TY - JOUR
T1 - Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides
T2 - A Post-Hoc Analysis of Clinical Trial Data
AU - Querfeld, Christiane
AU - Scarisbrick, Julia J.
AU - Assaf, Chalid
AU - Kim, Youn H.
AU - Guitart, Joan
AU - Quaglino, Pietro
AU - Hodak, Emmilia
N1 - Funding Information:
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.
Funding Information:
The authors would like to acknowledge and thank the volunteers, investigators, and the study teams at the centers participating in these studies, and thank Erminio Bonizzoni, PhD, from the University of Milan, Italy, for performing the statistical analyses for the study. Editorial and medical writing assistance was provided by Judith Land, PhD, from Aptitude Health, The Hague, the Netherlands, funded by Helsinn Healthcare SA. The authors are fully responsible for all content and editorial decisions for this manuscript.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/7
Y1 - 2022/7
N2 - 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.
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.
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U2 - 10.1007/s40257-022-00687-y
DO - 10.1007/s40257-022-00687-y
M3 - Article
C2 - 35536441
AN - SCOPUS:85129842530
SN - 1175-0561
VL - 23
SP - 561
EP - 570
JO - American Journal of Clinical Dermatology
JF - American Journal of Clinical Dermatology
IS - 4
ER -