Risk factors for fistula formation after interstitial brachytherapy for locally advanced gynecological cancers involving vagina

PURPOSE: To determine risk factors for fistula formation after interstitial brachytherapy (ISBT) in patients with advanced gynecologic cancers. MATERIAL AND METHODS: We performed an Institutional Review Board (IRB) approved retrospective review of 44 patients treated with transperineal template-based ISBT from 2011 to 2017 at a major metropolitan county and university health system. All patients were treated with image-guided high-dose-rate ISBT. Statistical analysis was performed using the χ(2) test to identify factors correlated with fistula formation. Survival and tumor control outcomes were calculated using Kaplan Meier analyses. RESULTS: Patients had a mean age of 53 years (range, 28-81 years), a mean external beam dose of 43.1 Gy (range, 42.5-51.3 Gy), and a mean brachytherapy dose of 22.8 Gy (range, 21.3-30 Gy). Two of 44 patients had fistulas that could be definitively attributed to therapy for a fistula rate of 4.5%. Six additional patients (13.6%) developed fistula after treatment with associated recurrent disease but were included in the causality analysis. We analyzed patient tumor and treatment factors, and on univariate analyses we found that age ≥ 60 years, Hispanic ethnicity, bladder involvement, rectal D2 cc ≥ 70 Gy, and whether patients had post-radiation biopsies were predictors for fistula formation. The 1-year overall survival (OS), progression-free survival (PFS), and local control (LC) were 85%, 58.5%, and 76.9%, respectively, with a mean follow-up time 23 months (range, 4.0-68.8 months). CONCLUSIONS: We identified factors that predict fistula formation in patients with advanced gynecologic tumors treated with ISBT. These factors can be used to stratify patients into a high-risk group, with potential for modification of brachytherapy planning to reduce their risk of fistula formation.