An experimental blood test accurately detected HPV-linked head and neck cancer recurrence and confirmed when patients remained cancer-free, according to findings from a study led by University of North Carolina Lineberger Comprehensive Cancer Center researchers.

Bhisham Chera
Bhisham Chera, MD.

The findings, published in the Journal of Clinical Oncology, were from the largest and most comprehensive study using an experimental blood test to track patients with oropharyngeal cancer linked to human papillomavirus, or HPV.

The researchers reported the test was 99 percent accurate in confirming patients remained cancer-free after treatment compared with other screening methods. For patients who had two HPV-positive blood tests after treatment, the test was 94 percent accurate in detecting cancer recurrence.

“The major utility of this test is it’s going to improve our ability to monitor patients after they complete treatment,” said UNC Lineberger’s Bhisham Chera, MD, associate professor in the UNC School of Medicine Department of Radiation Oncology. “Currently, our methods to assess whether the cancer has recurred are invasive, expensive and not always accurate.”

HPV-link head and neck cancer

Infection with certain strains of HPV can cause cervical cancer, genital cancers and cancer of the oropharynx, which is the back of the throat, including the base of the tongue and tonsils.

Gaorav Gupta
Gaorav Gupta, MD, PhD.

With the goal to improve cancer tracking, UNC Lineberger researchers designed a test to detect HPV genetic material that dying cancer cells have released in to the blood. Intellectual property for a form of the experimental test was licensed to Naveris Inc.

“We developed a technology that enabled us to distinguish HPV DNA that came from a tumor from HPV that’s simply related to infection,” said UNC Lineberger’s Gaorav Gupta, MD, PhD, assistant professor in the UNC School of Medicine Department of Radiation Oncology.

Study findings

In their latest study, researchers evaluated 115 patients who underwent chemotherapy and radiation treatment for oropharyngeal squamous cell carcinoma linked to HPV16.

Patients were screened for recurrence using PET/CT body scans, chest imaging, and physician evaluations. They received a blood test every six to nine months.

“For this study, we systematically applied our assay to over 1000 patient blood samples obtained from the clinical study,” said Sunil Kumar, PhD postdoctoral fellow at UNC Lineberger.

Initially, 28 patients had a positive HPV blood test, indicating a possible recurrence, but only 15 of those patients were diagnosed with recurrence based on a biopsy.

When 28 patients who initially received a positive test result underwent a second blood test, only 16 were found to be HPV positive.

That indicated to researchers that two consecutive positive blood tests indicated a recurrence, and led to a sensitivity level for the test of 94 percent.

“In this study, we had accumulated enough follow-up data to see who was going to develop recurrence and who wasn’t,” Gupta said. “That allowed us to determine that the test performs best if you look at two consecutively confirmed blood tests.”

Meanwhile, for 87 patients who had negative HPV blood tests in all their screening sessions, none developed recurrence.

Opportunity for improved screenings

Chera said the experimental test could improve follow-up screening for this type of head and neck cancer, which can involve imaging every six months or annually, and inserting a scope into the nose and down the throat every two to three months in the first two years after a person completes treatment.

“With this new technology, it offers a noninvasive way to accurately monitor patients for cancer recurrence,” Chera said. “In the long run, blood-based surveillance could be more effective, and possibly help us to detect cancer sooner.”

Authors and Disclosures

In addition to Chera, Gupta and Kumar other authors included Sunil Kumar, PhD; Colette Shen, MD, PhD; Robert Amdur, MD; Roi Dagan, MD; Rebecca Green, MSW; Emily Goldman, BS; Jared Weiss, MD; Juneko Grilley-Olson, MD; Shetal Patel, MD, PhD; Adam Zanation, MD; Trevor Hackman, MD; Jeff Blumberg, MD; Samip Patel, MD; Brian Thorp, MD; Mark Weissler, MD; Wendell Yarbrough, MD, MMHC, FACS; Nathan Sheets, MD; William Mendenhall, MD; and Xianming M. Tan, PhD.

Conflicts of interest: Chera holds ownership interest (including patents) in and is a consultant/advisory board member for Naveris Inc. Kumar is a co-inventor on a patent application regarding a method for measuring tumor-derived viral nucleic acids in blood samples, which is owned by the University of North Carolina at Chapel Hill and licensed to Naveris Inc. Gupta holds ownership interest (including patents) in, and is a consultant/advisory board member for Naveris Inc.

The study was funded by the University Cancer Research Fund, BWF, the National Institutes of Health/National Cancer Institute, UNC School of Medicine Department of Radiation Oncology, UNC Lineberger, and the University of Florida School of Medicine Department of Radiation Oncology.