Real-world patient-reported outcomes of women receiving initial endocrine-based therapy for HR+/HER2-advanced breast cancer in five European countries

被引:13
作者
Davie, Alison [1 ]
Carter, Gebra Cuyun [2 ]
Rider, Alex [3 ]
Pike, James [3 ]
Lewis, Katie [3 ]
Bailey, Abigail [3 ]
Price, Gregory L. [2 ]
Ringeisen, Francois [4 ]
Pivot, Xavier [5 ]
机构
[1] Eli Lilly & Co Ltd, Windlesham GU20 6PH, Surrey, England
[2] Eli Lilly & Co, Indianapolis, IN 46204 USA
[3] Adelphi Real World, Macclesfield SK10 5JB, Cheshire, England
[4] Eli Lilly SA, Geneva, Switzerland
[5] Paul Strauss Canc Ctr, Strasbourg, France
关键词
Advanced breast cancer; Health-related quality of life; Real-world evidence; Patient-reported outcomes; QUALITY-OF-LIFE; CLINICAL-TRIALS; PAIN; ORGANIZATION; INTERFERENCE; METASTASES; SURVIVAL; SUBTYPES; MODERATE; QLQ-C30;
D O I
10.1186/s12885-020-07294-2
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
BackgroundEndocrine therapy (ET)-based regimens are the mainstay of treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer. With the introduction of new treatment classes, it is important to examine patient symptoms and health-related quality of life (HRQoL) at the start of this changing therapeutic landscape. This real-world study describes the patient-reported outcomes (PROs) of women with HR+/HER2- advanced breast cancer receiving ET-based regimens who were naive to systemic treatment in the advanced setting across five European countries (EU5).MethodsData were collected between March and July 2017 from surveyed oncologists and their patients at a single time point using the multinational Adelphi Advanced Breast Cancer Disease Specific Programme (TM). Patients completed PRO questionnaires on HRQoL (EORTC QLQ-C30), pain severity and interference, and work and activity impairment. A multiple linear regression model explored factors associated with HRQoL.ResultsAcross EU5, 226 physicians provided data on 781 women with HR+/HER2- advanced breast cancer taking their first ET-based regimen for advanced disease, of whom 252 provided PRO data. This subset had a mean age of 67.1years, 94% were postmenopausal, 89% were diagnosed with advanced breast cancer at initial presentation, 79% had stage IV disease (66% of these patients had bone metastases and 38% had visceral metastases, including 18% with liver metastases) and 77% were on endocrine-only therapy as their initial treatment for advanced disease. The mean EORTC QLQ-C30 global health score (50.9) was worse than the reference value for patients with advanced breast cancer (60.2). Fatigue, pain, and insomnia were the most severe symptoms, and mean functioning scores were also worse than reference values. "Worst pain" and "pain interference" were moderate/severe for 42 and 80% of patients. Mean activity impairment was 44%, and greater activity impairment was associated with poorer HRQoL.ConclusionsDespite receiving first-line ET-based regimens for advanced disease, these women had a poor HRQoL and high levels of symptoms, pain, pain interference and activity impairment. New treatments that maintain a stable disease state and reduce activity impairment may have a positive effect on the HRQoL of those living with advanced breast cancer.
引用
收藏
页数:15
相关论文
共 58 条
[1]   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].
AARONSON, NK ;
AHMEDZAI, S ;
BERGMAN, B ;
BULLINGER, M ;
CULL, A ;
DUEZ, NJ ;
FILIBERTI, A ;
FLECHTNER, H ;
FLEISHMAN, SB ;
DEHAES, JCJM ;
KAASA, S ;
KLEE, M ;
OSOBA, D ;
RAZAVI, D ;
ROFE, PB ;
SCHRAUB, S ;
SNEEUW, K ;
SULLIVAN, M ;
TAKEDA, F .
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) :365-376
[2]   Real-world physician and patient behaviour across countries: Disease-Specific Programmes - a means to understand [J].
Anderson, P. ;
Benford, M. ;
Harris, N. ;
Karavali, M. ;
Piercy, J. .
CURRENT MEDICAL RESEARCH AND OPINION, 2008, 24 (11) :3063-3072
[3]  
[Anonymous], 1995, EORTC QLQ-C30 scoring manual
[4]   Progression-free Survival With First-line Endocrine-based Therapies Among Postmenopausal Women With HR+/HER2-Metastatic Breast Cancer: A Network Meta-analysis [J].
Ayyagari, Rajeev ;
Tang, Derek ;
Patterson-Lomba, Oscar ;
Zhou, Zhou ;
Xie, Jipan ;
Chandiwana, David ;
Dalai, Anand A. ;
Niravath, Polly Ann .
CLINICAL THERAPEUTICS, 2018, 40 (04) :628-639
[5]   Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer [J].
Basaran, Gul A. ;
Twelves, Chris ;
Dieras, Veronique ;
Cortes, Javier ;
Awada, Ahmad .
CANCER TREATMENT REVIEWS, 2018, 63 :144-155
[6]  
Bray F, 2018, CA-CANCER J CLIN, V68, P394, DOI [10.3322/caac.21609, 10.3322/caac.21492]
[7]  
Caldeira R, 2016, ONCOL THER, V4, P189, DOI 10.1007/s40487-016-0033-z
[8]   4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4) [J].
Cardoso, F. ;
Senkus, E. ;
Costa, A. ;
Papadopoulos, E. ;
Aapro, M. ;
Andre, F. ;
Harbeck, N. ;
Aguilar Lopez, B. ;
Barrios, C. H. ;
Bergh, J. ;
Biganzoli, L. ;
Boers-Doers, C. B. ;
Cardoso, M. J. ;
Carey, L. A. ;
Cortes, J. ;
Curigliano, G. ;
Dieras, V. ;
El Saghir, N. S. ;
Eniu, A. ;
Fallowfield, L. ;
Francis, P. A. ;
Gelmon, K. ;
Johnston, S. R. D. ;
Kaufmann, B. ;
Koppikar, S. ;
Krop, I. E. ;
Mayer, M. ;
Nakigudde, G. ;
Offersen, B. V. ;
Ohno, S. ;
Pagani, O. ;
Paluch-Shimon, S. ;
Penault-Llorca, F. ;
Prat, A. ;
Rugo, H. S. ;
Sledge, G. W. ;
Spence, D. ;
Thomssen, C. ;
Vorobiof, D. A. ;
Xu, B. ;
Norton, L. ;
Winer, E. P. .
ANNALS OF ONCOLOGY, 2018, 29 (08) :1634-1657
[9]   Truthfulness in patient-reported outcomes: factors affecting patients' responses and impact on data quality [J].
Chang, Eric M. ;
Gillespie, Erin F. ;
Shaverdian, Narek .
PATIENT-RELATED OUTCOME MEASURES, 2019, 10 :171-186
[10]  
Cleeland C. S., 1994, Annals Academy of Medicine Singapore, V23, P129