Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study

Completed

• Conditions: Squamous Cell Cutaneous Carcinoma of the Skin

• Registration Number: NCT03325738
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-30
• Primary Completion: 2017-06-30
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-30
• Study Completion: 2018-09-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Benefit of Cetuximab at 6 weeks	6 weeks	To Assess the clinical benefit (complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) after 6 weeks of treatment with Cetuximab

Secondary Outcome Measures

Name	Time	Method
Progression free survival PFS	December 2017	The PFS will be calculated between date of treatment beginning (Cetuximab) and date of progression, death or starting another anticancer treatment. Patients who did not progress, did not die at the time of analysis or are lost of follow-up will be censored at the date of the latest news.
Cetuximab safety	December 2017	The safety profile will be described using the common toxicity criteria from the NCI v4.03 and biological, including occurrence of acne-like rash.
Overall survival OS	December 2017	2. The OS will be calculated between date of treatment beginning (Cetuximab) and the date of death for any reason. Patients who did not die at the time of analysis or are lost of follow-up will be censored at the date of the latest news.
Disease stabilization delay	December 2017	The DSD will be measured from the start of the treatment until the criteria for progression is objectively documented.
Objective response rate ORR	December 2017	The ORR will be defined as the sum of partial responses plus complete responses after 6 weeks of treatment with Cetuximab.
Overall response delay	December 2017	The DOR will be measured from the time measurement criteria are first met for CR/PR until the first date that progressive disease is objectively documented (without other anticancer treatment).
Best overall response BOR	December 2017	The BOR will be recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation.

Trial Locations

Locations (1)

PEYRADE Frédéric; 🇫🇷 Nice, France