Evidence map›Paper›PMID 28479237›Full record

ReviewThe Journal of urology2018

Adjuvant Therapy for High Risk Localized Kidney Cancer: Emerging Evidence and Future Clinical Trials.

Andrew T Lenis, Nicholas M Donin, David C Johnson, Izak Faiena, Amirali Salmasi, Alexandra Drakaki, Arie Belldegrun, Allan Pantuck, Karim Chamie

2 registry-linked trialsOpen access · greenAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Journal of 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 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% 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.

NCT00326898 phase3completednot on this map

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2006 to 2021Enrolled1,943ConditionsClear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer AJCC v6 and v7, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7ArmsLaboratory Biomarker Analysis, Placebo, Quality-of-Life Assessment, Sorafenib Tosylate, Sunitinib Malate
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
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  12. Adjuvant therapy in renal cell carcinoma: the perspective of urologists.International journal of clinical oncology · 2019
    Article
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  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Andrew T LenisInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California.
Nicholas M DoninInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California.
David C JohnsonInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California.
Izak FaienaInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California.
Amirali SalmasiInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California.
Alexandra DrakakiDivision of Hematology/Oncology, Department of Medicine, University of California, Los Angeles, Los Angeles, California.
Arie BelldegrunInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California.
Allan PantuckInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California.
Karim ChamieInstitute of Urologic Oncology, Department of Urology, University of California, Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, California. Electronic address: kchamie@mednet.ucla.edu.
University of California, Los Angeles · US

Funding

NCI NIH HHS L30 CA154326
6 · The paper itself

Abstract

purposeWe reviewed the literature on adjuvant therapies for patients with high risk localized kidney cancer following surgical resection. In this analysis we merge 2 recently published prospective trials with conflicting results within the context of their respective designs. In addition, we spotlight upcoming trials that use novel immunotherapy based checkpoint inhibitors and have the potential to establish a new standard of care. MATERIALS AND

methodsWe searched PubMed

resultsAdjuvant therapies for high risk localized kidney cancer can be grouped into the categories of 1) traditional immunotherapy, 2) inhibitors of the vascular endothelial growth factor and mTOR (mammalian target of rapamycin) pathways, 3) vaccines and antibody dependent cytotoxic agents, and 4) immune checkpoint inhibitors. Several trials of traditional immunotherapy, such as interferon-α and high dose interleukin-2, failed to demonstrate benefit as adjuvant treatment and were associated with significant adverse events. Vascular endothelial growth factor and mTOR inhibitors have less severe toxicity in metastatic disease and, therefore, are natural considerations for adjuvant trials. However, current data are conflicting. The ASSURE (Sunitinib Malate or Sorafenib Tosylate in Treating Patients with Kidney Cancer that was Removed by Surgery, NCT00326898) trial found no recurrence-free survival benefit of sorafenib or sunitinib over placebo, while S-TRAC (Clinical Trial Comparing Efficacy and Safety of Sunitinib versus Placebo for the Treatment of Patients at High Risk of Recurrent Renal Cell Cancer, NCT00375674) revealed that 1 year of sunitinib improved recurrence-free survival by 1.2 years. Vaccine based treatments and antibody dependent cytotoxic agents have had mixed results. New trials evaluating immune checkpoint inhibitors are planned, given the impressive efficacy and tolerability as second line agents in metastatic disease. Future adjuvant trials are likely to be guided by molecular signatures to treat patients most likely to benefit.

conclusionsBased on the available data, there appears to be no role for traditional immunotherapy as adjuvant treatment in patients with high risk localized kidney cancer following surgical resection. S-TRAC provides evidence that 1 year of adjuvant sunitinib in patients with higher risk locoregional disease increases the median time to recurrence. However, the data on overall survival are immature and adverse effects are common. Results from trials investigating immune checkpoint inhibitors are highly anticipated.

Indexed as

Antineoplastic AgentsCancer VaccinesCarcinoma, Renal CellChemotherapy, AdjuvantClinical Trials as TopicEvidence-Based MedicineHumansImmunotherapyKidney NeoplasmsResearch DesignAntineoplastic AgentsCancer Vaccinesadjuvantscarcinomaimmunologickidney neoplasmsrenal cell

Identifiers

PMID28479237
PMCPMC5720927
OpenAlexW2610918292

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.