J Breast Cancer.
2023 Oct;26(5):436-445
https://doi.org/10.4048/jbc.2023.26.e29
pISSN 1738-6756·eISSN 2092-9900
Original Article
Received: Feb 8, 2023
Revised: Jun 13, 2023
Accepted: Jun 19, 2023
Published online: Jul 11, 2023
Correspondence to
Su-Yeon Yu
Department of Medical Information, College
of Nursing and Health, Kongju National
University, 56 Gongjudaehak-ro, Gongju 32588,
Korea.
Email: suyeon.yu@kongju.ac.kr
© 2023 Korean Breast Cancer Society
This is an Open Access article distributed
under the terms of the Creative Commons
Attribution Non-Commercial License (https://
creativecommons.org/licenses/by-nc/4.0/)
which permits unrestricted non-commercial
use, distribution, and reproduction in any
medium, provided the original work is properly
cited.
ORCID iDs
Mihai Park
https://orcid.org/0000-0001-8481-5503
Su-Yeon Yu
https://orcid.org/0000-0001-5488-5068
Ha-Lim Jeon
https://orcid.org/0000-0002-9429-8711
Inmyung Song
https://orcid.org/0000-0001-7772-6617
Funding
This research was partly supported by the
Health Insurance Review & Assessment
Service (#G000K31-2015-73) and Korea
Disease Control and Prevention Agency
(#2023-10-012), Republic of Korea. The
https://ejbc.kr
Factors Affecting Health-Related
Quality of Life in Patients With
Metastatic Breast Cancer
Mihai Park 1
, Su-Yeon Yu 2
, Ha-Lim Jeon 3
, Inmyung Song 4
1
School of Pharmacy, Sungkyunkwan University, Suwon, Korea
2
Department of Medical Information, College of Nursing and Health, Kongju National University, Gongju,
Korea
3
School of Pharmacy, Jeonbuk National University, Jeonju, Korea
4
Department of Health Administration, College of Nursing and Health, Kongju National University, Gongju,
Korea
ABSTRACT
Purpose: Improving survival and health-related quality of life (HRQOL), along with symptom
relief, is important for the treatment of metastatic breast cancer (MBC). This study measured
HRQOL and analyzed its influence on sociodemographic and clinical factors in patients with
MBC.
Methods: We interviewed 298 patients with MBC to investigate their sociodemographic
characteristics and HRQOL by using EuroQol-5D-5L (EQ-5D) between September and
October 2014. We also reviewed medical records to examine the clinical condition of the
patients, including disease progression, adverse events, treatments, chronic disease, and
metastatic areas. The distribution of the EQ-5D index was compared between different
clinical conditions by using the Kruskal-Wallis test. We also conducted multiple regression
analyses to identify the factors affecting HRQOL in patients with MBC.
Results: The mean EQ-5D index was 0.79 for all patients surveyed. The mean EQ-5D
index score was significantly lower in patients in the progressed state than in those in the
progression-free survival state (0.73 vs. 0.80, p = 0.0002). The HRQOL of patients treated with
chemotherapy alone was significantly lower than that of patients treated with hormonal or
targeted therapy (0.76 vs. 0.82 or 0.85; p = 0.0020). Regression analysis revealed that the clinical
factors associated with lower HRQOL were progressed state, chemotherapy, and adverse events,
such as hair loss or stomatitis. Finally, young age, high income, and employment were the
sociodemographic factors that were positively associated with better HRQOL.
Conclusion: This study provides new information on the health utility of MBC patients
on the basis of various patient characteristics and offers insights that can assist medical
professionals in treating patients with MBC and help policymakers implement cancer
strategies. Further research is needed to reflect the changing environment of cancer
treatment and enrich available evidence.
Keywords: Breast Neoplasms; Neoplasm Metastasis; Quality of Life
436
EuroQol-5D Index in Patients With Metastatic Breast Cancer
funding sources had no role in the study
design, data collection and analysis, decision
to publish, or preparation of the manuscript.
Conflict of Interest
The authors declare that they have no conflict
of interest.
Data Availability
