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

NCT ID: NCT03325738

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-09-11

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".

Conditions

Squamous Cell Cutaneous Carcinoma of the Skin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Histologically Confirmed squamous cell cutaneous carcinoma of the skin (SCCS)

2. Locally advanced SCCS that is surgically unresectable, or metastatic SCCS, with documented progression, and who received a treatment of Cetuximab in monotherapy,

3. Patients have to be anti EGFR-naïve,

4. Age ≥ 18 years

5. Eastern Cooperative Oncology Group performance status ≤ 2; life expectancy ≥ 3 months

6. Presence of at least one measurable target lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

7. Adequate hematologic, hepatic, and renal functions

8. Available medical data

9. Chemotherapy naïve patient in metastatic or locally advanced conditions (Cisplatinum used concomitantly with radiotherapy is allowed)

Exclusion Criteria

1. Prior radiotherapy within the last 4 weeks before the start of cetuximab (radiotherapy in concomitance with cetuximab is allowed if this is administrated in another lesion than the lesion treated by Cetuximab).

2. Prior therapy with an agent that targets EGFR

3. Instable systemic diseases or active uncontrolled infections.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PEYRADE Frédéric

Nice, , France

Countries

France

Other Identifiers

2017/05

Identifier Type: -

Identifier Source: org_study_id