2020—2022年辽宁省肿瘤医院免疫检查点抑制剂的使用情况分析

目的 分析辽宁省肿瘤医院2020—2022年免疫检查点抑制剂的使用情况以及变化趋势，为规范其管理及临床合理使用提供参考。方法 收集2020—2022年辽宁省肿瘤医院免疫检查点抑制剂使用数据，分析销售金额、用药频度（DDDs）、限定日费用（DDC）以及排序比（B/A）。结果 2020—2022年免疫检查点抑制剂销售金额大幅增长。帕博利珠单抗和替雷利珠单抗使用金额较大，排名靠前。2022年新增的品种（阿替利珠单抗、卡度尼利单抗、赛帕利单抗、斯鲁利单抗、舒格利单抗、恩沃利单抗）销售金额排名靠后。替雷利珠单抗的DDDs近3年大幅增加。卡度尼利单抗、度伐利尤单抗、帕博利珠单抗、纳武利尤单抗DDC值偏高，且B/A＜1。信迪利单抗、替雷利珠单抗、卡瑞利珠单抗、特瑞普利单抗DDC在2022年有大幅度的下降，DDC值较低，且B/A＞1。结论 2020—2022年辽宁省肿瘤医院免疫检查点抑制剂的使用总体上比较合理，但仍需进一步加强监管力度，保障患者用药的安全、有效和经济。     

Pembrolizumab in Asian patients with microsatellite-instability-high/mismatch-repair-deficient colorectal cancer

The phase 3 KEYNOTE-177 study evaluated pembrolizumab versus chemotherapy with or without bevacizumab or cetuximab in patients with newly diagnosed, microsatellite-instability-high (MSI-H)/mismatch-repair-deficient (dMMR) metastatic colorectal cancer (mCRC). Primary endpoints were progression-free survival (PFS) per RECIST v1.1 by blinded independent central review (BICR) and overall survival (OS). Secondary endpoints were overall response rate (ORR) per RECIST v1.1 by BICR and safety. Here, we report results from the post hoc analysis of patients who were enrolled in Asia from the final analysis (FA) of KEYNOTE-177. A total of 48 patients from Japan, Korea, Singapore, and Taiwan (pembrolizumab, n = 22; chemotherapy, n = 26) were included. At FA, median time from randomization to data cutoff (February 19, 2021) was 45.3 (range 38.1–57.8) months with pembrolizumab and 43.9 (range 36.6–55.1) months with chemotherapy. Median PFS was not reached (NR; 95% confidence interval [CI] 1.9 months–NR) with pembrolizumab versus 10.4 (95% CI 6.3–22.0) months with chemotherapy (hazard ratio [HR] 0.56, 95% CI 0.26–1.20). Median OS was NR (range 13.8 months–NR) versus 30.0 (14.7–NR) months (HR 0.65, 95% CI 0.27–1.55) and ORR was 50% (95% CI 28–72) versus 46% (95% CI 27–67). Grade 3/4 treatment-related adverse events (TRAEs) were reported by two patients (9%) in the pembrolizumab arm and 20 (80%) in the chemotherapy arm. Immune-mediated adverse events or infusion reactions were reported by six patients (27%) and 10 patients (40%), respectively. No deaths due to TRAEs occurred. These data support first-line pembrolizumab as a standard of care for patients from Asia with MSI-H/dMMR mCRC. ClinicalTrials.gov identifier: NCT02563002.     

帕博利珠单抗致甲状腺功能障碍文献分析

目的 探索帕博利珠单抗致甲状腺功能障碍发生的规律和临床特点，为临床安全用药提供参考。方法 检索知网、维普、万方、PubMed、Web of Science数据库，收集关于帕博利珠单抗致免疫性皮肤病的文献数据并进行统计分析。结果 纳入16篇文献，共16例甲状腺功能障碍病例，年龄为30～77岁；甲状腺功能障碍发生时间最早为给药后14 d，最晚为给药后240 d；常规给予左甲状腺素治疗甲状腺功能减退及给予甲硫咪唑治疗甲状腺功能亢进，经过治疗后多数患者甲状腺功能障碍好转。结论 在使用帕博利珠单抗时要注意监测甲状腺功能障碍不良反应，一旦发生应及时进行相应治疗。