Evidence map›Paper›PMID 28967554›Full record

Trial reportEuropean urology2018

Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results.

Robert J Motzer, Alain Ravaud, Jean-Jacques Patard, Hardev S Pandha, Daniel J George, Anup Patel, Yen-Hwa Chang, Bernard Escudier, Frede Donskov, Ahmed Magheli and 11 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European urology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 115 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 5 pooled it
15.3field-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.

NCT00375674 phase3completednot on this map

Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc

TypeinterventionalSponsorPfizerRan2007 to 2017Enrolled674ConditionsKidney NeoplasmsArmsSunitinib malate, Placebo
NCT07172386 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Study on the Safety and Efficacy of Super-selective Tumour Arterial Embolisation in Combination With Toripalimab and Axitinib as a Preoperative Treatment for Advanced Renal Cell Carcinoma

TypeinterventionalSponsorTianjin Medical University Second HospitalRan2025 to 2027Enrolled40ConditionsRenal Cell Carcinoma (RCC)ArmsToripalimab and axitinib
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 5 syntheses or guidelines pooled it, 221 citations in OpenAlex.

  1. Guideline
  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. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  11. Trial
  12. Phase III Trial of Adjuvant Sunitinib in Patients with High-Risk Renal Cell Carcinoma: Exploratory Pharmacogenomic Analysis.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Trial
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 18 institutions in 9 countries.

Robert J MotzerDepartment of Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.
Alain RavaudDepartment of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.
Jean-Jacques PatardCentre Hospitalier De Mont De Marsan, Mont-de-Marsan, France.
Hardev S PandhaDepartment of Clinical and Experimental Medicine and Department of Microbial Sciences, University of Surrey, Guildford, UK.
Daniel J GeorgeDivision of Oncology, Duke Cancer Center, Durham, NC, USA.
Anup PatelSpire Roding Hospital, London, UK.
Yen-Hwa ChangDepartment of Urology, Taipei Veterans General Hospital, Taipei, Taiwan.
Bernard EscudierDepartment of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
Frede DonskovDepartment of Oncology, Aarhus University Hospital, Aarhus, Denmark.
Ahmed MagheliDepartment of Urology, Charité Universitaetsmedizin Berlin, Berlin, Germany.
Giacomo CarteniDivision of Oncology and Division of Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy.
Brigitte LaguerreMedical Oncology, Centre Eugene Marquis, Rennes, France.
Piotr TomczakKlinika Onkologii Oddzial Chemioterapii, Poznan, Poland.
Jan BrezaDepartment of Urology, Slovak Medical University in Bratislava, Bratislava, Slovakia.
Paola GerlettiPfizer S.r.L, Milan, Italy.
Mariajose LechugaPfizer S.r.L, Milan, Italy.
Xun LinPfizer Inc., La Jolla, CA, USA.
Michelle CaseyPfizer Inc., Collegeville, PA, USA.
Lucile SerfassPfizer Oncology, Paris, France.
Allan J PantuckDepartment of Urology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA.
Michael StaehlerDepartment of Urology, University Hospital of Munich, Munich, Germany.
Pfizer (Italy) · ITPfizer (United States) · USAarhus University Hospital · DKAzienda di Rilievo Nazionale ed Alta Specializzazione · ITBordeaux Population Health · FRCentre Eugène Marquis · FRCentrum Onkologii · PLCharité - Universitätsmedizin Berlin · DEDuke Medical Center · USInstitut Gustave Roussy · FRLMU Klinikum · DEMemorial Sloan Kettering Cancer Center · USPfizer (France) · FRRonald Reagan UCLA Medical Center · USSlovak Medical University · SKSpire London East Hospital · GBTaipei Veterans General Hospital · TWUniversity of Surrey · GB

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundAdjuvant sunitinib significantly improved disease-free survival (DFS) versus placebo in patients with locoregional renal cell carcinoma (RCC) at high risk of recurrence after nephrectomy (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.59-0.98; p=0.03).

objectiveTo report the relationship between baseline factors and DFS, pattern of recurrence, and updated overall survival (OS). DESIGN, SETTING, AND

participantsData for 615 patients randomized to sunitinib (n=309) or placebo (n=306) in the S-TRAC trial. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Subgroup DFS analyses by baseline risk factors were conducted using a Cox proportional hazards model. Baseline risk factors included: modified University of California Los Angeles integrated staging system criteria, age, gender, Eastern Cooperative Oncology Group performance status (ECOG PS), weight, neutrophil-to-lymphocyte ratio (NLR), and Fuhrman grade. RESULTS AND LIMITATIONS: Of 615 patients, 97 and 122 in the sunitinib and placebo arms developed metastatic disease, with the most common sites of distant recurrence being lung (40 and 49), lymph node (21 and 26), and liver (11 and 14), respectively. A benefit of adjuvant sunitinib over placebo was observed across subgroups, including: higher risk (T3, no or undetermined nodal involvement, Fuhrman grade ≥2, ECOG PS ≥1, T4 and/or nodal involvement; hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.55-0.99; p=0.04), NLR ≤3 (HR 0.72, 95% CI 0.54-0.95; p=0.02), and Fuhrman grade 3/4 (HR 0.73, 95% CI 0.55-0.98; p=0.04). All subgroup analyses were exploratory, and no adjustments for multiplicity were made. Median OS was not reached in either arm (HR 0.92, 95% CI 0.66-1.28; p=0.6); 67 and 74 patients died in the sunitinib and placebo arms, respectively.

conclusionsA benefit of adjuvant sunitinib over placebo was observed across subgroups. The results are consistent with the primary analysis, which showed a benefit for adjuvant sunitinib in patients at high risk of recurrent RCC after nephrectomy. PATIENT SUMMARY: Most subgroups of patients at high risk of recurrent renal cell carcinoma after nephrectomy experienced a clinical benefit with adjuvant sunitinib.

trial registrationClinicalTrials.gov NCT00375674.

Indexed as

NephrectomyAgedAngiogenesis InhibitorsCarcinoma, Renal CellChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansIndolesKaplan-Meier EstimateKidney NeoplasmsMaleMiddle AgedProportional Hazards ModelsPyrrolesRisk FactorsAngiogenesis InhibitorsIndolesPyrrolesSunitinibAdjuvantDisease-free survivalRenal cell carcinomaSunitinib

Identifiers

PMID28967554
PMCPMC6684251
OpenAlexW2758082149

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Registered trials

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.