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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
Author(s) -
Rischin Danny,
Spigel David R.,
Adkins Douglas,
Wein Richard,
Arnold Susanne,
Singhal Nimit,
Lee Oliver,
Murugappan Swami
Publication year - 2016
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.24311
Subject(s) - medicine , panitumumab , head and neck cancer , rash , oncology , clinical endpoint , regimen , adverse effect , surgery , cancer , cetuximab , clinical trial , colorectal cancer
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