Assessment of Adverse Events and Quality of Life of Cancer

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VA L U E I N H E A LT H R E G I O N A L I S S U E S 2 ( 2 0 1 3 ) 1 0 3 – 1 0 6
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/vhri
Assessment of Adverse Events and Quality of Life of Cancer Patients in a
Secondary Level Care, Rural Hospital in South India
S.K.R. Sowmya, PharmD1, Dixon Thomas, MPharm, MS, PhD1,*, Seeba Zachariah, MPharm, PhD1, Alexander Daniel Sunad, MS,
FAIS, FICS2
1
Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education & Research, Anantapur, AP, India; 2RDT Hospital, Bathalapalli,
Anantapur, AP, India
AB ST RAC T
Objective: To grade adverse events (AEs) occurring after chemotherapy in the cancer patients and to explore the quality-of-life (QOL)
findings among posttherapy cancer patients in a rural, secondary level
care Indian hospital. Methods: A cross-sectional study was carried
out during a 6-month period in a rural secondary level care hospital
situated at Anantapur district in South India. Patient and cancer
demographics were collected from the cases treated in the study site.
The European Organization for Research and Treatment of Cancer
Quality of Life Questionnaire-C30 v 3.0 Telugu (regional language of
the study site) module and Common Terminology Criteria for Adverse
Events v 4.0 of Cancer Therapy Evaluation Program, USA, were used to
assess the QOL and severity grades of AEs, respectively. Results: Most
AEs were mild or moderate, with only a few being severe. Insomnia
(27.98%), nausea (13.50%), vomiting (12.81%), fatigue (10.90%), and
pain (11.68%) were common, with insomnia being the most frequent.
The different scores of the QOL scale (functional, symptomatic,
financial, and global health status scores) were assessed independently. Among the functional scale parameters, the cognitive and
physical functioning scores were good (85.14 and 82.79, respectively)
and the social, emotional, and role functioning scores were moderate
(77.94, 72.30, and 71.65, respectively). The overall effect of symptoms
on QOL showed that the pain score was higher and interfered to a
higher extent in patients (36.02) and the dyspnea score was the least
and occurred to a lesser extent (7.20). But certain variables such as
anorexia, for example, showed a greater interquartile range and SD,
which implied that it gave a lesser chance for the prediction of results
for that particular condition. Financial burden existed to a moderate
level on an average in all the patients. Conclusions: The occurrence
and severity of AEs was low, indicating that the patients tolerated and
responded well to therapy. The survivorship is yet to be estimated and
the life expectancy to be studied by further investigation of the subjects.
Keywords: adverse events, chemotherapy, CTCAE, EORTC-QLQ C30,
QOL.
Introduction
chemotherapy have been described, namely, induction, consolidation/intensification, adjuvant, neoadjuvant, maintenance,
salvage, and combination chemotherapies. Combination chemotherapy is usually preferred to outweigh risk-benefit ratios and
maintain the QOL of patients [6].
The most common and important complications of chemotherapy include the following:
Cancer is a leading cause of death around the globe and
accounted for 7.6 million deaths (13% of all deaths) in the year
2008. Cancer is a disease with significant chances of reduction in
quality of life (QOL) [1]. Cancer cells may invade nearby tissues,
and they may spread through the bloodstream and the lymphatic
system to other parts of the body [2]. Spread of cancer and
affected normal functioning of organs may eventually lead to
death. Many of the cancers can be cured by surgery, radiotherapy,
and/or chemotherapy, especially if detected early. Treatment is a
sequential process of interventions, including psychosocial support, surgery, radiotherapy, chemotherapy, and palliative care
that aim at curing the disease or considerably prolonging life
expectancy besides improving the patient’s QOL [3]. Protocols for
the treatment of various types of cancers are available from
different agencies with respect to the increase in QOL [4,5]. Based
on the time of administration of chemotherapy, various types of
Copyright & 2013, International Society for Pharmacoeconomics and
Outcomes Research (ISPOR). Published by Elsevier Inc.
Gastrointestinal complications such as mucositis, xerostomia,
constipation, diarrhea, and nausea and vomiting.
Hematological complications including anemia, neutropenia,
and thrombocytopenia.
To prevent and manage these complications induced by
chemotherapy or radiation, supportive care agents are administered [7].
