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

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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Déclaration de conflit d'intérêts

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: G. Villacampa: Consulting Fees (e.g. advisory boards); AstraZeneca. Other (speakers' bureaus); MSD, GSK and Pierre Fabre. C. Falato: Contracted Research; Fellowship from the Swedish Society for Medical Research. L. Paré: Receipt of Intellectual Property Rights/Patent Holder; HER2DX filing. C. Hernando: None declared. M. Arumí: Other; Roche, Eisai, MSD. C. Saura: Consulting Fees (e.g. advisory boards); Astrazeneca, Daiichi Sankyo, Exact Sciences, MSD, Philips, Pierre-Fabre, Puma Biotechnology, Roche, SeaGen, Zymeworks. Other (Consultant); Astrazeneca, AX'S Consulting sprl, Byondis B.V, Eisai, Exeter Pharma, Roche, MediTech, Novartis, Pfizer, Pierre Fabre, PintPharma and SeaGen. G. Gomez Melis: None declared. M. Muñoz: Consulting Fees (e.g. advisory boards); Pierre Fabre. Other; Eisai, Lilly, Novartis, Pfizer, Roche. M. Gil-Gil: Consulting Fees (e.g. advisory boards); AstraZeneca, Agendia. Other; Pfizer, Roche, Novartis, Pierre-Faber, Daiichi-Sankyo, Eisai. Y. Izarzugaza: Consulting Fees (e.g. advisory boards); Novartis. Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g. speakers' bureaus); Novartis, Pfizer. N. Ferrer: None declared. J. Najera-Zuloaga: None declared. A. Montaño: None declared. E. Ciruelos: Consulting Fees (e.g. advisory boards); Pfizer, Daiichi Sankyo, Novartis, MSD, AstraZeneca, Roche, Lilly. Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g. speakers' bureaus); Roche, Lilly. S. González-Santiago: Consulting Fees (e.g. advisory boards); Roche, Lilly, MSD, Pharmamar, Clovis, Pfizer. Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g. speakers' bureaus); Novartis, GSK, MSD, Pfizer. P. Villagrasa: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g. speakers' bureaus); Summit NS ESMO 2019 speaker. Other; Oncolytics. J. Gavilá: Consulting Fees (e.g. advisory boards); Lilly, AstraZeneca, Novartis, Pfizer, Roche. Other; AstraZeneca, Lilly, Novartis, Pfizer, Roche. A. Prat: Salary; Pfizer, Roche, Lilly, Amgen, Novartis, MSD Oncology, Daiichi Sankyo, Guardant Health. Receipt of Intellectual Property Rights/Patent Holder; PCT/EP2016/080056: HER2 AS A PREDICTOR OF RESPONSE TO DUAL HER2 BLOCKADE IN THE ABSENCE OF CYTOTOXIC THERAPY, WO/2018/096191. Chemoendocrine score (CES) Based on PAM50 for breast cancer with positive hormone receptors with an intermediate risk of recurrence, METHODS FOR BREAST CANCER TREATMENT AND PREDICTION OF THERAPEUTIC RESPONSE (US 63/023785), HER2DX filing. Consulting Fees (e.g. advisory boards); Amgen, Novartis, Bristol-Myers Squibb, PUMA, Daiichi Sankyo, Astrazeneca, Roche, Pfizer, Boehringer, Oncolytics Biotech, Abbvie, NanoString Technologies. Contracted Research; Roche, Novartis, Incyte, Puma Biotechnology. Ownership Interest (stock, stock options, or other ownership interest excluding diversified mutual funds); Reveal Genomics. Other; Oncolytics, Daiichi Sankyo, Peptomyc SL. T. Pascual: Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g. speakers' bureaus); AstraZeneca, Pfizer. Consulting Fees (e.g. advisory boards); Novartis.