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

BACKGROUND

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.

PATIENTS AND METHODS

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).

RESULTS

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.

CONCLUSIONS

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.