免疫相关不良事件作为接受PD-L1抑制剂的复发或转移性鼻咽癌的预后生物标志物：一项多中心、单臂、2期研究的事后分析。

IF 4 2区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Oral oncology Pub Date : 2025-02-01 DOI:10.1016/j.oraloncology.2024.107161

Shihong Xu , Jiagang He , Zheran Liu , Yiyan Pei , Junyou Ge , Yan Qing , Youneng Wei , Ye Chen , Xingchen Peng

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引用次数: 0

摘要

背景：在接受免疫检查点抑制剂（ICIs）治疗的各种癌症患者中，免疫相关不良事件（irAEs）与更好的治疗结果相关。本研究探讨了复发或转移性鼻咽癌（R/M鼻咽癌）患者irAEs与ICI预后之间的关系。方法：对2019年2月26日至2021年1月13日期间接受抗pd - l1抑制剂治疗的153例R/M NPC患者进行事后分析。这些患者被纳入了一项多中心、单臂、2期临床试验，这是迄今为止评估抗pd - l1治疗先前治疗过的R/M NPC的最大研究。结果：经历过irAEs的患者总体缓解率（ORR）和疾病控制率（DCR）明显高于未经历irAEs的患者(31.2% vs. 17.1%, p = 0.039；66.7% vs. 44.8%, p = 0.017)。此外，irAEs患者的中位无进展生存期（PFS）更长（129天比56天，p = 0.007）。内分泌相关irAEs患者表现出更高的DCR(71.8%对46.2%,p = 0.012)，更长的PFS（144天对69天，p = 0.02）和总生存期（OS: 746天对438天，p = 0.02）。相比之下，≥3级irae患者或需要全身性类固醇治疗的患者的中位生存期较短(179天vs 466天，p = 0.03；166天对462天，p = 0.02)。结论：irae的发生，特别是那些涉及内分泌系统的irae，与抗pd - l1治疗的疗效增强和R/M NPC患者生存期延长有关，突出了irae作为预后生物标志物的潜力。

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Immune-related adverse events as prognostic biomarkers in recurrent or metastatic nasopharyngeal carcinoma receiving PD-L1 inhibitor: A post-hoc analysis of the multicenter, single-arm, phase 2 study

Background

Immune-related adverse events (irAEs) have been associated with better therapeutic outcomes in patients receiving immune checkpoint inhibitors (ICIs) across various cancers. This study investigates the association between irAEs and ICI outcomes in patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

Methods

A post hoc analysis was performed on 153 patients with R/M NPC who received anti-PD-L1 inhibitors between February 26, 2019, and January 13, 2021. These patients were enrolled in a multicenter, single-arm, phase 2 clinical trial, which represents the largest study to date evaluating anti-PD-L1 therapy in previously treated R/M NPC.

Results

Patients who experienced irAEs had significantly higher overall response rates (ORR) and diseade control rates (DCR) compared to those without irAEs (31.2 % vs. 17.1 %, p = 0.039; 66.7 % vs. 44.8 %, p = 0.017). Additionally, the median progression-free survival (PFS) was longer in patients with irAEs (129 days vs. 56 days, p = 0.007). Patients with endocrine-related irAEs exhibited higher DCR (71.8 % vs. 46.2 %, p = 0.012), and longer PFS (144 days vs. 69 days, p = 0.02) and overall survival (OS: 746 days vs. 438 days, p = 0.02). In contrast, patients with grade ≥ 3 irAEs or those requiring systemic steroid therapy had shorter median OS (179 days vs. 466 days, p = 0.03; 166 days vs. 462 days, p = 0.02).

Conclusions

The occurrence of irAEs, particularly those involving the endocrine system, is associated with enhanced efficacy of anti-PD-L1 therapy and extended survival in patients with R/M NPC, highlighting their potential as prognostic biomarkers.

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来源期刊

Oral oncology 医学-牙科与口腔外科

CiteScore

8.70

自引率

10.40%

发文量

505

审稿时长

20 days

期刊介绍： Oral Oncology is an international interdisciplinary journal which publishes high quality original research, clinical trials and review articles, editorials, and commentaries relating to the etiopathogenesis, epidemiology, prevention, clinical features, diagnosis, treatment and management of patients with neoplasms in the head and neck. Oral Oncology is of interest to head and neck surgeons, radiation and medical oncologists, maxillo-facial surgeons, oto-rhino-laryngologists, plastic surgeons, pathologists, scientists, oral medical specialists, special care dentists, dental care professionals, general dental practitioners, public health physicians, palliative care physicians, nurses, radiologists, radiographers, dieticians, occupational therapists, speech and language therapists, nutritionists, clinical and health psychologists and counselors, professionals in end of life care, as well as others interested in these fields.