiveTo conduct a randomized phase 2 trial comparing sunitinib and everolimus in non-clear cell RCC (non-ccRCC). DESIGN, SETTING, AND

participantsPatients with metastatic, non-ccRCC, or ccRCC with >20% sarcomatoid features (ccSRCC) were randomized to receive sunitinib or everolimus with crossover at disease progression. OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: Primary end point was progression-free survival (PFS) in first-line therapy; 108 patients were needed to show improvement in median PFS (mPFS) from 12 wk with sunitinib to 20 wk with everolimus. RESULTS AND LIMITATIONS: Interim analysis of 68 patients (papillary [27], chromophobe [12], unclassified [10], translocation [7], ccSRCC [12]) prompted early trial closure. The mPFS in first-line therapy was 6.1 mo with sunitinib and 4.1 mo with everolimus (p=0.6); median overall survival (mOS) was not reached with sunitinib and was 10.5 mo with everolimus, respectively (p=0.014). At final analysis, mOS was 16.2 and 14.9 mo with sunitinib and everolimus, respectively (p=0.18). There were four partial responses (PRs) in first-line therapy (sunitinib: 3 of 33 [9%]; everolimus, 1 of 35 [2.8%]) and four PRs in second-line therapy (sunitinib: 2 of 21 [9.5%]; everolimus, 2 of 23 [8.6%]), with mPFS of 1.8 mo and 2.8 mo, respectively. In patients without sarcomatoid features in their tumors (n=49), mOS was 31.6 mo with sunitinib and 10.5 mo with everolimus (p=0.075). Genomic profiling of a chromophobe RCC from a patient with a PR to first-line everolimus revealed a somatic TSC2 mutation.

conclusionsIn this trial, everolimus was not superior to sunitinib. Both agents demonstrated modest efficacy, underscoring the need for better therapies in non-ccRCC. PATIENT SUMMARY: This randomized phase 2 trial provides the first head-to-head comparison of everolimus and sunitinib in patients with metastatic non-clear cell renal cell carcinoma (non-ccRCC). The observed very modest efficacy underscores the need to develop more effective therapies for non-ccRCC.

Indexed as

AdultAgedAntineoplastic AgentsCarcinoma, Renal CellDisease-Free SurvivalEarly Termination of Clinical TrialsEverolimusFemaleHumansIndolesKidney NeoplasmsMaleMiddle AgedProspective StudiesPyrrolesSunitinibAntineoplastic AgentsEverolimusIndolesPyrrolesSunitinibEverolimusNon–clear cell renal cell carcinomaRenal cell carcinomaSunitinib

Identifiers

PMID26626617
PMCPMC4879109
OpenAlexW2173523195

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.