Cisplatin Plus C225 Shows Marginal Effect for Treatment of Head and Neck Cancer

ORLANDO, FL — May 20, 2002 —

Adding target therapy with the investigational anticancer antibody C225 (Erbitux) to standard cisplatin chemotherapy appears to increase the response rate for patients with head and neck cancer.

Results presented here Sunday at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO) show a 22.6 percent response rate with C225/cisplatin compared to 9.3 percent with cisplatin plus placebo.

 Those results were only “marginally statistically significant,” said lead investigator, Barbara A Burtness, MD, of Yale University, New Haven, Connecticut, United States.

 During her presentations, she said cisplatin-based therapy remains “the standard of care for these patients, but our results suggest that further evaluation of C225 is warranted.”

 She noted that the investigators estimated the median progression-free survival in the control arm would be 3.37 months and thus estimated that they had enrolled enough patients to demonstrate a doubling of the median progression-free survival. “But the median survival in the control arm was actually 4.10 months, and we would have needed to enroll 222 patients to demonstrate a doubling effect,” she said.

 The study, conducted by the Eastern Cooperative Oncology Group (ECOG), enrolled 123 patients who had measurable, histologically confirmed squamous cell head and neck cancer that was incurable with surgery or radiation. Seventy-six percent of the patients were men, and the mean age was 59.4.

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