FDA Clears Oral Stent Solution for Radiotherapy in Head and Neck Cancer

Investigators of a prospective observational study published in Clinical and Translational Radiation Oncology reported that administering oral stents to survivors of oropharyngeal cancer undergoing treatment with IMRT correlated with an improvement in long-term patient-reported symptoms.

The FDA has granted clearance to Stentra, an oral stent solution, for use in the treatment of patients with head and neck cancer, according to a press release from Kallisio.¹

The solution combines patient oral data with advanced 3D printing to redirect radiation to the target tumor area and limit toxicity to surrounding tissue. Stentra was designed for use in combination with radiotherapy strategies including intensity-modulated radiation therapy (IMRT). The tool is believed to keep the patient’s tongue, lips, and other organs safe from the high-dose radiation target zone by immobilizing them.

According to its developers, Stentra makes use of a “patient-customized solution for precise and targeted radiation therapy,” and manages toxicity effectively by protecting surrounding healthy tissue from intense radiation doses. Additionally, its mechanism allows patient-tailored oral stents to be formed in less than 5 days.

“Designed to address each patient's unique treatment and anatomical needs, Stentra delivers an unmatched level of customization and effectiveness in addressing the critical need to safeguard healthy tissue during radiation therapy,” Rajan Patel, co-founder and chief executive officer at Kallisio, said in the press release.¹ “FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.”

Eugene Koay, MD, PhD, an associate professor of Gastrointestinal Radiation Oncology at The University of Texas, MD Anderson Cancer Center, developed Stentra’s foundational technology.

Investigators of a prospective observational study published in Clinical and Translational Radiation Oncology reported that administering oral stents to survivors of oropharyngeal cancerundergoing treatment with IMRT correlated with an improvement in long-term patient-reported symptoms.² Among patients who received unilateral neck radiotherapy, the use of a tongue-deviating stent significantly reduced taste impairment symptoms (P = .047). Investigators also reported a significant improvement in the proportion of patients who experienced a lack of appetite when using an oral stent (P = .019).

For those who underwent bilateral neck radiotherapy, 10% of patients who received a tongue-depressing stent had severe dysphagia following radiation compared with 18% of those who did not receive a stent (P = .013). Additionally, 84% and 75% of patients in each respective treatment group reported having no symptoms related to mouth or throat sores (P = .028).

In this study, investigators assessed how oral stents affected long-term patient-reported symptoms in those with oropharyngeal cancer who received IMRT using the MD Anderson Symptom Inventory Head and Neck module (MDASI-HN). A score of 5 or higher correlated with moderate or severe radiation-associated symptoms. Patients were stratified based on IMRT volume and the use of oral stents.

The study cohort included 462 patients who had survived oropharyngeal cancer. Most patients were male (83.3%), White (97.0%), and had primary tumor sites in the tonsil (53.7%). Additionally, most of the population received 66 Gy of radiation in 30 fractions (48%), as well as 70 Gy in 33 fractions (36%).

Overall, 94 patients with tonsil cancer received unilateral neck radiotherapy, which included 49 who were treated with an oral stent. Additionally, 364 patients underwent treatment with bilateral radiotherapy, which included 152 with tonsil cancer and 212 with primary disease on the base of the tongue.

References

1. Kallisio patient-tailored oral stent for head and neck cancer (HNC) treatment receives FDA clearance. News release. Kallisio. January 18, 2024. Accessed January 19, 2024. http://tinyurl.com/24fyx54h
2. Stieb S, Perez-Martinez I, Mohamed ASR, et al. The impact of tongue-deviating and tongue-depressing oral stents on long-term radiation-associated symptoms in oropharyngeal cancer survivors. Clin Transl Radiat Oncol. 2020;24:71-78. doi:10.1016/j.ctro.2020.05.014.