For patients with a treatment-resistant and rapidly progressing form of head and neck cancer, immunotherapy appears to double overall survival and improve quality of life, with fewer side effects.
The new findings from the large, randomized international trial were considered so successful that the trial was stopped early to allow patients in the comparison group to receive the new drug.
“These exciting results indicate that there is a new standard of care option for a population of head and neck cancer patients with no other treatment options,” says Robert Ferris, professor, and chief of the head and neck surgery division at the University of Pittsburgh Medical Center.
The new drug, nivolumab, which belongs to a class of drugs known as immunotherapeutics, enables the body’s immune system to destroy cancer cells. It’s currently approved to treat certain types of cancers, including melanoma and lung cancer.
The trial enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma, a rapidly progressing form of the disease with an especially poor prognosis, who had not responded to platinum-based chemotherapy. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed.
The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36 percent of the nivolumab group was alive, compared to just 17 percent of the standard chemotherapy group.
Nivolumab treatment also doubled the number of patients whose tumors shrunk, and the number whose disease had not progressed after six months of treatment. Importantly, these benefits were achieved with just one-third the rate of serious adverse events reported in the standard chemotherapy group.
In addition, on average, patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, while those in the chemotherapy group reported a decline.
While nivolumab improved survival rates in the overall study population, it appeared to be most successful in patients whose tumors were positive for the human papillomavirus (HPV). This is important because the fraction of head and neck cancers attributable to HPV infection has increased by 250 percent over the past several decades, Ferris explains.
“Unfortunately, most patients in this trial still experienced a progression of their cancer, demonstrating that we still have a lot of work to do. But, the future appears brighter than ever before because there is a new class of agents, immunotherapies, which we now know can prolong survival and improve quality of life, with few side effects, in head and neck cancer.”
The research team currently is working to identify new biomarkers that will allow them to develop a better understanding of how drug resistance develops, and how to best design effective combinations of medications that may improve patient responses.
The findings were presented at the American Society of Clinical Oncology meeting in Chicago.
Researchers from the University of Texas MD Anderson Cancer Center, Stanford Cancer Institute, the University of Chicago, the University of Michigan, Ohio State University, the Dana-Farber Cancer Institute, Centre Leon Berard, Centre Antoine Lacassagne, Institut Gustave Roussy, Fondazione IRCCS Istituto Nazionale Tumori, the Institute of Cancer Research, the University Hospital Essen, and National Cancer Center Hospital East and Kobe University Hospital are coauthors of the study.
The trial was funded by Bristol-Myers Squibb, which is now seeking FDA approval for the use of nivolumab in head and neck carcinoma.
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