April 12 2022
Two studies are designed to impact the head and neck treatment landscape with a similar mission: to determine if neck lymph node imaging can prevent patients with head and neck cancers from receiving additional, unnecessary treatment. The elimination of the additional treatment could ultimately improve quality of life and maintain the survival outcomes for their respective populations. NRG Oncology’s NRG-HN006 is an ongoing study that is comparing sentinel lymph node (SLN) biopsy with the standard of care elective neck dissection (END) for early-stage oral cavity cancer patients with negative baseline PET-CT scans. CCTG HN11 is a clinical trial in development led by the Canadian Cancer Trials Group (CCTG), with Study Champions involved from NRG Oncology. CCTG HN11 will evaluate lymphatic mapping with single photon emission computed tomography (SPECT-CT) to see if this imaging technique could help define the neck region at risk for recurrence of cancer and thus guide where radiotherapy should be administered.
Early-stage oral cavity cancer may spread from the primary tumor site to the neck lymph nodes in 20-30% of patients, despite appearing clinically and radiographically uninvolved. NRG-HN006 is a phase II/III clinical trial for patients with node-negative early-stage oral cavity cancer. The trial will randomly assign eligible patients to receive END, which is the standard of care for this population, or to receive the SLN biopsy. Currently, SLN is heavily used in breast cancer and melanomas, but is not as commonly used in head and neck cancers. SLN biopsies capitalize on the lymphatic draining patterns of oral cavity tumors and can isolate the most likely involved lymph nodes without subjecting patients to the potential complications of END. In phase II of this trial, researchers will focus on the primary endpoint of quality of life, while they will focus on quality of life and disease-free survival in phase III.
“When treated with END, many of these patients experience long-term side effects from the treatment, which includes the need for more extensive surgery in the neck following the resection of the primary oral cavity tumor, increasing the risk of significant morbidity, muscle weakness due to spinal accessory nerve damage, and other impairments to a patient’s quality of life,” stated Stephen Y. Lai, MD, PhD, FACS, of the Department of Head and Neck Surgery at the University of Texas MD Anderson Cancer Center.
“It is incredibly important to determine if SLN biopsies can help inform physicians in the decision-making process on which patients could benefit from additional neck dissection and those who do not need it,” added Dr. Lai.
CCTG HN11, also known as the “SELECT study”, is a randomized, controlled, phase III clinical trial for patients with lateralized oropharyngeal carcinoma (OPC). The study is comparing the effectiveness of standard radiotherapy target volume to personalized radiotherapy target volume selection guided by the lymphatic mapping technique. The standard of care for these patients is to supply radiotherapy to both sides of the neck to address gross and microscopic disease. Evidence shows that only approximately 15% of these patients have gross cancerous lymph nodes on the opposite side of their neck and treating both sides increases the risk of several adverse events including swallowing impairment, dry mouth, and the insertion of a temporary feeding tube. The SELECT study instead utilizes SPECT-CT to image the neck and see if this helps to identify lymphatic drainage patterns that increase the risk for disease spread to the other side of the neck in patients and where specifically the risk of spread would be located.
“OPC is one of the most common types of head and neck cancer. The SELECT study is extremely significant in the fact that it looks to preserve such a large population of head and neck cancer patients from overtreatment with radiation and, instead, looks to personalize treatment to provide a better outcome for the patient,” mentioned John R. de Almeida, MD, MSc, FRCSC, of the Department of Otolaryngology – Head and Neck Surgery at the University Health Network Princess Margaret Cancer Centre and the Co-Principal Investigator and Surgical Oncology Lead of the CCTG HN11 trial.
“We speculate that this alternative could provide a more cost-effective and safer approach to care for OPC patients,” added Dr. de Almeida. “I look forward to working with Dr. James Bates, the champion for radiation oncology on this trial in NRG Oncology, and Dr. Steven Chinn, the champion for surgical oncology on this trial, to offer it to NRG Oncology patients in addition those within the CCTG.”
Both of these trials provide an integral opportunity to reevaluate our current practices in head and neck cancer to allow for more personalized and precise treatment with a substantial focus on quality of life following a patient’s treatment. This research has relied on combined efforts from various key stakeholders in the process from NRG Oncology and the Canadian Cancer Trials Group as well as the Study Champions process and organizations’ committees. NRG looks forward to the continued advancements made within the global head and neck cancer portfolio.