医学
生活质量(医疗保健)
内科学
置信区间
化疗
来曲唑
乳腺癌
健康相关生活质量
随机对照试验
物理疗法
癌症
三苯氧胺
护理部
疾病
作者
Guillermo Villacampa,Claudette Falato,Laia Paré,Cristina Hernándo,Miriam Arumí,Cristina Saura,Guadalupe Gómez,Montserrat Muñoz,Miguel Gil-Gil,Yann Izarzugaza,Neus Ferrer,Josu Najera‐Zuloaga,Álvaro Montaño,Eva Ciruelos,Santiago González-Santiago,Patricia Villagrasa,Joaquín Gavilá,Aleix Prat,Tomás Pascual
标识
DOI:10.1016/j.ejca.2022.07.028
摘要
In the phase II CORALLEEN trial, patients with PAM50 luminal B early breast cancer (EBC) were randomised to neoadjuvant ribociclib plus letrozole (R + L) or chemotherapy based on anthracyclines and taxanes. Results from the primary efficacy analysis showed a similar proportion of patients with response at surgery in both groups. How health-related quality of life (HRQoL) outcomes with R + L compare with chemotherapy in EBC setting is still unknown. Here, we report the results of the HRQoL analysis from the CORALLEEN study.A total of 106 women were randomised 1:1 to receive neoadjuvant R + L (n = 52) or chemotherapy (n = 54). Patient-reported outcomes were assessed using two questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR23. Change from baseline in the global health status, functional, and symptom scales was analysed using linear mixed-effect models, and between-treatment differences were estimated along with 95% confidence interval (95% CI).At baseline, the overall questionnaire available rate was 94.3%, and patient-reported outcomes were similar between treatment groups. At the end of the study treatment (24 weeks), patients receiving R + L showed better global health status scores with a between-treatment difference of 17.7 points (95% CI 9.2-26.2; p-value <0.001). The R + L group also presented numerically better outcomes in all functional and symptom scales. The larger between-treatment differences in symptom severity were found in fatigue (-28.9; 95% CI -38.5 to -19.3), appetite loss (-23; 95% CI -34.9 to -11.2) and systematic therapy side-effects (-11.4; 95% CI -18.3 to -4.6).Neoadjuvant R + L was associated with better HRQoL outcomes compared with chemotherapy in patients with luminal B EBC.ClinicalTrials.gov Identifier: NCT03248427.
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