Cetuximab and Radiotherapy for HPV-Associated Oropharynx Cancer
Name of a Trial
Phase III Randomized Study of Radiotherapy with Cisplatin or Cetuximab in Patients with Human Papilloma Virus-Associated Oropharyngeal Cancer (RTOG-1016). See a custom summary.
Dr. Andy Trotti, Radiation Therapy Oncology Group
Dr. Maura Gillison, Ohio State University
Why This Trial Is Important
Oropharyngeal squamous dungeon carcinoma (OSCC) is a form of conduct and neck cancer that forms in a center partial of a throat, that includes a bottom of a tongue, a tonsils, and a soothing palate. Although OSCC was once suspicion to be a singular disease, new investigate has suggested that it has dual graphic types: cancers that exam certain for tellurian papillomavirus (HPV) and those that are HPV-negative.
Oropharyngeal tumors disastrous for HPV have been associated to tobacco and ethanol abuse, since HPV-positive malignancies might be associated to passionate behavior. Patients with HPV-associated OSCC are expected to be younger during a time of diagnosis and have a softened augury than those with HPV-negative malignancies. In contrariety with a rates of other verbal cancers, that have depressed as smoking rates have declined, a occurrence of HPV-positive OSCC is on a rise.
Current diagnosis strategies for oropharyngeal cancer are formed on growth stage, rather than HPV status, and include of medicine or deviation with or though cisplatin-based chemotherapy. Cancer response rates following cisplatin-based chemotherapy and radiotherapy are generally good, though studies have shown that this multiple diagnosis proceed dramatically increases poisonous side effects. Since some-more than 80 percent of patients with HPV-positive tumors tarry during slightest 5 years after diagnosis, these patients might do only as good on a less-toxic regimen.
One study questioning a multiple of cetuximab, a monoclonal antibody destined opposite a protein called EGFR, and radiotherapy in conduct and neck cancer demonstrated softened studious presence compared with deviation alone. The use of this multiple increasing skin irritation, though differently it had a same side effects as radiotherapy alone. An analysis of patients in this hearing suggested that those with OSCC who were masculine and younger, a organisation that mirrors a HPV-positive population, benefited many from a multiple therapy. These formula suggested that deviation and cetuximab, instead of cisplatin-based chemotherapy, might revoke diagnosis toxicity though compromising cancer control for patients with HPV-positive OSCC.
In this clinical trial, patients with HPV-positive OSCC will be incidentally reserved to accept cisplatin chemotherapy and intensity-modulated deviation therapy (IMRT) or cetuximab and IMRT. Prior to treatment, patients will finish a computer-administered consult on conduct and neck cancer risk factors, including tobacco exposure, ethanol use, and verbal hygiene. During and after treatment, patients will also news a poisonous side effects they experience. Clinicians will guard a patients for growth response, toxicity, peculiarity of life, progression-free survival, and altogether survival.
“This is a initial randomized proviso III hearing specific to a HPV-positive studious population,” pronounced Dr. Gillison. “There are a lot of peculiarity of life outcomes incorporated [into a trial] about both strident toxicity and long-term toxicity, and a patients are stating their toxicity knowledge directly on things like nausea, vomiting, ability to swallow, pain, and appetite turn regulating touch-screen surveys.
“It also includes things that we have never looked during before, that will concede us to do a cost-effectiveness analysis. The initial intensity outcome is that one of a treatments is softened than a other. Then we get an answer in terms of illness control. If a dual treatments are equivalent, afterwards we see that one gives a studious a best peculiarity of life. There is also a probability that they are equal and one of them has a cost-benefit to multitude over a other,” Dr. Gillison added.
For More Information
See a lists of entrance criteria and hearing hit information or call a NCI’s Cancer Information Service during 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.