What question did this study set out to answer?

The study aims to evaluate the impact of prior exposure to immune checkpoint inhibitors on the outcomes of chemotherapy in recurrent or metastatic head and neck cancer.

March 12, 2026Open Access

54P Impact of treatment sequence between immune checkpoint inhibitors and paclitaxel/cetuximab in recurrent or metastatic head and neck cancer

Key Points

The study aims to evaluate the impact of prior exposure to immune checkpoint inhibitors on the outcomes of chemotherapy in recurrent or metastatic head and neck cancer.
Retrospective review of 180 patients with recurrent or metastatic head and neck squamous cell carcinoma
Categorized patients into prior-ICI and ICI-naive groups
Primary endpoint: overall survival; secondary endpoints: progression-free survival and objective response rate
Survival outcomes analyzed with Kaplan-Meier estimates and Cox proportional hazards models
Median progression-free survival was 8.1 months for prior-ICI group versus 5.3 months for ICI-naive group (p < 0.01)
Median overall survival was 13.6 months for prior-ICI group versus 11.1 months for ICI-naive group (p < 0.01)
Objective response rate was 55.2% for prior-ICI versus 31.8% for ICI-naive group (p < 0.01)
Prior ICI exposure significantly improved progression-free and overall survival in Cox analyses

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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