Evidence map›Paper›PMID 26272427›Full record

Trial reportClinical genitourinary cancer2015

Atrasentan in Patients With Advanced Renal Cell Carcinoma: A Phase 2 Trial of the ECOG-ACRIN Cancer Research Group (E6800).

Michael A Carducci, Judith Manola, Suresh G Nair, Glenn Liu, Steven Rousey, Janice P Dutcher, George Wilding

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical genitourinary cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 25% 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

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Endothelin and the tumor microenvironment: a finger in every pie.Clinical science (London, England : 1979) · 2024
    Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Bone Pain and Muscle Weakness in Cancer Patients.Current osteoporosis reports · 2017
    Review
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

7 authors at 6 institutions in 1 country.

Michael A CarducciJohns Hopkins Kimmel Cancer Center, Baltimore, MD.
Judith ManolaDepartment of Biostatistics & Computational Biology, Dana-Farber Cancer Institute, Boston, MA. Electronic address: jmanola@jimmy.harvard.edu.
Suresh G NairHematology/Oncology Associates, Lehigh Valley Hospital-Cedar Crest, Allentown, PA.
Glenn LiuUniversity of Wisconsin Carbone Cancer Center, Wisconsin Institute for Medical Research, Madison, WI.
Steven RouseyMetro-Minnesota CCOP, Edina, MN.
Janice P DutcherOur Lady of Mercy Cancer Center, New York Medical College, Bronx, NY.
George WildingUniversity of Wisconsin Carbone Cancer Center, Madison, WI.
University of Wisconsin Carbone Cancer Center · USDana-Farber Cancer Institute · USJohns Hopkins University · USLehigh Valley Hospital · USMetro-Minnesota Community Oncology Research Consortium · USNew York Medical College · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
Johns Hopkins University NCTN Lead Academic Site ProgramU10CA180802 · NCI · JOHNS HOPKINS UNIVERSITY · PI ARMSTRONG, DEBORAH K, BRAHMER, JULIE RENEE · 2014 to 2018
$3.3M
National Clinical Trials Network Research at the University of WisconsinU10CA180799 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ANDERSON, BETHANY M, KUSHNER, DAVID M · 2014 to 2018
$2.8M
NCI NIH HHS CA180794NCI NIH HHS CA180799NCI NIH HHS CA180802NCI NIH HHS CA180820NCI NIH HHS CA189859NCI NIH HHS CA189863NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA189863NCI NIH HHS UG1 CA233196
6 · The paper itself

Abstract

backgroundAtrasentan, an oral endothelin receptor A antagonist, demonstrated phase 1 activity in patients with renal cell carcinoma (RCC). A phase 2 study was undertaken in patients with measurable or bone-only metastatic RCC in the pre-VEGF/TKI era. METHODS AND MATERIALS: Patients were stratified by disease status and prior immunotherapy. Eligible patients had no prior chemotherapy, 0 to 1 prior immunotherapies, and an Eastern Cooperative Oncology Group performance status of 0 to 2. Patients received atrasentan 10 mg per day until progression. The primary end point was progression-free (PF) rate at 6 months. Rates of 25% among patients treated with prior immunotherapy and 45% among patients with no prior immunotherapy were considered promising. A 2-stage design was used for cohorts without prior immunotherapy.

resultsFrom 2003 to 2005, 98 patients were registered. Median treatment duration was 9.9 weeks (range, 0.3-107 weeks). Toxicities were mild; 71% of patients reported no grade 3 or higher treatment-related events. Grade 4 events included neutropenia (n = 3), dyspnea (n = 2), thrombosis (n = 1), and arrhythmia (n = 1). Two grade 5 events (dyspnea and constitutional) were possibly treatment related. Six-month PF rates (90% confidence interval) were 14% (6-25), 0% (0-39), 8% (1-23), and 22% (8-44), respectively, for patients with prior immunotherapy/measurable disease (n = 44), prior immunotherapy/bone metastases (n = 6), no prior immunotherapy/measurable disease (n = 25), and no prior immunotherapy/bone metastases (n = 18). Median PF survival was 2.3 months (95% confidence interval, 2.0-3.5 months).

conclusionAlthough well tolerated, atrasentan did not yield 6-month PF rates supporting its use as first-line monotherapy in patients with advanced RCC.

Indexed as

AdultAgedAged, 80 and overAtrasentanBone NeoplasmsCarcinoma, Renal CellDisease-Free SurvivalEndothelin Receptor AntagonistsFemaleHumansKidney NeoplasmsMaleMiddle AgedPyrrolidinesTreatment OutcomeAtrasentanEndothelin Receptor AntagonistsPyrrolidinesBone metastasesEndothelin A receptor antagonistKidney cancerPain palliationProgression-free survival

Identifiers

PMID26272427
PMCPMC4637227
OpenAlexW2111802606

What OpenQuestion holds

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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.