Evidence map›Paper›PMID 27498080›Full record

Trial reportThe Lancet. Oncology2016

Active surveillance in metastatic renal-cell carcinoma: a prospective, phase 2 trial.

Brian I Rini, Tanya B Dorff, Paul Elson, Cristina Suarez Rodriguez, Dale Shepard, Laura Wood, Jordi Humbert, Linda Pyle, Yu-Ning Wong, James H Finke and 4 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The Lancet. Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 96 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 3 pooled it
19.2field-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

96 citing papers in PubMed, 3 syntheses or guidelines pooled it, 251 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
  4. Trial
  5. Trial
  6. Lesion detection by [European journal of nuclear medicine and molecular imaging · 2019
    Trial
  7. Article
  8. First-in-humanTheranostics · 2026
    Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. 2024 CUA-KCRNC Expert Report: Management of non-clear cell renal cell carcinoma.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024
    Article
  17. Review
  18. The Treatment of Metastatic Renal Cell Carcinoma.Deutsches Arzteblatt international · 2024
    Review
  19. Review
  20. Article

36 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 6 institutions in 3 countries.

Brian I RiniCleveland Clinic Taussig Cancer Institute, Main Campus, Cleveland, OH, USA. Electronic address: rinib2@ccf.org.
Tanya B DorffUSC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Paul ElsonCleveland Clinic Taussig Cancer Institute, Main Campus, Cleveland, OH, USA.
Cristina Suarez RodriguezVall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.
Dale ShepardCleveland Clinic Taussig Cancer Institute, Main Campus, Cleveland, OH, USA.
Laura WoodCleveland Clinic Taussig Cancer Institute, Main Campus, Cleveland, OH, USA.
Jordi HumbertVall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.
Linda PyleRoyal Marsden NHS Foundation Trust, London, UK.
Yu-Ning WongFox Chase Cancer Center, Temple Health, Philadelphia, PA, USA.
James H FinkeCleveland Clinic Taussig Cancer Institute, Main Campus, Cleveland, OH, USA.
Patricia A RaymanCleveland Clinic Taussig Cancer Institute, Main Campus, Cleveland, OH, USA.
James M G LarkinRoyal Marsden NHS Foundation Trust, London, UK.
Jorge A GarciaCleveland Clinic Taussig Cancer Institute, Main Campus, Cleveland, OH, USA.
Elizabeth R PlimackFox Chase Cancer Center, Temple Health, Philadelphia, PA, USA.
Cleveland Clinic · USRoyal Marsden NHS Foundation Trust · GBUniversitat Autònoma de Barcelona · ESFox Chase Cancer Center · USTemple University Health System · USUSC Norris Comprehensive Cancer Center · US

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
NCI NIH HHS P30 CA014089
6 · The paper itself

Abstract

backgroundA subset of patients with metastatic renal-cell carcinoma show indolent growth of metastases. Because of the toxicity and non-curative nature of systemic therapy, some of these patients could benefit from initial active surveillance. We aimed to characterise the time to initiation of systemic therapy in patients with metastatic renal-cell carcinoma under active surveillance.

methodsIn this prospective phase 2 trial, we enrolled patients with treatment-naive, asymptomatic, metastatic renal-cell carcinoma from five hospitals in the USA, Spain, and the UK. Patients were radiographically assessed at baseline, every 3 months for year 1, every 4 months for year 2, then every 6 months thereafter. Patients continued on observation until initiation of systemic therapy for metastatic renal-cell carcinoma; a decision that was made at the discretion of the treating physician and patient. The primary endpoint of the study was time to initiation of systemic therapy in the per-protocol population. The follow-up of patients is ongoing.

findingsBetween Aug 21, 2008, and June 7, 2013, we enrolled 52 patients. Median follow-up of patients in the study was 38·1 months (IQR 29·4-48·9). In the 48 patients included in analysis, median time on surveillance from registration on study until initiation of systemic therapy was 14·9 months (95% CI 10·6-25·0). Multivariate analysis showed that higher numbers of International Metastatic Database Consortium (IMDC) adverse risk factors (p=0·0403) and higher numbers of metastatic disease sites (p=0·0414) were associated with a shorter surveillance period. 22 (46%) patients died during the study period, all from metastatic renal-cell carcinoma.

interpretationA subset of patients with metastatic renal-cell carcinoma can safely undergo surveillance before starting systemic therapy. Additional investigation is required to further define the benefits and risks of this approach.

fundingNone.

Indexed as

AgedCarcinoma, Renal CellFemaleFollow-Up StudiesHumansKidney NeoplasmsMaleMiddle AgedNeoplasm StagingNephrectomyPopulation SurveillancePrognosisProspective StudiesSpainSurvival RateTomography, X-Ray Computed

Identifiers

PMID27498080
PMCPMC9199453
OpenAlexW2484090454

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.