Maintenance and Concomitant Therapy Use with Chlormethine Gel Among Patients with Stage IA/IB Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma (MF-CTCL): A Real-World Evidence Study

Querfeld, Christiane; Nelson, Winnie W.; Gor, Deval; Pashos, Chris L.; Doan, Quan V.; Turini, Marco; Angello, James T.; Geskin, Larisa J.

doi:10.1007/s13555-022-00831-w

Cited by 6 publications

(6 citation statements)

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“…Among them, almost all patients (97%) who experienced ICD were also prescribed TCS. Previous prospective and real-life studies supported this combined approach and reported that the use of TCS allowed the long-term administration of CL gel until clinical response, without altering its activity ( 26 , 31 , 32 ). In particular, in the prospective, randomized, open-label MIDAS study, the use of topical triamcinolone ointment showed to be a useful adjuvant when treating patients with CL gel, reducing inflammation without altering the effectiveness of the therapy.…”

Section: Discussionmentioning

confidence: 97%

Effectiveness and tolerability of chlormethine gel for the management of mycosis fungoides: a multicenter real-life evaluation

Alberti-Violetti,

Ardigò,

Massone

et al. 2024

Front. Oncol.

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BackgroundTopical chlormethine (CL) is recommended as a first-line treatment for early-stage mycosis fungoides (MF) and in 2017, the European Medicines Agency approved the CL gel formulation to treat adult patients. More recently, to increase patient compliance and adherence, clinicians have developed flexible protocols that allow the concomitant use of CL gel with topical corticosteroids in daily practice regimens. Therefore, sharing real-life data on CL gel use and side effects management may help improve the use of this agent.ObjectivesTo expand knowledge about the actual use of CL gel in patients with MF, the present study assessed the improvement of MF skin lesions after CL gel treatment and provided information on the management of cutaneous adverse events (AEs) in a real-life setting.MethodsThis was an Italian retrospective study conducted among six dermatology referral centers. Patients ≥18 years affected by MF and in treatment with CL gel (160 µ/g), alone or in combination according to routine clinical practice, between December 2019 and December 2021 were considered. The study’s primary aim was to evaluate the effectiveness of CL gel in terms of overall response rate (ORR) after 3 months of treatment.ResultsA total of 79 patients (61% male) with different stages of MF (84% early stage) were included. CL gel was prescribed mainly in association with topical corticosteroids (66% of patients). ORR after 3 months of treatment was 42%, with no differences between early- and advanced-stage MF. Response rates improved over time up to 97% after 18 months of treatment. Overall, 66 AEs were reported in 67% of patients; most were hyperpigmentation (45%) and irritant contact dermatitis (37%). Six AEs led to treatment discontinuation, and five out of six (83%) patients who reported these events resumed treatment after interruption. No AEs were classified as severe.ConclusionsOur observations support the use of CL gel in patients with early- and advanced-stage MF, making it a valuable treatment option.

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Section: Discussionmentioning

confidence: 97%

Effectiveness and tolerability of chlormethine gel for the management of mycosis fungoides: a multicenter real-life evaluation

Alberti-Violetti,

Ardigò,

Massone

et al. 2024

Front. Oncol.

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“…The novel gel formulation has also been used in clinical practice as a maintenance therapy, with positive effects on progression-free survival and QOL ( 29 ). Real-world data showed that most patients continued using chlormethine gel after a PR ( 3 ). While no guidelines are available for maintenance treatment with chlormethine gel, this treatment option does have several attributes that may make it particularly suitable for maintenance therapy for patients with MF.…”

Section: Discussionmentioning

confidence: 99%

“…While chlormethine gel is currently used in clinical practice as maintenance therapy, clear guidelines for this treatment in a maintenance setting are lacking. Data from the United States-based prospective, observational PROVe study, which assessed chlormethine gel in real-world clinical practice, showed that the majority of patients (91%) continued using chlormethine gel in a maintenance setting ( 3 ). Maintenance therapy was defined as continued chlormethine gel use after achieving at least PR, and most patients maintained their once-daily treatment schedule.…”

Section: Chlormethine Gel As Maintenance Treatment For Mfmentioning

confidence: 99%

“…Mycosis fungoides (MF), the most common form of cutaneous T-cell lymphoma, is a rare disease that generally presents with patches or plaques on the skin ( 1 , 2 ). MF has a slowly progressive, chronic clinical course ( 3 ). While patients may achieve complete or partial remission after initial treatment, most will experience disease recurrence and a few will eventually have disease progression ( 4 ).…”

Section: Introductionmentioning

confidence: 99%

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Expert opinions and clinical experiences with chlormethine gel as maintenance treatment for patients with mycosis fungoides

Geskin,

Querfeld,

Hodak

et al. 2024

Front. Med.

