Evidence map›Paper›PMID 20871263›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2010

Phase II study of the histone deacetylase inhibitor Romidepsin in relapsed small cell lung cancer (Cancer and Leukemia Group B 30304).

Gregory A Otterson, Lydia Hodgson, Herbert Pang, Everett E Vokes, Cancer and Leukemia Group B

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. Review
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  18. Epigenetics of lung cancer: a translational perspective.Cellular oncology (Dordrecht, Netherlands) · 2019
    Review
  19. Article
  20. Observational
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

5 authors.

Gregory A OttersonThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210, USA. greg.otterson@osumc.edu
Lydia Hodgson
Herbert Pang
Everett E Vokes
Cancer and Leukemia Group B

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
MEDICAL CENTER OF DELAWARE CCOPU10CA045418 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GRUBBS, STEPHEN S. · 1987 to 2014
$14.5M
SYRACUSE HEMATOLOGY-ONCOLOGY CCOPU10CA045389 · NCI · HEMATOLOGY-ONCOLOGY ASSOCIATES/CTL NY · PI KIRSHNER, JEFFREY JAY · 1987 to 2014
$7.4M
Heartland Research Consortium CCOPU10CA114558 · NCI · MISSOURI BAPTIST MEDICAL CENTER · PI LYSS, ALAN P · 2005 to 2014
$6.0M
Cancer and Leukemia Group B - The Ohio State UniversityU10CA077658 · NCI · OHIO STATE UNIVERSITY · PI BLOOMFIELD, CLARA D · 1998 to 2013
$6.0M
CANCER &LEUKEMIA GROUP BU10CA032291 · NCI · DANA-FARBER CANCER INSTITUTE · PI BURSTEIN, HAROLD J. · 1985 to 2013
$5.8M
WUSM CANCER AND LEUKEMIA GROUP BU10CA077440 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L · 1998 to 2013
$4.4M
CANCER AND LEUKEMIA GROUP B--RPCI/SUNYABU10CA059518 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LEVINE, ELLIS G · 1993 to 2013
$4.0M
CANCER AND LEUKEMIA GROUP B GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032291NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA045389NCI NIH HHS U10 CA045418NCI NIH HHS U10 CA047577NCI NIH HHS U10 CA059518NCI NIH HHS U10 CA077440NCI NIH HHS U10 CA077597NCI NIH HHS U10 CA077658NCI NIH HHS U10 CA114558NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

introductionTreatment of small cell lung cancer (SCLC) is initially gratifying with most patients responding to platinum-based chemotherapy. Treatment of relapsed disease gives much lower response rates of short duration. We undertook this study of the protein deacetylase inhibitor Romidepsin in chemosensitive recurrent SCLC based on preclinical data that suggested this to be an active target.

methodsPatients had recurrent chemosensitive SCLC (relapse ≥90 days since completion of platinum-based chemotherapy). Treatment was administered as weekly infusions of Romidepsin at 13 mg/m(2) for 3 of 4 weeks. We designed a two-stage phase II study targeting a response rate of 30% (<10% response would be uninteresting and ≥30% worthy of further study).

resultsSixteen patients (10 male, 6 female) were accrued to the first stage of this study. Most (11 patients, 69%) presented with extensive-stage SCLC, and all had received prior chemotherapy, with 11 having received prior radiation. Eastern Cooperative Oncology Group performance status was excellent with 0 in 6 patients (38%) and 1 in 10 patients. No objective responses were seen, and stable disease was the best response seen in 3 patients (19%). Toxicity was modest with 3 patients suffering grade 3 toxicity (lymphopenia, insomnia, nausea, vomiting, and hyponatremia) and one patient with grade 4 thrombocytopenia. Median progression-free survival was 1.8 months, and median overall survival was 6 months.

conclusionRomidepsin given on a weekly schedule in patients with chemosensitive, recurrent SCLC was inactive and will not be pursued further in this setting.

Indexed as

Salvage TherapyAdultAgedAged, 80 and overAntibiotics, AntineoplasticClinical Trials, Phase I as TopicDepsipeptidesDrug Resistance, NeoplasmFemaleHistone DeacetylasesHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingAntibiotics, AntineoplasticDepsipeptidesHistone Deacetylasesromidepsin

Identifiers

PMID20871263
PMCPMC3782083

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Registered trials

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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.