Evidence map›Paper›PMID 28271282›Full record

Trial reportJournal of neuro-oncology2017

Characterization of the peripheral neuropathy associated with brentuximab vedotin treatment of Mycosis Fungoides and Sézary Syndrome.

Zachary A Corbin, Annie Nguyen-Lin, Shufeng Li, Ziba Rahbar, Mahkam Tavallaee, Hannes Vogel, Katrin A Salva, Gary S Wood, Youn H Kim, Seema Nagpal

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of neuro-oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

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

  1. Interventions for mycosis fungoides.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. What factors guide treatment selection in mycosis fungoides and Sezary syndrome?Hematology. American Society of Hematology. Education Program · 2021
    Article
  10. Review
  11. Chemotherapy and peripheral neuropathy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Review
  12. Pain in the Cancer Survivor.Cancer treatment and research · 2021
    Article
  13. Oral mycosis fungoides with CD30JAAD case reports · 2019
    Article
  14. Article
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Zachary A CorbinDivision of Neuro-Oncology, Department of Neurology and Neurological Sciences, Stanford University, 875 Blake Wilbur Drive, CC 2221, Stanford, CA, 94305-5826, USA.
Annie Nguyen-LinDepartment of Dermatology, Stanford University, Stanford, CA, USA.
Shufeng LiDepartment of Dermatology, Stanford University, Stanford, CA, USA.
Ziba RahbarDepartment of Dermatology, Stanford University, Stanford, CA, USA.
Mahkam TavallaeeDepartment of Dermatology, Stanford University, Stanford, CA, USA.
Hannes VogelDepartment of Pathology, Stanford University, Stanford, CA, USA.
Katrin A SalvaDepartment of Dermatology, University of Wisconsin and The Middleton VA Medical Center, Madison, WI, USA.
Gary S WoodDepartment of Dermatology, University of Wisconsin and The Middleton VA Medical Center, Madison, WI, USA.
Youn H KimDepartment of Dermatology, Stanford University, Stanford, CA, USA.
Seema NagpalDivision of Neuro-Oncology, Department of Neurology and Neurological Sciences, Stanford University, 875 Blake Wilbur Drive, CC 2221, Stanford, CA, 94305-5826, USA. snagpal@stanford.edu.

Funding

Skin Diseases Research Center at the University of WisconsinP30AR066524 · NIAMS · UNIVERSITY OF WISCONSIN-MADISON · PI WOOD, GARY S · 2014 to 2018
$2.6M
Spectrum Stanford Center for Clinical and Translational Research and EducationTL1TR001084 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$1.1M
BLRD VA I01 BX002204NCATS NIH HHS TL1 TR001084NIAMS NIH HHS P30 AR066524
6 · The paper itself

Abstract

Chemotherapy-induced peripheral neuropathy (CIPN) is common, frequently limits chemotherapy dosing, and negatively impacts quality of life. The National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0, and the Total Neuropathy Score clinical version (TNSc) are both validated scores to quantify peripheral neuropathy (PN), with the TNSc being more sensitive to clinical changes. Mycosis fungoides and Sézary syndrome (MF/SS) are characterized by a chronic course, where current therapies are generally non-curative and treatment toxicities have the potential for significant lasting effects. Brentuximab vedotin (BV) is an antibody-drug-conjugate composed of an anti-CD30 monoclonal antibody linked to the microtubule-disrupting agent, monomethyl auristatin E, with a known associated CIPN. In our phase II clinical trial of BV in MF/SS, 25 (69%) of 36 patients developed PN, with 18 (50%) developing Clinically Significant PN, CTCAE v4.0 grade 2 or higher. The median time to grade 2 PN was 15 weeks (range 0.4-48) after the initial dose. By Kaplan-Meier calculation, the median time to improvement from Clinically Significant PN was 30 weeks from the last BV dose. Seventy-four percent had improvement by 24 months. We found that TNSc scores significantly correlated with CTCAE grade, with Spearman correlation coefficient 0.68 (p < 0.001). By logistic regression, for each 100 mg increase in BV total dose, the likelihood of developing Clinically Significant PN increased by 23% (95% CI 4-46%). Improved monitoring of CIPN associated with BV is of paramount importance in the MF/SS population.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBrentuximab VedotinFemaleHumansImmunoconjugatesMaleMiddle AgedMycosis FungoidesPeripheral Nervous System DiseasesSezary SyndromeSkin NeoplasmsYoung AdultAntineoplastic AgentsBrentuximab VedotinImmunoconjugatesBrentuximab vedotinChemotherapy-induced peripheral neuropathyMycosis fungoidesNeuropathySézary syndromeTotal neuropathy score

Identifiers

PMID28271282
PMCPMC5955867

What OpenQuestion holds

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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.