title: Phase II study of single-agent panitumumab in patients with incurable cutaneous squamous cell carcinoma.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Single-agent panitumumab is safe and effective in the management of patients with advanced CSCC even in a previously extensively pre-treated cohort.
authors.affiliation: Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane; Diamantina Institute, University of Queensland, Brisbane, Australia. Electronic address: matthew.foote@health.qld.gov.au.
authors.forename: M C
authors.initials: MC
authors.lastname: Foote
authors.affiliation: Department of Medical Oncology, Princess Alexandra Hospital, Brisbane.
authors.forename: M
authors.initials: M
authors.lastname: McGrath
authors.affiliation: Department Medical Oncology, Royal North Shore Hospital, Sydney.
authors.forename: A
authors.initials: A
authors.lastname: Guminski
authors.affiliation: Department Medical Oncology, Royal Brisbane and Womens Hospital, Brisbane.
authors.forename: B G M
authors.initials: BGM
authors.lastname: Hughes
authors.affiliation: Research Unit, Cancer Services, Princess Alexandra Hospital, Brisbane.
authors.forename: J
authors.initials: J
authors.lastname: Meakin
authors.affiliation: Department of Medical Oncology, Princess Alexandra Hospital, Brisbane.
authors.forename: D
authors.initials: D
authors.lastname: Thomson
authors.affiliation: Queensland Cancer Control Analysis Team, Queensland Health, Brisbane.
authors.forename: D
authors.initials: D
authors.lastname: Zarate
authors.affiliation: Diamantina Institute, University of Queensland, Brisbane, Australia.
authors.forename: F
authors.initials: F
authors.lastname: Simpson
authors.affiliation: Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane; Diamantina Institute, University of Queensland, Brisbane, Australia.
authors.forename: S V
authors.initials: SV
authors.lastname: Porceddu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000077544:Panitumumab; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
chemical_list: D000911:Antibodies, Monoclonal; D000077544:Panitumumab
keywords: cutaneous; panitumumab; squamous cell carcinoma