Zhu Xiayi, Qiu Jie, Zhang Ya, Lin Chunni, Wang Xiaohui, Shi Xiwei, Yang Siya, Wu Qiaoyan, Cong Li
School of Nursing, Hunan Normal University, Changsha, Hunan 410013, China.
School of Nursing, Hunan Normal University, Changsha, Hunan 410013, China.
Pharmacol Res. 2025 Feb;212:107598. doi: 10.1016/j.phrs.2025.107598. Epub 2025 Jan 11.
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.
To provide evidence supporting clinical decision-making for neoadjuvant chemoimmunotherapy in LA-SCCHN treatment.
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).
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).
Neoadjuvant chemoimmunotherapy has shown promising efficacy and safety for LA-SCCHN, but further randomized trials are needed to confirm long-term survival benefits.
新辅助化疗免疫疗法已成为局部晚期头颈部鳞状细胞癌(LA-SCCHN)的一种有前景的治疗方法。然而,缺乏与新辅助化疗的临床结果比较。
为LA-SCCHN治疗中新辅助化疗免疫疗法的临床决策提供支持证据。
从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新辅助化疗免疫疗法和化疗的疗效及安全性的研究。该研究已在PROSPERO(CRD42024573816)注册。
共纳入28项临床试验,涉及2021例患者。新辅助化疗免疫疗法组的病理完全缓解(pCR)率显著更高(33%对18%,P = 0.04)和部分缓解(PR)率(65%对38%,P < 0.01)。总生存期(OS)(风险比:0.85,95%置信区间:0.77 - 0.93)和无进展生存期(PFS)(风险比:0.72,95%置信区间:0.61 - 0.86)未发现显著差异。关于安全性结果,在单臂试验中,3 - 4级治疗相关不良事件(TRAEs)在化疗免疫疗法组中发生率为14%,化疗组为13%,5级TRAEs分别为0%和4%,无显著差异(P = 0.80;P = 0.08)。在随机对照试验(RCTs)和非随机对照试验中,化疗免疫疗法3 - 4级TRAEs的风险比(RR)更高(RR:1.42,95%置信区间:0.87 - 2.31)。
新辅助化疗免疫疗法对LA-SCCHN显示出有前景的疗效和安全性,但需要进一步的随机试验来证实长期生存获益。