1. Multi-Institutional Study Validates Safety of Intraoperative Cesium-131 Brachytherapy for Treatment of Recurrent Head and Neck Cancer
- Author
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Alyssa Calder, Bhupesh Parashar, Jennifer E. Johnson, Pierre Lavertu, Chad Zender, Min Yao, David Cognetti, Joseph Curry, Vidhya Karivedu, Trisha Wise-Draper, Jena Patel, Voichita Bar-Ad, David I. Kutler, Alice Tang, Vinita Takiar, Adam Luginbuhl, Michael Cheng, Shuchi Gulati, Tingting Zhan, and William M. Keane
- Subjects
medicine.medical_specialty ,Cancer Research ,Osteoradionecrosis ,medicine.medical_treatment ,Brachytherapy ,brachytherapy ,Clinical Trials and Supportive Activities ,Oncology and Carcinogenesis ,surgery ,recurrent ,Rare Diseases ,Clinical Research ,Percutaneous endoscopic gastrostomy ,medicine ,Dental/Oral and Craniofacial Disease ,Adverse effect ,Prospective cohort study ,RC254-282 ,Original Research ,Cancer ,business.industry ,Head and neck cancer ,reirradiation head and neck ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Evaluation of treatments and therapeutic interventions ,medicine.disease ,Head and neck squamous-cell carcinoma ,Surgery ,Oncology ,Cohort ,head and neck cancer ,Patient Safety ,business ,6.4 Surgery ,Cesium-131 - Abstract
IntroductionSurgery is the primary treatment for resectable, non-metastatic recurrent head and neck squamous cell carcinoma (HNSCC). We explore the safety and oncologic benefit of intraoperative Cesium-131 (Cs-131) brachytherapy combined with salvage local and/or regional surgical resection.Methods and MaterialsFindings were reported from a single arm multi-institutional prospective phase 1/2 trial involving surgery plus Cs-131 (surgery + Cs-131) treatment. The results of two retrospective cohorts—surgery alone and surgery plus intensity modulated radiation therapy (surgery + ReIMRT)—were also described. Included patients had recurrent HNSCC and radiation history. Safety, tumor re-occurrence, and survival were evaluated.ResultsForty-nine patients were enrolled in the surgery + Cs-131 prospective study. Grade 1 to 3 adverse events (AEs) occurred in 18 patients (37%), and grade 4 AEs occurred in 2 patients. Postoperative percutaneous endoscopic gastrostomy (PEG) tubes were needed in 10 surgery + Cs-131 patients (20%), and wound and vascular complications were observed in 12 patients (24%). No cases of osteoradionecrosis were reported in the surgery + Cs-131 cohort. We found a 49% 2-year disease-free survival at the site of treatment with a substantial number of patients (31%) developing metastatic disease, which led to a 31% overall survival at 5 years.ConclusionsAmong patients with local/regional recurrent HNSCC status-post radiation, surgery + Cs-131 demonstrated acceptable safety with compelling oncologic outcomes, as compared to historic control cohorts.Clinical Trial RegistrationClinicalTrials.gov, identifiers NCT02794675 and NCT02467738.
- Published
- 2021
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