Efficacy and safety of serplulimab with DP induction chemotherapy followed by nimotuzumab and IMRT in locally advanced nasopharyngeal carcinoma: A retrospective study.

Abstract

e18093 Background: Induction chemotherapy is the new standard of care for locally advanced nasopharyngeal carcinoma (LANPC). Whereas managing LANPC still presents various challenges. This study aims to evaluate the efficacy and safety of serplulimab plus docetaxel and cisplatin induction chemotherapy, followed by nimotuzumab (nimo) and Intensity Modulated Radiation Therapy (IMRT), highlighting the potential of integrating immune checkpoint inhibition with targeted therapy in this setting. Methods: This retrospective study involved 43 LANPC patients (non-keratinizing, WHO criteria) at clinical stages III-IVA, treated from March 2023 to November 2023. Eligible patients were ≥18 years old and received 4 cycles of serplulimab plus docetaxel and cisplatin followed by 6 weeks of nimo with IMRT. After induction therapy, multidisciplinary team evaluated efficacy via RECIST 1.1. Complete response (CR) was defined as no detectable nasopharyngeal tumor or mucosal bulge on nasoendoscopy. Results: Among the 39 patients meeting eligibility criteria, the median age was 51 years; the median EBV DNA level was 554.0 copies/ml. Via TNM staging, 11(28%) patients were classified as T4 and 12(31%) patients as N3. 19(49%) patients were in stage III, and 20(51%) patients were in stage IVA. As of 31 Dec 2024, the median follow-up was 17 months. Among 38 patients in PPS(table), The CR was 71%, PR was 29%, with ORR and DCR both at 100%(95% CI 91-100). Median OS and PFS were not reached. The 1-year OS rate was 97.4% due to the unexplained death of one patient. Lower CR was noted among patients with T4 disease. Safety profile was consistent with previous reports, furthermore, patients with renal impairment experienced no additional adverse effects. Conclusions: Serplulimab plus docetaxel and cisplatin induction chemotherapy followed by nimo with IMRT demonstrates promising efficacy and tolerability in treating LANPC. Continuous follow-up is essential for assessing long-term survival outcomes. Tumor response. PPS (Efficacy analysis set, n=38)* BOR, n (%) CR 27 (71) PR 11 (29) ORR, % (95% CI) 100 (91, 100) DCR, % (95% CI) 100 (91, 100) Median PFS, months (95% CI) NR (NE, NE) Median OS, months (95% CI) NR (NE, NE) *PPS, per protocol set, included patients receiving ≥1 dose of serplulimab or TP, and having completed ≥1 post-treatment tumor assessment unless treatment was discontinued before the first tumor assessment due to disease progression or death; BOR, best overall response; CR, complete response; PR, partial response; ORR, objective response rate; DCR, disease control rate; PFS, progression-free survival; OS, overall survival; NR, not reached; NE, not estimable.