Patient-centered outcomes in breast cancer: Description of EQ-5D-5L and EORTC-QLQ-BR23 measurements in real world data.
Authors: Monteiro Mariana Ribeiro , Nunes Natalia , Crespo James , Kinupe Abrahao Ana Beatriz , Buscacio Gustavo , Lerner Lilian Campos Caldeira , Sermoud Leticia , Arakelian Renata , Piotto Gustavo Henrique Munhoz , Ferreira Cynthia Lemos , Campos Roberta , de Azevedo Debora Victorino , Andrade Perla de Melo , Vieira Thamirez de Almeida , Pecoraro Juliana Pompeu , Vieira Fernando Meton de Alencar Camara , Gaui Maria De Fatima Dias , Araujo Luiz H. 
Published: June 2022

e18621

Background: Major improvements in breast cancer (BC) treatments have led to a significant increase in overall survival. Quality of life (QoL) is one of the main goals of cancer treatment and patient-centered outcomes are measured in almost all randomized clinical trials, but real-world data are lacking in the literature. Methods: This is a prospective, multicenter, observational study of female BC patients, without prior systemic treatment, treated between 2012 and 2019 in private healthcare in Sao Paulo and Rio de Janeiro, Brazil. QoL was assessed by EQ-5D-5L and EORTC-QLQ-BR23 at baseline, 3, 6, 9 and 12 months. All measures were presented as means and analyzed according to staging and subtypes using the Kruskal-Wallis test. A linear mixed model was used to assess the changes in the mean scores over time. Results were reported as increments relative to the baseline category, using 95% confidence intervals and p values. Results: A total of 1,372 female BC patients were evaluated, with a median age at diagnosis of 53.8 years. Stage 0, I, II, III and IV were diagnosed in 11%, 36%, 31%, 16% and 3% of the patients, respectively. Among the five dimensions of the EQ-5D-5L questionnaire, at baseline, the main reported problem was anxiety/depression, in which 37.1% and 19.5% reported slight and moderate symptoms, respectively. In the EQ VAS (visual analogue scale), patients stage III and IV had significantly lower score at baseline, 77.1 and 69.7 respectively, compared to stage I and II, 79.5 and 79.2 respectively (p = 0.016). Despite the high symptom burden at baseline, patients with metastatic BC had the most significant improvement after treatment, with 8.85 points difference at 12 months in absolute values from baseline (p = 0.005). Among EORTC-QLQ-BR23 measures, the baseline scores were similar between all stages, except for more “breast symptoms” in stage III patients, and more “systemic therapy” symptoms and better “sexual functioning” for stage IV patients, compared with early stages (p < 0.005). When we assess the impact of surgical treatment over time, patients undergoing lumpectomy had a better perception of “body image”, and axillary dissection led to more “arm symptoms” after 12 months. Similarly, radiotherapy enhanced “breast symptoms” and patients treated with chemotherapy had significantly more “systemic therapy” side effects compared with other treatments. Conclusions: In our population, patients with stage III/IV BC had worse baseline health perception, but those with metastatic disease had the greatest improvement over time, due to the benefit of systemic treatment. Patients undergoing chemotherapy, mastectomy, and radiation therapy reported worse QoL and long-term side effects. Early diagnosis and access to treatments with fewer side effects should be our future goals.