328 - Quality-of-Life and Late Toxic Effects of Stereotactic Pelvic Adjuvant Radiation Therapy in Patients with Uterine Cancers: Update to the SPARTACUS Phase I/II Trial
Presenter(s)
E. W. Leung1,2, K. Han3, L. Mendez4, E. Barnes5, V. Velker6, A. AlQaderi1,7, M. Davidson8, A. P. Gladwish9, P. Cheung2, D. A. Loblaw10, L. Zhang11, H. P. Hu12, E. Donovan13, A. Taggar1, and D. P. D'Souza14; 1Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada, 2Department of Radiation Oncology, University of Toronto, Toronto, ON, Canada, 3Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, 4London Health Sciences Centre, London, ON, Canada, 5Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Odette Cancer Centre, University of Toronto, Toronto, ON, Canada, 6Department of Radiation Oncology, Western University, London, ON, Canada, 7University of Toronto, Toronto, ON, Canada, 8Department of Medical Physics, Kelowna General Hospital, BC Cancer, Kelowna, BC, Canada, 9Royal Victoria Hospital, Barrie, ON, Canada, 10Ontario Institute of cancer research, Toronto, ON, Canada, 11Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada, 12Odette Cancer Cancer, Sunnybrook Health Sciences Centre, Toronto, ON, Canada, 13Juravinski Cancer Centre, Hamliton, ON, Canada, 14Department of Oncology, Division of Radiation Oncology, London Health Sciences Centre, Western University, London, ON, Canada
Purpose/Objective(s):
Adjuvant pelvic radiation (RT) in uterine cancers plays an important role in improving local control after surgery. By decreasing the number of treatments (hypofractionation), overall visits can be minimized with potential benefits to the healthcare system and patient out-of-pocket costs. We previous published favorable acute toxicities and quality-of-life in uterine cancer patients treated with 5-fraction hypofractionated RT. The goal of this current analysis is to evaluate late toxicities up to 2 years, and patient-reported outcomes following stereotactic hypofractionated adjuvant pelvic radiation.Materials/Methods:
A multicenter prospective phase I/II trial of uterine cancer patients treated with 30 Gy in 5 fractions was conducted. Stereotactic pelvic RT was delivered with volumetric arc radiation with body-vacuum immobilization and 3D image-guidance. Toxicity assessment, outcomes and patient-reported quality-of-life (QOL, EORTC core QLQ-C30 and endometrial EN24) were collected at baseline, fractions 3 and 5, and 6 weeks, and 3, 6, 9, 12, 18 and 24 months. Higher scores represent better global QOL/health status or worse symptoms (scale 0 – 100). Changes in QOL over time (between 6-24 months compared to baseline) were investigated with linear mixed-effects models. A p-value threshold of 0.05 was used for statistical significance; change in QOL score of 10 points or more was considered clinically significant.Results:
A total of 61 patients were enrolled. Tumor histologies included 39 endometrioid adenocarcinoma, 15 serous/clear cell, 3 carcinosarcoma, and 4 dedifferentiated. Sixteen patients received sequential chemotherapy, and 9 received vault brachytherapy. Median follow-up was 27 months (IQR 3-60). From 6 – 24 month follow-up, worst gastrointestinal tract (GI) toxic effects of grade 1 were observed in 23 patients (37.7%) and grade 2 in 5 patients (8.2%). For genitourinary (GU) worst toxic effects, grade 1 were observed in 10 patients (16.4%) and of grade 2 in 7 patients (11.5%). Two patients had ‘other’ grade 3 toxicities (infection and cholecystitis). For patient-reported outcomes, no significant change in global health status, GU or GI symptoms were observed from 6 to 24 months compared to baseline. Lymphedema was clinically and statistically significantly worse at 18 and 24 months compared with baseline. Sexual and vaginal problems were also significantly worse at 6 and 18 months. Vault brachytherapy was associated with increased urological symptoms. Nine patients recurred distantly, 1 patient was diagnosed with a local recurrence during RT and 1 patient had a synchronous metastasis and distal vaginal recurrence (out-of-field).Conclusion:
Stereotactic hypofractionated pelvic radiation for uterine cancer appears well-tolerated with up to 2-year follow-up; however, changes in quality of life for lymphedema and sexual health have been observed. Longer follow-up data and randomized studies are needed to further evaluate this treatment technique.