In accordance with the ICMJE data sharing
policy, the authors have agreed to make the
data available upon request.
Author Contributions
Conceptualization: Park M, Yu SY; Data
curation: Park M, Yu SY, Jeon HL, Song I;
Formal analysis: Yu SY; Investigation: Park M;
Methodology: Park M, Yu SY, Song I; Project
administration: Jeon HL; Supervision: Park M,
Yu SY; Writing - original draft: Park M, Yu SY,
Jeon HL; Writing - review & editing: Park M, Yu
SY, Song I.
https://ejbc.kr
INTRODUCTION
Breast cancer is the most commonly diagnosed cancer in women, with 2.26 million incident
cases occurring worldwide in 2020 [1]. It is also the leading cause of cancer-related deaths
in women, followed by lung and colorectal cancers [1]. Although breast cancer has been
extensively investigated, the worldwide prevalence of metastatic breast cancer (MBC), which
is the most advanced form of breast cancer, is unknown [2]. In Korea, MBC accounts for
approximately 1% of all breast cancer [3]. Although patients with early-stage breast cancer
usually have good prognosis and have a five-year survival rate of over 90%, MBC is recognized
as an incurable disease with a survival rate of 27%–34% [3,4]. Therefore, efforts to develop
new treatments for MBC, particularly those targeting hormone receptors or gene mutations,
have been ongoing over the past decade [5].
Investigators regard quality of life as an important endpoint to measure in clinical trials
and survivorship studies, along with survival outcomes [6,7]. Survival times have increased
because of the availability of new treatments, and the paradigm has shifted to patient-
centered care in recent years. Health-related quality of life (HRQOL) is a quality-of-life
concept that focuses on the effects of illness and treatment on various aspects of health,
including physical, mental, and emotional status [8,9]. HRQOL can be measured using
generic, disease-specific, or condition-specific instruments [10]. Although disease-specific
instruments allow for greater sensitivity to the domains most relevant to the disease,
generic instruments have the unique advantage of permitting comparisons with the general
population or between groups with different diseases [11]. Therefore, generic instruments
are well suited to assist decision makers in allocating limited healthcare resources effectively.
However, few studies have evaluated the HRQOL of women with MBC or other clinical
conditions by using generic instruments [12-14]. Little is known about this topic in the
Korean population. Patients with the same disease may have different HRQOLs across
countries owing to differences in culture and the availability of new treatments. Therefore, it
is necessary to assess the HRQOL of Korean patients with MBC.
We measured the HRQOL of patients with MBC who visited two tertiary hospitals in Korea
in terms of progression-free survival (PFS) and progressed state, which are commonly
considered in the cost-effectiveness analyses of MBC [15-17], by using the EuroQol-5D-5L
(EQ-5D). EQ-5D is one of the most popular generic instruments used to estimate HRQOL
[18,19], and EQ-5D index values are commonly used to estimate quality-adjusted life year
gains in the economic evaluations of healthcare interventions. In addition, we stratified
patients according to various clinical conditions such as progression status, therapy type, and
number of adverse events, as well as factors affecting their EQ-5D index values.
METHODS
HRQOL measurements
We assessed the HRQOL by using the official version of the EQ-5D provided by the EuroQol
Group. The EQ-5D-5L consists of five dimensions (mobility, self-care, usual activities, pain/
discomfort, and anxiety/depression) that are measured in five levels. By combining 1 level
from each of the 5 dimensions, the EQ-5D-5L yielded 3,125 possible health states. The EQ-5D
index was calculated using the EQ-5D-5L valuation set created for the Korean population in
2014 [20,21].
https://doi.org/10.4048/jbc.2023.26.e29 437
EuroQol-5D Index in Patients With Metastatic Breast Cancer

