Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma

Официальное название

Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Patients With Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy and Radical Surgery: A Single-Center Ambispective Cohort Study

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Observation
  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.
• Лучевая терапия Postoperative 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.
• Препарат PD-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.

Первичные конечные точки

• 1-Year Event-Free Survival (EFS) [Срок оценки: 1-Year]
• Pathological Complete Response (pCR) Rate [Срок оценки: At the time of surgery]

Вторичные конечные точки (8)

• 1-Year Overall Survival (OS) [Срок оценки: 1-Year]
• Major Pathological Response (MPR) Rate [Срок оценки: At the time of surgery]
• Failure Patterns [Срок оценки: 1-Year]
• Incidence of Grade ≥3 Radiotherapy-Related Toxicities (RTOG/EORTC) [Срок оценки: 1-Year]
• Incidence of Grade ≥3 Immunotherapy-Related Adverse Events (NCI-CTCAE v6.0) [Срок оценки: 1-Year]
• Swallowing Function [Срок оценки: 1-Year]
• Nutritional Status Assessed by NRS-2002 Score [Срок оценки: 1-Year]
• Quality of Life (Clinically Documented Functional Assessment) [Срок оценки: 1-Year]

Критерии участия

Критерии включения

• Age 18-80 years, any gender.
• Expected survival ≥ 6 months.
• Adequate major organ function; ECOG performance status 0-1.
• 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.
• No evidence of distant metastasis based on auxiliary examinations.
• No prior antitumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapies.
• Received 2 cycles of neoadjuvant chemoimmunotherapy (toripalimab + TP regimen) and underwent R0 resection.
• Women of childbearing potential must agree to use effective contraception during treatment and for 3 months after.
• Signed informed consent (if the participant lacks capacity, by a legally authorized representative), voluntarily participates in the study, and demonstrates good compliance.

Критерии исключения

• History of radiotherapy to the head and neck region.
• Severe bone marrow suppression, hepatic or renal failure, or uncontrolled severe infections, cardiovascular diseases, or other conditions that may preclude tolerance of treatment.
• Active autoimmune diseases, history of organ transplantation requiring long-term immunosuppressive therapy, or severe immunodeficiency that may result in serious immune-related adverse events.
• Active infections requiring systemic therapy.
• 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.
• 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.
• History of substance abuse, alcoholism, or drug abuse.
• Pregnant or breastfeeding women.
• Participation in other interventional clinical trials simultaneously.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Stomatology, Zhujiang Hospital, Southern Medical University, Haizhu District — Гуанчжоу

Идентификаторы

NCT: NCT07457099 · 2025-KY-505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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