Retrospective multicentric survival analysis of patients receiving TPEx regimen as first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma

ESMO Open. 2025 Apr;10(4):104544. doi: 10.1016/j.esmoop.2025.104544. Epub 2025 Apr 11.

Abstract

Background: TPEx regimen (docetaxel, platinum, cetuximab) is a first-line treatment option for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) if combined positive score <1, or in case of high tumor burden. We sought to evaluate the survival rates of patients receiving TPEx in real life as first-line treatment of R/M HNSCC, particularly since the advent of immunotherapy (IO) as second-line therapy.

Methods: This multicentric retrospective study included patients treated by a first cycle of TPEx between 2018 and 2023, with a performance status of 0 or 1. The primary endpoint was overall survival (OS). Secondary end-points were progression free survival (PFS1), rate of patients exposed to IO after TPEx, PFS of patients on second line treatment (PFS2).

Results: A total of 204 patients were included, mainly men (86%), previously treated for a localized HNSCC (78%). Some 32% of patients had a clinically threatening disease. Combined positive score was available for 88 patients (43%). Patients were treated with a median of four cycles of TPEx, followed by cetuximab maintenance for 154 patients. After a median follow-up of 35.8 months, median OS was 17.9 months [95% confidence interval (CI) 15.7-19.6 months], median PFS1 was 6.0 months (95% CI 5.7-6.9 months) and median PFS2 was 2.5 months (95% CI 2.0-2.8 months). Among the 182 patients who progressed under TPEx, 148 patients were exposed to IO (81.3%) in subsequent lines.

Conclusion: Median OS of 17.9 months under TPEx as first-line treatment of R/M HNSCC compares favorably with historical data. IO exposure after progression on TPEx was the rule.

Keywords: PD-1 inhibitors; antineoplastic combined chemotherapy protocols; cetuximab; immunotherapy; metastatic; platinum; squamous cell carcinoma of head and neck.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Cetuximab / administration & dosage
  • Cetuximab / therapeutic use
  • Docetaxel* / administration & dosage
  • Docetaxel* / therapeutic use
  • Female
  • Head and Neck Neoplasms* / drug therapy
  • Head and Neck Neoplasms* / mortality
  • Head and Neck Neoplasms* / pathology
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local* / drug therapy
  • Neoplasm Recurrence, Local* / mortality
  • Retrospective Studies
  • Squamous Cell Carcinoma of Head and Neck* / drug therapy
  • Squamous Cell Carcinoma of Head and Neck* / mortality
  • Squamous Cell Carcinoma of Head and Neck* / pathology
  • Survival Analysis

Substances

  • Docetaxel
  • Cetuximab