Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study
Purpose: In the MONALEESA-3 Phase III trial of patients with hormone receptor–positive human epidermal growth factor receptor–negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-report...
Main Authors: | , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2020-12-01
|
Series: | Breast |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S0960977620301867 |
id |
doaj-a5b481e9a0e5458182d897e58fbb782f |
---|---|
record_format |
Article |
spelling |
doaj-a5b481e9a0e5458182d897e58fbb782f2020-12-23T04:58:36ZengElsevierBreast1532-30802020-12-0154148154Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 studyPeter A. Fasching0J. Thaddeus Beck1Arlene Chan2Michele De Laurentiis3Francisco J. Esteva4Guy Jerusalem5Patrick Neven6Xavier Pivot7Giulia V. Bianchi8Miguel Martin9David Chandiwana10Brad Lanoue11Antonia Ridolfi12Yingbo Wang13Karen Rodriguez Lorenc14Arnd Nusch15University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany; Corresponding author. University Hospital Erlangen, Maximiliansplatz 2, Erlangen, 91054, Germany.Highlands Oncology Group, Fayetteville, AR, USABreast Cancer Research Centre-Western Australia, Nedlands, WA, AustraliaIstituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Naples, ItalyNYU Langone Health, New York, NY, USACHU de Liège, University of Liège, Liège, BelgiumMultidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, BelgiumInstitut Régional Du Cancer, Strasbourg, FranceFondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, ItalyInstituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, SpainNovartis Pharmaceuticals Corporation, East Hanover, NJ, USANovartis Pharmaceuticals Corporation, East Hanover, NJ, USANovartis Pharma SAS, Rueil-Malmaison, FranceNovartis Pharma AG, Basel, SwitzerlandNovartis Pharmaceuticals Corporation, East Hanover, NJ, USAPractice for Haematology and Internal Oncology, Velbert, GermanyPurpose: In the MONALEESA-3 Phase III trial of patients with hormone receptor–positive human epidermal growth factor receptor–negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL). Methods: Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs. Results: Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62–1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61–1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60–1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57–1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58–1.12]) trended in favor of ribociclib vs placebo. Conclusions: In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.http://www.sciencedirect.com/science/article/pii/S0960977620301867Breast cancerMetastaticPatient-reported outcomesQuality of life |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Peter A. Fasching J. Thaddeus Beck Arlene Chan Michele De Laurentiis Francisco J. Esteva Guy Jerusalem Patrick Neven Xavier Pivot Giulia V. Bianchi Miguel Martin David Chandiwana Brad Lanoue Antonia Ridolfi Yingbo Wang Karen Rodriguez Lorenc Arnd Nusch |
spellingShingle |
Peter A. Fasching J. Thaddeus Beck Arlene Chan Michele De Laurentiis Francisco J. Esteva Guy Jerusalem Patrick Neven Xavier Pivot Giulia V. Bianchi Miguel Martin David Chandiwana Brad Lanoue Antonia Ridolfi Yingbo Wang Karen Rodriguez Lorenc Arnd Nusch Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study Breast Breast cancer Metastatic Patient-reported outcomes Quality of life |
author_facet |
Peter A. Fasching J. Thaddeus Beck Arlene Chan Michele De Laurentiis Francisco J. Esteva Guy Jerusalem Patrick Neven Xavier Pivot Giulia V. Bianchi Miguel Martin David Chandiwana Brad Lanoue Antonia Ridolfi Yingbo Wang Karen Rodriguez Lorenc Arnd Nusch |
author_sort |
Peter A. Fasching |
title |
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study |
title_short |
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study |
title_full |
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study |
title_fullStr |
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study |
title_full_unstemmed |
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study |
title_sort |
ribociclib plus fulvestrant for advanced breast cancer: health-related quality-of-life analyses from the monaleesa-3 study |
publisher |
Elsevier |
series |
Breast |
issn |
1532-3080 |
publishDate |
2020-12-01 |
description |
Purpose: In the MONALEESA-3 Phase III trial of patients with hormone receptor–positive human epidermal growth factor receptor–negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL). Methods: Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs. Results: Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62–1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61–1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60–1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57–1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58–1.12]) trended in favor of ribociclib vs placebo. Conclusions: In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL. |
topic |
Breast cancer Metastatic Patient-reported outcomes Quality of life |
url |
http://www.sciencedirect.com/science/article/pii/S0960977620301867 |
work_keys_str_mv |
AT peterafasching ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT jthaddeusbeck ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT arlenechan ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT micheledelaurentiis ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT franciscojesteva ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT guyjerusalem ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT patrickneven ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT xavierpivot ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT giuliavbianchi ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT miguelmartin ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT davidchandiwana ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT bradlanoue ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT antoniaridolfi ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT yingbowang ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT karenrodriguezlorenc ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study AT arndnusch ribociclibplusfulvestrantforadvancedbreastcancerhealthrelatedqualityoflifeanalysesfromthemonaleesa3study |
_version_ |
1724373691554332672 |