# Cetuximab plus 5‐fluorouracil in patients with advanced cutaneous squamous cell carcinoma: a retrospective cohort study

**Authors:** Julia Huynh, Thomas Eigentler, Rose K. C. Moritz, Gabriela Poch, Max Schlaak, Gabor Dobos

PMC · DOI: 10.1111/ddg.15695 · Journal Der Deutschen Dermatologischen Gesellschaft · 2025-05-23

## TL;DR

A study found that combining cetuximab and 5-fluorouracil can control disease in some patients with advanced skin cancer.

## Contribution

This is the first retrospective study evaluating cetuximab plus 5-FU in advanced cutaneous squamous cell carcinoma.

## Key findings

- 45% of patients had stable disease with the combination therapy.
- The treatment was well tolerated with a median progression-free survival of 3 months.
- No complete remissions were observed in the 20-patient cohort.

## Abstract

For patients with locally advanced (la) or metastatic (m) cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery/radiation or systemic anti‐PD1 therapy, anti‐EGFR in combination with chemotherapy is a rational treatment option.

We analyzed data from 20 patients with cSCC in this monocentric, retrospective study. 4/20 patients had laSCC and 16/20 patients had mSCC. Patients received combined cetuximab and 5‐FU between 2015 and 2023. Nine patients received cetuximab + 5‐FU as second‐line therapy (8 patients after anti‐PD‐1, 1 patient after radiochemotherapy).

One patient had partial response (PR) and 9/20 (45.0%) had stable disease (SD). Disease control rate (PR + SD) was 50%. No complete remissions were observed. One of the non‐responders suffered from laSCC, nine patients had mSCC with distant metastases (including parotid) and locoregional lymph node metastases. Treatment was well tolerated, with a median PFS of 3 months (95% confidence interval [CI] 2 months to not assessable [NA]) and median overall survival (OS) of 29 months (95% CI 11–NA). The most common adverse event was acne‐like rash in 40.0% of patients.

For patients with advanced cSCC who are contraindicated to or have progressed on first‐line cemiplimab, combination of cetuximab and 5‐FU is a well‐tolerated but limited treatment option.

## Linked entities

- **Chemicals:** 5-fluorouracil (PubChem CID 3385), 5-FU (PubChem CID 3385)
- **Diseases:** cutaneous squamous cell carcinoma (MONDO:0002529)

## Full-text entities

- **Genes:** EGFR (epidermal growth factor receptor) [NCBI Gene 1956] {aka ERBB, ERBB1, ERRP, HER1, NISBD2, NNCIS}, PDCD1 (programmed cell death 1) [NCBI Gene 5133] {aka ADMIO4, AIMTBS, CD279, PD-1, PD1, SLEB2}
- **Diseases:** lymph node metastases (MESH:D008207), metastases (MESH:D009362), acne (MESH:D000152), cSCC (MESH:D002294), rash (MESH:D005076)
- **Chemicals:** Cetuximab (MESH:D000068818), cemiplimab (MESH:C000627974), 5-FU (MESH:D005472)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

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## References

37 references — full list in the complete paper: https://tomesphere.com/paper/PMC12338410/full.md

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Source: https://tomesphere.com/paper/PMC12338410