Evidence map›Paper›PMID 26282642›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Evaluation of the Safety and Benefit of Phase I Oncology Trials for Patients With Primary CNS Tumors.

Mrinal M Gounder, Lakshmi Nayak, Solmaz Sahebjam, Alona Muzikansky, Armando J Sanchez, Serena Desideri, Xiaobu Ye, S Percy Ivy, L Burt Nabors, Michael Prados and 3 more

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PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. 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
1.0field-weighted citation impact, top 23% 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

10 citing papers in PubMed, 16 citations in OpenAlex.

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  10. Multiple Expressed Endogenous Glioma Epitopes as Novel Vaccines for Gliomas.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Article
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

13 authors at 7 institutions in 1 country.

Mrinal M GounderMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA. gounderm@mskcc.org.
Lakshmi NayakMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Solmaz SahebjamMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Alona MuzikanskyMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Armando J SanchezMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Serena DesideriMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Xiaobu YeMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
S Percy IvyMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
L Burt NaborsMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Michael PradosMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Stuart GrossmanMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Lisa M DeAngelisMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Patrick Y WenMrinal M. Gounder, Armando J. Sanchez, and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical School, New York, NY; Lakshmi Nayak and Patrick Y. Wen, Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School; Alona Muzikansky, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Solmaz Sahebjam, Moffitt Cancer Center, University of South Florida, Tampa, FL; Serena Desideri, Xiaobu Ye, and Stuart Grossman, Johns Hopkins Sidney Kimmel Cancer Center, Baltimore; S. Percy Ivy, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, MD; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; and Michael Prados, University of California at San Francisco, San Francisco, CA.
Dana-Farber Brigham Cancer Center · USUniversity of Alabama at Birmingham · USHarvard University · USUniversity of South Florida · USMassachusetts General Hospital · USMoffitt Cancer Center · USSidney Kimmel Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposePatients with high-grade gliomas (HGG) are frequently excluded from first-in-human solid tumor trials because of perceived poor prognosis, excessive toxicities, concomitant drug interactions, and poor efficacy. We conducted an analysis of outcomes from select, single-agent phase I studies in patients with HGG. We compared outcomes to pooled analysis of published studies in solid tumors with various molecular and cytotoxic drugs evaluated as single agents or as combinations. PATIENT AND

methodsIndividual records of patients with recurrent HGG enrolled onto Adult Brain Tumor Consortium trials of single-agent, cytotoxic or molecular agents from 2000 to 2008 were analyzed for baseline characteristics, toxicities, responses, and survival.

resultsOur analysis included 327 patients with advanced, refractory HGG who were enrolled onto eight trials involving targeted molecular (n=5) and cytotoxic (n=3) therapies. At enrollment, patients had a median Karnofsky performance score of 90 and median age of 52 years; 62% were men, 63% had glioblastoma, and the median number of prior systemic chemotherapies was one. Baseline laboratory values were in an acceptable range to meet eligibility criteria. Patients were on the study for a median of two cycles (range, <one to 56 cycles), and 96% were evaluable for primary end points. During cycle 1, grade≥3 nonhematologic and grade≥4 hematologic toxicities were 5% (28 of 565 adverse events) and 0.9% (five of 565 adverse events), respectively, and 66% of these occurred at the highest dose level. There was one death attributed to drug. Overall response rate (complete and partial response) was 5.5%. Median progression-free and overall survival times were 1.8 and 6 months, respectively.

conclusionPatients with HGG who meet standard eligibility criteria may be good candidates for solid tumor phase I studies with single-agent molecular or cytotoxic drugs with favorable preclinical rationale and pharmacokinetic properties in this population.

Indexed as

Research DesignAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsCentral Nervous System NeoplasmsClinical Trials, Phase I as TopicDatabases, FactualDisease-Free SurvivalDisease ProgressionFemaleHumansMaleMiddle AgedMolecular Targeted TherapyAntineoplastic Agents

Identifiers

PMID26282642
PMCPMC4857195
OpenAlexW2135540701

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.