Sep 28

SS 15 - Immunotherapy Integration and Immuno Biomarkers Across Mucosal and Cutaneous SCC

172 - Phase 2 Trial of First-Line Camrelizumab plus Concurrent Chemoradiotherapy in Patients with Nonoperative Locally Advanced Oral Squamous Cell Carcinoma: Outcomes and Toxicity Profile

10:45am - 10:55am ET

Room 107

Presenter(s)

Feng Liu, MD - Hunan Cancer Hospital, Changsha, Hunan

F. Liu¹, H. Wang¹, Y. Li¹, W. Zhu¹, X. Chen¹, Y. Shi², C. Jiang¹, L. He¹, Y. Li¹, S. Hu¹, K. Chen¹, Y. Qiu¹, X. Ye¹, C. Fan¹, X. Wu¹, H. Liu³, W. Wu¹, S. Xiao¹, and Q. Zhao¹; ¹Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China, ²Hengyang Medical School, University of South China, Hengyang, China, ³Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China

Purpose/Objective(s):

Long-term follow-up of the phase 3 KEYNOTE-412 trial demonstrated that adding an anti-PD-1 antibody to concurrent chemoradiotherapy (CCRT) confers clinical benefit in patients with unresected locally advanced head and neck squamous cell carcinoma. However, oral cancer patients constituted only a small subset in this study, resulting in an unmet need for robust evidence specific to this population. Thus, this trial aimed to evaluate the efficacy and safety of CCRT combined with concurrent and adjuvant camrelizumab as first-line therapy for patients with nonoperative locally advanced oral squamous cell carcinoma (LAOSCC).

Materials/Methods:

This open-label, single-arm phase 2 trial enrolled 91 patients with nonoperative (inoperable or surgeryrefusing), stage III to IVB oral squamous cell carcinoma (OSCC). All patient received CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. Intensity-modulated radiation therapy (IMRT) was administered at doses of 70.0 Gy in 35 fractions, 60.2 Gy in 35 fractions, and 50.4 Gy in 28 fractions for high-risk, intermediate-risk, and low-risk planning target volumes (PTVs), respectively. Cisplatin (100 mg/m² every 3 weeks) was delivered concurrently with radiotherapy. Camrelizumab (200mg on days 1, 22, 43) was administered concomitantly with CCRT, followed by adjuvant 200 mg doses every 3-weeks for 1 year or until disease progression, occurrence of unacceptable adverse events (AEs), or withdrawal of consent. The primary endpoint was disease-free survival (DFS). Secondary outcomes included treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence free survival (LRRFS), distant metastasisfree survival (DMFS), and treatment-ralatied toxicity.

Results:

The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 98.9%, 87.9%, and 11.0%, respectively. The 2-year DFS, OS, LRFS, LRRFS, and DMFS were 71.4%, 89.0%, 78.0%, 75.8%, 84.6%, respectively. Multivariate analysis identified tumor location (tongue vs. other), PD-L1 combined positive score (CPS, =1 vs. <1), betel nut chewing history (yes vs. no), and T stage (T1-2 vs T3-4) as significant prognostic factors associated with DFS, LRFS, DMFS, and OS. Common ( incidence = 10%) severe (= grade 3) treatment-related toxicities included oral mucositis (63.7%), lymphopenia (35.2%), dysphagia (22.0%), nausea (14.3%), dermatitis (12.1%), and hyponatremia (11.0%). Reactive capillary endothelial proliferation (RCEP) occurred in 5.5% of patients, all of which were grade 1-2. No grade 5 toxicities were reported.

Conclusion:

Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment demonstrates substantial efficacy in nonoperative locally advanced oral squamous cell carcinoma patients, with manageable toxicity.