Evidence map›Paper›PMID 21902684›Full record

Trial reportBritish journal of haematology2011

Impact of high-risk classification by FISH: an eastern cooperative oncology group (ECOG) study E4A03.

Susanna J Jacobus, Shaji Kumar, Hajime Uno, Scott A Van Wier, Greg J Ahmann, Kimberly J Henderson, Natalie S Callander, Michael E Williams, David S Siegel, Philip R Greipp and 2 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Approach to the Older Adult With Multiple Myeloma.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2019
    Article
  7. Review
  8. Article
  9. Myeloma: management of the newly diagnosed high-risk patient.Hematology. American Society of Hematology. Education Program · 2016
    Review
  10. Article
  11. Article
  12. Lenalidomide in multiple myeloma-a practice guideline.Current oncology (Toronto, Ont.) · 2013
    Article
  13. Article
  14. 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

12 authors.

Susanna J JacobusDana-Farber Cancer Institute, Boston, MA, USA.
Shaji Kumar
Hajime Uno
Scott A Van Wier
Greg J Ahmann
Kimberly J Henderson
Natalie S Callander
Michael E Williams
David S Siegel
Philip R Greipp
S Vincent Rajkumar
Rafael Fonseca

Funding

ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
CHROMOSOMAL ABNORMALITIES IN MYELOMA AS DETECTED BY FISHR01CA083724 · NCI · MAYO CLINIC COLL OF MEDICINE, ROCHESTER · PI FONSECA, RAFAEL · 2000 to 2013
$4.0M
ONCOLOGYU10CA013650 · NCI · MAYO CLINIC ROCHESTER · PI HABERMANN, THOMAS MATTHEW · 1985 to 2013
$3.1M
NCI NIH HHS CA13650NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA66636NCI NIH HHS R01 CA083724NCI NIH HHS U10 CA013650NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA066636NCI NIH HHS U24 CA114737
6 · The paper itself

Abstract

Lenalidomide with dexamethasone is a standard induction treatment regimen for newly diagnosed myeloma (although a Federal Drug Administration indication is still absent). In the context of the Phase 3 clinical trial E4A03 (lenalidomide plus dexamethasone in low or high doses), we queried whether a fluorescence in situ hybridization (FISH)-based genetic classification into high risk (HR) and standard risk (SR) multiple myeloma (MM) would remain clinically significant. Of 445 E4A03 patients, 126 had FISH analysis; 21 were classified HR with t(4;14), t(14;16), or 17p13 deletions. Median survival follow-up approached 3 years. Patients with FISH data tended to be younger and healthier compared to the rest of the study population and, consequently, had superior overall survival (OS) results. Within the FISH cohort, shorter OS in the HR versus SR group (P = 0·004) corresponded to a hazard ratio of 3·48 [95% confidence interval: (1·42-8·53)], an effect also observed in multivariate analysis. Two-year OS rates were 91% for SR MM and 76% for HR MM. There was also evidence of interaction between risk status and treatment (P = 0·026). HR patients were less likely to attain good partial response (SR 46% and HR 30%, Odds Ratio = 2·0 [0·7-5·6]), but overall response rates were not different. FISH-based risk classification retained prognostic significance in patients receiving lenalidomide-based induction.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleHumansIn Situ Hybridization, FluorescenceLenalidomideMaleMiddle AgedMultiple MyelomaPrognosisSurvival AnalysisThalidomideDexamethasoneLenalidomideThalidomide

Identifiers

PMID21902684
PMCPMC3192237

What OpenQuestion holds

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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.