Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial
Cathalijne C B Post, Stephanie M de Boer, Melanie E Powell, Linda Mileshkin, Dionyssios Katsaros, Paul Bessette, Christine Haie-Meder, Nelleke P B Ottevanger, Jonathan A Ledermann, Pearly Khaw, Romerai D'Amico, Anthony Fyles, Marie Hélène Baron, Henry C Kitchener, Hans W Nijman, Ludy C H W Lutgens, Susan Brooks, Ina M Jürgenliemk-Schulz, Amanda Feeney, Geraldine Goss, Roldano Fossati, Prafull Ghatage, Alexandra Leary, Viet Do, Andrea A Lissoni, Mary McCormack, Remi A Nout, Karen W Verhoeven-Adema, Vincent T H B M Smit, Hein Putter, Carien L Creutzberg, Cathalijne C B Post, Stephanie M de Boer, Melanie E Powell, Linda Mileshkin, Dionyssios Katsaros, Paul Bessette, Christine Haie-Meder, Nelleke P B Ottevanger, Jonathan A Ledermann, Pearly Khaw, Romerai D'Amico, Anthony Fyles, Marie Hélène Baron, Henry C Kitchener, Hans W Nijman, Ludy C H W Lutgens, Susan Brooks, Ina M Jürgenliemk-Schulz, Amanda Feeney, Geraldine Goss, Roldano Fossati, Prafull Ghatage, Alexandra Leary, Viet Do, Andrea A Lissoni, Mary McCormack, Remi A Nout, Karen W Verhoeven-Adema, Vincent T H B M Smit, Hein Putter, Carien L Creutzberg
Abstract
Purpose: The survival results of the PORTEC-3 trial showed a significant improvement in both overall and failure-free survival with chemoradiation therapy versus pelvic radiation therapy alone. The present analysis was performed to compare long-term adverse events (AE) and health-related quality of life (HRQOL).
Methods and materials: In the study, 660 women with high-risk endometrial cancer were randomly assigned to receive chemoradiation therapy (2 concurrent cycles of cisplatin followed by 4 cycles of carboplatin/paclitaxel) or radiation therapy alone. Toxicity was graded using Common Terminology Criteria for Adverse Events, version 3.0. HRQOL was measured using EORTC QLQ-C30 and CX24/OV28 subscales and compared with normative data. An as-treated analysis was performed.
Results: Median follow-up was 74.6 months; 574 (87%) patients were evaluable for HRQOL. At 5 years, grade ≥2 AE were scored for 78 (38%) patients who had received chemoradiation therapy versus 46 (24%) who had received radiation therapy alone (P = .008). Grade 3 AE did not differ significantly between the groups (8% vs 5%, P = .18) at 5 years, and only one new late grade 4 toxicity had been reported. At 3 and 5 years, sensory neuropathy toxicity grade ≥2 persisted after chemoradiation therapy in 6% (vs 0% after radiation therapy, P < .001) and more patients reported significant tingling or numbness at HRQOL (27% vs 8%, P < .001 at 3 years; 24% vs 9%, P = .002 at 5 years). Up to 3 years, more patients who had chemoradiation therapy reported limb weakness (21% vs 5%, P < .001) and lower physical (79 vs 87, P < .001) and role functioning (78 vs 88, P < .001) scores. Both treatment groups reported similar long-term global health/quality of life scores, which were better than those of the normative population.
Conclusions: This study shows a long-lasting, clinically relevant, negative impact of chemoradiation therapy on toxicity and HRQOL, most importantly persistent peripheral sensory neuropathy. Physical and role functioning impairments were seen until 3 years. These long-term data are essential for patient information and shared decision-making regarding adjuvant chemotherapy for high-risk endometrial cancer.
Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.
Source: PubMed