Hollings clinical trial shows promise treating HPV-related head and neck cancers

Russell Breault, 66, enjoys the simple things in life. He loves his F-150 truck, fishing and spending time with his family. A decade ago, he ended his 40-year relationship with smoking in order to live a healthier life. In 2021, life took an unexpected turn for Breault after he noticed a mass growing in his neck that made even the simplest tasks difficult.

“I could barely talk. The side of my neck looked like a balloon, and I knew something wasn’t right,” he said.

The Orangeburg, South Carolina, resident went to his primary care doctor, who then referred him to specialists in Greenville for a PET scan. The scan revealed an 8 centimeter mass involving his left tonsil and neck as well as lung nodules that appeared to be signs of cancer spread. Both were biopsied, and he was diagnosed with metastatic human papillomavirus (HPV)-related throat cancer.

Breault knew he wanted to go somewhere that had trained specialists to treat head and neck cancer. In August 2021, Breault arrived at MUSC Hollings Cancer Center, the state’s only National Cancer Institute-designated cancer center, to meet with John Kaczmar, M.D., a medical oncologist specializing in head and neck cancers.

“There are two main causes of a cancer like this – smoking and HPV,” Kaczmar said. “In his case, he had both. It used to be that smoking was the No. 1 cause of head and neck cancer, but now, we’ve seen a shift with HPV accounting for more cases. Smoking can impact how an HPV-related cancer behaves. Oftentimes, HPV-related cancers in smokers are more aggressive and spread quicker than patients who didn’t smoke.”

 

Given the size of the tumor, Kaczmar wanted to do everything he could to try to slow progression and shrink the tumor. He felt Breault was a good candidate for a nationwide phase two clinical trial being offered at Hollings that tested the effectiveness of immunotherapy combined with a HPV cancer vaccine for patients with recurrent or metastatic HPV-associated head and neck cancer.

“Immunotherapy by itself shrinks the size of cancer in about 25% of head and neck cancer patients. Around 35% of patients in this group will see their tumor shrink from chemotherapy,” Kaczmar said. “What we are trying to do in this trial is improve the response rate and duration of response to immunotherapy so more people can benefit with a type of treatment that doesn’t cause as many negative side effects as chemotherapy.”

Breault said he was determined to do everything he could to beat the cancer. His kids, now all grown up, came to his first appointment with Kaczmar. “He told me about the clinical trial, and my kids thought it was a good idea. I decided to go with their instinct and give it a shot.”

Breault started the trial immediately, returning to Hollings every three weeks for treatment and tests. Breault said the success he has seen while participating in the trial has allowed him to continue living a high-quality life.

Kaczmar said the trial studies the efficacy and safety of using a novel T-cell immunotherapy drug called PDS0101 with another immunotherapy drug called pembrolizumab. Previous research has shown that PDS0101 can stimulate high levels of HPV16-specific CD8+ and CD4+ T-cells, which in turn can activate multiple pathways for the immune system to target, and kill, the cancer.

“When the protein PD-L1 interacts with the PD-1 receptor on a cancer cell, it essentially tells the immune system to stand down and not attack the tumor. What this trial does is adds a combination immunotherapy approach to block that interaction while increasing stimulation of the immune system to HPV virus-specific antigens so the immune system can better recognize the tumor as foreign and attack it.”

Head and neck cancer is now the most diagnosed HPV-related cancer in the country, surpassing cervical cancer for the top spot. Kaczmar said the HPV vaccine is the best way to avoid HPV-related cancers in the first place.

“The HPV vaccine has been shown to be very effective in preventing HPV-related cancers. Many people with head and neck cancer today, like Mr. Breault, didn’t have access to that vaccine decades ago. What we hope to see is that as vaccination rates increase among men and women, we will start to see head and neck HPV-related cancers plateau and hopefully see a reduction in new cases.”

Seeing success

Now several months into the trial, Breault’s tumor has dramatically shrunk in size – going from nearly 8 cm down to around 2 cm. “It’s crazy to see how much can change in less than a year. I thank God for helping me and giving me a good doctor like Dr. Kaczmar.”

Kaczmar said Breault is the first patient at Hollings to be put on the trial as a first-line defense, having had no curative intent therapy like chemotherapy or radiation. The results so far leave Kaczmar hopeful that this combined treatment can help other head and neck cancer patients.

“The treatments involved in this trial so far have been very tolerable, which is nice because sometimes investigative treatments can produce some side effects. The main side effects of the study treatment we’ve seen are some pain and redness around the injection site and fatigue.” 

While he doesn’t know what the future holds after he finishes the trial, Breault is back to his normal routine of washing his new truck, fishing and spending time with his three children and six grandchildren. He said he is grateful for the time he has, doing the things he loves with the people he loves.

“It means a lot to me to have access to something like this clinical trial at Hollings,” he said. “I tell my friends, if they have cancer, to go to Hollings. I can’t believe how far I’ve come this fast. I truly believe coming to Hollings saved my life.”

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