Squamous Cell Cutaneous Carcinoma of the Skin Clinical Trial
Official title:
Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study
Localized cutaneous squamous cell carcinoma (CSCC) is usually treated by radical surgery with
or without radiotherapy. The cure rate is high around 90% of cases (1). Unresectable CSCC
represents less than 10% of all CSCC. The prognosis of these advanced forms is poor, without
any proven treatment option. The number of studies investigating systemic treatment of
advanced or metastatic CSCC is limited, mostly based on phase II trials or case reports.
Systemic treatment includes cytotoxic chemotherapy such as cisplatin and 5-Fluoro-uracil
(5FU), immunotherapy (interferon alpha) or retinoic acid (13CRa) (1,2). Recently, epidermal
growth factor receptor (EGFR) targeting agents have been explored (1,2). The anti-EGFR
monoclonal antibody Cetuximab has shown some clinical efficacy in advanced CSCC alone or
concomitant with radiotherapy or chemotherapy (3-5). A recent phase II study aimed at
investigating the role of Cetuximab in 36 patients with unresectable CSCC (6). The authors
reported a disease control rate at 6 weeks of 69% (95% CI, 52% to 84%). The best responses
were eight partial responses and two complete responses. There were no Cetuximab-related
deaths. There were three related serious adverse events: two grade 4 infusion reactions and
one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients
and was associated with prolonged Progression Free Survival (PFS) (6). The authors concluded
that regarding the Cetuximab therapeutic index it could be interesting in this particular
situation mainly for elderly patient. Unfortunately, the small number of patient included not
allowed to draw definitive conclusion. It was interesting to note that the Disease rate
control (DRC) with Cetuximab increased of 15% comparatively of DRC with chemotherapy.
Additionally it seems that in case of efficacy the functional improvement of
Cetuximab-sensitive patients occurred after very few infusions.
Taking these data together it seemed logical to design a larger retrospective clinical trial
to confirm these results in "real life patients".
n/a