- Luginbuhl, Adam;
- Calder, Alyssa;
- Kutler, David;
- Zender, Chad;
- Wise-Draper, Trisha;
- Patel, Jena;
- Cheng, Michael;
- Karivedu, Vidhya;
- Zhan, Tingting;
- Parashar, Bhupesh;
- Gulati, Shuchi;
- Yao, Min;
- Lavertu, Pierre;
- Takiar, Vinita;
- Tang, Alice;
- Johnson, Jennifer;
- Keane, William;
- Curry, Joseph;
- Cognetti, David;
- Bar-Ad, Voichita
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.