QOL is a ubiquitous concept that has different philosophical,
political, and health-related definitions and can be broken down
Conflict of Interest: The authors have indicated that they have no conflicts of interest with regard to the content of this article.
Address correspondence to: Dixon Thomas, Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education &
Research, Chiyyedu Post, Anantapur, AP 515721, India.
E-mail: [email protected]
2212-1099/$36.00 – see front matter Copyright & 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.vhri.2013.01.011
104
VA L U E I N H E A LT H R E G I O N A L I S S U E S 2 ( 2 0 1 3 ) 1 0 3 – 1 0 6
Table 1 – Status of patients diagnosed with cancer.
Treatment stage
Number of patients
Just diagnosed
Surgery done
Chemotherapy taken
Dead
18
42
38
8
Table 2 – Types of cancers among the total study
population.
S. No.
conceptually into physical, emotional, and social concerns. Physical concerns vary largely on the basis of an individual’s response
to the treatment, with eminent problems of concern being
fatigue, pain, and so on [8]. Emotional concerns mainly include
depression and fear of death. Social concerns include family,
societal, and spiritual issues. The subjects may experience none,
some, or all of the above-mentioned concerns, but the extent to
which these concerns affect a subject is purely individualized [9].
QOL has been used in cancer clinical trials for evaluation in the
past. In 1990, the National Cancer Institute in the United States
began applying QOL measures to compare treatments, and also
to serve as a measure of end point in cancer clinical trials;
identify side effects and consequences of cancer treatment to
assess rehabilitation needs; and predict response to future treatment [10].
Some of the commonly used performance status measurement scales are as follows:
1. The Karnofsky Performance Index
2. European Organization for Research and Treatment of Cancer
(EORTC) Modular Approach
3. The World Health Organization Functional Scale
4. The Zubrod Scale (or the Eastern Cooperative Oncology Group
Performance Status Rating Scale) [11].
The study was planned to grade the adverse events (AEs) and
to explore the findings of QOL in posttherapy cancer patients in
rural India.
1
2
3
4
5
6
7
8
9
10
Type of cancer
Number of patients
Breast
Colon
Stomach
Ovary
Cervix
Rectum
Esophagus
Penis
Vulva
Buccal mucosa
15
12
11
10
8
6
5
1
1
1
from the study because of difficulties in the assessment of this
patient group by using the current tools. To evaluate the QOL of
the subjects prone to cancer, the EORTC Quality of Life Questionnaire (QLQ)-C 30 v 3.0 Telugu module (local language) [12,13]
was used. The Telugu-translated module was available from the
EORTC, which was validated by the publisher. The severity of AEs
experienced by the patients was measured by using the Common
Terminology Criteria for Adverse Events (CTCAE) v 4.0 of Cancer
Therapy Evaluation Program, USA [14], to grade AEs. The severity
has been differentiated from grades 1 to –5, indicating that the
events may be mild, moderate, severe, life-threatening, or fatal.
Insomnia was the most common event with 18 mild, 14 moderate, and 9 severe effects of the event. The average of the obtained
grades was taken, and the percentages were calculated for
individual AEs. The selected tools are commonly used in the
QOL studies in cancer. The subjects were informed and given a
verbal explanation about the study being conducted by the
pharmacist, and an oral consent was obtained before taking the
interview. The study was approved by the institutional review
board. The QOL questionnaire was filled by the pharmacy intern
while chemotherapy was being given. The data analysis was
done as mentioned in the guidelines of the QLQ.
Methods
A cross-sectional study for a duration of 6 months in 2011 was
conducted at a rural secondary level care hospital in India.
Patients with cancer of various types and sites attending the
departments of general surgery and gynecology were included.
Patients received chemotherapy both as inpatient and as an
ambulatory patient. The pediatric patient group was excluded
12
Results
A total of 70 subjects were studied including 47 women and 23
men. The cases obtained were segregated and are tabulated on
the basis of the stage of treatment in Table 1.
Number of paents with chemotherapy cycles
10
8
6
Number of paents
4
2
0
6 cycles
5 cycles
4 cycles
3 cycles
2 cycles
1 cycle
Fig. 1 – Patients on chemotherapy cycles.
105
VA L U E I N H E A LT H R E G I O N A L I S S U E S 2 ( 2 0 1 3 ) 1 0 3 – 1 0 6
Table 3 – Number of adverse events experienced by
patients with grades.
