氮芥凝胶治疗蕈样肉芽肿的有效性和耐受性：一项多中心真实世界评估
Effectiveness and tolerability of chlormethine gel for the management of mycosis fungoides: a multicenter real-life evaluation.
作者信息
Alberti-Violetti Silvia, Ardigò Marco, Massone Cesare, Pileri Alessandro, Sala Raffaella, Teoli Miriam, Grandi Vieri, Quaglino Pietro, Pimpinelli Nicola, Berti Emilio
机构信息
Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
San Gallicano Dermatological Institute IRCCS, Rome, Italy.
出版信息
Front Oncol. 2024 Jan 4;13:1298296. doi: 10.3389/fonc.2023.1298296. eCollection 2023.
BACKGROUND
Topical 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.
OBJECTIVES
To 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.
METHODS
This 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.
RESULTS
A 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.
CONCLUSIONS
Our observations support the use of CL gel in patients with early- and advanced-stage MF, making it a valuable treatment option.
背景
外用氮芥（CL）被推荐作为早期蕈样肉芽肿（MF）的一线治疗药物，2017年，欧洲药品管理局批准了CL凝胶制剂用于治疗成年患者。最近，为了提高患者的依从性和坚持性，临床医生制定了灵活的方案，允许在日常治疗方案中同时使用CL凝胶和外用糖皮质激素。因此，分享CL凝胶使用和副作用管理的真实数据可能有助于改善该药物的使用。
目的
为了扩展关于CL凝胶在MF患者中实际使用的知识，本研究评估了CL凝胶治疗后MF皮肤病变的改善情况，并提供了在实际临床环境中皮肤不良事件（AE）管理的信息。
方法
这是一项在六个皮肤科转诊中心进行的意大利回顾性研究。纳入了2019年12月至2021年12月期间年龄≥18岁、患有MF且正在接受CL凝胶（160µ/g）治疗的患者，治疗方式为单独使用或根据常规临床实践联合使用。该研究的主要目的是评估治疗3个月后CL凝胶在总缓解率（ORR）方面的有效性。
结果
共纳入79例不同分期的MF患者（61%为男性）（84%为早期）。CL凝胶主要与外用糖皮质激素联合使用（66%的患者）。治疗3个月后的ORR为42%，早期和晚期MF之间无差异。治疗18个月后缓解率随时间提高至97%。总体而言，67%的患者报告了66例AE；大多数是色素沉着（45%）和刺激性接触性皮炎（37%）。6例AE导致治疗中断，报告这些事件的6例患者中有5例（83%）中断后恢复治疗。没有AE被分类为严重。
结论
我们的观察结果支持在早期和晚期MF患者中使用CL凝胶，使其成为一种有价值的治疗选择。
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