Danny Rischin1, David R Spigel2, Douglas Adkins3, Richard Wein4, Susanne Arnold5, Nimit Singhal6, Oliver Lee7, Swami Murugappan8. 1. Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. 2. Sarah Cannon Research Institute, Nashville, Tennessee. 3. Washington University School of Medicine, St. Louis, Missouri. 4. Department of Otolaryngology - Head and Neck Surgery, Tufts Medical Center, Boston, Massachusetts. 5. University of Kentucky, Markey Cancer Center, Lexington, Kentucky. 6. Royal Adelaide Hospital and University of Adelaide, Adelaide, SA, Australia. 7. Amgen, South San Francisco, California. 8. Amgen, Thousand Oaks, California.
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.
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.
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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