Highlights
- •CORALLEEN trial included patients with luminal B early breast cancer.
- •Patients received neoadjuvant ribociclib plus letrozole (R + L) or chemotherapy.
- •Health-related quality of life (HRQoL) was better in the R + L arm.
- •R + L was associated with better global health status in comparison with chemotherapy.
- •R + L also presents better results in symptom and fatigue scales.
Abstract
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 <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).
Conclusions
Neoadjuvant R + L was associated with better HRQoL outcomes compared with chemotherapy
in patients with luminal B EBC.
Registration identification
ClinicalTrials.gov Identifier: NCT03248427.
Keywords
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References
- The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study.Lancet Oncol. 2015; 16: 25-35https://doi.org/10.1016/S1470-2045(14)71159-3
- Palbociclib and letrozole in advanced breast cancer.N Engl J Med. 2016; 375: 1925-1936https://doi.org/10.1056/nejmoa1607303
- Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.Lancet Oncol. 2016; 17: 425-439https://doi.org/10.1016/S1470-2045(15)00613-0
- Ribociclib as first-line therapy for HR-positive, advanced breast cancer.N Engl J Med. 2016; 375: 1738-1748https://doi.org/10.1056/nejmoa1609709
- MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2-advanced breast cancer who had progressed while receiving endocrine therapy.J Clin Oncol. 2017; 35: 2875-2884https://doi.org/10.1200/JCO.2017.73.7585
- MONARCH 3: abemaciclib as initial therapy for advanced breast cancer.J Clin Oncol. 2017; 35: 3638-3646https://doi.org/10.1200/JCO.2017.75.6155
- Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial.Lancet Oncol. 2018; 19: 904-915https://doi.org/10.1016/S1470-2045(18)30292-4
- Overall survival with palbociclib and fulvestrant in advanced breast cancer.N Engl J Med. 2018; 379: 1926-1936https://doi.org/10.1056/nejmoa1810527
- Overall survival with ribociclib plus endocrine therapy in breast cancer.N Engl J Med. 2019; 381: 307-316https://doi.org/10.1056/nejmoa1903765
- The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy - MONARCH 2: a randomized clinical trial.JAMA Oncol. 2020; 6: 116-124https://doi.org/10.1001/jamaoncol.2019.4782
- Overall survival with ribociclib plus fulvestrant in advanced breast cancer.N Engl J Med. 2020; 382: 514-524https://doi.org/10.1056/nejmoa1911149
- Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis.Lancet Oncol. 2019; 20: 1360-1369https://doi.org/10.1016/S1470-2045(19)30420-6
- Overall survival of CDK4/6-inhibitor-based treatments in clinically relevant subgroups of metastatic breast cancer: systematic review and meta-analysis.J Natl Cancer Inst. 2020; 112: 1089-1097https://doi.org/10.1093/jnci/djaa071
- Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial.Lancet Oncol. 2020; 21: 33-43https://doi.org/10.1016/S1470-2045(19)30786-7
- Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer.Ann Oncol. 2018; 29: 2334-2340https://doi.org/10.1093/annonc/mdy448
- Potent cell-cycle inhibition and upregulation of immune response with abemaciclib and anastrozole in Neomonarch, phase II neoadjuvant study in HR+/HER2- Breast cancer.Clin Cancer Res. 2020; 26: 566-580https://doi.org/10.1158/1078-0432.CCR-19-1425
- Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study.Lancet Oncol. 2021; 22: 212-222https://doi.org/10.1016/S1470-2045(20)30642-2
- Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR1, HER22, node-positive, high-risk, early breast cancer (monarchE).J Clin Oncol. 2020; 38: 3987-3998https://doi.org/10.1200/JCO.20.02514
- Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-the penelope-B trial.J Clin Oncol. 2021; 39: 1518-1530https://doi.org/10.1200/JCO.20.03639
- 4th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 4).Ann Oncol. 2018; 29: 1634-1657https://doi.org/10.1093/annonc/mdy192
- Administration D: Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance for Industry DRAFT GUIDANCE.([Internet] [cited 2021 Aug 4]. Available from:)
- The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.J Natl Cancer Inst. 1993; 85: 365-376https://doi.org/10.1093/jnci/85.5.365
- The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study.J Clin Oncol. 1996; 14: 2756-2768https://doi.org/10.1200/JCO.1996.14.10.2756
- EORTC QLQ-C30 scoring manual The EORTC QLQ-C30 Introduction.EORTC QLQ-C30 Scoring Man. vol. 30. 2001: 1-67
- Interpreting the significance of changes in health-related quality-of-life scores.J Clin Oncol. 1998; 16: 139-144
- Minimally important differences for interpreting EORTC QLQ-C30 scores in patients with advanced breast cancer.JNCI Cancer Spectr. 2019; 3: 1-7https://doi.org/10.1093/jncics/pkz037
- Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.JAMA. 2013; 309 (PMID: 23443445): 814-822
- International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.Lancet Oncol. 2020; 21: e83-e96https://doi.org/10.1016/S1470-2045(19)30790-9
- A beta-binomial mixed-effects model approach for analysing longitudinal discrete and bounded outcomes.Biom J. 2019; 61: 600-615https://doi.org/10.1002/bimj.201700251
- Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.Eur J Cancer. 2022; 168: 12-24https://doi.org/10.1016/j.ejca.2022.03.006
- Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial.Lancet Oncol. 2019; 20: 1750-1759https://doi.org/10.1016/S1470-2045(19)30565-0
- Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor–positive metastatic breast cancer: patient-reported outcomes in the PEARL study.Eur J Cancer. 2021; 156: 70-82https://doi.org/10.1016/j.ejca.2021.07.004
- Patient-reported outcomes of palbociclib plus exemestane with GnRH agonist versus capecitabine in premenopausal women with hormone receptor-positive metastatic breast cancer: a prospective, open-label, randomized phase ll trial (KCSG-BR 15-10).Cancers (Basel). 2020; 12: 1-12https://doi.org/10.3390/cancers12113265
- Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2.Breast Cancer Res Treat. 2018; 170: 535-545https://doi.org/10.1007/s10549-018-4769-z
- Ribociclib plus fulvestrant for advanced breast cancer: health-related quality-of-life analyses from the MONALEESA-3 study.Breast. 2020; 54: 148-154https://doi.org/10.1016/j.breast.2020.09.008
- Health-related quality of life in premenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer treated with ribociclib plus endocrine therapy: results from a phase III randomized clinical trial (MONALEESA-7).Ther Adv Med Oncol. 2020; 12
- Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study.Ann Oncol. 2021; 32: 1571-1581https://doi.org/10.1016/j.annonc.2021.09.015
- Quality of life (QOL) with ribociclib (RIB) plus aromatase inhibitor (AI) versus abemaciclib (ABE) plus AI as first-line (1L) treatment (tx) of hormone receptor-positive/human epidermal growth factor receptor–negative (HR+/HER2−) advanced breast cancer (ABC), assessed via matching-adjusted indirect comparison (MAIC).J Clin Oncol. 2022; 40: 1015
- Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study.Ann Oncol. 2022; 33https://doi.org/10.1016/j.annonc.2022.03.006
- Luminal B breast cancer: molecular characterization, clinical management, and future perspectives.J Clin Oncol. 2014; 32: 2794-2803https://doi.org/10.1200/JCO.2013.54.1870
Article info
Publication history
Published online: September 03, 2022
Accepted:
July 26,
2022
Received in revised form:
July 24,
2022
Received:
June 20,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
