Evidence map›Paper›PMID 23787123›Full record

Trial reportClinical lymphoma, myeloma & leukemia2013

Subcutaneous omacetaxine mepesuccinate in patients with chronic-phase chronic myeloid leukemia previously treated with 2 or more tyrosine kinase inhibitors including imatinib.

Jorge E Cortes, Franck E Nicolini, Meir Wetzler, Jeffrey H Lipton, Luke Akard, Adam Craig, Nisha Nanda, Annie-Claude Benichou, Janis Leonoudakis, H Jean Khoury and 3 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical lymphoma, myeloma & leukemia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
5.3field-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

20 citing papers in PubMed, 65 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Omacetaxine: a protein translation inhibitor for treatment of chronic myelogenous leukemia.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
    Article
  16. Targeting translation initiation in breast cancer.Translation (Austin, Tex.) · 2014
    Review
  17. Review
  18. Observational
  19. Article
  20. Cephalotaxus Alkaloids.The Alkaloids. Chemistry and biology
    Review
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 10 institutions in 7 countries.

Jorge E CortesThe University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: jcortes@mdanderson.org.
Franck E Nicolini
Meir Wetzler
Jeffrey H Lipton
Luke Akard
Adam Craig
Nisha Nanda
Annie-Claude Benichou
Janis Leonoudakis
H Jean Khoury
Andreas Hochhaus
Michele Baccarani
Hagop M Kantarjian
The University of Texas MD Anderson Cancer Center · USEmory University · USFranciscan Health Indianapolis · USHôpital Lyon Sud · FRJena University Hospital · DEPrincess Margaret Cancer Centre · CARoswell Park Comprehensive Cancer Center · USStragen (France) · FRTeva Pharmaceuticals (Czechia) · CZUniversity of Bologna · IT

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THALL, PETER F · 1990 to 2014
$41.8M
NCI NIH HHS CA016672NCI NIH HHS P01 CA049639NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

introductionOmacetaxine mepesuccinate (omacetaxine) is a first-in-class cephalotaxine that has demonstrated efficacy in CML. In this analysis we evaluated omacetaxine in CML patients with resistance or intolerance to 2 or more tyrosine kinase inhibitors (TKIs). PATIENTS AND

methodsData were pooled from 2 phase II trials of subcutaneous omacetaxine, administered at 1.25 mg/m(2) twice daily for 14 consecutive days every 28 days until response, then for 7 days every 28 days as maintenance. Patients with resistance or intolerance to imatinib and at least 1 other approved TKI (dasatinib and/or nilotinib) were included; results for patients in chronic phase (CP) are reported here. Major cytogenetic response (MCyR) was the primary end point.

resultsEighty-one patients with CML-CP (median age, 59 years; range, 26-83 years) were included in the analysis. All patients previously received imatinib, 69 (85%) previously received dasatinib, and 48 (59%) previously received nilotinib. Median omacetaxine exposure was 7.5 months (range, 0.03-38.6 months), with 13 patients ongoing. MCyR was reported in 16 patients (20%; one-sided 95% lower confidence limit, 12.8%), including 8 complete responses; median duration was 17.7 months (95% confidence interval, 4.1 months - not reached). Fifty-six patients (69%) achieved and/or maintained hematologic response for at least 8 weeks; median duration was 12.2 months (range, 8.4-26.2 months). Median failure-free and overall survival were 9.6 months and 34 months, respectively. Toxicity was mainly hematologic: the most common grade 3/4 adverse events were thrombocytopenia (67%), neutropenia (47%), and anemia (37%).

conclusionOmacetaxine produced clinically meaningful responses with acceptable tolerability in patients with CML-CP previously treated with 2 or more TKIs.

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBenzamidesDrug Administration ScheduleFemaleHarringtoninesHomoharringtonineHumansImatinib MesylateInfusions, SubcutaneousLeukemia, Myeloid, Chronic-PhaseMaleAngiogenesis InhibitorsAntineoplastic Agents, PhytogenicBenzamidesHarringtoninesHomoharringtonineImatinib MesylatePiperazinesProtein Kinase InhibitorsPyrimidinesDasatinibHomoharringtonineIntoleranceNilotinibResistance

Identifiers

PMID23787123
PMCPMC3775895
OpenAlexW2047725399

What OpenQuestion holds

Textmetadata
LicenceTDM
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.