Quality of life (QoL) in a phase III trial of pelvic external beam radiation therapy (PXRT) versus vaginal cuff brachytherapy followed by paclitaxel/carboplatin chemotherapy (VCB/C) in patients with high risk, early stage endometrial carcinoma: An NRG Oncology/Gynecologic Oncology Group study.

5593Background: In GOG Study 249, VCB/C was not superior to PXRT in overall survival or treatment failure rate (Randall et al, ASTRO, 2017). Here we compare QoL, fatigue, neurotoxicity, and gastrointestinal (GI) symptoms between patients randomized to VCB/C versus PXRT, and examine the association between primary comorbid illness plus obesity on QoL. Methods: The Functional Assessment of Cancer Therapy (FACT) – Endometrial Trial Outcome Index (FACT-En TOI) for QoL, FACIT-Fatigue subscale, FACT/GOG-Neurotoxicity subscale, and 6 items from the FACT-En for gastrointestinal (GI) symptoms were measured at baseline, 4 and 11 weeks, 8 and 14 months post-enrollment. Treatment differences were assessed with a linear mixed model adjusting for pretreatment score, assessment time, and age at enrollment. Results: 540 of 601 eligible patients provided evaluable patient-reported assessments. QOL was not statistically significantly different between treatment arms. However, fatigue and neurotoxicity were significantly wo...