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.
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.
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
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.
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."