Purpose: We evaluated 32 patients with either unresectable and locally recurrent oral cancer or oral cancer with distant metastasis who were treated with immune checkpoint inhibitors (ICIs) at the Department of Oral and Maxillofacial Surgery of Hiroshima University Hospital.
Methods: The following data were collected for 24 patients treated with Nivolumab and 8 patients treated with Pembrolizumab: sex, age, primary site, histological type, stage, performance status (PS), target lesion, number and line of administration, observation period, neutrophil lymphocyte ratio (NLR) immediately before treatment, immune-related adverse events (irAE), overall response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS).
Result: The 1-year OS rate of the 24 patients treated with Nivolumab was 45.8%, and the 1-year PFS rate was 20.0%. The 21 patients treated with Nivolumab who were evaluable for efficacy were 2 complete response (CR), 1 partial response (PR), 5 stable disease (SD), and 13 progression disease (PD; ORR with Nivolumab was 14.2% and DCR was 38%. The 1-year OS rate and 1-year PFS rate of the 8 patients with Pembrolizumab were both 42.9%. Seven patients were evaluable for response: 2 had PR and 5 had PD, and both ORR and DCR were 28.6%. Of the 32 patients in total, ICIs were discontinued in all but one case due to irAE in seven patients.
Conclusion: ICIs have been used successfully in patients with unresectable local recurrence and distant metastasis of oral cancer. Patients with NLR less than 5.6 immediately before treatment showed significant anti-tumor activity (P=0.0148).
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