Evaluating the Treatment Patterns of Chlormethine/Mechlorethamine Gel in Patients With Stage I-IIA Mycosis Fungoides: By-time Reanalysis of a Randomized Controlled Phase 2 Study.
Clin Lymphoma Myeloma Leuk
; 21(2): 119-124.e4, 2021 02.
Article
in En
| MEDLINE
| ID: mdl-33358692
ABSTRACT
BACKGROUND:
The pivotal 201 Study investigated chlormethine/mechlorethamine gel treatment for patients with early stage disease mycosis fungoides and demonstrated the treatment was not inferior to chlormethine ointment. However, overall response rates do not provide information about response patterns. The study objective was to assess the value of by-time analysis of clinical response data in visualizing response over time.METHODS:
This post hoc analysis re-evaluated chlormethine efficacy using a by-time approach that investigated the trend to treatment response and permitted assessment of response, both monthly between 1 and 6 months, and once every 2 months between 7 and 12 months, over the course of 1 year. In addition, very good partial response was redefined as a ≥ 75% response.RESULTS:
By-time analyses of Composite Assessment of Index Lesion Severity (CAILS) and modified severity-weighted assessment tool (mSWAT) showed response rates at 1 month (respectively, 8.5% and 5.9%) that increased over time to peak at 10 months (78.9% and 54.4%). Early, intermittent, and late response patterns were observed. In total, 32.5% of patients experienced very good partial response over 2 consecutive visits, indicating that â¼ 33% of patients could expect to have very good to complete response within 1 year.CONCLUSION:
By-time analysis for clinical response provides complementary information to traditional overall response rate data regarding response peak time and changes over time.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Skin Neoplasms
/
Mycosis Fungoides
/
Antineoplastic Agents, Alkylating
/
Mechlorethamine
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Humans
Language:
En
Journal:
Clin Lymphoma Myeloma Leuk
Journal subject:
NEOPLASIAS
Year:
2021
Document type:
Article