2900 - Chemotherapy plus Nimotuzumab and Immunotherapy as Induction Regime Followed by Sequential Chemoradiotherapy and Consolidation Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Open-Label, Phase II Trial
Presenter(s)
M. Zhang, J. B. Liu, B. Hou, C. Liu, N. SU, J. Zang, and M. Shi; Department of Radiation Oncology, Xijing Hospital, Air Force Medical University, Xi'an, China
Purpose/Objective(s): Concurrent chemoradiotherapy (CCRT) is the standard treatment opinion for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are not candidates for surgical intervention. However, the treatment outcomes of CCRT remains poor, with over 50% of patients developing disease recurrence. Phase II clinical trials have demonstrated that the combination of anti-EGFR therapy with PD-1 inhibitors represents an effective treatment approach for recurrent/metastatic head and neck squamous cell carcinoma. To further evaluate the therapeutic potential of this combination approach in LA-HNSCC, we conducted a prospective study to assess the efficacy and safety of a novel treatment paradigm incorporating TP chemotherapy combined with nimotuzumab and immunotherapy as induction therapy, followed by CCRT and consolidation immunotherapy in patients with surgically unresectable LA-HNSCC.
Materials/Methods: All patients with LA-HNSCC who met the eligibility criteria were consecutively enrolled in the study. The induction therapy regimen consisted of TP chemotherapy (docetaxel 75 mg/m² + cisplatin 60 mg/m²) combined with nimotuzumab (400 mg) and penpulimab (200 mg), administered every three weeks for a total of two cycles. The concurrent chemoradiotherapy regimen consisted of definitive radiotherapy with a dose of 66-70 Gy to GTV, combined with concurrent cisplatin chemotherapy (100 mg/m²). Subsequent maintenance immunotherapy included 6 cycles of penpulimab every three weeks. The primary endpoint was 2-year progression free survival.
Results: A total of 25 patients were enrolled. With a median follow-up duration of 25 months (range: 7-31 months), disease progression occurred in 6 patients. The 2-year OS, PFS, DMFS and LRRFS were 75.7%, 68.4%, 81.8% and 79.1%, respectively. The overall response rate (ORR) of induction therapy was 52%, while the ORR in the patients who had finished following CCRT was 85%. Five patients (20%) experienced grade 4 myelosuppression following induction therapy, and 8 patients (32%) experienced =grade 3 hematologic toxicity after completing the entire treatment regimen.
Conclusion: TP chemotherapy combined with nimotuzumab and immunotherapy as induction regime followed by sequential chemoradiotherapy and consolidation immunotherapy demonstrates promising therapeutic efficacy and an acceptable toxicity profile. (Registration number: ChiCTR2200064587.)