Meenu Meenakshi, Dhiman Pravesh, Kumar Muninder, Pradhan Pranita, Pandey Shivam
Pharmacology, All India Institute of Medical Sciences, Bilaspur, Bilaspur, IND.
Medical Oncology, All India Institute of Medical Sciences, Bilaspur, Bilaspur, IND.
Cureus. 2025 Jan 1;17(1):e76709. doi: 10.7759/cureus.76709. eCollection 2025 Jan.
The aim of the review was to systematically review real-world data on the effectiveness and safety of pembrolizumab in recurrent/metastatic/unresectable head and neck squamous cell cancer (HNSCC) patients. Two independent reviewers retrieved the studies separately and simultaneously. PubMed, Embase, Scopus, Web of Science, and Cochrane Central were searched for prospective and retrospective studies on recurrent/metastatic/unresectable HNSCC patients treated with either pembrolizumab monotherapy or pembrolizumab combination therapy published till November 2024. Studies published in the English language and available as full-text articles were included while studies with patients treated with additional chemotherapeutic agents that do not include chemotherapy with fluorouracil, platinum, cetuximab, or radiotherapy were excluded. Outcomes were overall response rate, progression-free survival, overall survival, and adverse events. Forest plots were generated using RevMan software version 5.4 (2020; The Cochrane Collaboration, London, United Kingdom). The ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool was used for the assessment of the potential risk of bias and the quality of evidence was synthesized using GRADEpro (Evidence Prime Inc., Hamilton, Canada). We identified 5884 records, removed 2784 duplicate records, and screened 3100 studies. A total of 2931 records were excluded based on title/abstract. Of the remaining 169 articles, nine studies satisfied eligibility criteria and were included for final review. Pooled data suggested that 1006 patients were administered with pembrolizumab monotherapy while 448 patients received pembrolizumab combination therapy. Monotherapy improved the overall response rate compared to combination therapy. No significant difference in progression-free survival and overall survival was found between the two groups. Adverse events were reported less in pembrolizumab monotherapy compared to pembrolizumab combination therapy. The studies were assessed at high risk of bias and graded at low to very low quality of evidence. The study showed some beneficial effects of pembrolizumab monotherapy in recurrent/metastatic/unresectable HNSCC patients in real-world scenarios. However, more studies are required to generate robust evidence.
本综述的目的是系统回顾帕博利珠单抗在复发/转移/不可切除的头颈部鳞状细胞癌（HNSCC）患者中的有效性和安全性的真实世界数据。两名独立 reviewers 分别同时检索研究。在 PubMed、Embase、Scopus、Web of Science 和 Cochrane Central 中检索截至 2024 年 11 月发表的关于接受帕博利珠单抗单药治疗或帕博利珠单抗联合治疗的复发/转移/不可切除 HNSCC 患者的前瞻性和回顾性研究。纳入以英文发表且可获取全文的研究，排除研究中患者接受不包括氟尿嘧啶、铂类、西妥昔单抗化疗或放疗的其他化疗药物治疗的研究。结局指标为总缓解率、无进展生存期、总生存期和不良事件。使用 RevMan 软件版本 5.4（2020；英国伦敦 Cochrane 协作网）生成森林图。ROBINS-I（非随机干预研究中的偏倚风险）工具用于评估潜在偏倚风险，证据质量使用 GRADEpro（加拿大汉密尔顿 Evidence Prime 公司）进行综合分析。我们识别出 5884 条记录，去除 2784 条重复记录，并筛选了 3100 项研究。基于标题/摘要共排除 2931 条记录。在其余的 169 篇文章中，9 项研究符合纳入标准并纳入最终综述。汇总数据显示，1006 例患者接受帕博利珠单抗单药治疗，448 例患者接受帕博利珠单抗联合治疗。与联合治疗相比，单药治疗提高了总缓解率。两组之间在无进展生存期和总生存期方面未发现显著差异。与帕博利珠单抗联合治疗相比，帕博利珠单抗单药治疗报告的不良事件较少。这些研究被评估为高偏倚风险，证据质量分级为低至极低。该研究显示在真实世界场景中，帕博利珠单抗单药治疗对复发/转移/不可切除的 HNSCC 患者有一些有益效果。然而，需要更多研究来产生有力证据。