Adverse event
Nausea (13.50%)
Vomiting (12.81%)
Fatigue (10.90%)
Dyspnea (0.37%)
Pain (11.68%)
Insomnia (27.98%)
Anorexia (4.90%)
Constipation (7.16%)
Diarrhea (6.03%)
Grades
1
2
3
4
5
1
6
11
1
6
18
1
3
2
15
14
6
0
8
14
6
5
7
1
0
2
0
3
9
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Of those patients, 10 were referred to higher centers to receive
treatment; of the remaining 60 patients, 18 were just diagnosed
but not advised for surgery or chemotherapy. Among the remaining 42, all the patients underwent surgery for cancer and 38
patients who underwent surgery received chemotherapy. Of all
the patients, 8 patients were not dead at the time of study
closure.
The center was treating solid cancers only. We do not have data
on the other types of cancer diagnosed, if any. The study population had one or more of the cancer(s) mentioned in Table 2.
Among all the patients who were diagnosed with cancer, only
39 patients received chemotherapy as a part of their treatment.
During the study period, the patients were at different stages of
therapy. Considering both male and female patients together, the
number of cycles taken by them during the study period has been
noted, as shown in Figure 1. The remaining 32 patients did not
receive any chemotherapy as a part of their treatment and are in
the process of treatment or to be referred to higher centers.
Dyspnea was the least experienced effect and was found to be
mild in only one patient. A complete description of the grading of
different AEs is given in Table 3. None of the events was either
life-threatening or fatal. All possible neutropenia was treated
with filgrastim.
Insomnia was found to occur at a higher percentage followed
by nausea, vomiting, pain, and so on.
Using the EORTC QLQ-C30 v 3.0 module, the QOL was measured for the patients who underwent surgery, chemotherapy, or
both. The module contained a functional scale that included
physical, role, emotional, cognitive, and social functioning and a
symptomatic scale that included symptoms such as nausea and
vomiting, fatigue, dyspnea, pain, insomnia, anorexia, constipation, and diarrhea. The scores of 38 patients were taken, omitting
one patient because of death in the study period. More details are
given in Table 4.
Upon calculation of individual’s raw scores from using the
QOL questionnaire, the individual scores were obtained by substituting the raw scores in the formula given. By applying
descriptive statistics, we obtained the mean, SD, median, and
the interquartile range of the data sets of 37 patients whose QOL
data were taken.
Of all the functional scale parameters, the cognitive and
physical functioning scale parameter was found to be better
compared with the remaining functional scale parameters. Of
all the symptomatic scale parameters, dyspnea and constipation
symptoms were least in all the patients. But the parameters with
a greater interquartile range and SD were not predictable and
varied depending on the individual’s disease status.
Of the 70 subjects included, a few had existing comorbidities
such as diabetes and ascites, and many had financial deficit, due
to which some subjects were not able to attend their scheduled
chemotherapy cycles. It was reported by some patients that the
AEs were much severe when the maintenance medications were
not taken, especially after 20 days of chemotherapy. Postchemotherapy complications, that is, febrile neutropenia and afebrile
neutropenia, were also evident in patients who had completed
the entire course of chemotherapy, although they were seen even
during the course after 1 week of therapy when the subjects
came for a routine checkup and were treated with filgrastim.
Discussion
Of the total patients diagnosed, the number of male patients was
less compared with the number of female patients. But literature
has suggested that men suffer from higher rates of cancer than
do women of all cancer sites worldwide [15]. Contrary to this, the
World Health Organization India office has shown that the
prevalence and incidence rates are higher in females than in
males in India [16]. Of all types of cancer, breast cancer was
found to occur at a higher incidence compared with other cancer
types in women. The main reason for the occurrence of cancers
at a higher rate would have been the poor lifestyle and poor
hygiene although the genetic factors need to be studied further.
The study population aged 40 to 50 years was the group with
higher incidences of cancers. It may be by chance, or further
Table 4 – Functional, symptomatic parameters of QOL scores.
Parameters
Physical functioning
Role functioning
Emotional functioning
Cognitive functioning
Social functioning
Nausea and vomiting
Fatigue
Dyspnea
Pain
Insomnia
Anorexia
Constipation
Diarrhea
IQR, interquartile range; QOL, quality of life.
