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Page 45
allied
academies
February 25-26, 2019 | Paris, France
13
th
World Cancer Congress
Journal of Medical Oncology and Therapeutics | Volume 4
Comparison of adverse drug reactions and health related quality of life in Triple Negative Breast Cancer
patients treated with AC-Taxane+carboplatin Vs AC-Taxane regimen: A prospective cohort study
Mrs Faheema Nafees
Treatment in Breast Cancer, UAE
A
nthracycline-Taxane containing regimen is the standard
treatment for curative breast cancer chemotherapy
from last two decades. Recent evidences showed improved
efficacy when platinum compounds added to Anthracycline-
Taxane containing regimen in any clinical setting (neoadjuvant,
adjuvant and metastatic) for treating Triple Negative Breast
Cancer (TNBC). But safety data on each regimen in TNBC is
limiting although established data available on individual drug
only. A crucial factor is to understand the impact of therapy
on Quality of Life (QoL) of patients as it is influenced by every
step of the treatment. In this prospective, cohort questionnaire
based study, we evaluated whether ADRs and QoL from 2
different chemotherapy regimens differed in patients with
triple negative breast cancer.
The study was conducted in the Dept. of Radiotherapy, Govt.
Medical College, Calicut, India over a period of 8 months from
January 2017 to August. Patients with TNBC who satisfied
eligibility criteria were selected and divided into 2 groups based
on their chemotherapy regimen. The patients who received
Adriamycin and Cyclophosphamide (AC) followed by docetaxel
(T) were assigned to group AC-T and those who received AC
followed by docetaxel and carboplatin (Cb) were in group AC-
TCb. List of ADRs were prepared using Cancer Care Ontario
(CCO) drug formulary list. ADRs documented either from the
patients or from their laboratory reports were graded as per
NCI CTCAE guidelines. QoL mean scores were analyzed using
EORTC QLQ C30 and EORTC QLQ BR23 questionnaires filled up
by the patients during the study. Statistical analysis were done
using PASW statistics 18, version 2009.
Data of 81 TNBC patients were collected in which 29 (35.8%)
patients received AC-T and 52 (64.2%) AC-TCb regimens.
Mean age of AC-T was 50.28±9.071 and 49.87±9.30 years
for AC-TCb. Among thirteen system organ classification
studied, ADRs in dermatological system, gastrointestinal (P
value=0.644), cardiovascular (P value=0.131), ophthalmological
(P value=0.533), neurological (P value=0.904), musculoskeletal
(P value=0.066), auditory (P value=0.452), psychological (P
value=0.303), hematological (P value=0.753), administration
site (P value=0.252), respiratory (P value=0.094), were
statistically insignificant. A statistically significant difference in
ADRs under general disorders was confirmed among different
chemotherapy regimens and confined to AC-TCb regimen (P
value=0.011). Hand-foot syndrome, grade 3 was present in 1
subject from AC-T and 1 from AC-TCb; 1 subject from AC-T with
grade 4. Vomiting, grade 4 type was present for one subject
from AC-TCb. Constipation, grade 3 type was present for one
subject from AC-TCb. Mucositis grade 4 type was observed
from one subject each in AC-T and AC-TCb. Diarrhea, grade
3 was reported from a subject receiving AC-TCb. Although
hematological reactions were a few, most of them belongs to
grade 3/4. Anemia, grade 3/4 was reported in 1 from AC-T, 1
from AC-TCb.
Febrile neutropenia, grade 3/4 was observed in 4 subjects from
AC-T and 5 fromAC-TCb. 10 subjects fromAC-T and 12 fromAC-
TCb had neutropenia, grade 3/4. 9 subjects from AC-T, 8 from
AC-TCb had insomnia, grade 3/4. One subject from AC-T had
hearing impaired, grade 4.
QoL mean score was insignificant among the regimen. Among
EORTC QLQ C30 functional scale, emotional, cognitive and
social domains shows significant difference; higher mean
scores were observed for subjects receiving AC-TCb for all these
three {(62.7, P = 0.046), (74.3, P=0.000) and (66.02, p=0.010)
respectively}. Higher functional scale score indicates better
functioning and quality of life. Among EORTCQLQC30 symptom
scale, a significant difference in the mean scores were observed
in dyspnea and constipation domains; for both, the higher
mean scores were reported for subjects receiving AC-T {(35.6,
P = 0.001) and (48.7, P=0.046) respectively}. Higher symptom
score indicates poor quality of life. All the domains from both
functional and symptom scale in EORTC QLQ BR 23 found to be
insignificant among the groups.
Both regimens were tolerated by the subjects reasonably very
well with majority of adverse effects were mild. Severe (Grade
3 or 4) adverse effects were rare. In our study ADRs from two
different taxane based chemotherapy regimens were observed
statistically insignificant except in general disorders while
QoL, functional domains of breast and disability due to breast
symptoms were independent of the chemotherapy regimens
showing that no regimen is superior to another. On the other
hand, three variables from the functional and two from
symptom scale indicate carboplatin based chemotherapy is
better in TNBC compared to taxane alone. The major limitation
of this study was the small sample size and shorter duration.
Amore comprehensive study with a greater number of patients
is required to get more conclusive results.
e:
faheemakandoth@gmail.com