Evidence map›Paper›PMID 35213214›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

External Validation of the 2003 Leibovich Prognostic Score in Patients Randomly Assigned to SORCE, an International Phase III Trial of Adjuvant Sorafenib in Renal Cell Cancer.

Bhavna Oza, Tim Eisen, Eleni Frangou, Grant D Stewart, Axel Bex, Alastair W S Ritchie, Rick Kaplan, Benjamin Smith, Ian D Davis, Martin R Stockler and 10 more

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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

10 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Application of Genomic Sequencing to Refine Patient Stratification for Adjuvant Therapy in Renal Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  10. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Bhavna OzaMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, United Kingdom.ORCID 0000-0003-3860-1349
Tim EisenDepartment of Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.ORCID 0000-0001-9663-4873
Eleni FrangouMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, United Kingdom.ORCID 0000-0002-5978-292X
Grant D StewartDepartment of Surgery, University of Cambridge, Cambridge, United Kingdom.ORCID 0000-0003-3188-9140
Axel BexRoyal Free London NHS Foundation Trust UCL Division of Surgery and Interventional Science, London, United Kingdom.ORCID 0000-0002-8499-2662
Alastair W S RitchieMRC Clinical Trials Unit Trial, London, United Kingdom.
Rick KaplanMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, United Kingdom.ORCID 0000-0002-0189-8348
Benjamin SmithMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, United Kingdom.ORCID 0000-0002-7079-4956
Ian D DavisDepartment of Medical Oncology, Eastern Health, Melbourne, Australia.ORCID 0000-0002-9066-8244
Martin R StocklerANZUP Cancer Trials Group, Sydney, Australia.ORCID 0000-0003-3793-8724
Laurence AlbigesInstitut Gustave Roussy, Villejuif, France.ORCID 0000-0002-5734-3480
Bernard EscudierInstitut Gustave Roussy, Villejuif, France.
James LarkinThe Royal Marsden Hospital, NHS Foundation Trust, London, United Kingdom.ORCID 0000-0001-5569-9523
Steven JoniauDepartment of Development and Regeneration-Urogenital, Abdominal and Plastic Surgery, Leuven, Belgium.ORCID 0000-0003-3195-9890
Barry HancockUniversity of Sheffield, Sheffield, United Kingdom.
Gregers G HermannUrology Research Unit, Department of Urology, Herlev, Denmark.ORCID 0000-0002-8413-5919
Joaquim BellmuntBeth Israel Deaconess Medical Center-IMIM Research Lab, Boston, MA.ORCID 0000-0003-2328-3421
Mahesh K B ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, United Kingdom.ORCID 0000-0003-0166-1700
Patrick RoystonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, United Kingdom.
Angela MeadeMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, United Kingdom.ORCID 0000-0001-6424-0554

Funding

Cancer Research UK C2845/A6858Cancer Research UK C9685/A25177Medical Research Council MC_UU_12023/25
6 · The paper itself

Abstract

purposeThe 2003 Leibovich score guides prognostication and selection to adjuvant clinical trials for patients with locally advanced renal cell carcinoma (RCC) after nephrectomy. We provide a robust external validation of the 2003 Leibovich score using contemporary data from SORCE, an international, randomized trial of sorafenib after excision of primary RCC.

methodsData used to derive the 2003 Leibovich score were compared with contemporary data from SORCE. Discrimination and calibration of the metastasis-free survival outcome were assessed in data from patients with clear-cell RCC, using Cox proportional hazards regression, Kaplan-Meier curves, and calculation of Harrell's c indexes. Secondary analyses involved three important SORCE groups: patients with any non-clear-cell subtype, papillary, and chromophobe carcinomas.

resultsFour hundred seven recurrences occurred in 982 patients in the Leibovich cohort and 520 recurrences were recorded in 1,445 patients in the primary SORCE cohort. Clear discrimination between intermediate-risk and high-risk SORCE cohorts was shown; hazard ratio 2.74 (95% CI, 2.29 to 3.28), c-index 0.63 (95% CI, 0.61 to 0.65). A hazard ratio of 0.61 (95% CI, 0.53 to 0.70) confirmed poor calibration of the two cohorts. Discrimination was observed in secondary populations, with c-indexes of 0.64 (95% CI, 0.59 to 0.69) for non-clear-cell RCC, 0.63 (95% CI, 0.56 to 0.69) for papillary RCC, and 0.65 (95% CI, 0.55 to 0.76) for chromophobe RCC.

conclusionThe 2003 Leibovich score discriminates between intermediate-risk and high-risk clear-cell and non-clear-cell RCC groups in contemporary data, supporting its use for risk stratification in adjuvant clinical trials. Over time, metastasis-free survival for patients with locally advanced RCC has improved. Contemporary data from adjuvant RCC trials should be used to improve prognostication for patients with RCC.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsHumansNephrectomyPrognosisRecurrenceSorafenibSorafenib

Identifiers

PMID35213214
PMCPMC9148696

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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.