帕博利珠单抗联合二甲双胍治疗转移性头颈部癌的 II 期可行性研究
A Phase II Feasibility Study Combining Pembrolizumab and Metformin in Patients with Metastatic Head and Neck Cancer.
二甲双胍联合帕博利珠单抗耐受性良好,仅出现轻度胃肠道不良事件,并展现出有前景的活性,值得在随机试验中进一步研究。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Efficacy and safety of neoadjuvant treatment with PD-1 inhibitor in locally advanced head and neck squamous cell carcinoma.
Efficacy and safety of neoadjuvant treatment with PD-1 inhibitor in locally advanced head and neck squamous cell carcinoma.
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头颈部鳞状细胞癌(HNSCC)是常见的恶性肿瘤。传统治疗疗效不稳定,存在复发、耐药及副作用风险。免疫治疗在复发/转移性晚期HNSCC中取得了良好效果,但其新辅助应用的相关研究尚不充分。
本研究通过回顾性分析临床数据,评估PD-1抑制剂作为新辅助治疗用于LA-HNSCC的疗效与安全性,为治疗策略提供科学依据。
本研究对2020年11月至2024年3月在汕头大学肿瘤医院接受治疗的局部晚期头颈部鳞状细胞癌(LA-HNSCC)患者进行回顾性分析。实验组给予新辅助PD-1抑制剂联合化疗,对照组仅接受化疗。疗效依据RECIST 1.1标准评估,治疗相关不良事件依据CTCAE 5.0分级。采用SPSS 27.0软件及Kaplan-Meier法进行统计分析,p<0.05认为差异有统计学意义。两组基线特征均衡良好(P>0.05),基于RECIST的疗效结局无显著差异(P>0.05)。研究组病理降级率及病理完全缓解(pCR)显著更高(P = 0.032),安全性良好,总生存期(OS)改善(P = 0.044)。新辅助免疫化疗与总生存期改善相关,手术与较低死亡风险相关。这些发现为探索性结果,需在更大规模的前瞻性研究中加以证实。新辅助免疫化疗与LA-HNSCC患者病理缓解和OS改善相关,且安全性可接受。这些探索性发现值得在更大规模的前瞻性研究中加以验证。对2020年11月至2024年3月在汕头大学肿瘤医院接受治疗的局部晚期头颈部鳞状细胞癌(LA-HNSCC)患者进行的回顾性分析。实验组接受新辅助PD-1抑制剂联合化疗,对照组仅接受化疗。
疗效依据RECIST 1.1标准评估,治疗相关不良事件依据CTCAE 5.0分级。采用SPSS 27.0软件和Kaplan-Meier法进行统计分析,p<0.05视为具有统计学意义。两组基线特征均衡良好(P>0.05),基于RECIST的疗效结局无显著差异(P>0.05)。研究组病理降级率和病理完全缓解(pCR)显著更高(P = 0.032),安全性良好,总生存期(OS)改善(P = 0.044)。新辅助治疗方案和手术干预被确定为与OS改善相关的因素。鉴于样本量和组间不平衡,这些应被解读为探索性结果。新辅助免疫化疗与LA-HNSCC患者病理缓解和OS改善相关,且安全性可接受。这些探索性发现值得在更大规模的前瞻性研究中加以验证。对2020年11月至2024年3月在汕头大学肿瘤医院接受治疗的局部晚期头颈部鳞状细胞癌(LA-HNSCC)患者进行的回顾性分析。试验组给予新辅助PD-1抑制剂联合化疗,对照组单纯给予化疗。疗效评价参照RECIST 1.1标准,治疗相关不良事件依据CTCAE 5.0进行分级。采用SPSS 27.0软件及Kaplan-Meier法进行统计分析,以p<0.05为差异有统计学意义。两组基线特征均衡良好(P>0.05),wi
Head and neck squamous cell carcinoma (HNSCC) is a common malignant tumor. Traditional treatments have unstable efficacy, with risks of relapse, drug resistance and side effects. Immunotherapy has achieved good results in recurrent/metastatic advanced HNSCC, but relevant research on its neoadjuvant application is insufficient.
This study retrospectively analyzes clinical data to evaluate the efficacy and safety of PD-1 inhibitors as neoadjuvant therapy for LA-HNSCC, providing a scientific basis for treatment strategies.
This study conducted a retrospective analysis of patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) treated at Shantou University Cancer Hospital from November 2020 to March 2024. The experimental group was administered neoadjuvant PD-1 inhibitor combined with chemotherapy, while the control group received chemotherapy alone. Efficacy was evaluated in accordance with RECIST 1. 1 criteria, and treatment-related adverse events were graded based on CTCAE 5. 0. SPSS 27. 0 software and Kaplan-Meier method were employed for statistical analysis, with p<0.
05 considered statistically significant. Baseline characteristics were well balanced between the two groups (P>0. 05), with no significant difference in RECIST-based efficacy outcomes (P>0. 05). The study group exhibited a significantly higher pathological downgrading rate and pathological complete response (pCR) (P = 0. 032), a favorable safety profile, and improved overall survival (OS) (P = 0. 044). Neoadjuvant immunochemotherapy was associated with improved overall survival, and surgery was associated with a lower risk of death.
These findings are exploratory and require confirmation in larger prospective studies. Neoadjuvant immunochemotherapy was associated with improved pathological response and OS in LA-HNSCC, with an acceptable safety profile. These exploratory findings warrant confirmation in larger prospective studies. a retrospective analysis of patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) treated at Shantou University Cancer Hospital from November 2020 to March 2024. The experimental group was administered neoadjuvant PD-1 inhibitor combined with chemotherapy, while the control group received chemotherapy alone. Efficacy was evaluated in accordance with RECIST 1. 1 criteria, and treatment-related adverse events were graded based on CTCAE 5. 0. SPSS 27. 0 software and Kaplan-Meier method were employed for statistical analysis, with p<0. 05 considered statistically significant. Baseline characteristics were well balanced between the two groups (P>0. 05), with no significant difference in RECIST-based efficacy outcomes (P>0. 05). The study group exhibited a significantly higher pathological downgrading rate and pathological complete response (pCR) (P = 0.
032), a favorable safety profile, and improved overall survival (OS) (P = 0. 044). Neoadjuvant treatment regimen and surgical intervention were identified as factors associated with improved OS. These should be interpreted as exploratory given the sample size and group imbalance. Neoadjuvant immunochemotherapy was associated with improved pathological response and OS in LA-HNSCC, with an acceptable safety profile. These exploratory findings warrant confirmation in larger prospective studies. A retrospective analysis of patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) treated at Shantou University Cancer Hospital from November 2020 to March 2024.
The experimental group was administered neoadjuvant PD-1 inhibitor combined with chemotherapy, while the control group received chemotherapy alone. Efficacy was evaluated in accordance with RECIST 1. 1 criteria, and treatment-related adverse events were graded based on CTCAE 5. 0. SPSS 27. 0 software and Kaplan-Meier method were employed for statistical analysis, with p<0. 05 considered statistically significant. Baseline characteristics were well balanced between the two groups (P>0. 05), wi
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