Toxicity similar in two treatment groups at 24 months, but worse tumor control with cetuximab
MONDAY, Dec. 17, 2018 (HealthDay News) — For treatment of human papillomavirus (HPV)-positive low-risk oropharyngeal cancer, cetuximab shows no benefit compared with the standard cisplatin regimen in terms of reduced toxicity and results in worse tumor control, according to a study recently published in The Lancet.
Hisham Mehanna, Ph.D., from the University of Birmingham in the United Kingdom, and colleagues conducted a phase 3 trial at 32 head and neck treatment centers in Ireland, the Netherlands, and the United Kingdom. Adult patients with HPV-positive low-risk oropharyngeal cancer were randomly assigned to receive radiotherapy (70 Gy in 35 fractions) plus either intravenous cisplatin (166 participants; 100 mg/m² on days 1, 22, and 43 of radiotherapy) or intravenous cetuximab (168 participants; 400 mg/m² loading dose followed by seven weekly infusions of 250 mg/m²).
The researchers found that overall (acute and late) severe (grade 3 to 5) toxicity was similar between treatment groups at 24 months (P = 0.98). Similarly, overall all-grade toxicity did not differ significantly by mean number of events per patient (P = 0.49) at 24 months. However, cisplatin and cetuximab differed significantly in two-year overall survival (97.5 versus 89.4 percent; hazard ratio, 5; P = 0.001) and in two-year recurrence (6 versus 16.1 percent; hazard ratio, 3.4; P = 0.0007).
“Cisplatin and radiotherapy should be used as the standard of care for HPV-positive low-risk patients who are able to tolerate cisplatin,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.
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