Evidence map›Paper›PMID 21760592›Full record

ArticleLeukemia2011

A phase Ib study of vosaroxin, an anticancer quinolone derivative, in patients with relapsed or refractory acute leukemia.

J E Lancet, F Ravandi, R M Ricklis, L D Cripe, H M Kantarjian, F J Giles, A F List, T Chen, R S Allen, J A Fox and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Leukemia, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01913951 (A Phase I Study of Vosaroxin Plus Azacitidine for Patients With Myelodysplastic Syndrome), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

NCT01913951 phase1completednot on this mapstarted 2013, after this paper: background citation

A Phase I Study of Vosaroxin Plus Azacitidine for Patients With Myelodysplastic Syndrome

TypeinterventionalSponsorWashington University School of MedicineRan2013 to 2024Enrolled35ConditionsMyelodysplastic SyndromesArmsvosaroxin, Azacitidine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Establishing a Preclinical Multidisciplinary Board for Brain Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Article
  8. Article
  9. Article
  10. Emerging therapies for acute myeloid leukemia.Journal of hematology & oncology · 2017
    Review
  11. Review
  12. Review
  13. Review
  14. New drugs in acute myeloid leukemia.Annals of oncology : official journal of the European Society for Medical Oncology · 2016
    Review
  15. Review
  16. Review
  17. Article
  18. Novel therapeutics in acute myeloid leukemia.Current hematologic malignancy reports · 2014
    Review
  19. Novel and emerging drugs for acute myeloid leukemia.Current cancer drug targets · 2012
    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

12 authors at 7 institutions in 1 country.

J E LancetDepartment of Malignant Hematology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA. jeffrey.lancet@moffitt.org
F Ravandi
R M Ricklis
L D Cripe
H M Kantarjian
F J Giles
A F List
T Chen
R S Allen
J A Fox
G C Michelson
J E Karp
Sunesis (United States) · USJohns Hopkins University · USThe University of Texas MD Anderson Cancer Center · USIndiana University Bloomington · USMoffitt Cancer Center · USThe University of Texas Health Science Center at San Antonio · USUniversity of South Florida · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

This study of vosaroxin evaluated dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), pharmacokinetics (PK), clinical activity and pharmacodynamics in relapsed/refractory leukemia. Dosing was weekly (days 1, 8 and 15) or twice weekly (days 1, 4, 8 and 11). Seventy-three treated patients had a median age of 65 years, 85% had acute myeloid leukemia and 78% had refractory disease. Weekly schedule: 42 patients received 18-90 mg/m(2); MTD was 72 mg/m(2). Twice-weekly schedule: 31 patients received 9-50 mg/m(2); MTD was 40 mg/m(2). DLT was stomatitis; primary non-hematologic toxicity was reversible gastrointestinal symptoms and febrile neutropenia. Thirty-day all-cause mortality was 11%. Five patients had complete or incomplete remissions; median duration was 3.1 months. A morphologic leukemia-free state (bone marrow blast reduction to <5%) occurred in 11 additional patients. Antileukemic activity was associated with total dose or weekly time above 1 μmol/l plasma vosaroxin concentration (P<0.05). Vosaroxin exposure was dose proportional over 9-90 mg/m(2). The average terminal half-life was ~25 h and clearance was non-renal. No induction or inhibition of vosaroxin metabolism was evident. Vosaroxin-induced DNA damage was detected as increased intracellular γH2AX. Vosaroxin had an acceptable safety profile, linear PK and encouraging clinical activity in relapsed/refractory leukemia.

Indexed as

Salvage TherapyAdultAgedAged, 80 and overDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansLeukemia, Myeloid, AcuteMaleMiddle AgedNaphthyridinesNeoplasm Recurrence, LocalNeoplasm StagingPrecursor Cell Lymphoblastic Leukemia-LymphomaThiazolesNaphthyridinesThiazolesvosaroxin

Identifiers

PMID21760592
PMCPMC4576993
OpenAlexW2068449076

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.