Abstract
There is no standard of care for unresectable cutaneous squamous cell carcinoma (cSCC). Chemotherapy, alone or combined with radiotherapy, is commonly used mostly as palliative treatment; moreover, its poor safety profile limits its use most of the time, especially in elderly patients. Thus, alternative options are needed. Targeted molecular inhibitors, such as the epidermal growth factor receptor inhibitor cetuximab, seem promising, but data are limited. We retrospectively evaluated clinical outcomes of cetuximab as a single agent in this indication. The primary endpoint was the Disease Control Rate (DCR) at 6 weeks according to RECIST criteria. Secondary endpoints included DCR at 12 weeks, objective response rate (ORR) at 6 and 12 weeks, progression-free-survival (PFS), overall survival (OS), and safety profile. Fifty-eight patients received cetuximab as monotherapy. The median age was 83.2 (range, 47.4 to 96.1). The majority of patients was chemotherapy naïve. The median follow-up was 11.7 months (95% CI: 9.6-30.1). The DCR at 6 and 12 weeks was 87% and 70%, respectively. The ORR was 53% and 42%, respectively, at 6 and 12 weeks. The median PFS and OS were 9.7 months (95% CI: 4.8-43.4) and 17.5 months (95% CI: 9.4-43.1), respectively. Fifty-one patients (88%) experienced toxicity, and 67 adverse events related to cetuximab occurred. Most of them (84%) were grade 1 to 2. Our study shows that cetuximab is safe and efficient for the treatment of patients, even elderly ones, with advanced cSCC. These results indicate that cetuximab is a promising agent to test in new combinations, especially with immune checkpoint inhibitors such as anti–PD-1 agents.
Highlights
Nonmelanoma skin cancers, 20% of which are cutaneous squamous cell carcinomas, are the most common malignant tumor in western countries
To the best of our knowledge, this is the largest cohort reporting clinical outcomes of cetuximab prescribed in real-life conditions in unselected patients with locally advanced unresectable or metastatic cutaneous squamous cell carcinoma (cSCC)
It is important to keep in mind that our cohort included a large proportion of immunocompromised patients (~33%), who are always excluded from clinical trials, and for whom the clinical outcomes with immunotherapy are more uncertain
Summary
Nonmelanoma skin cancers, 20% of which are cutaneous squamous cell carcinomas (cSCC), are the most common malignant tumor in western countries. The incidence of cSCC is increasing yearly, and European data show that the age-standardized incidence ranges from 9 to 96 per 100,000 male inhabitants and 5 to 68 per 100,000 female inhabitants. The treatment of unresectable or metastatic cSCC remains highly challenging. Investigation of systemic therapies for advanced cSCC has been limited to a few prospective trials, and most of the time, retrospective data concern a highly selected population. Its use is often limited by a poor safety profile, with many adverse events, especially in elderly patients, who are the largest population of concern in the field of cSCC. A large proportion of patients with unresectable cSCC are ineligible to receive standard chemotherapy regimens because of age (>70 years), Performance Status (PS) ≥1, or severe comorbidities (ie, cardiac or renal insufficiency)
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