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皮肤 T 细胞淋巴瘤经莫格利珠单抗单药治疗和莫格利珠单抗联合依托泊苷联合治疗的真实世界病例系列。

Cutaneous T cell lymphoma treated with mogamulizumab monotherapy and mogamulizumab plus etoposide combined therapy: A real-world case series.

机构信息

Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan.

出版信息

Dermatol Ther. 2022 Nov;35(11):e15858. doi: 10.1111/dth.15858. Epub 2022 Oct 1.

Abstract

Since the efficacy of mogamulizumab has been confirmed by a phase III, randomized study, mogamulizumab is one of the promising first-line therapies for advanced cutaneous T cell lymphoma (CTCL), though its efficacy is not completely satisfactory. Therefore, several anti-lymphoma drugs such as etoposide were recently used to enhance the anti-tumor effects of mogamulizumab for the treatment of mycosis fungoides (MF). In this report, the anti-tumor effects of mogamulizumab and post mogamulizumab therapy were retrospectively evaluated in 11 cases of CTCL in real-world clinical practice. The best response rate (RR) was 45.5% (95% confidence interval [CI], 21.3%-72.0%) for the total cohort, 50.0% (95%CI, 21.5%-78.5%) for the MF cohort, and 33.3% (95%CI, 5.6%-79.8%) for the primary cutaneous peripheral T cell lymphoma not otherwise specified (PCPTCL-NOS) cohort. The objective response rate (ORR) at 1 month (ORR1) for the total cohort was 45.5% (95%CI, 21.3%-72.0%), and ORR at 4 months (ORR4) was 27.3% (95%CI, 9.2%-57.1%). The mean time to next treatment (TTNT) was 16.0 weeks (3-100 weeks) for all patients, 16.5 months (3-100 weeks) for the MF cohort, and 9.0 (7-16) weeks for the PCPTCL-NOS cohort. The efficacy rate of etoposide-based therapy was 71.4% (95%CI, 35.9%-98.0%) for all patients, 80% (95%CI, 35.9%-98.0%) in the MF cohort, and 50% (95%CI, 9.5%-90.5%) in the PCPTCL-NOS cohort. The median duration of response was 182 (45-323) weeks. The safety profile of mogamulizumab monotherapy in the present cohort was comparable to the previous phase III, randomized trial. The present study suggests that the efficacy and safety profiles of mogamulizumab monotherapy as second-line therapy and beyond in a real-world Japanese cohort were comparable to those in the previous phase III, randomized trial.

摘要

由于莫格利珠单抗的疗效已在一项 III 期随机研究中得到证实,因此它是晚期皮肤 T 细胞淋巴瘤(CTCL)有前途的一线治疗方法之一,尽管其疗效并非完全令人满意。因此,最近使用几种抗淋巴瘤药物,如依托泊苷,来增强莫格利珠单抗治疗蕈样真菌病(MF)的抗肿瘤作用。在本报告中,我们回顾性评估了莫格利珠单抗在真实临床实践中治疗 11 例 CTCL 的抗肿瘤作用和莫格利珠单抗治疗后的疗效。总队列的最佳缓解率(RR)为 45.5%(95%置信区间[CI],21.3%-72.0%),MF 队列为 50.0%(95%CI,21.5%-78.5%),原发性皮肤外周 T 细胞淋巴瘤未另作说明(PCPTCL-NOS)队列为 33.3%(95%CI,5.6%-79.8%)。总队列的 1 个月客观缓解率(ORR1)为 45.5%(95%CI,21.3%-72.0%),4 个月时的 ORR4 为 27.3%(95%CI,9.2%-57.1%)。所有患者的下一次治疗时间(TTNT)平均值为 16.0 周(3-100 周),MF 队列为 16.5 个月(3-100 周),PCPTCL-NOS 队列为 9.0 周(7-16 周)。基于依托泊苷的治疗有效率在所有患者中为 71.4%(95%CI,35.9%-98.0%),MF 队列为 80%(95%CI,35.9%-98.0%),PCPTCL-NOS 队列为 50%(95%CI,9.5%-90.5%)。中位缓解持续时间为 182 周(45-323 周)。本队列中单用莫格利珠单抗的安全性与之前的 III 期随机试验相当。本研究表明,莫格利珠单抗单药作为二线及以上治疗在日本真实世界队列中的疗效和安全性与之前的 III 期随机试验相当。

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