Evidence map›Paper›PMID 33656660›Full record

Observational studyAmerican journal of clinical dermatology2021

The PROVe Study: US Real-World Experience with Chlormethine/Mechlorethamine Gel in Combination with Other Therapies for Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma.

Ellen J Kim, Joan Guitart, Christiane Querfeld, Michael Girardi, Amy Musiek, Oleg E Akilov, James T Angello, William L Bailey, Larisa J Geskin

Erratum issued Registry-linked trialOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in American journal of clinical dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06421571 (A Greek, Prospective Non-interventional Study Investigating the Effectiveness and the Mechanism of Action of Chlormethine), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
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.

NCT06421571 unknown statusnot on this mapstarted 2023, after this paper: background citation

A Greek, Prospective Non-interventional Study Investigating the Effectiveness and the Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients

TypeobservationalSponsorNational and Kapodistrian University of AthensRan2023 to 2025Enrolled40ConditionsMycosis Fungoides
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 39 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 1 country.

Ellen J KimDepartment of Dermatology, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA. Ellen.Kim@pennmedicine.upenn.edu.ORCID http://orcid.org/0000-0001-9099-7614
Joan GuitartNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Christiane QuerfeldDivision of Dermatology, City of Hope, Duarte, CA, USA.
Michael GirardiDepartment of Dermatology, Yale School of Medicine, New Haven, CT, USA.
Amy MusiekDivision of Dermatology, Washington University School of Medicine, St. Louis, MO, USA.
Oleg E AkilovDepartment of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
James T AngelloHelsinn Therapeutics (U.S.) Inc., Iselin, NJ, USA.
William L BaileyHelsinn Therapeutics (U.S.) Inc., Iselin, NJ, USA.
Larisa J GeskinDepartment of Dermatology, Columbia University, New York, NY, USA.
Helsinn Therapeutics (United States) · USCity of Hope · USColumbia University · USNorthwestern University · USUniversity of Pennsylvania · USUniversity of Pittsburgh Medical Center · USWashington University in St. Louis · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundChlormethine/mechlorethamine gel is a skin-directed therapy for patients with mycosis fungoides cutaneous T-cell lymphoma. Currently, real-world data on chlormethine gel are lacking.

objectiveOur objective was to analyze the effect of chlormethine gel in combination with other therapies on efficacy, safety, and health-related quality of life in a real-world setting.

methodsThis prospective, observational study enrolled adult patients actively using chlormethine gel. Patients were monitored for up to 2 years during standard-of-care clinic visits. No specific visit schedules or clinical assessments, with the exception of patient-completed questionnaires, were mandated because of the expected variability in practice patterns. The primary efficacy endpoint was the proportion of patients with stage IA-IB disease receiving chlormethine + topical corticosteroids + other with ≥ 50% decrease in body surface area from baseline to 12 months. Response was assessed at each visit using by-time analysis, which investigates the trend to treatment response and allows assessment of response over time. Health-related quality of life was assessed with the Skindex-29 questionnaire.

resultsIn total, 298 patients were monitored. At 12 months post-treatment initiation, 44.4% (chlormethine + topical corticosteroids + other) and 45.1% (patients receiving chlormethine + other treatment) of efficacy-evaluable patients were responders. By-time analysis demonstrated that peak response occurred (chlormethine + other; 66.7%) at 18 months. There was a significant correlation between responder status and lower post-baseline Skindex-29 scores.

conclusionsThis real-world study confirmed that chlormethine gel is an important therapeutic option for patients with mycosis fungoides and contributes to reducing the severity of skin lesions and improving health-related quality of life.

Indexed as

Administration, CutaneousAdministration, OralAgedAntineoplastic Agents, AlkylatingAntineoplastic Combined Chemotherapy ProtocolsDrug Administration ScheduleFemaleFollow-Up StudiesGelsHumansMaleMechlorethamineMiddle AgedMycosis FungoidesNeoplasm StagingProspective StudiesAntineoplastic Agents, AlkylatingGelsMechlorethamine

Identifiers

PMID33656660
PMCPMC8068681
OpenAlexW3134176584

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.