Mean ⫾ SD
Median
IQR
82.79649 ⫾ 18.1451
71.65703 ⫾ 26.84191
72.30946 ⫾ 21.432
85.14081 ⫾ 20.3313
77.94676 ⫾ 17.13806
23.87135 ⫾ 27.08485
31.79014 ⫾ 20.61103
7.20649 ⫾ 15.97511
36.02378 ⫾ 29.5326
30.62784 ⫾ 30.80797
23.42108 ⫾ 30.28862
8.1073 ⫾ 19.88256
15.31395 ⫾ 23.03132
86.66
83.33
75
100
83.33
16.66
33.33
0
33.33
33.33
0
0
0
80–93.33
50–100
62.53–87.53
83.33–100
66.66–91.7
0–50
11.11–44.44
0
16.66–58.33
0–66.66
66.66
0–0
33.33
106
VA L U E I N H E A LT H R E G I O N A L I S S U E S 2 ( 2 0 1 3 ) 1 0 3 – 1 0 6
associated factors, if any, need to be studied with different
objectives. Some of the patients were known cases of the disease
in the past, and some had a relapse of the disease. This was also
majorly seen in women than in men. According to UK statistics,
which has given cancer incidence by age, it is stated that 1 in 10
cancers is diagnosed in people aged 25 to 49 years. Almost twice
as many cases were diagnosed in women (an average of 20,054
per year) than in men (10,291) in this age group in the United
Kingdom during 2006 to 2008 (ratio of 2:1); this difference can be
attributed to the high incidence of breast cancer, which accounts
for around 45% of all cancers in females in this age group [17].
The patients were at different stages of chemotherapy in their
treatment at the end of the study period. The QOL interview was
done even though the status of chemotherapy was different.
Some patients had a good QOL even after the completion of their
course, and some suffered from AEs in the early stages of
chemotherapy itself. This was probably due to poor compliance
to therapy, insufficient dietary supplements, and poor lifestyle
among the patients, which need to be studied further.
The AE grading was done during the interview of QOL. Pain
and insomnia due to pain were high in patients who underwent
surgery. But, on the whole, the severity of insomnia was high
(27.98%). This was followed by nausea (13.50%), vomiting
(12.81%), pain (11.68%), and fatigue (10.90%). The other AEs that
occurred at a lesser severity were constipation (7.16%), diarrhea
(6.03%), anorexia (4.90%), and dyspnea (0.37%).
A huge variety of QOL scales have been designed by various
organizations. Of these questionnaires, EORTC-QLQ C30 version
3.0 is one of the most accepted tools. EORTC has provided a
separate questionnaire for each type of cancer, and it is available
in 48 languages. In the present study, we have not measured the
scores by using the specified QLQs because the number of cases
of each type was less. We have used the Telugu version of the
general questionnaire for all types of cancer.
The version of questionnaire used has included all the aspects
including the functional scales, symptomatic scales, effect of
treatment cost on the patient’s finances, and the global health
status measure. The availability of the Telugu version of this valid
tool was an advantage for the study.
Among the functional scale parameters, the cognitive and
physical functioning scores were good (85.14 and 82.79, respectively) and the social, emotional, and role functioning scores were
moderate (77.94, 72.30, and 71.65, respectively). The overall effect
of symptoms on QOL showed that pain score was higher and
interfered to a higher extent in patients (36.02) and dyspnea score
was the least and occurred to a lesser extent (7.20). But certain
variables such as anorexia, for example, showed a greater
interquartile range and SD, which implied that it gave a lesser
chance for the prediction of results for that particular condition.
The AEs experienced because of chemotherapy were common
and could be alleviated by certain interventions to certain levels.
Also, it is suggested that adherence to the full chemotherapy
course plan was an important aspect to improve the QOL in
cancer patients in the long run.
Conclusions
Overall frequencies and grades of AEs were low, indicating that
the patients tolerated and responded well to the therapy. Most
common AEs were insomnia, nausea, vomiting, pain, and fatigue.
QOL scores of patients undergoing chemotherapy were minimal
for all cancer types in general. The findings of the study were
only a representation of cancer treatment in a secondary level,
charitable hospital in South India. Future studies shall reveal
reasons for the reduction in QOL and effective management
strategies such as dietary and lifestyle modifications, exercise,
counseling, empowering, and adjuvant medication.
Source of financial support: The authors have no other
financial relationships to disclose.
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