Study participants and procedures

A total of 298 female patients with MBC were recruited from two tertiary hospitals in Seoul,
Korea, between September and October 2014. Only patients who agreed to participate in
the study and signed an informed consent form were surveyed to measure their HRQOL and
its influence on sociodemographic, economic, and educational characteristics. Most of the
patients included in the survey were outpatients, and only six were inpatients. They were
interviewed in person by three pre-trained nurses during medical visits or hospitalizations.
Survey guidelines were created to instruct the interviewers about the interview process and
eliminate deviations.

Patient medical records were reviewed to collect clinical information on metastatic lesions,
adverse events associated with treatment, type of treatment in the preceding four weeks,
and disease progression status. Patients with MBC were classified in terms of PFS and
progression state, as assessed by a doctor. PFS was further classified into responsive and
stable phases on the basis of response evaluation. These two health states are frequently used
in pharmacoeconomic studies of cancer drugs [15-17]. The physician in charge determined
the patients’ Eastern Cooperative Oncology Group Performance State (ECOG-PS) score,
which is widely used to assess the functional performance status of patients [22].

Statistical analyses
We analyzed the distribution of the patients’ sociodemographic and clinical characteristics. We
then calculated the EQ-5D index according to the clinical condition of the patients with MBC
and compared the means by using the Kruskal-Wallis test. Multiple regression analyses were
also conducted to assess the effect of sociodemographic factors and clinical conditions on the
EQ-5D index. Three regression models were used to identify the factors affecting HRQOL by
classifying treatment types, adverse events, and sociodemographic factors. Model 1 included
clinical status and treatment as independent variables, Model 2 included adverse events and the
variables in Model 1, and Model 3 explored the effects of sociodemographic factors.

The EQ-5D index scores ranged from zero to one and did not follow a normal distribution.
Thus, we applied a beta distribution to the multiple regressions. The beta distribution is a
very flexible starting point because it allows for the modeling of data that are left and right
skewed and have heteroscedastically distributed outcomes [23]. The beta regression model
was shown to be superior to alternative regressions in previous HRQOL studies, and the
logit function has been commonly used as a link of choice [24,25]. Three regression models
were analyzed to demonstrate the differential effects of the independent variables. Model
1 included only clinical characteristics as independent variables, Model 2 included adverse
events and the variables in Model 1, and Model 3 included socioeconomic characteristics.
Statistical analysis was performed using Stata Statistical Software Release 17 (StataCorp LLC,
College Station, USA).

Ethical approval
This study was approved by the Institutional Review Boards (IRBs) of two tertiary hospitals
in Seoul (IRB No. 2014-08076 and 2014-0875). Informed consent was obtained from all
participants in the study.

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EuroQol-5D Index in Patients With Metastatic Breast Cancer

RESULTS
Among the 298 patients surveyed, 71.47% were in their 40s and 50s, and 78.86% had attained
a high school or higher education level. Among the respondents, 75.17% were married or
living with someone, 82.88% were either unemployed or homemakers, and 38.58% earned
more than USD 4,000 in family income per month (Table 1). The ECOG-PS ranged from

Table 1. General characteristics of study subjects

Variable Value
Female 298 (100.00)
EQ-5D index score 0.79 ± 0.13
Age (yr) 52.31 ± 9.50
Age (yr)
20–39 24 (8.05)
40–49 96 (32.21)
50–59 117 (39.26)
60 and older 60 (20.13)
Unknown 1 (0.34)
Marital status
Never married 34 (11.41)
Married/cohabitating 224 (75.17)
Widowed/divorced/separated 40 (13.42)
Education
Secondary school graduate or less 63 (21.15)
High school graduate 137 (45.97)
College graduate or higher 98 (32.89)
Family income monthly ($)
< 2,000 83 (27.85)
2,000–3,999 100 (33.56)
4,000–5,999 58 (19.46)
6,000–7,999 31 (10.40)
≥ 8000 26 (8.72)
Employed
Yes 51 (17.11)
No 247 (82.88)
Sleep difficulty
Yes 119 (39.93)
No 179 (60.07)
Mastectomy
Yes 219 (73.49)
No 79 (26.51)
Chronic diseases*
Yes 112 (37.97)
No 186 (62.03)
ECOG-PS
0 94 (37.60)
1 150 (60.00)
2 6 (2.40)
Unknown 48 (16.11)
Disease progression
PFS-responsive 93 (31.21)
PFS-stable 155 (52.01)
Progressive state 50 (16.78)
Adverse event
Febrile neutropenia 27 (9.06)
Diarrhea or vomiting 50 (16.78)
Hand-foot syndrome 168 (56.38)
Stomatitis 80 (26.85)
Fatigue 170 (57.05)
Hair loss 100 (33.56)
(continued to the next page)

