Evidence map›Paper›PMID 33549705›Full record

Trial reportInternational journal of radiation oncology, biology, physics2021

Neoadjuvant SABR for Renal Cell Carcinoma Inferior Vena Cava Tumor Thrombus-Safety Lead-in Results of a Phase 2 Trial.

Vitaly Margulis, Yuval Freifeld, Laurentiu M Pop, Subrata Manna, Payal Kapur, Ivan Pedrosa, Alana Christie, Osama Mohamad, Samantha Mannala, Nirmish Singla and 7 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing 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.

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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 69 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 2 countries.

Vitaly MargulisDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
Yuval FreifeldDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Urology, Lady Davis Carmel Medical Center, Haifa, Israel.
Laurentiu M PopDepartment of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
Subrata MannaDepartment of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
Payal KapurKidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Pathology, University of Texas Southwestern Medical Center, Dallas, Texas.
Ivan PedrosaDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Radiology, University of Texas Southwestern Medical Center, Dallas, Texas.
Alana ChristieKidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
Osama MohamadDepartment of Radiation Oncology, University of California, San Francisco, California.
Samantha MannalaDepartment of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
Nirmish SinglaDepartments of Urology and Oncology, The James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Michael WaitKidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Cardiovascular and Thoracic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.
Aditya BagrodiaDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
Solomon L WolduDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
Jeffrey GahanDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas.
James BrugarolasKidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Division of Hematology/Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.
Robert TimmermanKidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
Raquibul HannanKidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: raquibul.hannan@utsouthwestern.edu.
The University of Texas Southwestern Medical Center · USCarmel Medical Center · ILJohns Hopkins Medicine · USUniversity of California, San Francisco · US

Funding

University of Texas Southwestern Medical Center SPORE in Kidney CancerP50CA196516 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI James Brugarolas · 2016 to 2026
$24.7M
NON-INVASIVE PHYSIOLOGIC PREDICTORS OF AGGRESSIVENESS IN RENAL CELL CARCINOMAR01CA154475 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI PEDROSA, IVAN · 2011 to 2024
$4.3M
Quantitative Non-Contrast Perfusion using Arterial Spin Labeling for Assessment of Cancer Therapy ResponseU01CA207091 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI MADHURANTHAKAM, ANANTH J, MALDJIAN, JOSEPH A · 2017 to 2022
$3.1M
NCI NIH HHS P50 CA196516NCI NIH HHS R01 CA154475NCI NIH HHS U01 CA207091
6 · The paper itself

Abstract

purposeTo evaluate the feasibility, safety, oncologic outcomes, and immune effect of neoadjuvant stereotactic radiation (Neo-SAbR) followed by radical nephrectomy and thrombectomy (RN-IVCT). METHODS AND MATERIALS: These are results from the safety lead-in portion of a single-arm phase 1 and 2 trial. Patients with kidney cancer (renal cell carcinoma [RCC]) and inferior vena cava (IVC) tumor thrombus (TT) underwent Neo-SAbR (40 Gy in 5 fractions) to the IVC-TT followed by open RN-IVCT. Absence of grade 4 to 5 adverse events (AEs) within 90 days of RN-IVCT was the primary endpoint. Exploratory studies included pathologic and immunologic alterations attributable to SAbR.

resultsSix patients were included in the final analysis. No grade 4 to 5 AEs were observed. A total of 81 AEs were reported within 90 days of surgery: 73% (59/81) were grade 1, 23% (19/81) were grade 2, and 4% (3/81) were grade 3. After a median follow-up of 24 months, all patients are alive. One patient developed de novo metastatic disease. Of 3 patients with metastasis at diagnosis, 1 had a complete and another had a partial abscopal response without the concurrent use of systemic therapy. Neo-SABR led to decreased Ki-67 and increased PD-L1 expression in the IVC-TT. Inflammatory cytokines and autoantibody titers reflecting better host immune status were observed in patients with nonprogressive disease.

conclusionsNeo-SAbR followed by RN-IVCT for RCC IVC-TT is feasible and safe. Favorable host immune environment correlated with abscopal response to SABR and RCC relapse-free survival, though direct causal relation to SABR has yet to be established.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsNeoadjuvant TherapyNephrectomyRadiosurgeryThrombectomyVena Cava, InferiorAdultAgedFeasibility StudiesFemaleHumansMaleMiddle AgedVenous Thrombosis

Identifiers

PMID33549705
PMCPMC8856732
OpenAlexW3128331051

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.