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Maintenance treatment can be recommended for patients with mycosis fungoides (MF) whose disease responds to primary treatment. While positive outcomes have been observed in small studies with maintenance therapy, there is a lack of practical guidelines and agreement on when and how maintenance therapy for MF should be approached. In this article, we discuss expert opinions and clinical experiences on the topic of maintenance therapy for patients with MF, with a focus on chlormethine gel. Ideally, patients should have a durable response before initiating maintenance therapy. The definition of and required duration of durable response are topics that are open to debate and currently have no consensus. Chlormethine gel has several attributes that make it suitable for maintenance therapy; it can be easily applied at home, can be combined with other treatment options for maintenance, and has a manageable safety profile. Chlormethine gel as maintenance therapy can be applied at decreasing frequencies after active treatment with chlormethine gel or other therapies until the minimally effective dose is reached. Patients generally tend to adhere well to chlormethine gel maintenance regimens and may remain on treatment for several years. The experiences described here may be useful for clinicians when deciding on maintenance treatment regimens for their patients. Development of guidelines based on clinical trial outcomes will be important to ensure the most effective maintenance treatment strategies are used for patients with MF.

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“…A post-hoc analysis of the PROVe data showed that most concomitant therapies used with chlormethine gel were initiated prior to the start of chlormethine gel. In over half of cases the concomitant therapy was used for at least 12 months ( 20 ).…”

Section: Chlormethine Gel Combination Regimensmentioning

confidence: 99%

Chlormethine gel in combination with other therapies for treatment of mycosis fungoides: a review with patient cases

Ardigò,

Nikbakht,

Teoli

et al. 2024

Front. Med.

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Topical chlormethine gel has been approved as monotherapy for treatment of adult patients with mycosis fungoides (MF), the most common form of cutaneous T-cell lymphoma. In clinical practice, chlormethine gel is often combined with other skin-directed or systemic therapies to optimize response and target recalcitrant lesions. Positive outcomes with combination regimens using chlormethine gel and topical corticosteroids, phototherapy, retinoids, methotrexate, or interferon-α have been reported in literature. However, there are no treatment guidelines on the use of combination regimens with chlormethine gel. To provide real-world evidence and guidance on the use of chlormethine gel combination regimens, several cases of patients treated with chlormethine gel combined with phototherapy (n = 5), retinoids (n = 16), or mogamulizumab (n = 3) are presented. These different combination regimens showed promising results. Most patients had a complete or partial response following treatment and the combinations were well-tolerated over extended treatment periods. Patients receiving chlormethine gel with retinoids had long-term periods of remission, even after treatment discontinuation. Durations of response of up to 3 years were observed in these patients. This long-term disease control may be the result of disease-modifying effects of chlormethine. Previous studies have shown targeted reductions in malignant T-cell clones in patients treated with chlormethine gel as well as improved post-treatment responses. Further research is needed to determine the effectiveness and safety of combination treatment regimens with chlormethine gel and to assess the impact chlormethine gel has on disease control.

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Maintenance and Concomitant Therapy Use with Chlormethine Gel Among Patients with Stage IA/IB Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma (MF-CTCL): A Real-World Evidence Study

Cited by 6 publications

References 5 publications

Effectiveness and tolerability of chlormethine gel for the management of mycosis fungoides: a multicenter real-life evaluation

Effectiveness and tolerability of chlormethine gel for the management of mycosis fungoides: a multicenter real-life evaluation

Expert opinions and clinical experiences with chlormethine gel as maintenance treatment for patients with mycosis fungoides

Chlormethine gel in combination with other therapies for treatment of mycosis fungoides: a review with patient cases

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