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. (17th December 2015)

• Record Type: Journal Article
• Authors: Rischin, Danny; Spigel, David R.; Adkins, Douglas; Wein, Richard; Arnold, Susanne; Singhal, Nimit; Lee, Oliver; Murugappan, Swami
• Is Part Of: Head & neck. Volume 38(2016)Supplement 1
• Page Start: E1756
• Page End: E1761
• Publication Date: 2015-12-17
• Subjects: recurrent or metastatic squamous cell carcinoma of the head and neck -- panitumumab -- Panitumumab Regimen In Second‐line Monotherapy of Head and Neck Cancer (PRISM) trial -- monotherapy -- human papillomavirus (HPV) -- p16; Head -- Diseases -- Periodicals; Neck -- Diseases -- Periodicals; Head -- Periodicals; Neck -- Periodicals; Face -- Periodicals; 617.51059
• DOI: 10.1002/hed.24311
• Languages: English
• ISSNs: 1043-3074

Abstract

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. © 2015 Wiley Periodicals, Inc. Head Neck 38 : E1756–E1761, 2016