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EuroQol-5D Index in Patients With Metastatic Breast Cancer

Table 1. (Continued) General characteristics of study subjects

Variable Value
Type of treatment
Chemotherapy 210 (70.47)
Hormonal therapy 82 (27.52)
Targeted therapy 76 (25.50)
None 9 (3.02)
Unknown 4 (1.34)
Metastatic area
Bone 151 (51.19)
Liver 73 (24.75)
Lung 102 (34.58)
Lymph 153 (51.86)
Pleura 25 (8.47)
Brain 21 (7.12)
Skin 12 (4.07)
Other 36 (12.20)
Unknown 3 (1.01)
Values are presented as number (%) or mean ± standard deviation.
EQ-5D = EuroQol-5D-5L; ECOG-PS = Eastern Cooperative Oncology Group Performance Status; PFS = progression-
free survival.
*Any illness lasting more than 3 months.

zero to one for most patients: 37.60% were fully active, with a score of zero, and 60.00% had
experienced restrictions in physically strenuous activity but were ambulatory, with a score of
one. Only 2.40% of the patients had an ECOG-PS score of two, thus indicating that they were
capable of self-care but were unable to perform any work activities. Most patients (83.22%)
had PFS, and the remaining 49 patients were in a progressed state. Among the patients with
PFS, 31.21% and 52.01% were in responsive and stable states, respectively. Most patients
(70.47%) received chemotherapy, and 27.52% and 25.50% were treated with hormonal
and targeted therapies, respectively, either as monotherapy or in combination. Among the
patients, 84.90% experienced one or more adverse events in the previous four weeks, with
fatigue (57.05%) and hand–foot syndrome (56.38%) being the most common. Lymph nodes
(51.86%) and bones (51.19%) were the most frequent sites of metastasis.

The EQ-5D index was summarized according to the clinical status of the patients with MBC
(Table 2). The mean score for the total sample of patients was 0.79. The mean score was
significantly higher in patients with PFS than in those in the progressed state (0.80 vs. 0.73, p
= 0.0002). Within PFS, patients in the responsive phase had higher HRQOL than those in the
stable phase; however, the difference was not significant (0.82 vs. 0.79). Patients who received
chemotherapy had significantly lower HRQOL than those who received hormonal or targeted
therapy (p = 0.0020). In addition, an increase in the number of adverse events and higher
ECOG-PS scores were significantly associated with a lower HRQOL (p = 0.0001 for both).

Regression Model 1 showed that HRQOL was negatively associated with older age (p =
0.025), chemotherapy (p = 0.034), and progressed state (p = 0.005; Table 3). In Model 2,
chemotherapy no longer had a negative effect on HRQOL. However, adverse events, such
as hair loss (p = 0.056) and stomatitis (p = 0.084), were negatively associated with HRQOL.
Other adverse events, mastectomy, and duration of illness from diagnosis appeared to
decrease the HRQOL but at a statistically insignificant extent. Model 3 showed that HRQOL
increased significantly when household income was USD 8,000 or more compared with USD
2,000 (p = 0.042) and when the patient with MBC was employed (p = 0.003).

