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

Danny Rischin, David R. Spigel, Douglas Adkins, Richard Wein, Susanne Arnold, Nimit Singhal, Oliver Lee, Swami Murugappan

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Background 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). Methods 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. Results 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). Conclusion Panitumumab monotherapy had limited activity in previously treated patients with recurrent or metastatic SCCHN.

Original languageEnglish
Pages (from-to)E1756-E1761
JournalHead and Neck
Volume38
DOIs
StatePublished - Apr 1 2016

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

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