Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial

Introduction: 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 patie...

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Published in:European journal of cancer (1990) 2022-10, Vol.174, p.232-242
Main Authors: Villacampa, Guillermo, Falato, Claudette, Paré, Laia, Hernando, Cristina, Arumí, Miriam, Saura, Cristina, Gómez, Guadalupe, Muñoz, Montserrat, Gil-Gil, Miguel, Izarzugaza, Yann, Ferrer, Neus, Najera-Zuloaga, Josu, Montaño, Alvaro, Ciruelos, Eva, González-Santiago, Santiago, Villagrasa, Patricia, Gavilá, Joaquín, Prat, Aleix, Pascual, Tomás
Format: Article
Language:English
Subjects:
Anthracycline
Appetite loss
Breast cancer
Chemotherapy
Clinical outcomes
Global health
Medicin och hälsovetenskap
Patients
Public health
Quality of life
Questionnaires
Targeted cancer therapy
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Summary:Introduction: 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. Methods: 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). Results: 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
ISSN:0959-8049
1879-0852
1879-0852
DOI:10.1016/j.ejca.2022.07.028