PMID- 35536441
OWN - NLM
STAT- MEDLINE
DCOM- 20220801
LR  - 20221031
IS  - 1179-1888 (Electronic)
IS  - 1175-0561 (Print)
IS  - 1175-0561 (Linking)
VI  - 23
IP  - 4
DP  - 2022 Jul
TI  - Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with 
      Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data.
PG  - 561-570
LID - 10.1007/s40257-022-00687-y [doi]
AB  - BACKGROUND: Chlormethine 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. OBJECTIVE: To expand these 
      results by performing a post-hoc analysis of study 202. PATIENTS AND METHODS: 
      Patients 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. 
      RESULTS: No 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. CONCLUSIONS: This 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.
CI  - (c) 2022. The Author(s).
FAU - Querfeld, Christiane
AU  - Querfeld C
AD  - City of Hope Cancer Center and Beckman Research Institute, 1500 East Duarte Rd, 
      Duarte, CA, 91010, USA. cquerfeld@coh.org.
FAU - Scarisbrick, Julia J
AU  - Scarisbrick JJ
AD  - University of Birmingham, Birmingham, UK.
FAU - Assaf, Chalid
AU  - Assaf C
AD  - Department of Dermatology and Venerology, Helios Klinikum Krefeld, Krefeld, 
      Germany.
AD  - Academic Teaching Hospital of the University of Aachen, Aachen, Germany.
FAU - Kim, Youn H
AU  - Kim YH
AD  - Department of Dermatology, Stanford Cancer Center, Stanford, CA, USA.
FAU - Guitart, Joan
AU  - Guitart J
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
FAU - Quaglino, Pietro
AU  - Quaglino P
AD  - Department of Medical Sciences, Dermatology Clinic, University of Turin, Turin, 
      Italy.
FAU - Hodak, Emmilia
AU  - Hodak E
AD  - Division of Dermatology, Rabin Medical Center, Beilinson Hospital, Petah Tikvah, 
      Israel.
AD  - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
LA  - eng
SI  - ClinicalTrials.gov/NCT00168064
SI  - ClinicalTrials.gov/NCT00535470
PT  - Journal Article
DEP - 20220510
PL  - New Zealand
TA  - Am J Clin Dermatol
JT  - American journal of clinical dermatology
JID - 100895290
RN  - 0 (Gels)
RN  - 0 (Ointments)
RN  - 50D9XSG0VR (Mechlorethamine)
SB  - IM
MH  - Clinical Trials as Topic
MH  - Dermatitis, Contact/epidemiology
MH  - Gels
MH  - Humans
MH  - *Mechlorethamine/adverse effects
MH  - *Mycosis Fungoides/drug therapy
MH  - Ointments
MH  - *Skin Neoplasms/drug therapy
MH  - Treatment Outcome
PMC - PMC9334402
COIS- C. Querfeld: Research grant: Celgene; clinical investigator: Helsinn, Celgene, 
      Trillium, miRagen, Bioniz, Kyowa Kirin; advisory board: Helsinn, miRagen, Bioniz, 
      Almirall, Trillium, Kyowa Kirin, Stemline Therapeutics. J.J. Scarisbrick: 
      Consultancy: Takeda, Helsinn, Recordati, 4SC, Kyowa, Mallinckrodt, miRagen; 
      research grant: Kyowa. C. Assaf: Advisory board: 4SC, Takeda, Helsinn, Innate 
      Pharma, Recordati Rare Diseases, Kyowa. Y.H. Kim: Steering committee and research 
      funding: Eisai; research funding: Forty Seven; advisory board member: Seattle 
      Genetics; steering committee member, advisory board, and research funding: Kyowa 
      Hakko Kirin; research funding: Portola, Horizon; research funding: Soligenix; 
      steering committee, advisory board, research funding: Innate; research funding: 
      Elorac; advisory board and research funding: Galderma; steering committee and 
      research funding: Corvus; research funding Trillium. J. Guitart: Research 
      support: Galderma, Soligenix; scientific advisory board: Kyowa Kirin. P. 
      Quaglino: Advisory board: 4SC, Takeda, Actelion, Innate Pharma, Helsinn, 
      Recordati Rare Diseases, Kyowa, Therakos. E. Hodak: Scientific advisory board: 
      Actelion, Helsinn, Recordati Rare Diseases, Takeda; speakers' bureau: Helsinn, 
      Rafa, Takeda.
EDAT- 2022/05/11 06:00
MHDA- 2022/08/02 06:00
PMCR- 2022/05/10
CRDT- 2022/05/10 11:18
PHST- 2022/03/17 00:00 [accepted]
PHST- 2022/05/11 06:00 [pubmed]
PHST- 2022/08/02 06:00 [medline]
PHST- 2022/05/10 11:18 [entrez]
PHST- 2022/05/10 00:00 [pmc-release]
AID - 10.1007/s40257-022-00687-y [pii]
AID - 687 [pii]
AID - 10.1007/s40257-022-00687-y [doi]
PST - ppublish
SO  - Am J Clin Dermatol. 2022 Jul;23(4):561-570. doi: 10.1007/s40257-022-00687-y. Epub 
      2022 May 10.