Short-Course Adjuvant Vaginal Cuff Brachytherapy in Early Endometrial Cancer Compared with Standard of Care (SAVE): A Randomized Clinical Trial

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PURPOSE Vaginal cuff brachytherapy (VCB) is widely used for adjuvant treatment of endometrial cancer, yet limited randomized data examine the optimal dose/fractionation. We aimed to study short-course VCB using patient-reported outcomes. METHODS We conducted a prospective, randomized, multicenter trial examining short-course adjuvant VCB (11 Gy × two fractions at the surface) compared with standard regimens (7 Gy × three fractions at 0.5 cm depth, 6 Gy × five fractions at the vaginal surface, or 5-5.5 Gy × four fractions at 0.5 cm depth). Eligible patients underwent hysterectomy and had pathologically confirmed endometrioid adenocarcinoma, serous sarcoma, clear cell sarcoma, or carcinosarcoma. Patients with stage I and II cancers were included, with lymphovascular invasion required for stage IAG1. The primary outcome was Global Health Status measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core Module (QLQ-C30) with a prespecified noninferiority margin of 15 points. Secondary outcomes included patient-reported outcomes, toxicities, and recurrences. RESULTS Fifty-four patients enrolled in each arm. The QLQ-C30 for the experimental arm was within the predefined boundary, and thus two fractions were noninferior to standard of care at 1 month ( P = .000005) and 12 months ( P = .0005). Using EORTC Quality of Life Questionnaire - Endometrial Cancer Module for patient-reported vaginal/sexual, urologic, and GI symptoms, the change in mean patient-reported symptom score from baseline to 1 and 12 months was not significantly different between arms. Using Common Terminology Criteria for Adverse Events v5 20 patients (37%) in the experimental arm and 31 patients (57%) in the control arm experienced short-term adverse events related to study treatment ( P = .053). At 28-month median follow-up, the vaginal control rate was 96% in both arms. The isolated vaginal control rate in the experimental arm was 100%. CONCLUSION Short-course VCB has noninferior short-term quality of life compared with standard regimens with acceptable short-term acute toxicity and cancer control outcomes.