Real-life experience with chlormethine gel for early-stage mycosis fungoides with emphasis on types and management of cutaneous side-effects
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Naveh, Hadas Prag; Amitay‐Laish, Iris; Zidan, Omri; Leshem, Yael Anne; Sherman, Shany; Noyman, Yehonatan; Taieb, Joseph; Didkovsky, Elena; Hodak, Emmilia

doi:10.1080/09546634.2021.1967266

Cited by 11 publications

(18 citation statements)

References 29 publications

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“…The suspension rate is highly variable among the included studies and only Gilmore et al 18 reported the discontinuation of chlormethine in all patients. Regarding real‐world experience, Geskin et al 22 did not report this data, while other two studies demonstrated a suspension rate of 27.5% 20 and 29.2% 25 …”

Section: Resultsmentioning

confidence: 91%

“…Clinical response could be lower when CG is used as monotherapy, as suggested by a randomized controlled study 10 . Indeed, the majority of the published studies considered GC in association to other therapies 17,19,20,22–25 . In our real‐life experience, only 18% of the patients were treated with CG as monotherapy.…”

Section: Discussionmentioning

confidence: 95%

“…A real‐life single‐center study conducted by Prag Naveh et al 20 accurately detailed the most common CG side effects: 36% of the sample developed ICD and ACD (Allergic Contact Dermatitis), 14% hyperpigmentation, 9% pruritus and 9% unmasking effect (clinical appearance of new early‐stage lesions not previously observed in the application area within the first weeks of treatment). The clinical response rate was around 50% and adverse events were controlled decreasing the CG application rate or associating topical steroids.…”

Section: Resultsmentioning

confidence: 99%

“…Patients included are usually in early stages, with a male prevalence and a high response rate (80.0%–100.0%). Only Kim et al 25 and Geskin et al 22 considered also advanced stages of MF, while female prevalence was detected only by Garcia‐Saleem et al 24 Moreover, three studies showed a response rate lower than 66.7% 10,20,25 …”

Section: Resultsmentioning

confidence: 99%

“…To the best of our knowledge, this is the first review article focusing only on the gel formulation of chlormethine in MF, including real‐life experience. Although authors reported their casuistic on gel preparation, only few of them described their data in a real world setting, 20,25,26 discussing the practical implication of this new formulation. Moreover, this is the largest Italian casuistic to date on MF and CG.…”

Section: Discussionmentioning

confidence: 99%

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Topical chlormethine gel in the treatment of mycosis fungoides: A single‐center real‐life experience and systematic review of the literature

Laghi¹,

Franceschini

Mandel

et al. 2022

Dermatologic Therapy

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Gel formulation of chlormethine (CG) has gained a preeminent role among therapies available for mycosis fungoides (MF). To evaluate the frequency of use of CG for MF treatment and to determine the limits and potentialities of CG in a real-world setting.A systematic review of articles published prior to October 2021 was performed. Articles were included in the review if a full-text English version was available. MEDLINE (PubMed), Scopus, and Web of Science were each queried from their date of inception with the following terms: "mechlorethamine gel", "chlormethine gel", and "mycosis fungoides". The reference lists of the studies retrieved were searched manually. Moreover, this study included all consecutive patients with different stages of MF (from IA to IIB) who started treatment with CG gel between July 2020 and May 2021. Data of the literature were compared to our single-center real-life experience.Of the surveyed literature, 11 publications were included in the final analysis describing a total of 548 patients with MF. Eleven patients with a median (standard deviation) age of 66 years (15.1) were enrolled and followed up, receiving CG (0.02% chlormethine HCl). Response to treatment resulted higher (90.1%) in our study population than in other real-world experiences published in literature. This systematic review supports the role of CG for MF treatment, showing its limits and potentialities. Our single-center real-life experience revealed an elevated percentage of clinical response with high safety and tolerance, demonstrating its versatile use with dose and application rate adaptability. K E Y W O R D S drug-related side effects and adverse reactions, lymphoma, mechlorethamine, mycosis fungoides, nitrogen mustard compounds, cutaneous T-cell lymphoma Primary cutaneous T-cell lymphomas (CTCLs) represent a heterogeneous group of lymphoproliferative disorders involving almost exclusively the skin. 1 Mycosis fungoides (MF) is the most common entity, consisting in

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Section: Resultsmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 95%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Topical chlormethine gel in the treatment of mycosis fungoides: A single‐center real‐life experience and systematic review of the literature

Laghi¹,

Franceschini

Mandel

et al. 2022

Dermatologic Therapy

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Chlormethine Gel for Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: A Review of Efficacy and Safety in Clinical Trial and Real-World Settings

et al. 2022

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Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data

Hodak

2022

Am J Clin Dermatol

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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.

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Real-life experience with chlormethine gel for early-stage mycosis fungoides with emphasis on types and management of cutaneous side-effects ^#

Cited by 11 publications

References 29 publications

Topical chlormethine gel in the treatment of mycosis fungoides: A single‐center real‐life experience and systematic review of the literature

Topical chlormethine gel in the treatment of mycosis fungoides: A single‐center real‐life experience and systematic review of the literature

Chlormethine Gel for Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: A Review of Efficacy and Safety in Clinical Trial and Real-World Settings

Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data

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Real-life experience with chlormethine gel for early-stage mycosis fungoides with emphasis on types and management of cutaneous side-effects #

Cited by 11 publications

References 29 publications

Topical chlormethine gel in the treatment of mycosis fungoides: A single‐center real‐life experience and systematic review of the literature

Topical chlormethine gel in the treatment of mycosis fungoides: A single‐center real‐life experience and systematic review of the literature

Chlormethine Gel for Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: A Review of Efficacy and Safety in Clinical Trial and Real-World Settings

Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data

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Real-life experience with chlormethine gel for early-stage mycosis fungoides with emphasis on types and management of cutaneous side-effects ^#