Document Detail


Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides.
MedLine Citation:
PMID:  23069814     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the efficacy and safety of a novel mechlorethamine hydrochloride, 0.02%, gel in mycosis fungoides. DESIGN Randomized, controlled, observer-blinded, multicenter trial comparing mechlorethamine, 0.02%, gel with mechlorethamine, 0.02%, compounded ointment. Mechlorethamine was applied once daily for up to 12 months. Tumor response and adverse events were assessed every month between months 1 and 6 and every 2 months between months 7 and 12. Serum drug levels were evaluated in a subset of patients.
SETTING: Academic medical or cancer centers.
PATIENTS: In total, 260 patients with stage IA to IIA mycosis fungoides who had not used topical mechlorethamine within 2 years and were naive to prior use of topical carmustine therapy.
MAIN OUTCOME MEASURES: Response rates of all the patients based on a primary clinical end point (Composite Assessment of Index Lesion Severity) and secondary clinical end points (Modified Severity-Weighted Assessment Tool and time-to-response analyses).
RESULTS: Response rates for mechlorethamine gel vs ointment were 58.5% vs 47.7% by the Composite Assessment of Index Lesion Severity and 46.9% vs 46.2% by the Modified Severity-Weighted Assessment Tool. By the Composite Assessment of Index Lesion Severity, the ratio of gel response rate to ointment response rate was 1.23 (95% CI, 0.97-1.55), which met the prespecified criterion for noninferiority. Time-to-response analyses demonstrated superiority of mechlorethamine gel to ointment (P< .01). No drug-related serious adverse events were seen. Approximately 20.3% of enrolled patients in the gel treatment arm and 17.3% of enrolled patients in the ointment treatment arm withdrew because of drug-related skin irritation. No systemic absorption of the study medication was detected.
CONCLUSION: The use of a novel mechlorethamine, 0.02%, gel in the treatment of patients with mycosis fungoides is effective and safe.
TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT00168064.
Authors:
Stuart R Lessin; Madeleine Duvic; Joan Guitart; Amit G Pandya; Bruce E Strober; Elise A Olsen; Christopher M Hull; Elizabeth H Knobler; Alain H Rook; Ellen J Kim; Mark F Naylor; David M Adelson; Alexa B Kimball; Gary S Wood; Uma Sundram; Hong Wu; Youn H Kim
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  JAMA dermatology     Volume:  149     ISSN:  2168-6084     ISO Abbreviation:  JAMA Dermatol     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-02-20     Completed Date:  2013-03-11     Revised Date:  2013-12-13    
Medline Journal Info:
Nlm Unique ID:  101589530     Medline TA:  JAMA Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  25-32     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00168064
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MeSH Terms
Descriptor/Qualifier:
Administration, Cutaneous
Adolescent
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Alkylating / administration & dosage,  adverse effects,  therapeutic use*
Female
Gels
Humans
Male
Mechlorethamine / administration & dosage,  adverse effects,  therapeutic use*
Middle Aged
Mycosis Fungoides / drug therapy*,  pathology
Neoplasm Staging
Ointments
Severity of Illness Index
Single-Blind Method
Skin Neoplasms / drug therapy*,  pathology
Time Factors
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
K24 AR002102/AR/NIAMS NIH HHS; R01 FD003017/FD/FDA HHS
Chemical
Reg. No./Substance:
0/Antineoplastic Agents, Alkylating; 0/Gels; 0/Ointments; 51-75-2/Mechlorethamine
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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