Evidence map›Paper›PMID 39315857›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

Health-related quality of life in cutaneous T-cell lymphoma: A post hoc analysis of a phase 3 trial in mycosis fungoides and Sézary syndrome.

P L Ortiz Romero, Y H Kim, K Molloy, P Quaglino, J Scarisbrick, S Thornton, K Sandilands, J E Dent, A Nixon, A Williams and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01728805 (Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT01728805 phase3completednot on this map

Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

TypeinterventionalSponsorKyowa Kirin, Inc.Ran2012 to 2021Enrolled372ConditionsCutaneous T-Cell LymphomaArmsKW-0761, Vorinostat
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. 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

11 authors.

P L Ortiz RomeroHospital 12 de Octubre, Medical School, University Complutense, Madrid, Spain.
Y H KimStanford University School of Medicine and Cancer Institute, Stanford, CA, USA.
K MolloyTallaght University Hospital/Trinity College Dublin, Dublin, Ireland.
P QuaglinoUniversity of Turin, Turin, Italy.ORCID https://orcid.org/0000-0003-4185-9586
J ScarisbrickUniversity Hospital Birmingham, Birmingham, UK.
S ThorntonSusan Thornton, Cutaneous Lymphoma Foundation, Philadelphia, PA, USA.
K SandilandsKyowa Kirin International, Marlow, UK.
J E DentChilli Consultancy, Salisbury, UK.
A NixonChilli Consultancy, Salisbury, UK.ORCID https://orcid.org/0000-0003-3454-9491
A WilliamsKyowa Kirin International, Marlow, UK.
M M ShinoharaUniversity of Washington and Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID https://orcid.org/0000-0003-1388-5330

Funding

Kyowa Kirin Services Ltd, Galabank Business Park, Galashiels, Scotland TD1 1QH
6 · The paper itself

Abstract

backgroundMycosis fungoides (MF) and Sézary syndrome (SS) are common subtypes of cutaneous T-cell lymphoma that primarily affect the skin but may spread to the lymph nodes, viscera and blood. The symptom burden may compromise health-related quality of life (HRQL). The phase 3 MAVORIC study (ClinicalTrials.gov identifier NCT01728805) in patients with relapsed/refractory MF/SS reported improved HRQL with mogamulizumab compared with vorinostat.

objectivesUse baseline (pre-treatment) data from the MAVORIC study to describe the symptom burden of MF/SS and identify characteristics associated with worse HRQL.

methodsData were from 372 adults with stage IB-IVB histologically confirmed relapsed/ refractory MF or SS. Associations between demographic and medical history variables and worse HRQL (Skindex-29, ItchyQol and Functional Assessment of Cancer Therapy - General [FACT-G]) were determined by regression models.

resultsIn the cohort of 372 adults, 70% were white; 42% were female; mean age was 63 (SD 13.0) years. Fifty-five per cent had MF and 45% had SS; 77% had advanced (stage IIB-IV) disease, involving the skin in all patients and the blood and/or nodes in 66%. HRQL scores showed impairment versus normative means (where available), with the greatest impact on Symptoms and Emotions in the Skindex-29, Functioning in the ItchyQol, and Functional Wellbeing in the FACT-G. In regression analysis, worse HRQL across all domains and total score was associated with being female and younger, worse mSWAT score and worse itch for the Skindex-29 (n = 352), and being female, younger, Black/African American, worse performance status and worse itch for the ItchyQol (n = 369). Associations across domains and total score were not found for the FACT-G. Associations between domains and demographic/medical history were seen for all instruments.

conclusionsThe symptoms of advanced MF/SS compromise all HRQL domains. Treatment goals and therapeutic choice should be informed by individual patients' disease burden.

Indexed as

Mycosis FungoidesQuality of LifeSezary SyndromeSkin NeoplasmsAdultAgedAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, Humanized

Identifiers

PMID39315857
PMCPMC11934017

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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.