Evidence map›Paper›PMID 33461782›Full record

Trial reportEuropean urology2021

Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial.

Robert J Motzer, Paul Russo, Naomi Haas, Christian Doehn, Frede Donskov, Marine Gross-Goupil, Sergei Varlamov, Evgeny Kopyltsov, Jae Lyun Lee, Ho Yeong Lim and 15 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01235962 (A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
7.8field-weighted citation impact, top 2% 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.

NCT01235962 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

TypeinterventionalSponsorNovartis PharmaceuticalsRan2010 to 2019Enrolled1,538ConditionsRenal Cell Carcinoma (RCC), CancerArmspazopanib, placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Advances in Adjuvant Therapy for Renal Cell Carcinoma: Perspectives on Risk Stratification and Treatment Outcomes.International journal of urology : official journal of the Japanese Urological Association · 2025
    Review
  10. Review
  11. Perioperative therapies for metastatic renal cell carcinoma.Journal of cancer metastasis and treatment · 2025
    Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Treatment Landscape of Renal Cell Carcinoma.Current treatment options in oncology · 2023
    Review
  20. Adjuvant therapy for renal cell carcinoma: 2023 Canadian Kidney Cancer Forum consensus statement.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 11 countries.

Robert J MotzerMemorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.
Paul RussoMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Naomi HaasUniversity of Pennsylvania, Philadelphia, PA, USA.
Christian DoehnUniversity of Lubeck Medical School and Urologikum Lubeck, Lubeck, Germany.
Frede DonskovAarhus University Hospital, Aarhus, Denmark.
Marine Gross-GoupilBordeaux University Hospital, Bordeaux, France.
Sergei VarlamovAltai Regional Cancer Center, Barnaul, Russia.
Evgeny KopyltsovState Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia.
Jae Lyun LeeUniversity of Ulsan College of Medicine, Seoul, South Korea.
Ho Yeong LimSungkyunkwan University, Seoul, South Korea.
Bohuslav MelicharPalacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.
Milada ZemanovaCharles University and General University Hospital, Prague, Czech Republic.
Brian RiniCleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.
Toni K ChoueiriDana-Farber Cancer Institute, Boston, MA, USA.
Lori WoodQueen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, NS, Canada.
M Neil ReaumeThe Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.
Arnulf StenzlUniversity Hospital Tubingen, Tubingen, Germany.
Simon ChowdhuryGuy's and St Thomas' National Health Service Foundation, St. Thomas' Hospital, London, UK.
Ray McDermottTallaght University Hospital and Cancer Trials Ireland, Dublin, Ireland.
Agnieszka MichaelUniversity of Surrey, Guildford, UK.
Miguel IzquierdoNovartis Oncology, East Hanover, NJ, USA.
Paola AimoneNovartis Pharma AG, Basel, Switzerland.
Hong ZhangNovartis Oncology, East Hanover, NJ, USA.
Cora N SternbergEnglander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA.
PROTECT study investigators
Memorial Sloan Kettering Cancer Center · USNovartis (United States) · USAarhus University Hospital · DKBordeaux Population Health · FRCancer Trials Ireland · IECharles University · CZCleveland Clinic · USDalhousie University · CADana-Farber Cancer Institute · USNovartis (Switzerland) · CHOttawa Hospital · CAPalacký University Olomouc · CZState Healthcare Institution "Regional Clinical Oncological Dispensary" · RUSt Thomas' Hospital · GBSungkyunkwan University · KRUniversity Children's Hospital Tübingen · DEUniversity of Lübeck · DEUniversity of Pennsylvania · USUniversity of Surrey · GBUniversity of Ulsan · KR

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

Most studies indicate no benefit of adjuvant therapy with VEGFR tyrosine kinase inhibitors in advanced renal cell carcinoma (RCC). PROTECT (NCT01235962) was a randomized, double-blind, placebo-controlled phase 3 study to evaluate adjuvant pazopanib in patients with locally advanced RCC at high risk of relapse after nephrectomy (pazopanib, n = 769; placebo, n = 769). The results of the primary analysis showed no difference in disease-free survival between pazopanib 600 mg and placebo. Here we report the final overall survival (OS) analysis (median follow-up: pazopanib, 76 mo, interquartile range [IQR] 66-84; placebo, 77 mo, IQR 69-85). There was no significant difference in OS between the pazopanib and placebo arms (hazard ratio 1.0, 95% confidence interval 0.80-1.26; nominal p > 0.9). OS was worse for patients with T4 disease compared to those with less advanced disease and was better for patients with body mass index (BMI) ≥30 kg/m

Indexed as

Carcinoma, Renal CellKidney NeoplasmsDisease-Free SurvivalHumansIndazolesNeoplasm Recurrence, LocalNephrectomyPyrimidinesSulfonamidesIndazolespazopanibPyrimidinesSulfonamidesPazopanibRenal cell carcinomaTyrosine kinase inhibitor

Identifiers

PMID33461782
PMCPMC8407394
OpenAlexW3119708965

What OpenQuestion holds

Textmetadata
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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.