Concurrent chemoradiotherapy plus nimotuzumab versus chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma with a suboptimal response to induction chemotherapy: a randomized phase 2 trial

Rákkutatás · Nasopharyngeal carcinoma · EGFR

Adding nimotuzumab to concurrent chemoradiotherapy does not improve survival in patients with locoregionally advanced nasopharyngeal carcinoma (LA‑NPC) who had a suboptimal response to induction chemotherapy.

Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) is the standard treatment for locoregionally advanced nasopharyngeal carcinoma (LA‑NPC); however, patients with a suboptimal response to IC, defined as detectable Epstein‑Barr virus DNA and/or stable or progressive disease after IC, remain at high risk of treatment failure. Here we report an open‑label, randomised, phase 2 trial evaluating whether adding nimotuzumab, a humanised anti‑epidermal growth factor receptor antibody, to CCRT improves outcomes in this high‑risk population. A total of 246 patients with untreated, non‑keratinising, stage II‑IVA LA‑NPC were randomly assigned (1:1) to receive CCRT with or without nimotuzumab. The primary endpoint was 2‑year progression‑free survival (PFS); secondary endpoints included overall survival, distant metastasis‑free survival, locoregional relapse‑free survival, short‑term response rate, and safety. At a median follow‑up of 47 months, the 2‑year PFS was 81.0 % (90 % confidence interval [CI], 74.3–86.1) in the nimotuzumab plus CCRT group and 80.8 % (90 % CI, 74.2–85.7) in the CCRT‑alone group (hazard ratio, 0.93 [90 % CI, 0.63–1.37]; p = 0.70). Survival outcomes were similar between groups, while low‑grade rash occurred more frequently with nimotuzumab. These findings indicate that adding nimotuzumab to CCRT does not improve survival in patients with LA‑NPC with a suboptimal response to IC, underscoring the need for predictive biomarkers and alternative therapeutic strategies.

The study demonstrates that inclusion of nimotuzumab does not confer survival advantage in high‑risk LA‑NPC patients with inadequate response to induction chemotherapy, guiding clinicians toward alternative strategies and discouraging unnecessary exposure to additional targeted therapy.

Bizonyítékszint: Állatkísérletes. Állatmodellben vizsgálták.

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