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EuroQol-5D Index in Patients With Metastatic Breast Cancer

Table 2. Quality of life according to the clinical condition of metastatic breast cancer
Variable No. Mean ± SD p-value
All patients 298 0.79 ± 0.13
Disease progression 0.0002
Progression-free survival: responsive 93 0.82 ± 0.10
Progression-free survival: stable 155 0.79 ± 0.12
Progressive state 50 0.73 ± 0.19
Type of therapy within one month 0.0020
Chemotherapy only 134 0.76 ± 0.145
Hormonal therapy only 54 0.82 ± 0.10
Targeted therapy only 15 0.85 ± 0.07
Chemotherapy & hormone 21 0.83 ± 0.05
Chemotherapy & target 54 0.81 ± 0.10
Target & hormone 6 0.82 ± 0.05
Chemotherapy & hormone & target 1 0.68
Number of adverse events 0.0001
≤2 178 0.81 ± 0.11
≥3 120 0.75 ± 0.15
ECOG-PS 0.0001
0 94 0.85 ± 0.06
1 150 0.76 ± 0.13
2 6 0.46 ± 0.32
SD = standard deviation; ECOG-PS = Eastern Cooperative Oncology Group Performance Status.

Table 3. Factors affecting quality of life of patients with metastatic breast cancer
Variable Reference (if categorical) Model 1 Coefficient Model 2 Coefficient Model 3 Coefficient
Age (yr) −0.009** −0.008** −0.005
Progressive state Progression-free survival −0.271*** −0.288*** −0.254***
Chemotherapy Other treatment −0.178** −0.081
Duration of illness from diagnosis (mon) −0.031 −0.026
No surgery† −0.067 −0.063
Hair loss No hair loss −0.156*
Stomatitis No stomatitis −0.147*
Diarrhea or vomiting No diarrhea or vomiting −0.154
Neutropenia No neutropenia 0.105
Hand-foot syndrome No hand-foot syndrome −0.062
Family monthly income $2,000–$3,999 < $2,000 0.053
Family monthly income $4,000–$5,999 < $2,000 0.009
Family monthly income $6,000–$7,999 < $2,000 −0.009
Family monthly income ≥ $8,000 < $2,000 0.259*
College graduate or higher High school graduate or less 0.079
Employed Unemployed 0.312***
Married or cohabitating Other marital status 0.079
Akaike information criteria (−488) (−491) (−490)
Bayesian information criteria (−462) (−447) (−450)
*p < 0.1, **p < 0.05, and ***p < 0.01.
†
Any surgery regardless of duration from surgery to survey.

DISCUSSION
This study found that the HRQOL of patients with MBC was the highest in the responsive
phase of PFS and decreased as the disease progressed. However, the difference in the EQ-5D
indices between health states was small, with a maximum value of 0.09. The current study
showed a higher quality of life than a previous study (0.79 vs. 0.71 for the stable state, 0.82
vs. 0.78 for the responsive phase, and 0.73 vs. 0.44 for the progressed state) conducted in
the United Kingdom [26]. Lloyd et al. [26] interviewed the general population by using the
standard gamble to determine the health state utility with hypothetical health scenarios
developed to describe the health states of MBC and adverse events occurring in patients.

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EuroQol-5D Index in Patients With Metastatic Breast Cancer

The HRQOL reported by the patients with advanced MBC differed from that measured by
using a hypothetical scenario. Usually, patients report a higher quality of life than the general
population for the same health condition [27] because as patients adapt to their illness, they
take it less seriously than the general population who have not experienced the illness [28]. In
the current study, patients in the progressed state of MBC rated their HRQOL slightly lower
(0.09) than those in the treatment response stage. Patients evaluate and respond to their
overall health condition; however, the general population is likely to regard the disease as
described in the scenario without an accurate understanding of the disease. Consequently,
non-patients tend to perceive the disease more seriously than patients.

A few studies have measured the quality of life of patients with MBC in Korea, but most
have used disease-specific instruments [29,30]. A study that developed eight hypothetical
health states and measured them in the general population by using a preference-based
measurement, namely, the standard gamble, reported a quality of life of 0.352 for MBC [31].
South Korea uses economic evaluations to assess the value of new drugs when deciding
whether to reimburse patients. In this case, a generic instrument that reflects preferences
is used to measure quality of life, and the EQ-5D is the most commonly used instrument
recommended by the National Institute for Health and Care Excellence in the UK. However,
no study has used the EQ-5D to measure quality of life in Korean patients with MBC.

