Jouandet Marie, Nakouri Inès, Nadin Lawrence, Kieny Alice, Samimi Mahtab, Adamski Henri, Quéreux Gaëlle, Chaby Guillaume, Dompmartin Anne, L'Orphelin Jean-Matthieu
Department of Dermatology, Caen-Normandie University Hospital, 14000 Caen, France.
Biostatistics and Clinical Research Unit, Caen-Normandy University Hospital, 14000 Caen, France.
Cancers (Basel). 2022 Mar 25;14(7):1659. doi: 10.3390/cancers14071659.
Advanced mycosis fungoides (MF) and Sézary syndrome (SS) are rare, aggressive cutaneous T-cell lymphomas that may be difficult to treat. Mogamulizumab is a recent monoclonal antibody targeting the CCR4 receptor expressed on the surface of Sézary cells. It can be prescribed in MF/SS stages III to IV in the second line after systemic therapy or in stages IB-II after two unsuccessful systemic therapies. We lack data on long-term efficiency and potential side effects in real-life conditions. Our study aims to determine efficacy considering the median PFS of advanced CTCL with mogamulizumab. Secondary objectives were to consider tolerance and estimate delay until side effects appeared.
Data on patients with advanced cutaneous T-cell lymphomas were collected since French Authorization, in six French university hospitals. Patients were followed until they stopped mogamulizumab because of relapse or toxicity. For those still treated by mogamulizumab, the end point was 1 September 2021. We excluded 3 patients as they had already been included in the MAVORIC study and data was not available.
The median time of follow-up was 11.6 months. Of the 21 patients included, we reported four full-response patients, eight in partial response, one in stability, three in progression, and five were deceased. One patient had visceral progression, and seven had new lymphadenopathy. Progression-free survival was estimated at 22 months. Twenty patients presented adverse events, of which 10 were severe, i.e., grade III-IV. The median time between the introduction of mogamulizumab and the first adverse event was 21 days.
Our study suggests that mogamulizumab can give patients with advanced refractory CTCL a consequent PFS, estimated at 22 months. The long-term safety of mogamulizumab was determined to be acceptable since we reported few grade III-IV AEs, comparable with other studies. No other study using real-life data has been performed to investigate the AEs of mogamulizumab.
晚期蕈样肉芽肿（MF）和塞扎里综合征（SS）是罕见的侵袭性皮肤T细胞淋巴瘤，可能难以治疗。莫加莫珠单抗是一种新型单克隆抗体，靶向塞扎里细胞表面表达的CCR4受体。它可在全身治疗后的二线用于III至IV期的MF/SS，或在两次全身治疗失败后的IB-II期使用。我们缺乏关于其在实际临床环境中的长期疗效和潜在副作用的数据。本研究旨在通过莫加莫珠单抗治疗晚期蕈样肉芽肿的中位无进展生存期（PFS）来确定其疗效。次要目标是评估耐受性并估计出现副作用的时间。
自法国批准使用以来，在六家法国大学医院收集了晚期皮肤T细胞淋巴瘤患者的数据。患者一直随访至因复发或毒性而停用莫加莫珠单抗。对于仍在接受莫加莫珠单抗治疗的患者，终点时间为2021年9月1日。我们排除了3名患者，因为他们已被纳入MAVORIC研究且无法获取数据。
中位随访时间为11.6个月。纳入的21例患者中，有4例完全缓解，8例部分缓解，1例病情稳定，3例病情进展，5例死亡。1例患者出现内脏进展，7例出现新的淋巴结病。无进展生存期估计为22个月。20例患者出现不良事件，其中10例为严重不良事件，即III-IV级。开始使用莫加莫珠单抗至首次出现不良事件的中位时间为21天。
我们的研究表明，莫加莫珠单抗可为晚期难治性皮肤T细胞淋巴瘤患者带来约22个月的无进展生存期。由于我们报告的III-IV级不良事件较少，与其他研究相当，因此莫加莫珠单抗的长期安全性被认为是可接受的。尚未有其他研究使用实际临床数据来调查莫加莫珠单抗的不良事件。
