Evidence map›Paper›PMID 35536441›Full record

ArticleAmerican journal of clinical dermatology2022

Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data.

Christiane Querfeld, Julia J Scarisbrick, Chalid Assaf, Youn H Kim, Joan Guitart, Pietro Quaglino, Emmilia Hodak

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in American journal of clinical dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT00168064 phase2completednot on this map

A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)

TypeinterventionalSponsorYaupon TherapeuticsRan2006 to 2011Enrolled260ConditionsMycosis FungoidesArmsmechlorethamine-MCH (nitrogen mustard)
NCT00535470 phase2completednot on this map

An Open Label Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (Mechlorethamine - MCH) 0.04% Formulation in Patients With Stage I-IIA Mycosis Fungoides Who Have Completed 12 Months Treatment Without a Complete Response

TypeinterventionalSponsorYaupon TherapeuticsRan2007 to 2011Enrolled100ConditionsMycosis FungoidesArms0.04% Mechlorethamine gel
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. 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

7 authors.

Christiane QuerfeldCity of Hope Cancer Center and Beckman Research Institute, 1500 East Duarte Rd, Duarte, CA, 91010, USA. cquerfeld@coh.org.
Julia J ScarisbrickUniversity of Birmingham, Birmingham, UK.
Chalid AssafDepartment of Dermatology and Venerology, Helios Klinikum Krefeld, Krefeld, Germany.
Youn H KimDepartment of Dermatology, Stanford Cancer Center, Stanford, CA, USA.
Joan GuitartNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Pietro QuaglinoDepartment of Medical Sciences, Dermatology Clinic, University of Turin, Turin, Italy.
Emmilia HodakDivision of Dermatology, Rabin Medical Center, Beilinson Hospital, Petah Tikvah, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChlormethine gel was approved for treatment of mycosis fungoides, the most common cutaneous T-cell lymphoma, on the basis of results from study 201 and study 202. A post-hoc analysis of study 201 found interesting trends regarding improved efficacy of chlormethine gel vs ointment and noted a potential association between dermatitis and clinical response.

objectiveTo expand these results by performing a post-hoc analysis of study 202. PATIENTS AND

methodsPatients received chlormethine gel or ointment during study 201 (12 months) and higher-concentration chlormethine gel during study 202 (7-month extension). Response was assessed using Composite Assessment of Index Lesion Severity (CAILS). Associations between treatment frequency, response, and skin-related adverse events (AEs) were assessed using multivariate time-to-event analyses. Time-to-response and repeated measures analyses were compared between patients who only used chlormethine gel and those who switched from ointment to gel.

resultsNo associations were seen between treatment frequency and improved skin response (CAILS) or AE occurrence within the 201/202 study populations. However, an association was observed specifically between contact dermatitis and improved CAILS response at the next visit (p < 0.0001). Patients who used chlormethine gel during both studies had a significantly (p < 0.05) shorter time to response and higher overall response rates than patients who initiated treatment with ointment.

conclusionsThis post-hoc analysis shows that patients who initiated treatment using chlormethine gel had faster and higher responses compared with patients who initially used chlormethine ointment for 12 months. The development of contact dermatitis may be a potential prognostic factor for response. TRIAL REGISTRATION NUMBERS AND DATES OF REGISTRATION: Study 201: NCT00168064, September 14, 2002; Study 202: NCT00535470, September 26, 2007.

Indexed as

MechlorethamineMycosis FungoidesSkin NeoplasmsClinical Trials as TopicDermatitis, ContactGelsHumansOintmentsTreatment OutcomeGelsMechlorethamineOintments

Identifiers

PMID35536441
PMCPMC9334402

What OpenQuestion holds

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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.