Evidence map›Paper›PMID 20952518›Full record

ArticleHaematologica2011

Phase I study of sorafenib in patients with refractory or relapsed acute leukemias.

Gautam Borthakur, Hagop Kantarjian, Farhad Ravandi, Weiguo Zhang, Marina Konopleva, John J Wright, Stefan Faderl, Srdan Verstovsek, Sheela Mathews, Michael Andreeff and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Haematologica, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00217646 (Phase I Study of BAY 43-9006), which is not on this map. Cited by 117 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 3 pooled it
6.4field-weighted citation impact, top 3% 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.

NCT00217646 phase1completednot on this map

Phase I Study of BAY 43-9006 (NSC 724772) in Patients With Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2005Enrolled36ConditionsAdult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic LeukemiaArmsSorafenib Tosylate
3 · Its place in the literature

Who cites it

117 citing papers in PubMed, 3 syntheses or guidelines pooled it, 204 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Precision medicine in AML: overcoming resistance.International journal of hematology · 2024
    Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review

57 more citing papers are in PubMed but not listed here.

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 3 institutions in 2 countries.

Gautam BorthakurLeukemia Department, University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA.
Hagop Kantarjian
Farhad Ravandi
Weiguo Zhang
Marina Konopleva
John J Wright
Stefan Faderl
Srdan Verstovsek
Sheela Mathews
Michael Andreeff
Jorge E Cortes
The University of Texas MD Anderson Cancer Center · USLeukemia Research Foundation · USNational Institutes of Health · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Phase I Studies of Targeted Anti-Cancer TherapiesU01CA062461 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI YAO, JAMES C · 1994 to 2013
$7.2M
NCI NIH HHS U01 CA062461NCI NIH HHS U01CA062461
6 · The paper itself

Abstract

unlabelledBackground Sorafenib is a multi-kinase inhibitor with activity against fms-like tyrosine kinase 3 with internal tandem duplication mutation and Raf kinase among others. A phase I dose escalation study of sorafenib was conducted in patients with advanced myelodysplastic syndrome and relapsed or refractory acute leukemias. DESIGN AND

methodsFifty patients received one of two different schedules; Schedule "A": once or twice daily, five days per week, every week for a 21 day cycle, and Schedule "B": once or twice daily, for 14 days every 21 days. Dose limiting toxicities were grade 3/4 hypertension, hyperbilirubinemia, and amylase elevation. The recommended phase II dose in hematologic malignancies is 400 mg twice daily for both schedules.

resultsComplete remissions or complete remissions with incomplete recovery of platelets were achieved in 5 (10%) patients (all with fms-like tyrosine kinase 3-internal tandem duplication). Significant reduction in bone marrow and/or peripheral blood blasts was seen in an additional 17 (34%) patients (all with fms-like tyrosine kinase 3-internal tandem duplication). Eleven of these responses (including 3 complete remissions/complete remissions with incomplete recovery) lasted for 2 cycles or beyond. In conclusion, sorafenib is active and well tolerated in acute myelogenous leukemia with fms-like tyrosine kinase 3 internal tandem duplication mutation. Conclusions Additional studies of sorafenib in patients with acute myelogenous leukemia, particularly those with fms-like tyrosine kinase 3 internal tandem duplication, are warranted, including sorafenib-based combinations. (ClinicalTrials.gov Identifier: NCT00217646).

Indexed as

AdultAgedAged, 80 and overBenzenesulfonatesFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesNeoplasm Recurrence, LocalNiacinamidePhenylurea CompoundsPrecursor Cell Lymphoblastic Leukemia-LymphomaPrognosisBenzenesulfonatesNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsPyridinesSorafenib

Identifiers

PMID20952518
PMCPMC3012766
OpenAlexW1985620267

What OpenQuestion holds

Textmetadata
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.