Abstract
BackgroundThe 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. MethodsThis 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. ResultsBy-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 ∼ 33% of patients could expect to have very good to complete response within 1 year. ConclusionBy-time analysis for clinical response provides complementary information to traditional overall response rate data regarding response peak time and changes over time.
Highlights
Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphomas
The by-time analysis of the Composite Assessment of Index Lesion Severity (CAILS) clinical response data for patients with data showed that there was a modest level of clinical response (8.5%) at 1 month after treatment initiation, with a steady increase in response rates over time
The by-time analysis of the modified severity-weighted assessment tool (mSWAT) response data showed a modest proportion of patients with response (5.9%) 1 month after treatment initiation for patients with data, with a steady increase over time and a response rate of 54.4% at 10 months (Figure 2, Supplemental Table 2 in the online version)
Summary
Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphomas. For patients with early stage MF (stage IA-IIA), the use of skin-directed therapy, such as chlormethine ( known as mechlorethamine), is recommended.[1,2,3] Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells, resulting in cell death.[4] Topical chlormethine gel (chlormethine 0.016% w/w, equivalent to 0.02% chlormethine HCl) has been developed for the treatment of MF and is recommended.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
