A Phase 2 trial run by the Adult Head and Neck Oncology Program at Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) is seeking to reduce the side effects of postoperative therapy for certain head and neck cancer patients, helping them have a better quality of life while maintaining cancer cure rates.
The trial focuses on patients with HPV-positive squamous cell carcinoma of the oropharynx, the most common type of cancer caused by HPV in the United States. This cancer has seen increased incidence rates over the past several decades, especially among middle-aged men. Many patients do not have a history of heavy smoking or alcohol use, which cause most other head and neck cancers.
Previous studies showed that patients with HPV-positive head and neck cancer tend to have good long-term survival rates with current treatment programs, especially when compared to those with HPV-negative tumors.
Adjuvant Treatment Side Effects for HPV Cancer
Eleni M. Rettig, MD, of the Brigham’s Division of Otolaryngology-Head and Neck Surgery is the surgeon lead for the trial in conjunction with Danielle N. Margalit, MD, MPH, of DF/BWCC’s Radiation Oncology Department.
Dr. Rettig explained that complications from adjuvant therapy (radiation and chemotherapy) in addition to surgery can include difficulty speaking and swallowing, dry mouth, dental deterioration, loss of taste and smell, scar tissue and long-term jawbone damage.
“These side effects can be difficult to live with,” she said. “They have a negative impact on a patient’s mental health and everyday life and can also lead to other health problems. For example, if patients have difficulty swallowing, they can be at risk for aspiration pneumonia. In very severe cases, they may need additional surgeries to correct the problems.”
Exploring De-intensification Strategies
The study’s primary objective is to assess the disease-free survival of de-intensified adjuvant therapy after surgical resection. All patients in the trial will undergo surgery. After surgery, they will be risk-stratified into three groups based on tumor pathology.
Patients in the low-risk group will receive observation and no further therapy. Those in the intermediate-risk group will receive a reduced dose of radiation therapy compared with standard treatment. Those in the high-risk group will receive adjuvant radiation therapy but no chemotherapy.
“Reducing treatment toxicity while maintaining optimal cure rates is an important next step in how we care for these patients and is a central tenet in DF/BWCC’s mission to refine, improve and individualize cancer care,” Dr. Rettig said.
Transoral Robotic Surgery for Tumor Removal
According to Dr. Rettig, all patients in the trial will undergo transoral robotic surgery (TORS) to remove tumors from the mouth as well as lymph nodes from the neck. This advanced, minimally invasive surgical technique is proven to be a safe and effective way to remove tumors. The Brigham currently has three head and neck surgeons with TORS expertise on staff to treat patients.
“Removing these tumors used to require a more invasive approach through the neck or by splitting open the mandible,” Dr. Rettig said. “Now, patients at the Brigham can take advantage of this less morbid, less invasive procedure.”
To learn more or refer a patient to enroll in this study, please call 877-DF-TRIAL or visit www.dana-farber.org/clinical-trials2/detail/19-009.