Cetuximab plus radiation therapy has worse outcomes than the current standard of radiation and cisplatin for patients with human papillomavirus-positive (HPV+) oropharyngeal cancer. In fact, the researchers, who reported preliminary findings from a phase 3 study funded by the National Cancer Institute (NCI), were “surprised by the loss of tumor control with cetuximab.”
Cetuximab with radiation is an accepted standard of care, especially for patients who cannot tolerate cisplatin, and it is approved for patients with head and neck cancer, including oropharyngeal cancer. Researchers and the NCI are looking for more ways to “de-escalate” therapies for cancers that have a good prognosis, such as HPV+ cancer of the oropharynx. The goal of this trial was to find an alternative to cisplatin that would control the cancer as effectively but with fewer side effects.
The researchers enrolled 849 patients to randomly receive either cetuximab or cisplatin with radiation. The third, final interim analysis, after a median follow-up of 4.5 years, found that overall survival on the cetuximab arm was significantly inferior to the cisplatin arm. Moreover, serious adverse events were similar in both groups, although toxic side effects were more common in the cisplatin arm.
The study is the first randomized clinical trial specifically designed for patients with HPV+ oropharyngeal cancer, and “it establishes cisplatin with radiation as the standard of care.”