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Neoadjuvant immunochemotherapy (NAIC) has demonstrated promising pathological and survival outcomes in patients with resectable locally advanced oral and oropharyngeal squamous cell carcinoma (LA-OSCC/OPSCC). However, the optimal postoperative management strategy following NAIC and radical surgery remains undefined, particularly regarding the necessity of postoperative radiotherapy and the potential role of PD-1 inhibitor maintenance therapy.
This single-center, ambispective cohort study aims to compare event-free survival, pathological response, survival outcomes, failure patterns, treatment-related toxicities, and functional outcomes among three postoperative strategies: postoperative radiotherapy, postoperative PD-1 inhibitor maintenance, and observation alone. The study seeks to provide real-world evidence to support risk-adapted, individualized postoperative decision-making after NAIC
Patients with resectable LA-OSCC/OPSCC who received two cycles of neoadjuvant immunochemotherapy consisting of tislelizumab combined with paclitaxel and platinum chemotherapy, followed by R0 radical resection, were included. Based on multidisciplinary clinical decisions, pathological risk stratification, and patient preference, participants were managed postoperatively with one of three strategies:
The study incorporates both retrospective and prospective cohorts using identical eligibility criteria, treatment regimens, follow-up schedules, and outcome assessments to ensure data homogeneity. Survival outcomes, pathological response, treatment-related adverse events, and functional outcomes are systematically evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Adjuvant Therapy Group | Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery, with no postoperative adjuvant treatment and routine follow-up only. |
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| Postoperative Radiotherapy Group | Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery and postoperative radiotherapy according to multidisciplinary team decision. |
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| Postoperative Immunotherapy Maintenance Group | Patients received neoadjuvant immunochemotherapy followed by R0 radical surgery and postoperative PD-1 inhibitor maintenance therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Participants received neoadjuvant immunochemotherapy followed by R0 radical surgical resection. No postoperative adjuvant therapy was administered. Patients were managed with routine clinical follow-up, including scheduled physical examinations, imaging assessments, and functional evaluations according to institutional practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-Year Event-Free Survival (EFS) | Time from the date of radical surgery to the first occurrence of disease recurrence (local, regional, or distant), disease progression, death from any cause, or last follow-up, whichever occurs first. | 1-Year |
| Pathological Complete Response (pCR) Rate | Pathological complete response (pCR) is defined as the absence of residual viable tumor cells in both the primary tumor site and all resected lymph nodes, as assessed by postoperative histopathological examination. | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 1-Year Overall Survival (OS) | Time from the date of surgery to death from any cause or last follow-up. | 1-Year |
| Major Pathological Response (MPR) Rate | Major pathological response is defined as ≤10% residual viable tumor cells in the surgical specimen, as determined by histopathological evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (18-80 years) with histologically confirmed, treatment-naïve, locally advanced oral or oropharyngeal squamous cell carcinoma who were surgically resectable and had ECOG performance status 0-1. All participants received two cycles of neoadjuvant immunochemotherapy (tislelizumab plus paclitaxel and platinum) followed by R0 radical surgery and were managed postoperatively with radiotherapy, PD-1 inhibitor maintenance, or observation. Patients with prior head and neck radiotherapy, active autoimmune disease, uncontrolled severe comorbidities, pregnancy/lactation, or incomplete data were excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaozhi LV | Contact | 02062783160 | lxzsurgeon@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou, Guangzhou, Guangdong 510282 | Guangzhou | China |
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| Postoperative Radiotherapy | Radiation | Participants received neoadjuvant immunochemotherapy followed by R0 radical surgical resection and postoperative radiotherapy. Radiotherapy was delivered to the primary tumor bed and regional lymphatic drainage areas according to multidisciplinary team recommendations and institutional guidelines. |
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| PD-1 Inhibitor Maintenance Therapy | Drug | Participants received neoadjuvant immunochemotherapy followed by R0 radical surgical resection and postoperative immunotherapy maintenance with a PD-1 inhibitor. Immunotherapy was administered at standard dosing intervals according to institutional protocols until disease progression, unacceptable toxicity, or completion of the planned treatment course. |
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| At the time of surgery |
| Failure Patterns | Distribution of recurrence events categorized as local, regional, or distant. | 1-Year |
| Incidence of Grade ≥3 Radiotherapy-Related Toxicities (RTOG/EORTC) | The incidence of grade 3 or higher radiotherapy-related toxicities, assessed according to the Radiation Therapy Oncology Group / European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity criteria. Toxicity grades range from Grade 0 (no toxicity) to Grade 5 (death related to toxicity), with higher grades indicating more severe toxicity. | 1-Year |
| Incidence of Grade ≥3 Immunotherapy-Related Adverse Events (NCI-CTCAE v6.0) | The incidence of grade 3 or higher immunotherapy-related adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. Adverse event grades range from Grade 1 (mild) to Grade 5 (death related to adverse events), with higher grades indicating more severe toxicity. | 1-Year |
| Swallowing Function | Swallowing function was assessed based on clinically documented swallowing evaluations during follow-up visits, including physician-reported functional assessments. Functional status was categorized according to institutional clinical practice, with higher functional levels indicating better swallowing ability. | 1-Year |
| Nutritional Status Assessed by NRS-2002 Score | Nutritional status was assessed using the Nutritional Risk Screening 2002 (NRS-2002) score. The NRS-2002 score ranges from 0 to 7, with higher scores indicating greater nutritional risk. | 1-Year |
| Quality of Life (Clinically Documented Functional Assessment) | Quality of life was assessed based on clinically documented functional assessments recorded during routine follow-up visits. Evaluations focused on patient-reported symptoms and functional status related to daily activities. | 1-Year |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D057832 | Watchful Waiting |
| D018714 | Radiotherapy, Adjuvant |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D011878 | Radiotherapy |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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