What question did this study set out to answer?

To evaluate whether prior exposure to immune checkpoint inhibitors enhances the outcomes of paclitaxel plus cetuximab in patients with recurrent or metastatic HNSCC.

March 12, 2026Open Access

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Q: What does this research mean for the field?

Prior exposure to immune checkpoint inhibitors significantly improves overall survival, progression-free survival, and objective response rate in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with paclitaxel plus cetuximab. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Key Points

To evaluate whether prior exposure to immune checkpoint inhibitors enhances the outcomes of paclitaxel plus cetuximab in patients with recurrent or metastatic HNSCC.
Reviewed 180 patients with R/M HNSCC treated with paclitaxel plus cetuximab.
Categorized patients into prior-ICI and ICI-naive groups.
Analyzed survival outcomes using Kaplan-Meier estimates and Cox proportional hazards models.
Included variables with p < 0.05 in multivariate modeling.
Median progression-free survival was 8.1 months in the prior-ICI group versus 5.3 months in the ICI-naive group (p < 0.01).
Median overall survival was 13.6 months for prior-ICI patients compared to 11.1 months for ICI-naive patients (p < 0.01).
The objective response rate was higher in the prior-ICI group (55.2% vs 31.8%, p < 0.01).
Prior ICI exposure remained a significant factor for improved survival outcomes in multivariate analysis.

Abstract

Background: Immune checkpoint inhibitors (ICIs) have improved the prognosis of patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).Previous studies suggest that ICIs may enhance not only first-line outcomes but also the effectiveness of subsequent therapies; however, the heterogeneity of post-ICI treatments has not been adequately evaluated.Thus, it remains unclear whether prior ICI exposure truly influences the efficacy of subsequent chemotherapy.This study aimed to assess whether prior ICI exposure improves the outcomes of paclitaxel plus cetuximab (PC). Methods:We retrospectively reviewed 180 patients with R/M HNSCC who received PC at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research between March 2013 and October 2025.Patients were categorized into the prior-ICI group or the ICI-naive group.The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and objective response rate (ORR).Survival outcomes were analyzed using Kaplan-Meier estimates and Cox proportional hazards models.Variables with p < 0.05 in univariate Cox analysis were included in multivariate modeling.The study was approved by the institutional review board (2023-GB-076).Results: Among 178 eligible patients, 63 (35.4%) were in the prior-ICI group and 115 (64.6%) were in the ICI-naive group.Median PFS was 8.1 months in the prior-ICI group and 5.3 months in the ICI-naive group (p < 0.01).Median OS was 13.6 vs 11.1 months, respectively (p < 0.01).ORR was higher in the prior-ICI group (55.2% vs 31.8%,p < 0.01).In univariate analysis, prior ICI exposure significantly improved PFS (HR 0.55; 95% CI 0.39-0.77;p < 0.01) and OS (HR 0.62; 95% CI 0.43-0.91;p < 0.01).In multivariate analysis, prior ICI exposure remained an independent favorable factor for PFS (HR 0.58; 95% CI 0.39-0.85;p < 0.01) and OS (HR 0.57; 95% CI 0.38-0.86;p < 0.01). Conclusions:Prior ICI exposure significantly improved OS, PFS, and ORR in patients treated with PC.These findings clearly demonstrate that ICI administration before PC provides a survival advantage in R/M HNSCC and highlights the clinical relevance of treatment sequencing.

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