Induction Camrelizumab and Modified TPF (Nab-Paclitaxel, Cisplatin, and S-1) in Locoregionally Advanced Nasopharyngeal Carcinoma

Abstract

Induction chemo-immunotherapy has emerged as a potential treatment option for locoregionally advanced nasopharyngeal carcinoma (LANPC). This study aimed to evaluate the efficacy and safety of camrelizumab combined with modified TPF (nab-paclitaxel, cisplatin, and S-1) as induction chemo-immunotherapy in LANPC. Patients with stage T1-4N2-3M0 NPC who received induction chemo-immunotherapy were enrolled from July 2023 to May 2024. They underwent three cycles of chemo-immunotherapy, including camrelizumab 200 mg on day 1, nab-paclitaxel 260 mg/m² on day 1, cisplatin 25 mg/m² on days 1-3, and oral S-1 40-60 mg twice daily from days 1 to 14, every 21 days. The primary endpoint was the complete response (CR) rate, while secondary endpoints included the safety and objective response rate (ORR). A total of 30 patients were enrolled, with 29 (96.7%) completing three cycles of induction chemo-immunotherapy. The CR rate was 41.4% (12/29), achieving the predefined endpoint. The CR rate for the primary nasopharyngeal tumor and cervical lymph nodes was both 65.5% (19/29). Seventeen patients achieved a partial response (PR), resulting in an ORR of 100%. Grade 3 or 4 chemotherapy-related adverse events occurred in 26.6% of patients. Immune-related adverse events of any grade were reported in 20 (66.7%) patients, including reactive cutaneous capillary endothelial proliferation in 10 patients (40.0%), all of which were Grade 1 or 2. One patient (3.5%) experienced a Grade 3 rash. No treatment-related deaths occurred. Our study suggests that induction chemo-immunotherapy of camrelizumab plus modified TPF demonstrated an excellent CR rate and an acceptable safety profile in patients with LANPC. Trial Registration: ChiCTR240008603.

Keywords: PD‐1 inhibitor; chemotherapy; induction therapy; nasopharyngeal carcinoma; treatment response.

FIGURE 1

Trial profiles.

FIGURE 2

Waterfall plot of tumor regression in the per‐protocol population (n = 29). Each bar indicates one patient. The green horizontal line indicates a 30% decrease from the baseline.

FIGURE 3

The post hoc subgroup analysis of CR rates (n = 29). Data are presented as percentages with 95% CI. The variable “n” represents the number of patients achieving a CR, while “N” denotes the total number of patients available for assessment. The orange vertical line indicates the CR rate in the overall population, and the baby blue area shows the corresponding 95% CI.

FIGURE 4

Comparison of CPS status between the CR and non‐CR groups (n = 29). (A) CPS < 20 versus CPS ≥ 20. (B) CPS < 40 versus CPS ≥ 40. (C) CPS < 60 versus CPS ≥ 60. (D) CPS < 80 versus CPS ≥ 80.

FIGURE 5

EBV‐DNA levels before and after each cycle of induction chemo‐immunotherapy (n = 29).

FIGURE 6

Comparison of EBV‐DNA levels before and after each cycle of induction chemo‐immunotherapy between the CR and non‐CR groups (n = 29). (A) EBV‐DNA levels < 4000 copies/mL versus EBV‐DNA levels ≥ 4000 copies/mL. (B) Undetectable EBV‐DNA versus Detectable EBV‐DNA after the first cycle of chemo‐immunotherapy. (C) Undetectable EBV‐DNA versus Detectable EBV‐DNA after the second cycle of chemo‐immunotherapy. (D) Undetectable EBV‐DNA versus Detectable EBV‐DNA after the third cycle of chemo‐immunotherapy.