PMID- 34900741 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220429 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 11 DP - 2021 TI - Multi-Institutional Study Validates Safety of Intraoperative Cesium-131 Brachytherapy for Treatment of Recurrent Head and Neck Cancer. PG - 786216 LID - 10.3389/fonc.2021.786216 [doi] LID - 786216 AB - INTRODUCTION: Surgery 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 MATERIALS: Findings 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. RESULTS: Forty-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. CONCLUSIONS: Among 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 REGISTRATION: ClinicalTrials.gov, identifiers NCT02794675 and NCT02467738. CI - Copyright (c) 2021 Luginbuhl, Calder, Kutler, Zender, Wise-Draper, Patel, Cheng, Karivedu, Zhan, Parashar, Gulati, Yao, Lavertu, Takiar, Tang, Johnson, Keane, Curry, Cognetti and Bar-Ad. FAU - Luginbuhl, Adam AU - Luginbuhl A AD - Department of Otolaryngology, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Calder, Alyssa AU - Calder A AD - Department of Otolaryngology, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Kutler, David AU - Kutler D AD - Department of Otolaryngology, Weill Cornell Medical Center, New York, NY, United States. FAU - Zender, Chad AU - Zender C AD - Department of Otolaryngology, University of Cincinnati Medical Center, Cincinnati, OH, United States. FAU - Wise-Draper, Trisha AU - Wise-Draper T AD - Department of Medical Oncology, University of Cincinnati Medical Center, Cincinnati, OH, United States. FAU - Patel, Jena AU - Patel J AD - Department of Otolaryngology, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Cheng, Michael AU - Cheng M AD - Department of Otolaryngology, Weill Cornell Medical Center, New York, NY, United States. FAU - Karivedu, Vidhya AU - Karivedu V AD - Department of Medical Oncology, Ohio State University, Columbus, OH, United States. FAU - Zhan, Tingting AU - Zhan T AD - Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Parashar, Bhupesh AU - Parashar B AD - Department of Radiation Oncology, Zucker School of Medicine at Hofstra/Northwell, New York, NY, United States. FAU - Gulati, Shuchi AU - Gulati S AD - Department of Medical Oncology, University of Cincinnati Medical Center, Cincinnati, OH, United States. FAU - Yao, Min AU - Yao M AD - Department of Radiation Oncology, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland, OH, United States. FAU - Lavertu, Pierre AU - Lavertu P AD - Department of Radiation Oncology, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland, OH, United States. FAU - Takiar, Vinita AU - Takiar V AD - Department of Radiation Oncology, University of Cincinnati Medical Center, Cincinnati, OH, United States. FAU - Tang, Alice AU - Tang A AD - Department of Otolaryngology, University of Cincinnati Medical Center, Cincinnati, OH, United States. FAU - Johnson, Jennifer AU - Johnson J AD - Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Keane, William AU - Keane W AD - Department of Otolaryngology, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Curry, Joseph AU - Curry J AD - Department of Otolaryngology, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Cognetti, David AU - Cognetti D AD - Department of Otolaryngology, Thomas Jefferson University, Philadelphia, PA, United States. FAU - Bar-Ad, Voichita AU - Bar-Ad V AD - Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, United States. LA - eng SI - ClinicalTrials.gov/NCT02467738 SI - ClinicalTrials.gov/NCT02794675 GR - IK2 BX004360/BX/BLRD VA/United States PT - Journal Article DEP - 20211126 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC8660666 OTO - NOTNLM OT - Cesium-131 OT - brachytherapy OT - head and neck cancer OT - recurrent OT - reirradiation head and neck OT - surgery COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/12/14 06:00 MHDA- 2021/12/14 06:01 PMCR- 2021/01/01 CRDT- 2021/12/13 18:07 PHST- 2021/09/29 00:00 [received] PHST- 2021/11/08 00:00 [accepted] PHST- 2021/12/13 18:07 [entrez] PHST- 2021/12/14 06:00 [pubmed] PHST- 2021/12/14 06:01 [medline] PHST- 2021/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2021.786216 [doi] PST - epublish SO - Front Oncol. 2021 Nov 26;11:786216. doi: 10.3389/fonc.2021.786216. eCollection 2021.