About the Article
Article Files
[This article belongs to Volume - 71, Issue - 1]
Published on : 2026-01-20 01:22:33
Article Code: AMJ-20-01-2026-12364
Title : Five-Year Outcomes of Camrelizumab Plus Chemotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma: A Secondary Analysis of the CAPTAIN-1st Randomized Clinical Trial
Author(s) : Dr. Farid Guliyev, Dr. Aysel Mammadova, Dr. Elshan Abbasov, Dr. Nigar Alieva
Abstract :
Background: Nasopharyngeal carcinoma (NPC) is a distinct head and neck malignancy endemic to Southeast Asia
and North Africa with high rates of recurrence and metastasis. Camrelizumab, a humanized anti-PD-1 monoclonal
antibody, demonstrated promising efficacy in combination with chemotherapy in the first-line treatment of recurrent
or metastatic (R/M) NPC. However, long-term survival data beyond three years remain limited.
Methods: We conducted a secondary analysis of the CAPTAIN-1st Phase 3 randomized controlled trial with extended
f
ive-year follow-up. Patients with R/M NPC who had not received prior systemic chemotherapy for recurrent or
metastatic disease were randomized (1:1) to receive camrelizumab (200 mg every 3 weeks) plus gemcitabine and
cisplatin (GP) followed by camrelizumab maintenance, or placebo plus GP followed by placebo maintenance. The
primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective
response rate (ORR), duration of response (DoR), and safety.
Results: Between January 2019 and December 2020, 263 patients were enrolled. At a median follow-up of 62.8
months (range: 0.2-71.4), the median PFS was 11.8 months (95% CI: 10.4-14.2) in the camrelizumab group versus 7.6
months (95% CI: 6.6-8.4) in the placebo group (hazard ratio [HR] 0.52; 95% CI: 0.38-0.71; p<0.0001). Median OS was
42.8 months versus 28.4 months (HR 0.62; 95% CI: 0.45-0.85; p=0.002). The 5-year OS rates were 35.8% (95% CI:
28.2-43.4) versus 18.4% (95% CI: 12.1-24.7). ORR was 72.4% versus 64.8% (p=0.12). Complete responses were
observed in 28.2% versus 12.2% of patients (p=0.001). Long-term safety analysis revealed no new safety signals;
immune-related adverse events occurred in 42.4% versus 8.4% of patients.
Conclusions: This five-year analysis confirms durable long-term survival benefit with first-line camrelizumab plus
chemotherapy in recurrent or metastatic nasopharyngeal carcinoma, with approximately one-third of patients alive
at five years. These results establish camrelizumab-based chemoimmunotherapy as a standard-of-care with curative
potential for a subset of patients.