# Efficacy, safety, and survival outcomes of radiotherapy combined with nimotuzumab following induction chemotherapy in locally advanced head and neck cancer

## TL;DR

Adding nimotuzumab to radiotherapy after chemotherapy improves survival and tumor response in advanced head and neck cancer, especially for nasopharyngeal cancer, without increasing severe side effects.

## Contribution

Demonstrates that nimotuzumab combined with radiotherapy after chemotherapy improves survival and tumor control in locally advanced head and neck cancer.

## Key findings

- The observation group had a higher complete response rate and lower disease progression compared to the control group.
- Median overall survival was significantly longer in the nimotuzumab group.
- Nimotuzumab use was an independent protective factor for survival in multivariate analysis.

## Abstract

To evaluate the efficacy, safety, and impact on survival of adding nimotuzumab to radiotherapy after induction chemotherapy in patients with locally advanced head and neck cancer (HNC).

This retrospective cohort study included 313 patients with locally advanced HNC treated at a tertiary hospital between 2019 and 2022. Patients were divided into an observation group (n=145), receiving radiotherapy combined with nimotuzumab after induction chemotherapy, and a control group (n=168), receiving radiotherapy alone after induction chemotherapy. Baseline characteristics, short-term efficacy (assessed using RECIST 1.1 criteria, including complete response [CR] and partial response [PR]), overall survival (OS), progression-free survival (PFS), and adverse events were compared between the two groups, and a primary analysis restricted to nasopharyngeal carcinoma (NPC) patients was performed, as NPC comprised the majority of the cohort, to more accurately assess the survival benefits of nimotuzumab in this specific subgroup. Univariate and multivariate analyses were conducted to identify prognostic factors.

The observation group demonstrated a significantly higher complete response rate (41.38% vs. 25.00%, P < 0.05) and a lower incidence of disease progression (1.38% vs. 5.95%, P < 0.05) compared to the control group, indicating superior short-term tumor control. In terms of long-term outcomes, the median overall survival was significantly longer in the observation group (42.3 months vs. 31.7 months, P = 0.008). Multivariate Cox regression analysis further confirmed nimotuzumab use as an independent protective factor for survival (HR = 0.62, 95% CI: 0.41–0.93, P = 0.021), while advanced T stage (T3–T4) and clinical stage (III–IV) were identified as independent risk factors. Notably, subgroup analysis revealed that the survival benefit of nimotuzumab was particularly pronounced in patients with nasopharyngeal carcinoma, those younger than 60 years, and those with extensive lymph node involvement (N2–N3), a finding which remained robust in a sensitivity analysis restricted to nasopharyngeal carcinoma patients. Importantly, these efficacy advantages were achieved without a significant increase in severe toxicities, as no significant differences were observed in the incidence of grade ≥3 adverse events between the two groups (P > 0.05).

The addition of nimotuzumab to radiotherapy following induction chemotherapy significantly improves tumor response rates and long-term survival in patients with locally advanced head and neck cancer, without increasing severe treatment-related toxicity. Given that nasopharyngeal carcinoma constituted the majority of the cohort, this combination regimen represents a particularly promising therapeutic strategy for nasopharyngeal carcinoma. However, because only a small number of non-nasopharyngeal head and neck cancers were included, the observed overall survival benefit should not be generalized to non-nasopharyngeal head and neck cancers, and further prospective studies in more homogeneous populations are warranted to validate these findings.