Dr. Jean-Pascal Machiels of University Hospital Saint Luc, Belgium and colleagues conducted a Phase III trial to assess the efficacy of Zalutumumab on progression free survival (PFS) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after they had failed standard chemotherapy.
According to the final reports of the study there was a significant improvement in progression-free survival in patients after failure of platinum-based chemotherapy. Dose titration of zalutumumab on the basis of rash is safe.
AdvertisementBetween 2006 and 2009, a total of 286 subjects were recruited from 67 centers across Brazil, Europe, and Canada and randomly assigned to zalutumumab plus best supportive care (n = 191) or best supportive care alone (n = 95).
The findings exhibited an approximate 30% improvement in overall survival (OS) in patients taking zalutumumab, while this increase was not significantly different in patients given who were given best supportive care.
Through individual titration according to a skin rash evaluation, the appropriate dose for the zalutumumab group was evaluated beginning with 8 mg/kg loading dose, increasing by 4 mg/kg per week after three treatments (to a maximum of 16 mg/kg) if no rash or a grade 1 rash was noticed.
Zalutumumab group patients had longer progression free survival as opposed to controls, at 9.9 versus 8.4 weeks, and had a significant 37% less likely to experience disease progression or death during the study. In total, 189 zalutumumab patients and 94 controls completed a safety analysis. Dr. Machiels reported in the Lancet Oncology journal that any toxic effects were attributable to underlying disease or effect on healthy tissue.
The authors concluded by adding, "Our study supports the use of an anti-EGFR monoclonal antibody after platinum failure in patients with squamous-cell carcinoma of the head and neck."