Evidence map›Paper›PMID 20522709›Full record

Trial reportBlood2010

P-glycoprotein inhibition using valspodar (PSC-833) does not improve outcomes for patients younger than age 60 years with newly diagnosed acute myeloid leukemia: Cancer and Leukemia Group B study 19808.

Jonathan E Kolitz, Stephen L George, Guido Marcucci, Ravi Vij, Bayard L Powell, Steven L Allen, Daniel J DeAngelo, Thomas C Shea, Wendy Stock, Maria R Baer and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006363 (Phase III Randomized Study of Induction Chemotherapy With or Without MDR-Modulation With PSC-833), which is not on this map. Cited by 65 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 2 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.

NCT00006363 phase3completednot on this map

Phase III Randomized Study of Induction Chemotherapy With or Without MDR-Modulation With PSC-833 (NSC # 648265, IND # 41121) Followed by Cytogenetic Risk-Adapted Intensification Therapy Followed by Immunotherapy With rIL-2 (NSC # 373364, IND # 1969) vs. Observation in Previously Untreated Patients With AML < 60 Years

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2000Enrolled720ConditionsAdult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Erythroid Leukemia (M6), Adult Acute Megakaryoblastic Leukemia (M7)Armscytarabine, daunorubicin hydrochloride, etoposide, valspodar, filgrastim
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 2 syntheses or guidelines pooled it, 128 citations in OpenAlex.

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  7. Combined molecular and clinical prognostic index for relapse and survival in cytogenetically normal acute myeloid leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
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5 more citing papers are in PubMed but not listed here.

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 9 institutions in 1 country.

Jonathan E KolitzNorth Shore University Hospital, Hofstra University School of Medicine, Lake Success, NY 11042, USA. kolitz@nshs.edu
Stephen L George
Guido Marcucci
Ravi Vij
Bayard L Powell
Steven L Allen
Daniel J DeAngelo
Thomas C Shea
Wendy Stock
Maria R Baer
Vera Hars
Kati Maharry
Eva Hoke
James W Vardiman
Clara D Bloomfield
Richard A Larson
Cancer and Leukemia Group B
Leukemia Research Foundation · USThe Ohio State University · USUniversity of Chicago · USNorth Shore University Hospital · USDana-Farber Cancer Institute · USUniversity of Maryland, Baltimore · USUniversity of North Carolina at Chapel Hill · USWake Forest University · USWashington University in St. Louis · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
NORTH SHORE UNIV COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035279 · NCI · NORTH SHORE UNIVERSITY HOSPITAL · PI VINCIGUERRA, VINCENT P · 1985 to 2014
$7.3M
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 GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
CANCER AND LEUKEMIA GROUP B (CALGB)U10CA003927 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI HURD, DAVID D. · 1985 to 2008
$2.2M
CANCER AND LEUKEMIA GROUP BU10CA047559 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SHEA, THOMAS C. · 1991 to 2013
$1.8M
PARTICIPATION IN CALGBU10CA031983 · NCI · UNIVERSITY OF MARYLAND BALTIMORE · PI EDELMAN, MARTIN J · 1985 to 2002
$271k
CANCER AND LEUKEMIA GROUP B: RPMI/SUNYABU10CA002599 · NCI · ROSWELL PARK CANCER INSTITUTE · PI HENDERSON, EDWARD S. · 1985 to 1987
–
NCI NIH HHS CA02599NCI NIH HHS CA03927NCI NIH HHS CA31946NCI NIH HHS CA31983NCI NIH HHS CA32291NCI NIH HHS CA33601NCI NIH HHS CA35279NCI NIH HHS CA41287NCI NIH HHS CA47559NCI NIH HHS CA77440NCI NIH HHS CA77658NCI NIH HHS U10 CA003927NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032291NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035279NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA047559NCI NIH HHS U10 CA077440NCI NIH HHS U10 CA077658
6 · The paper itself

Abstract

Cancer and Leukemia Group B 19808 (CALGB 19808) is the only randomized trial of a second-generation P-glycoprotein (Pgp) modulator in untreated patients with acute myeloid leukemia (AML) younger than age 60 years. We randomly assigned 302 patients to receive induction chemotherapy regimens consisting of cytosine arabinoside (Ara-C; A), daunorubicin (D), and etoposide (E), without (ADE) or with (ADEP) PSC-833 (P). The incidence of complete remission was 75% with both regimens. Reversible grade 3 and 4 liver and mucosal toxicities were significantly more common with ADEP. Therapy-related mortality was 7% and did not differ by induction arm. Excess cardiotoxicity was not seen with high doses of D in ADE. The median disease-free survival was 1.34 years in the ADE arm and 1.09 years in the ADEP arm (P = .74, log-rank test); the median overall survival was 1.86 years in the ADE arm and 1.69 years in the ADEP arm (P = .82). There was no evidence of a treatment difference within any identifiable patient subgroup. Inhibition of Pgp-mediated drug efflux by PSC-833 did not improve clinical outcomes in younger patients with untreated AML. This trial was registered at www.clinicaltrials.gov as #NCT00006363.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily B, Member 1CyclosporinsCytarabineDaunorubicinEtoposideFemaleHumansLeukemia, Myeloid, AcuteMaleMiddle AgedRemission InductionSurvival RateTreatment OutcomeATP Binding Cassette Transporter, Subfamily B, Member 1CyclosporinsCytarabineDaunorubicinEtoposidevalspodar

Identifiers

PMID20522709
PMCPMC2938834
OpenAlexW2025941747

What OpenQuestion holds

Textmetadata
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.