在既往接受化疗和 PD-1 抑制剂治疗的转移性鼻咽癌二线治疗中重新使用 PD-1 抑制剂的疗效和安全性。
Efficacy and Safety of Re-Challenging PD-1 Inhibitors in Second-Line Treatment in Metastatic Nasopharyngeal Carcinoma Previously Treated with Chemotherapy and PD-1 Inhibitors.
发表日期：2024
作者：
Weixin Bei, Shuhui Dong, Guoying Liu, Lanfeng Lin, Yaofei Jiang, Nian Lu, Wangzhong Li, Hu Liang, Yanqun Xiang, Weixiong Xia
来源：
Epigenetics & Chromatin
摘要：
我们的目的是评估抗 PD1 再挑战联合化疗对既往抗 PD1 治疗后病情进展的转移性鼻咽癌 (mNPC) 患者的疗效和安全性。我们纳入了接受化疗联合 PD-1 免疫治疗的 mNPC 患者- 在抗 PD1 治疗进展后，检查点抑制剂 (ICIs) 或单独化疗。主要终点为无进展生存期（PFS），次要终点包括总生存期（OS）、疾病控制率（DCR）和客观缓解率（ORR）。2015年1月至2020年12月期间共有96名患者符合资格37 名患者 (38.5%) 属于 PD-1 ICI 再次挑战组，其余 59 名患者 (61.5%) 属于化疗组。 PD-1 ICI组和化疗组的ORR和DCR分别为37.8% vs 23.7%和86.5% vs 74.5%。中位随访期为 21.1 个月（IQR 16.1-28.7）后，时序分析表明，与化疗组相比，PD-1 ICI 再次挑战组的 PFS 显着改善（8.4 个月 [95% CI 4.3]） -14.0] vs 5.0 个月 [95% CI 2.8-7.2]，P = 0.03）。然而，两组之间的 OS 没有显着差异（28.3 个月与 24.1 个月，P = 0.09）。两组不良反应相似，但 PD-1 ICI 再次给药组 3 级或 4 级血小板减少症的发生率显着较高（18.9% vs 3.4%，P = 0.025）。 PD1 疗法可以受益于抗 PD1 再攻击与化疗的结合。然而，还需要进一步验证。© 2024 Bei 等人。
We aim to evaluate the efficacy and safety of anti-PD1 rechallenge in combination with chemotherapy in patients with metastatic nasopharyngeal carcinoma (mNPC) who have progressed on prior anti-PD1 therapy.We enrolled patients with mNPC who received chemotherapy combined with PD-1 immune-checkpoint inhibitors (ICIs) or chemotherapy alone after prior progression of anti-PD1 therapy. The primary endpoint was progress-free survival (PFS), and the secondary endpoints included overall survival (OS), disease control rate (DCR) and objective response rate (ORR).A total of 96 patients were eligible between January 2015 and December 2020. Thirty-seven (38.5%) were in the PD-1 ICIs re-challenge group, while the remaining 59 patients (61.5%) were in the chemotherapy group. The ORR and DCR of PD-1 ICIs group and chemotherapy group were 37.8% vs 23.7% and 86.5% vs.74.5%, respectively. After a median follow-up period of 21.1 months (IQR 16.1-28.7), the log-rank analysis demonstrated a significantly improved PFS in the PD-1 ICIs re-challenge group compared to the chemotherapy group (8.4 months [95% CI 4.3-14.0] vs 5.0 months [95% CI 2.8-7.2], P = 0.03). However, no significant difference in OS was observed between the two groups (28.3 vs 24.1 months, P = 0.09). The two groups had similar adverse reactions, but the incidence of grade 3 or 4 thrombocytopenia was significantly higher in the PD-1 ICIs re-challenge group (18.9% vs 3.4%, P = 0.025).mNPC patients who progressed from prior anti-PD1 therapy could benefit from the anti-PD1 rechallenge in combination with chemotherapy. However, further validation is needed.© 2024 Bei et al.