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)

Author:

Harbeck Nadia1ORCID,Franke Fabio2,Villanueva-Vazquez Rafael3,Lu Yen-Shen4ORCID,Tripathy Debu5,Chow Louis6,Babu Govind K7,Im Young-Hyuck8,Chandiwana David9,Gaur Anil10,Lanoue Brad9,Rodriguez-Lorenc Karen9,Bardia Aditya11

Affiliation:

1. Breast Center, Department of Obstetrics and Gynecology and CCCLMU, Ludwig-Maximilians University Munich (LMU), Marchioninistrasse 15, München, 81377, Germany

2. Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil

3. Institut Català d’Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain

4. National Taiwan University Hospital, Taipei

5. The University of Texas MD Anderson Cancer Center, Houston, TX, USA

6. Organisation for Oncology and Translational Research, Hong Kong

7. HCG Curie Centre of Oncology and Kidwai Memorial Institute of Oncology, Bangalore, Karnataka, India

8. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

9. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

10. Novartis Healthcare Pvt Ltd, Hyderabad, India

11. Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA

Abstract

Background: This analysis evaluated patient-reported outcomes (PROs) to assess health-related quality of life (HRQoL) in the phase III MONALEESA-7 trial, which previously demonstrated improvements in progression-free survival (PFS) and overall survival (OS) with ribociclib (cyclin-dependent kinase 4/6 inhibitor) + endocrine therapy (ET) compared with placebo + ET in pre- and perimenopausal patients with hormone-receptor-positive, HER2-negative (HR+/HER2−) advanced breast cancer (ABC). Methods: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire C30 (QLQ-C30) and the EQ-5D-5L were used to evaluate HRQoL. Results: EORTC QLQ-C30 assessments were evaluable for 335 patients in the ribociclib arm and 337 patients in the placebo arm. Adherence rates at baseline and ⩾1 postbaseline time point were 90% and 83%, respectively. Patients treated with ribociclib + ET had a longer time to deterioration (TTD) ⩾ 10% in global HRQoL {hazard ratio (HR), 0.67 [95% confidence interval (CI), 0.52–0.86]}. TTD ⩾ 10% in global HRQoL was delayed in ribociclib-treated patients without versus with disease progression [HR, 0.31 (95% CI, 0.21–0.48)]. TTD ⩾ 10% in pain was longer with ribociclib + ET than with placebo + ET [HR, 0.65 (95% CI, 0.45–0.92)]. Patients who received a nonsteroidal aromatase inhibitor experienced similar benefits with ribociclib versus placebo in global HRQoL and pain. Conclusion: HRQoL was maintained longer in patients who received ribociclib + ET versus placebo + ET. These data, combined with previously reported improvements in PFS and OS, support a strong clinical benefit-to-risk ratio with ribociclib-based treatment in pre- and perimenopausal patients with HR+/HER2− ABC.

Funder

Novartis Pharmaceuticals Corporation

Publisher

SAGE Publications

Subject

Oncology

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