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The goal of this observational study is to investigate the effectiveness of neoadjuvant chemoimmunotherapy (NACI) regimens in treating advanced oral squamous cell carcinoma (OSCC) patients. We analyzed clinicopathologic features of advanced OSCC patients who received PD-1 inhibitors in combination with carboplatin and paclitaxel before surgical tumor resection between 2020 and 2022. The Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and pathologic response were used to evaluate the efficacy of the NACI treatment. Adverse events apparently related to NACI treatment were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. Disease-free survival (DFS) and overall survival (OS) were calculated using the Kaplan-Meier survival curves and compared using the log rank test. Additionally, we calculated the area under curve (AUC) to compare the predictive value of PD-L1 expression with baseline serum lipid biomarkers for patient response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemoimmunotherapy+surgery | Patients who underwent neoadjuvant chemoimmunotherapy before surgery |
| |
| surgery | Patients who accepted the surgery alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor+carboplatin+albumin-bound paclitaxel | Drug | A comparative evaluation of patient prognosis between those who received neoadjuvant chemoimmunotherapy-surgery treatment and those who underwent surgery alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time(years) from day 1 of study treatment until death from any cause. | 2 years |
| Disease-free survival （DFS） | DFS(by months) is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease DFS is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease relapse. | 2 years |
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Inclusion Criteria:
Patients with advanced OSCC who received NACI before surgery
Advanced OSCC patients who only received surgery
Exclusion Criteria:
Patients with advanced OSCC who received NACI before surgery
Advanced OSCC patients who only received surgery
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| Name | Affiliation | Role |
|---|---|---|
| Jinsong Li | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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| D009057 |
| Stomatognathic Diseases |