Xiayi Zhu, Jie Qiu, Ya Zhang, Chunni Lin, Xiaohui Wang, Xiwei Shi, Siya Yang, Qiaoyan Wu, Li Cong
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The study was registered in the PROSPERO (CRD42024573816).</div></div><div><h3>Results</h3><div>A total of 28 clinical trials with 2021 patients were included. The neoadjuvant chemoimmunotherapy group had significantly higher pathologic complete response (pCR) (33 % vs. 18 %, <em>P</em> = 0.04) and partial response (PR) (65 % vs. 38 %, <em>P</em> < 0.01). No significant differences were found in overall survival (OS) (hazard ratio: 0.85, 95 % CI: 0.77–0.93) and progression-free survival (PFS) (hazard ratio: 0.72, 95 % CI: 0.61–0.86). Regarding safety outcomes, in the single-arm trials, grade 3–4 treatment-related adverse events (TRAEs) occurred in 14 % of the chemoimmunotherapy group and 13 % of the chemotherapy group, with grade 5 TRAEs at 0 % and 4 %, respectively, showing no significant difference (<em>P</em> = 0.80; <em>P</em> = 0.08). 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引用次数: 0
摘要
背景：新辅助化学免疫治疗是治疗局部晚期头颈部鳞状细胞癌（LA-SCCHN）的一种很有希望的治疗方法。然而，缺乏与新辅助化疗的临床结果的比较。目的：为LA-SCCHN新辅助化疗的临床决策提供依据。方法：检索PubMed、Web of Science、Embase和Cochrane图书馆，检索2024年8月10日前发表的关于LA-SCCHN新辅助化疗、免疫治疗和化疗的疗效和安全性的文献。该研究已在PROSPERO注册（CRD42024573816）。结果：共纳入28项临床试验，2021例患者。新辅助化疗组病理完全缓解（pCR） （33% vs. 18%, P = 0.04）和部分缓解（PR） （65% vs. 38%, P < 0.01）明显高于化疗组。总生存期（OS）（风险比：0.85,95% CI: 0.77-0.93）和无进展生存期（PFS）（风险比：0.72,95% CI: 0.61-0.86）无显著差异。关于安全性结局，在单臂试验中，化疗免疫治疗组和化疗组发生3 - 4级治疗相关不良事件（TRAEs）的比例分别为14%和13%，其中5级TRAEs分别为0%和4%，差异无统计学意义(P = 0.80；P = 0.08)。在随机对照试验和非随机对照试验中，化疗免疫治疗对3 - 4级TRAEs的风险比（RR）更高（RR: 1.42, 95% CI: 0.87-2.31）。结论：新辅助化疗免疫治疗对LA-SCCHN具有良好的疗效和安全性，但需要进一步的随机试验来证实长期生存益处。
Neoadjuvant chemoimmunotherapy for locally advanced squamous cell carcinoma of the head and neck: Systematic review and meta-analysis
Background
Neoadjuvant chemoimmunotherapy emerged as a promising treatment for locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, a comparison of clinical outcomes with neoadjuvant chemotherapy was lacking.
Objective
To provide evidence supporting clinical decision-making for neoadjuvant chemoimmunotherapy in LA-SCCHN treatment.
Methods
Literature was retrieved from PubMed, Web of Science, Embase, and the Cochrane Library for studies on the efficacy and safety of neoadjuvant chemoimmunotherapy and chemotherapy in LA-SCCHN published before August 10, 2024. The study was registered in the PROSPERO (CRD42024573816).
Results
A total of 28 clinical trials with 2021 patients were included. The neoadjuvant chemoimmunotherapy group had significantly higher pathologic complete response (pCR) (33 % vs. 18 %, P = 0.04) and partial response (PR) (65 % vs. 38 %, P < 0.01). No significant differences were found in overall survival (OS) (hazard ratio: 0.85, 95 % CI: 0.77–0.93) and progression-free survival (PFS) (hazard ratio: 0.72, 95 % CI: 0.61–0.86). Regarding safety outcomes, in the single-arm trials, grade 3–4 treatment-related adverse events (TRAEs) occurred in 14 % of the chemoimmunotherapy group and 13 % of the chemotherapy group, with grade 5 TRAEs at 0 % and 4 %, respectively, showing no significant difference (P = 0.80; P = 0.08). In both RCTs and non-RCT, chemoimmunotherapy had a higher Risk Ratio (RR) for grade 3–4 TRAEs (RR: 1.42, 95 % CI: 0.87–2.31).
Conclusion
Neoadjuvant chemoimmunotherapy has shown promising efficacy and safety for LA-SCCHN, but further randomized trials are needed to confirm long-term survival benefits.
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