Randomized phase II trial demonstrated the use of breast and kidney cancer drugs for head and neck cancers.
Study results that were presented recently at the 2020 Multidisciplinary Head and Neck Cancers Symposium demonstrated the use of a breast and kidney cancer targeted therapy drug for extending progression-free survival in patients with advanced head and neck cancer who are at high risk for recurrence after standard treatment.
In the randomized phase II trial, patients enrolled who received the mTOR inhibitor, everolimus, were more likely to be cancer-free a year after therapy compared to the placebo group. This was especially beneficial for patients with TP53 gene mutations. These findings thus present a new treatment option for a group of patients whose survival rates have not improved in more than 30 years.
“While cure rates tend to be upwards of 85 percent for patients with head and neck cancers associated with HPV, they tend to be less than 40 percent for patients with disease related to smoking,” said lead author Cherie-Ann O. Nathan, MD, professor and chair of otolaryngology/head and neck surgery at Louisiana State University (LSU) Health Shreveport and director of head and neck surgery at Feist-Weiller Cancer Centre.
Dr. Nathan also shred that these patients are recurring most often, and their survival rates have not changed in decades, despite advances in surgery, radiation therapy and chemotherapy.
Addressing this issue, the researchers focused on patients with advanced, HPV-negative head and neck squamous cell carcinoma (HNSCC), or HPV-positive disease and smoking history of more than 10 pack-years. The study population were 52 patients who received either everolimus or the placebo for one year.
After a year for treatment, 81 percent of patients on everolimus remained progression-free compared to 57 percent in the placebo group. Dr. Nathan clarified that this timepoint was not stipulated a priori and is a post-hoc analysis.
Dr. Nathan said the drug’s tolerability indicates that it may have potential as longer-term maintenance therapy to delay recurrence for high-risk patients. 16 of the 28 patients on everolimus and seven of the 24 patients on the placebo drug experienced Grade 3 or higher toxicities, including three and five serious adverse events, respectively.
“Although the sample size is small, as it closed due to lack of accrual, these finding indicate that patients at high risk for tumour relapse could be given mTOR inhibitors to stall progression and keep any residual cancer cells from growing. Our hope is that head and neck cancer can be treated as chronic disease, similar to some breast cancers,” Dr. Nathan explained.
“Everolimus is used for patients with breast cancer or renal cell cancer for extended periods without major side effects, and there is potential for patients with TP53-mutated head and neck disease to see a survival benefit, as well.” She added.
Future trials are still required to confirm the link between TP53 and survival, as well as to determine drug safety for patients with HNSCC on the drug for multiple years. [APBN]