Evidence map›Paper›PMID 22915641›Full record

Trial reportBlood2012

Phase 2 study of the lenalidomide and azacitidine combination in patients with higher-risk myelodysplastic syndromes.

Mikkael A Sekeres, Ramon V Tiu, Rami Komrokji, Jeffrey Lancet, Anjali S Advani, Manuel Afable, Ricki Englehaupt, Joyce Juersivich, David Cuthbertson, Jennifer Paleveda and 7 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
11.2field-weighted citation impact, top 1% 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

56 citing papers in PubMed, 131 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Review
  10. Frontline treatment options for higher-risk MDS: can we move past azacitidine?Hematology. American Society of Hematology. Education Program · 2023
    Article
  11. Article
  12. Article
  13. Review
  14. Azacitidine-induced myopericarditis in acute myeloid leukemia.Proceedings (Baylor University. Medical Center) · 2022
    Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. [Research Progress of Epigenetics in Pathogenesis and Treatment of Malignant Tumors].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2020
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 1 country.

Mikkael A SekeresLeukemia Program, Department of Hematologic Oncology and Blood Disorders, Cleveland Clinic Taussig Cancer Institute, 9500 Euclid Ave, Cleveland, OH 44195, USA. sekerem@ccf.org
Ramon V Tiu
Rami Komrokji
Jeffrey Lancet
Anjali S Advani
Manuel Afable
Ricki Englehaupt
Joyce Juersivich
David Cuthbertson
Jennifer Paleveda
Ali Tabarroki
Valeria Visconte
Hideki Makishima
Andres Jerez
Ronald Paquette
Alan F List
Jaroslaw P Maciejewski
Cleveland Clinic · USMoffitt Cancer Center · USUniversity of California, Los Angeles · USUniversity of South Florida · US

Funding

BONE MARROW FAILURE CLINICAL RESEARCH CENTERU54RR019397 · NCRR · CLEVELAND CLINIC LERNER COM-CWRU · PI MACIEJEWSKI, JAROSLAW P. · 2003 to 2008
$5.3M
Training/Research Center-Bone Marrow Failure SyndromesK24HL077522 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI MACIEJEWSKI, JAROSLAW P. · 2005 to 2014
$1.2M
NCRR NIH HHS U54 RR019397NCRR NIH HHS U54RR19397-03NHLBI NIH HHS K24 HL077522
6 · The paper itself

Abstract

Lenalidomide and azacitidine each have activity in myelodysplastic syndromes (MDS) patients, where both microenvironment and cell-regulatory mechanisms contribute to disease pathogenesis. The objective of this multicenter, phase 2 expansion trial was to determine the efficacy and safety of combination therapy with azacitidine (75 mg/m(2)/d for 5 days) and lenalidomide (10 mg/d for 21 days; 28-day cycle) in patients with higher-risk MDS. Among 36 patients enrolled (18 phase 1, 18 phase 2), median age was 68 years (range, 47-78 years) and follow-up was 12 months (range, 3-55 years). IPSS categories included intermediate-1 (n = 5 patients with excess blasts), intermediate-2 (20), and high (11). Common grade 3/4 nonhematologic adverse events included febrile neutropenia (22% of patients), other infection (11%), pulmonary (11%), cardiac (11%), constitutional (11%), and dermatologic (11%). The overall response rate (per modified MDS International Working Group criteria) was 72%: 16 patients (44%) achieved a complete response (CR), and 10 (28%) had hematologic improvement. Median CR duration was 17+ months (range, 3-39+); median overall survival was 37+ months (range, 7-55+) for CR patients, and 13.6 months for the entire cohort (range, 3-55). TET2/DNMT3A/IDH1/2 mutational status was associated with response in a limited number of patients. The lenalidomide/azacitidine combination is well-tolerated and highly active in treating greater-risk MDS.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineCohort StudiesDNA Mutational AnalysisFemaleHumansKaryotypingLenalidomideMaleMiddle AgedMyelodysplastic SyndromesThalidomideTreatment OutcomeAzacitidineLenalidomideThalidomide

Identifiers

PMID22915641
PMCPMC3525020
OpenAlexW1974749085

What OpenQuestion holds

Textmetadata
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.