Evidence map›Paper›PMID 18591543›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008

Low-dose interleukin-2 immunotherapy does not improve outcome of patients age 60 years and older with acute myeloid leukemia in first complete remission: Cancer and Leukemia Group B Study 9720.

Maria R Baer, Stephen L George, Michael A Caligiuri, Ben L Sanford, Sandra M Bothun, Krzysztof Mrózek, Jonathan E Kolitz, Bayard L Powell, Joseph O Moore, Richard M Stone and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
5.8field-weighted citation impact, top 4% 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

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 131 citations in OpenAlex.

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  10. 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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  13. Comparison of reduced-intensity hematopoietic cell transplantation with chemotherapy in patients age 60-70 years with acute myelogenous leukemia in first remission.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2011
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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

13 authors at 6 institutions in 1 country.

Maria R BaerUniversity of Maryland Greenebaum Cancer Center, Baltimore, MD 21201, USA. mbaer@umm.edu
Stephen L George
Michael A Caligiuri
Ben L Sanford
Sandra M Bothun
Krzysztof Mrózek
Jonathan E Kolitz
Bayard L Powell
Joseph O Moore
Richard M Stone
John Anastasi
Clara D Bloomfield
Richard A Larson
Roswell Park Comprehensive Cancer Center · USDuke University Hospital · USDana-Farber Cancer Institute · USDuke Medical Center · USNorth Shore University Hospital · USU-M Rogel Cancer Center

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
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 BU10CA047577 · NCI · DUKE UNIVERSITY · PI CRAWFORD, JEFFREY · 1988 to 2013
$2.2M
CANCER AND LEUKEMIA GROUP B (CALGB)U10CA003927 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI HURD, DAVID D. · 1985 to 2008
$2.2M
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 CA47577NCI NIH HHS CA77658NCI NIH HHS U10 CA033601
6 · The paper itself

Abstract

purposeCancer and Leukemia Group B (CALGB) 9720 evaluated subcutaneous low-dose recombinant interleukin-2 (rIL-2) maintenance immunotherapy as a strategy for prolonging remission in older patients with acute myeloid leukemia (AML). PATIENTS AND

methodsAML patients age 60 years and older in first complete remission after induction and consolidation chemotherapy were randomly assigned to no further therapy or a 90-day regimen of 14-day cycles of low-dose rIL-2, aimed at expanding natural killer (NK) cells, followed by 3-day higher doses aimed at activating cytotoxicity of expanded NK cells to lyse residual AML cells. All randomly assigned patients were included in an intention-to-treat analysis.

resultsA total of 163 (64%) of 254 patients who completed induction and consolidation chemotherapy on CALGB 9720 were randomly assigned to rIL-2 (n = 81) or no further therapy (n = 82); the most common reasons for lack of random assignment were patient refusal and relapse. Fifteen patients randomly assigned to rIL-2 never initiated it because of refusal, intercurrent medical problems, or relapse, and 24 patients initiated rIL-2 but stopped early because of toxicity or relapse. Grade 4 toxicities during rIL-2 therapy included thrombocytopenia (65%) and neutropenia (64%), and grade 3 toxicities included anemia (33%), infection (24%) and malaise/fatigue (14%). Forty-two patients (52%) randomly assigned to rIL-2 completed the full 90-day course. Patients in both arms had similar distributions of both disease-free (combined median = 6.1 months; P = .47) and overall survival (combined median = 14.7 months; P = .61) after random assignment. Moreover, the 42 patients who completed all planned therapy did not show prolongation of disease-free or overall survival.

conclusionLow-dose rIL-2 maintenance immunotherapy is not a successful strategy in older AML patients.

Indexed as

AgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDrug Resistance, MultipleDrug Resistance, NeoplasmFemaleHumansImmunotherapyInterleukin-2Leukemia, Myeloid, AcuteMaleMiddle AgedRemission InductionSurvival RateTreatment OutcomeAntineoplastic AgentsInterleukin-2

Identifiers

PMID18591543
PMCPMC2652081
OpenAlexW2033525557

What OpenQuestion holds

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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.