Phase II study of single-agent panitumumab in patients with incurable cutaneous squamous cell carcinoma

• Published in: Annals of oncology Vol. 25; no. 10; pp. 2047 - 2052
• Main Authors: Foote, M.C., McGrath, M., Guminski, A., Hughes, B.G.M., Meakin, J., Thomson, D., Zarate, D., Simpson, F., Porceddu, S.V.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01-10-2014; Oxford University Press
• Subjects: Aged; Aged, 80 and over; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antineoplastic agents; Biological and medical sciences; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - pathology; cutaneous; Dermatology; Disease-Free Survival; Drug-Related Side Effects and Adverse Reactions - pathology; Female; Humans; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Panitumumab; Pharmacology. Drug treatments; Skin Neoplasms - drug therapy; Skin Neoplasms - mortality; Skin Neoplasms - pathology; squamous cell carcinoma; Tumors; Tumors of the skin and soft tissue. Premalignant lesions; cutaneous; panitumumab; squamous cell carcinoma; Antineoplastic agent; Human; Skin disease; Squamous cell carcinoma; Basal cell carcinoma; Toxicity; Panitumumab; Monoclonal antibody; Malignant tumor; Epidermal growth factor receptor; Skin cancer; Skin squamous cell carcinoma; Treatment; Phase II trial; Skin; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdu368

Although advanced cutaneous squamous cell carcinoma (CSCC) is quite common, there are few prospective trials regarding its optimal management. This study evaluated the efficacy and safety of single-agent panitumumab in the treatment of patients with CSCC not suitable for local therapy.
Sixteen patients received single-agent panitumumab at a dose of 6 mg/kg repeated every 2 weeks for a minimum of three cycles and continued until progression, a maximum of nine cycles or dose-limiting toxicity. The primary end point was the best overall response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) criteria. Secondary end points included evaluation of safety, toxicity and progression-free survival (PFS).
Between May 2010 and May 2012, 16 patients were recruited. Fourteen patients were male and the median age was 68 years. Fifteen patients had locoregionally advanced or recurrent disease with 14 patients receiving previous radiotherapy and 7 receiving previous cytotoxic chemotherapy. The best ORR [partial (PR) or complete response (CR)] was 31% (3/16 PR, 2/16 CR) with a further 6 of 16 patients achieving SD. The median PFS and overall survival were 8 and 11 months respectively. Grade 3 or 4 events were observed in five patients (four being skin toxicity) with one patient ceasing due to skin toxicity. With a median follow-up of 24 months, 10 patients died due to progressive disease, 6 are alive, one patient with no evidence of disease at the time of analysis.
Single-agent panitumumab is safe and effective in the management of patients with advanced CSCC even in a previously extensively pre-treated cohort.