The HRQOL of a patient may depend on the type of treatment administered. Adamowicz and
Baczkowska-Waliszewska [32] reported that the quality of life measured using the EORTC-
QLQ30 was lower in the chemotherapy group than in patients receiving targeted therapy or
hormonal therapy. Women receiving hormone therapy reported fewer severe systemic side
effects than those treated with chemotherapy [32]. Schleinitz et al. [33] investigated the
HRQOL of women ≥ 25 years old by using the time trade-off method and reported that the
mean HRQOL score was higher in patients treated with hormone therapy than in those treated
with chemotherapy (0.54 vs. 0.48). In the current study, HRQOL was the highest among
patients receiving only targeted therapy (0.85) and the lowest among patients receiving only
chemotherapy (0.76); hormonal therapy was lower than targeted therapy (0.82).

Model 1 showed that chemotherapy was significantly associated with decreased HRQOL
in patients with MBC. However, when chemotherapy-related adverse events were added
as independent variables in Model 2, the significance of chemotherapy disappeared, and
chemotherapy-induced adverse events, such as hair loss and stomatitis, were significantly
associated with lower HRQOL. These findings suggest that adverse events are an important
cause of compromised HRQOL in patients undergoing chemotherapy. The relationship
between HRQOL and diarrhea/vomiting was not statistically significant; however, the EQ-5D
scores for these events were as low as those for hair loss.

Several studies have reported the effect of sociodemographic factors on the quality of life
of patients with MBC. Eljedi and Nofal [34] reported that patients who were employed and
had higher education and income levels were more likely to have higher HRQOL scores.
Other studies reported that financial difficulties significantly aggravate the quality of life of
patients with breast cancer [35-37]. The current study found that the effect of income was
significantly positive only in the highest income group, and this finding may be primarily due
to the benefits provided to patients with cancer by the national healthcare system. In Korea,
cancer patients pay a co-payment rate of 5%, with a cap on the annual burden associated with
cancer treatment, according to income. Although more than 60% of the patients surveyed

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EuroQol-5D Index in Patients With Metastatic Breast Cancer

in our study had a monthly household income of less than USD 40,000 and considering
that the respondents’ income levels were evenly distributed, economic levels might not have
significantly affected the results, except for those in the highest group.

Previous studies have shown that higher education [37] and employment [35] are predictors
of quality of life. However, employment alone was a significant predictor. Marital status was
not significantly associated with quality of life in our study, and this finding is consistent with
the results of a previous study [34].

Each regression model revealed that several factors affected the HRQOL of patients with
MBC. Among the clinically important factors, disease progression had the greatest effect on
the quality of life, and chemotherapy also resulted in a significant decrease.

This study had several limitations. First, the study included only six patients with an ECOG-
PS of two who were hospitalized because of a severe condition, and it was difficult to
interview them because of their critical condition. Generally, patients with progressive MBC
have an ECOG-PS score of zero or one when receiving outpatient treatment. Nonetheless,
the quality of life in advanced stages may have been slightly overestimated. Second, because
adverse events were not collected separately for each drug administered, it was not possible
to directly confirm the effect of adverse reactions according to treatment or to report the
effect of individual adverse reactions on the quality of life. Third, the treatment paradigm
for patients with MBC has changed significantly since our study with the adoption of new
targeted therapies and immunotherapies (e.g., cyclin-dependent kinase 4/6 inhibitors,
human epidermal growth factor receptor 2 inhibitors, and programmed death ligand 1
inhibitors). This change in treatment type may affect the patients’ quality of life. Our study
showed that HRQOL differed according to the therapy type (Table 2). Further studies are
needed to investigate the effects of these new drugs on the HRQOL.

This study found that disease progression, chemotherapy, and adverse events led to poor
HRQOL in patients with MBC. HRQOL differs depending on the clinical condition, and
several sociodemographic factors independently affect HRQOL. This study provides insights
that are useful for medical professionals who are treating patients and economic analysts
who are performing cost–utility studies.

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