No Benefit of Panitumumab Plus Radiotherapy vs Cisplatin-Based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
In the phase II CONCERT-2 trial reported in The Lancet Oncology, Giralt et al found that treatment with the EGFR inhibitor panitumumab (Vectibix) plus concurrent radiotherapy was associated with poorer local-regional control vs cisplatin chemoradiation in previously untreated patients with unresected stage III to IVB head and neck squamous cell carcinoma.
Study Details
In the open-label trial, 151 patients were randomly assigned 3:2 between November 2007 and November 2009 to receive radiotherapy plus three cycles of panitumumab at 9 mg/kg every 3 weeks (n = 90) or two cycles of cisplatin at 100 mg/m2 (n = 61) during radiotherapy. All patients received radiotherapy at 70 to 72 Gy to gross tumor and 54 Gy to areas of subclinical disease with accelerated fractionation radiotherapy. The primary endpoint was local-regional control at 2 years.
Poorer Outcomes
Local-regional control at 2 years was 51% in the panitumumab group vs 61% in the control group (hazard ratio [HR] = 1.61, P = .06). Progression-free survival at 2 years was 41% vs 62% (HR = 1.73, P = .03). Overall survival at 2 years was 63% vs 71% (HR = 1.59, P = .10).
The most common grade 3 or 4 adverse events were mucosal inflammation (42% vs 40%), dysphagia (40% vs 32%), and radiation skin injury (24% vs 11%). Serious adverse events occurred in 34% vs 40%.
The investigators concluded: “Panitumumab cannot replace cisplatin in the combined treatment with radiotherapy for unresected stage III–IVb squamous-cell carcinoma of the head and neck, and the role of EGFR inhibition in locally advanced squamous-cell carcinoma of the head and neck needs to be reassessed.”
Jordi Giralt, MD, of Vall d’Hebron Institute of Oncology, Barcelona, is the corresponding author for The Lancet Oncology article.
The study was funded by Amgen. For full disclosures of the study authors, visit www.thelancet.com.
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