Author: Allen Cone
Treating HPV-positive throat cancer with cetuximab and radiation had worse overall and progression-free survival results compared with the current method of treatment with radiation and cisplatin, the National Institutes of Health revealed Tuesday.
The trial, which was funded by the National Cancer Institute, was intended to test whether the combination would be less toxic than cisplatin but be just as effective for human papillomavirus-positive oropharyngeal cancer. The trial, which began in 2011, enrolled 849 patients at least 18 years old with the cancer to receive cetuximab or cisplatin with radiation. The trial is expected to finish in 2020.
Cetuximab, which is manufactured under the brand name Erbitux by Eli Lilly, and cisplatin, which as sold as Platinol by Pfizer, are used in chemotherapy.
The U.S. Food and Drug Administration had approved cetuximab with radiation for patients with head and neck cancer, including oropharyngeal cancer.
HPV, which is transmitted through intimate skin-to-skin contact, is the leading cause of oropharynx cancers, which are the throat at the back of the mouth, including the soft palate, the base of the tongue and the tonsils. Most people at risk are white, non-smoking males age 35 to 55 — including a 4-to-1 male ratio over females — according to The Oral Cancer Foundation.
The NIH released the trial results after an interim analysis showed that cetuximab with radiation wasn’t as effective.
In a median follow-up of 4.5 years, the test combination was found to be “significantly inferior” to the cisplatin method.
“Clinical trials designed to test less toxic treatment strategies for patients without compromising clinical benefit are a very important area of interest for NCI and the cancer research community,” said Dr. Shakun Malik, of NCI’s Division of Cancer Treatment and Diagnosis.
Toxic side effects were different, with adverse events of renal toxicity, hearing loss and bone marrow suppression more common in patients in the cisplatin group and body rash more frequent in the cetuximab method.
For patients who cannot tolerate cisplatin, cetuximab with radiation is an accepted standard of care.
“The goal of this trial was to find an alternative to cisplatin that would be as effective at controlling the cancer, but with fewer side effects,” lead investigator Dr. Andy Trotti, of the Moffitt Cancer Center in Tampa, Fla., said in a press release. “We were surprised by the loss of tumor control with cetuximab.”