No Benefit of Adding Panitumumab to Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
In the phase II CONCERT-1 trial reported in The Lancet Oncology, Mesía et al found that adding the EGFR inhibitor panitumumab (Vectibix) to standard cisplatin chemoradiation provided no benefit in previously untreated patients with unresected stage III to IVB head and neck squamous cell carcinoma.
Study Details
In the open-label trial, 150 patients were randomly assigned 3:2 between October 2007 and March 2009 to receive radiotherapy plus three cycles of panitumumab at 9.0 mg/kg and three cycles of cisplatin at 75 mg/m2 every 3 weeks (n = 87) or three cycles of cisplatin at 100 mg/m2 (n = 63). All patients received radiotherapy at 70 Gy to gross tumor and 50 Gy to areas at risk for subclinical disease with standard fractionation. The primary endpoint was local-regional control at 2 years.
No Benefit
Local-regional control at 2 years was 61% in the panitumumab group vs 68% in the control group (hazard ratio [HR] = 1.33, P = .31). Progression-free survival at 2 years was 61% vs 65% (HR = 1.15, P = .61). Overall survival at 2 years was 69% vs 78% (HR = 1.63, P = .12).
The most common grade 3 or 4 adverse events were mucosal inflammation (55% vs 24%), dysphagia (40% vs 27%), and radiation skin injury (31% vs 13%). Serious adverse events occurred in 43% vs 32%.
The investigators concluded: “In patients with locally advanced squamous-cell carcinoma of the head and neck, the addition of panitumumab to standard fractionation radiotherapy and cisplatin did not confer any benefit, and the role of EGFR inhibition in these patients needs to be reassessed.”
Ricard Mesía, MD, of Institut Català d’Oncologia, 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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