SS 08 - H&N 3: Addressing High-Risk Challenges Head On: Mitigating Toxicity and Reducing Recurrences
142 - A Phase II Trial of Camrelizumab in Combination with Concurrent Chemoradiotherapy as First-Line Treatment for Betel Nut-Related Locally Advanced Oral Squamous Cell Carcinoma
F. Liu1, H. Wang2, C. Jiang1, C. Fan1, X. Ye1, X. Wu1, L. He1, Y. Qiu1, Y. Li1, K. Chen1, Q. Zhao1, S. Xiao1, W. Wu1, W. Liu1, C. Tan3, Y. Li3, and R. He4; 1Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China, 2Department of Radiation Oncology, Hunan Cancer Hospital & the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China, 3Hengyang Medical School, University of South China, Hengyang, China, 4Hunan Normal University School of Medicine, Changsha, China
Purpose/Objective(s): Betel nut chewing is an established cause of oral cancer. We hypothesized that patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma (LAOSCC) can benefit from the addition of concurrent and adjuvant camrelizumab to cisplatin-based concurrent chemoradiotherapy (CCRT) as first-line treatment. The purpose of this single arm, phase 2 trial was to evaluate the efficacy and safety of CCRT plus concurrent and adjuvant camrelizumab as first-line treatment for patients with nonoperative betel nut-related LAOSCC. Materials/
Methods: This study was an open-label, single-arm phase 2 trial. A total of 60 patients with betel nut-related (consumption of at least 10 betel nuts per day for more than 5 years), nonoperative, stage III to IVB oral squamous cell carcinoma (OSCC) were enrolled. All patient were treated with CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. The concurrent head and neck irradiation using intensity-modulated radiation therapy (IMRT) was administered at a dose of 70 Gy in 35 fractions. Cisplatin was administered at a dosage of 100mg /m2 Q3W, concurrently with radiotherapy. Camrelizumab (200mg on days 1, 22, 43) was given concurrently to CCRT, and this was followed by adjuvant doses of 200mg every 3-weeks for 1 year or until disease progression, the occurrence of unacceptable adverse events (AEs), withdrawal of consent or investigator’s decision. The primary endpoint was disease-free survival (DFS). Secondary outcomes were treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related toxicity. Results: Median follow-up duration was 12 months. The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 100%, 88.3%, and 11.7%, respectively. The 1-year DFS, OS, LRFS, LRRFS, and DMFS were 86.7%, 95.0%, 91.7%, 88.3%, 86.7%, respectively. Compared to patients with a PD-L1 combined positive score (CPS) of < 1, those with a CPS =1 have significant higher CR rate (94.1% vs 55.5%, p = 0.001), DFS (92.2% vs 55.5%, p = 0.003), and OS (98.0% vs 77.8%, p = 0.011). The common (incidence = 10%) severe (= grade 3) toxic effects included oral mucositis (65.0%), decreased lymphocyte count (36.6%), dysphagia (23.3%), nausea (16.6%), hyponatremia (13.3%), weight loss (11.6%), vomiting (11.6%), and radiation dermatitis (10.0%). The incidence of reactive capillary endothelial proliferation (RCEP) was 6.7%, all of which are grade 1-2. No grade 5 toxicities were observed. Conclusion: Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment has demonstrated significant efficacy in patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma, with tolerable toxicity profiles. This trial is registered with chictr.org.cn (ChiCTR2200056298).