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 Registration ClinicalTrials.gov, identifiers NCT02794675 and NCT02467738.
Highlights
Surgery is the primary treatment for resectable, non-metastatic recurrent head and neck squamous cell carcinoma (HNSCC)
Forty-nine patients were enrolled in the surgery + Cs-131 prospective study
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%)
Summary
Surgery is the primary treatment for resectable, non-metastatic recurrent head and neck squamous cell carcinoma (HNSCC). The pattern of failure for head and neck squamous cell carcinoma (HNSCC) is classified as local, regional, or metastatic. If the pattern of failure is local or regional, surgery with or without re-irradiation is the standard of care for resectable tumors [3]. Systemic therapies, including chemotherapy and/or immunotherapy, remain the mainstay of treatment for metastatic disease. Based on this current standard, it is difficult to reconcile the high failure rate after salvage surgery alone with the additional morbidity and uncertain oncologic benefit of re-irradiation using external beam radiation therapy (EBRT). Surgery alone and surgery plus re-irradiation with intensity modulated radiation therapy (surgery + ReIMRT) pose major challenges
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