Efficacy and safety of neoadjuvant treatment with PD-1 inhibitor in locally advanced head and neck squamous cell carcinoma

Vollständiger Abstract

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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), 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), 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.