Improves progression-free survival in those with recurrent or metastatic squamous-cell disease
Monday, March 7, 2011 (Last Updated: 03/09/2011)
MONDAY, March 7 (HealthDay News) -- Zalutumumab, a human IgG1 monoclonal antibody targeting the epidermal growth factor receptor, appears to significantly prolong progression-free survival (PFS) in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy, according to a study published online March 7 in The Lancet Oncology.
In an open-label, parallel-group, phase 3 study, Jean-Pascal Machiels, M.D., of Cliniques Universitaires Saint Luc in Brussels, Belgium, and colleagues randomized 286 patients with recurrent or metastatic squamous-cell carcinoma of the head and neck with a World Health Organization (WHO) performance status of zero to two and progressive disease within six months of platinum-based chemotherapy, in a two to one ratio, to receive zalutumumab plus best supportive care or best supportive care with optional methotrexate (controls).
The investigators found that PFS was longer in the zalutumumab group than the control group (hazard ratio for progression or death, stratified by WHO performance status, 0.63). Median overall survival was not significantly different between the groups. Among 189 patients given zalutumumab and 94 controls included in the safety analysis, the investigators found that rash (21 versus 0 percent), anemia (6 versus 5 percent), pneumonia (5 versus 2 percent), and grade 3/4 infections (15 versus 9 percent) were more common among the zalutumumab group than the control group. In addition, serious adverse events, including tumor hemorrhage (15 versus 14 percent), pneumonia (7 versus 3 percent), and dysphagia (6 versus 2 percent), were more common among those in the zalutumumab group.
"Although zalutumumab did not increase overall survival, PFS was extended in patients with recurrent squamous-cell carcinoma of the head and neck who had failed platinum-based chemotherapy. Zalutumumab dose titration on the basis of rash is safe," the authors write.
The study was funded by Genmab. Four authors are employees of Genmab and hold stock or stock options in the company, and another author serves as a consultant for Genmab.
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