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: 1. Postoperative radiotherapy 2. Postoperative PD-1 inhibitor maintenance therapy 3. Observation without adjuvant therapy 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.
Study Type
OBSERVATIONAL
Enrollment
85
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.
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.
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.
Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District, Guangzhou, Guangzhou, Guangdong 510282
Guangzhou, China
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.
Time frame: 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.
Time frame: At the time of surgery
1-Year Overall Survival (OS)
Time from the date of surgery to death from any cause or last follow-up.
Time frame: 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
Time frame: At the time of surgery
Failure Patterns
Distribution of recurrence events categorized as local, regional, or distant.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1-Year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.