title: PRISM: Phase 2 trial with panitumumab monotherapy as second-line treatment in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
abstract: Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer (PRISM) trial evaluated the safety and efficacy of panitumumab as second-line monotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
  
  
  
  This was an open-label, single-arm, multicenter trial that enrolled patients with progressive disease or intolerance to first-line systemic chemotherapy for recurrent or metastatic SCCHN. Patients received panitumumab 9 mg/kg Q3W. The primary endpoint was overall response rate; secondary endpoints included disease control rate, overall survival (OS), progression-free survival (PFS), and safety.
  
  
  
  The overall response rate was 4% (2 of 51 patients) and the disease control rate was 39% (20 of 51 patients). Median PFS was 1.4 months (95% confidence interval [CI] = 1.3-2.4 months). Median OS was 5.1 months (95% CI = 4.3-8.3 months). The most common adverse events were rash/dermatitis acneiform (69%), fatigue (33%), dry skin (21%), and hypomagnesemia (21%). There was one treatment-related death (angioedema).
  
  
  
  Panitumumab monotherapy had limited activity in previously treated patients with recurrent or metastatic SCCHN. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1756-E1761, 2016.
authors.affiliation: Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: Danny
authors.initials: D
authors.lastname: Rischin
authors.affiliation: Sarah Cannon Research Institute, Nashville, Tennessee.
authors.forename: David R
authors.initials: DR
authors.lastname: Spigel
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Douglas
authors.initials: D
authors.lastname: Adkins
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, Tufts Medical Center, Boston, Massachusetts.
authors.forename: Richard
authors.initials: R
authors.lastname: Wein
authors.affiliation: University of Kentucky, Markey Cancer Center, Lexington, Kentucky.
authors.forename: Susanne
authors.initials: S
authors.lastname: Arnold
authors.affiliation: Royal Adelaide Hospital and University of Adelaide, Adelaide, SA, Australia.
authors.forename: Nimit
authors.initials: N
authors.lastname: Singhal
authors.affiliation: Amgen, South San Francisco, California.
authors.forename: Oliver
authors.initials: O
authors.lastname: Lee
authors.affiliation: Amgen, Thousand Oaks, California.
authors.forename: Swami
authors.initials: S
authors.lastname: Murugappan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D000077544:Panitumumab; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D000911:Antibodies, Monoclonal; D000077544:Panitumumab
keywords: Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer (PRISM) trial; human papillomavirus (HPV); monotherapy; p16; panitumumab; recurrent or metastatic squamous cell carcinoma of the head and neck