Evidence map›Paper›PMID 19821823›Full record

Trial reportBritish journal of haematology2010

Sequential phase II Southwest Oncology Group studies (S0112 and S0301) of daunorubicin and cytarabine by continuous infusion, without and with ciclosporin, in older patients with previously untreated acute myeloid leukaemia.

Thomas R Chauncey, Holly Gundacker, Mazyar Shadman, Alan F List, Shaker R Dakhil, Harry P Erba, Marilyn L Slovak, I-Ming Chen, Cheryl L Willman, Kenneth J Kopecky and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine.Proceedings of the National Academy of Sciences of the United States of America · 2010
    Trial
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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

11 authors at 9 institutions in 1 country.

Thomas R ChaunceyUniversity of Washington, Seattle, 98108, USA. tchaunce@u.washington.edu
Holly Gundacker
Mazyar Shadman
Alan F List
Shaker R Dakhil
Harry P Erba
Marilyn L Slovak
I-Ming Chen
Cheryl L Willman
Kenneth J Kopecky
Frederick R Appelbaum
SWOG Cancer Research Network · USUniversity of New Mexico · USCancer Research And Biostatistics · USCity Of Hope National Medical Center · USFred Hutch Cancer Center · USMoffitt Cancer Center · USUniversity of Michigan–Ann Arbor · USUniversity of Washington · USWichita Clinic · US

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035261 · NCI · GRANT/RIVERSIDE METHODIST HOSPITALS · PI KUEBLER, PHILIP J. · 1985 to 2014
$10.6M
KANSAS CITY COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035176 · NCI · NCI COMMUNITY ONCOLOGY RESEARCH PROGRAM · PI GAUR, RAKESH · 1985 to 2014
$8.0M
Montana Cancer Consortium CCOPU10CA067575 · NCI · MONTANA CANCER CONSORTIUM · PI MARCHELLO, BENJAMIN T. · 1995 to 2013
$6.5M
LSU MEDICAL CENTER MINORITY CCOPU10CA063845 · NCI · LSU HEALTH SCIENCES CENTER · PI VEITH, ROBERT W · 1994 to 2014
$6.4M
NCI NIH HHS CA11083NCI NIH HHS CA35090NCI NIH HHS CA35128NCI NIH HHS CA35261NCI NIH HHS CA37981NCI NIH HHS CA45808NCI NIH HHS CA46113NCI NIH HHS CA46282NCI NIH HHS CA58416NCI NIH HHS CA58658NCI NIH HHS CA58861NCI NIH HHS CA63845NCI NIH HHS CA74647NCI NIH HHS CA76462NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035261NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037981NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046113NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058416NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA063845NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA074647
6 · The paper itself

Abstract

Attempts to overcome multi-drug resistance in acute myeloid leukaemia (AML) have been limited by toxicities. To investigate the effect of reducing peak drug levels, we performed sequential phase II studies using continuous infusion daunorubicin and cytarabine without (AD) and then with ciclosporin (ADC) in older patients with AML. Untreated patients (age 56+ years) received daunorubicin (45 mg/m2 per day for 3 d) and cytarabine (200 mg/m2 per day for 7 d), both by continuous infusion, without (S0112, 60 patients) and then with (S0301, 50 patients) the addition of ciclosporin. Complete response (CR) rates were 38% on S0112 and 44% on S0301. Fatal induction toxicities occurred in 17% and 12% respectively, arising primarily from infection and haemorrhage. Median overall and relapse-free survival was 7 and 8 months for AD respectively, and 6 and 14 months for ADC. Patients with phenotypic or functional P-glycoprotein had somewhat higher CR rates with ADC than AD, although confidence intervals overlapped. In these sequential trials, continuous infusion AD produced CR rates comparable to those with bolus daunorubicin. The addition of ciclosporin did not cause undue toxicities, produced a similar CR rate, and possibly improved relapse-free survival. Further correlate analyses did not identify a subpopulation specifically benefitting from the addition of ciclosporin.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily B, Member 1CyclosporineCytarabineDaunorubicinDrug Resistance, MultipleDrug Resistance, NeoplasmEpidemiologic MethodsFemaleHumansInfusions, IntravenousLeukemia, Myeloid, AcuteMaleMiddle AgedATP Binding Cassette Transporter, Subfamily B, Member 1CyclosporineCytarabineDaunorubicinNeoplasm Proteins

Identifiers

PMID19821823
PMCPMC2967366
OpenAlexW1909015307

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.