Kadokawa Yukio, Inoue Satoko, Tatsumi Akitoshi, Uchida Mayako, Fujita Keiko, Takagi Mari, Inoue Takako, Ohe Shuichi, Nakai Yasutomo, Otsuka Tomoyuki, Abe Yutaro, Nakabori Tasuku, Isei Taiki, Kumagai Toru, Nishimura Kazuo, Ohkawa Kazuyoshi
Department of Pharmacy Osaka International Cancer Institute, Osaka Prefectural Hospital Organization Osaka Japan.
Faculty of Pharmaceutical Sciences Kobe Gakuin University Kobe Japan.
JGH Open. 2023 Feb 13;7(2):87-97. doi: 10.1002/jgh3.12868. eCollection 2023 Feb.
To investigate the outcomes in eight Japanese patients with cancer treated with mycophenolate mofetil (MMF) and corticosteroids for immune checkpoint inhibitor treatment-induced severe immune-related hepatitis (ir-hepatitis) and the efficacy and safety of MMF.
We retrospectively examined patient background, treatment course, as well as examination and imaging data using electronic medical records.
The ratio of male to female patients was 7:1, and the median age was 60 years (27-72 years). There were five and two cases of kidney cancer and malignant melanoma, respectively, and one case of lung cancer. The median number of days until MMF administration in addition to systemic corticosteroid therapy after the onset of ir-hepatitis was 14.5 (2-42). The patients were categorized as four "good responders" who showed an improvement in the liver function tests following MMF treatment and four "poor responders" who did not. Furthermore, the time from the onset of ir-hepatitis to initial MMF administration was significantly shorter in good responders (median 3 days, range 2-15 days) than in poor responders (median 25.5 days, range 14-42 days) ( = 0.042). No significant intergroup difference was observed in other clinical factors. No serious adverse events caused by MMF were observed in any case.
According to these findings, early recognition of corticosteroid refractoriness and the use of MMF may be beneficial in patients with ir-hepatitis.
探讨8例日本癌症患者接受霉酚酸酯（MMF）和皮质类固醇治疗免疫检查点抑制剂治疗引起的严重免疫相关性肝炎（ir-肝炎）的疗效及MMF的有效性和安全性。
我们使用电子病历回顾性研究了患者背景、治疗过程以及检查和影像数据。
男女患者比例为7:1，中位年龄为60岁（27 - 72岁）。分别有5例肾癌和2例恶性黑色素瘤患者，1例肺癌患者。ir-肝炎发作后除全身皮质类固醇治疗外开始使用MMF的中位天数为14.5天（2 - 42天）。患者被分为4例“良好反应者”（MMF治疗后肝功能检查有所改善）和4例“不良反应者”（未改善）。此外，良好反应者从ir-肝炎发作到首次使用MMF的时间（中位3天，范围2 - 15天）明显短于不良反应者（中位25.5天，范围14 - 42天）（P = 0.042）。其他临床因素在组间未观察到显著差异。任何病例均未观察到由MMF引起的严重不良事件。
根据这些发现，早期识别皮质类固醇难治性并使用MMF可能对ir-肝炎患者有益。
