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Proffered paper session - Breast cancer, metastatic

4295 - Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: results from MONALEESA-3


20 Oct 2018


Proffered paper session - Breast cancer, metastatic


Cytotoxic Therapy;  Supportive Care and Symptom Management

Tumour Site

Breast Cancer


Peter A. Fasching


Annals of Oncology (2018) 29 (suppl_8): viii90-viii121. 10.1093/annonc/mdy272


P.A. Fasching1, F.J. Esteva2, X. Pivot3, A. Nusch4, J.T. Beck5, A. Chan6, A. Pieris-Gunatilaka7, Y. Wang8, B. Lanoue9, D. Chandiwana9, P. Neven10

Author affiliations

  • 1 Department Of Gynecology And Obstetrics, Erlangen University Hospital, 91054 - Erlangen/DE
  • 2 Division Of Hematology And Medical Oncology, NYU Langone Health, New York/US
  • 3 Department Of Medical Oncology, Institut Régional du Cancer, Strasbourg/FR
  • 4 Department Of Oncology, Practice for Haematology and Internal Oncology, Velbert/DE
  • 5 Department Of Medical Oncology And Hematology, Highlands Oncology Group, Fayetteville/US
  • 6 Breast Cancer Research Center – Wa, Breast Cancer Research Center – WA, Nedlands/AU
  • 7 Medical Oncology, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 8 Oncology, Novartis Pharma AG, Basel/CH
  • 9 Oncology, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 10 Gynaecology And Obstetrics, University Hospitals Leuven, Leuven/BE


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Abstract 4295


In the MONALEESA-3 trial (NCT02422615), ribociclib + fulvestrant significantly improved progression-free survival (PFS) vs placebo + fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative BC who had received no or only 1 line of prior endocrine therapy for ABC. Here, we present PROs from the trial, including health-related quality of life (HRQoL).


Patients were randomized (2:1) to receive ribociclib (600 mg/day, 3-weeks-on/1-week-off) + fulvestrant (500 mg on Day 1 of every cycle and Cycle 1 Day 15; n = 484) or placebo + fulvestrant (n = 242). Time to definitive 10% deterioration from baseline (TTD) in HRQoL (global health status/quality of life scale score of the EORTC QLQ-C30 questionnaire [GHS/QLS]) and pain (BPI-SF questionnaire) were compared between treatment arms using a stratified log-rank test; a stratified Cox regression was used to estimate the hazard ratio with 95% confidence intervals (CI). PROs were also assessed using the EQ-5D-5L questionnaire.


Questionnaire compliance rates were high (>90% at baseline for each measure). Mean GHS/QLS was maintained or improved during every cycle of treatment in both arms (mean change from baseline up to Cycle 19 [n ≥ 50 in both arms]: ribociclib + fulvestrant 3.6–4.9; placebo + fulvestrant 1.3–4.3). At the end of treatment, addition of ribociclib to fulvestrant had not negatively impacted GHS/QLS (mean change from baseline: –5.2 points in the ribociclib arm [n = 184] vs –5.5 points in the placebo arm [n = 113]). Median TTD in GHS/QLS was not reached (NR) in the ribociclib arm (95% CI 22.1–NR) vs 19.4 months in the placebo arm (95% CI 16.6–NR); hazard ratio: 0.80 (95% CI 0.60–1.05). Using the BPI-SF scale, median TTD was 25.4 months in the ribociclib arm vs NR in the placebo arm for worst pain (hazard ratio: 0.81; 95% CI 0.58–1.13), 25.4 months vs NR for pain severity index (hazard ratio: 0.81; 95% CI 0.60–1.11), and NR vs NR for pain interference index (hazard ratio: 0.87, 95% CI 0.63–1.21).


As well as significantly prolonging PFS compared with placebo + fulvestrant, adding ribociclib to fulvestrant maintains quality of life.

Clinical trial identification

NCT02422615, April 21, 2015.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.


Novartis Pharmaceuticals Corporation.

Editorial Acknowledgement

John Munro of ArticulateScience Ltd.


P.A. Fasching: Grants and personal fees: Novartis; Personal fees: Roche, Pfizer, Celgene and Teva, during the conduct of the study. F.J. Esteva: Grants and personal fees; Novartis during the conduct of the study. A. Pieris-Gunatilaka, B. Lanoue: Employment: Novartis. Y. Wang, D. Chandiwana: Employment and stock ownership: Novartis. All other authors have declared no conflicts of interest.

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