Evidence map›Paper›PMID 22771265›Full record

Trial reportEuropean urology2012

A phase 2 trial of sunitinib in patients with advanced non-clear cell renal cell carcinoma.

Nizar M Tannir, Elizabeth Plimack, Chaan Ng, Pheroze Tamboli, Nebiyou B Bekele, Lianchun Xiao, Lisa Smith, Zita Lim, Lance Pagliaro, John Araujo and 4 more

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 4 pooled it
13.7field-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

74 citing papers in PubMed, 4 syntheses or guidelines pooled it, 165 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. 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
  7. Trial
  8. Trial
  9. Trial
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  12. Phase II Trial and Correlative Genomic Analysis of Everolimus Plus Bevacizumab in Advanced Non-Clear Cell Renal Cell Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
    Trial
  13. Trial
  14. Trial
  15. Phase II and biomarker study of the dual MET/VEGFR2 inhibitor foretinib in patients with papillary renal cell carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013
    Trial
  16. Review
  17. Article
  18. Article
  19. Metabolic parameters analysis ofAmerican journal of nuclear medicine and molecular imaging · 2025
    Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 1 country.

Nizar M TannirDepartment of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. ntannir@mdanderson.org
Elizabeth Plimack
Chaan Ng
Pheroze Tamboli
Nebiyou B Bekele
Lianchun Xiao
Lisa Smith
Zita Lim
Lance Pagliaro
John Araujo
Ana Aparicio
Surena Matin
Christopher G Wood
Eric Jonasch
The University of Texas MD Anderson Cancer Center · USFox Chase Cancer Center · 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 is a standard-of-care treatment in advanced clear cell renal cell carcinoma (ccRCC). Retrospective and expanded access data suggest sunitinib has activity in advanced non-clear cell renal cell carcinoma (nccRCC).

objectiveTo prospectively determine the clinical efficacy and safety of sunitinib in patients with advanced nccRCC. DESIGN, SETTING, AND

participantsThis is a single-arm phase 2 trial with a two-stage design. Eligibility criteria included pathologically confirmed nccRCC or ccRCC with ≥ 20% sarcomatoid histology, performance status 0-2, measurable disease, a maximum of two prior systemic therapies, and no prior treatment with tyrosine kinase inhibitors directed against the vascular endothelial growth factor receptors.

interventionPatients received sunitinib 50mg daily on a 4-wk on, 2-wk off schedule. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary end points were objective response rate (ORR) and progression-free survival (PFS). Secondary end points were safety and overall survival (OS). RESULTS AND LIMITATIONS: Fifty-seven patients were eligible (nccRCC histology: papillary, 27; chromophobe, 5; unclassified, 8; collecting duct or medullary carcinoma, 6; sarcomatoid, 7; and others, 4). Median PFS for 55 evaluable patients was 2.7 mo (95% confidence interval [CI], 1.4-5.4). Two patients with chromophobe and one patient with unclassified histology had a confirmed partial response (5% ORR). Median PFS for patients with papillary histology was 1.6 mo (95% CI, 1.4-5.4). Median PFS for patients with chromophobe histology was 12.7 mo (95% CI, 8.5-NA). Median OS for all patients was 16.8 mo (95% CI, 10.7-26.3). Treatment-emergent adverse events were consistent with sunitinib's mechanism of action. The nonrandomized design and small number of patients are limitations of this study.

conclusionsThe differential response of chromophobe histology to sunitinib suggests a therapeutically relevant biological heterogeneity exists within nccRCC. The low ORR and short PFS with sunitinib in the other nccRCC subtypes underscore the need to enroll patients with these diverse tumors in clinical trials.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Renal CellFemaleHumansIndolesKidney NeoplasmsMaleMiddle AgedNeoplasm StagingPyrrolesSunitinibYoung AdultAntineoplastic AgentsIndolesPyrrolesSunitinib

Identifiers

PMID22771265
PMCPMC3882163
OpenAlexW2161130083

What OpenQuestion holds

Textmetadata
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.