Locally Advanced Oral Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma
Conditions
Keywords
Neoadjuvant immunochemotherapy, oral cancer, oropharyngeal cancer, PD-1 inhibitor, postoperative radiotherapy, event-free survival, pathological response, real-world study
Brief summary
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
Detailed description
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.
Interventions
OTHERObservation
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.
RADIATIONPostoperative Radiotherapy
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.
DRUGPD-1 Inhibitor Maintenance Therapy
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.
Sponsors
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years, any gender. 2. Expected survival ≥ 6 months. 3. Adequate major organ function; ECOG performance status 0-1. 4. Treatment-naïve patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC), in accordance with the 8th edition of the American Joint Committee on Cancer (AJCC) staging system (2017) and the 2020 Chinese Stomatological Association (CSA) guidelines for pathological diagnosis of oral and oropharyngeal cancers, with clinical stages: cT3N0M0, cT1-3N1M0, cT4aN0-2M0, cT1-4aN3M0, or cT4bN0-3M0. 5. No evidence of distant metastasis based on auxiliary examinations. 6. No prior antitumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapies. 7. Received 2 cycles of neoadjuvant chemoimmunotherapy (toripalimab + TP regimen) and underwent R0 resection. 8. Women of childbearing potential must agree to use effective contraception during treatment and for 3 months after. 9. Signed informed consent (if the participant lacks capacity, by a legally authorized representative), voluntarily participates in the study, and demonstrates good compliance.
Exclusion criteria
1. History of radiotherapy to the head and neck region. 2. Severe bone marrow suppression, hepatic or renal failure, or uncontrolled severe infections, cardiovascular diseases, or other conditions that may preclude tolerance of treatment. 3. Active autoimmune diseases, history of organ transplantation requiring long-term immunosuppressive therapy, or severe immunodeficiency that may result in serious immune-related adverse events. 4. Active infections requiring systemic therapy. 5. Cardiovascular/cerebrovascular events within 6 months prior to study treatment, including myocardial infarction, severe/unstable angina, coronary or peripheral artery bypass surgery, symptomatic heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. 6. Bleeding tendency/disorders: clinically significant bleeding or clear bleeding tendency within the past 28 days, including but not limited to gastrointestinal bleeding, epistaxis (excluding mild nosebleeds or blood-streaked sputum), or persistent bleeding/clotting disorders. 7. History of substance abuse, alcoholism, or drug abuse. 8. Pregnant or breastfeeding women. 9. Participation in other interventional clinical trials simultaneously.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-Year Event-Free Survival (EFS) | 1-Year | 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. |
| Pathological Complete Response (pCR) Rate | At the time of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-Year Overall Survival (OS) | 1-Year | Time from the date of surgery to death from any cause or last follow-up. |
| Major Pathological Response (MPR) Rate | At the time of surgery | Major pathological response is defined as ≤10% residual viable tumor cells in the surgical specimen, as determined by histopathological evaluation |
| Failure Patterns | 1-Year | Distribution of recurrence events categorized as local, regional, or distant. |
| Incidence of Grade ≥3 Radiotherapy-Related Toxicities (RTOG/EORTC) | 1-Year | 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. |
| Incidence of Grade ≥3 Immunotherapy-Related Adverse Events (NCI-CTCAE v6.0) | 1-Year | 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. |
| Swallowing Function | 1-Year | 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. |
| Nutritional Status Assessed by NRS-2002 Score | 1-Year | 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. |
| Quality of Life (Clinically Documented Functional Assessment) | 1-Year | 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. |
Countries
China
Contacts
CONTACTXiaozhi LV
Outcome results
None listed