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Critique
by:
Kathleen
I.
Pritchard,
M.D.
Head,
Clinical
Trials
and
Epidemiology,
Professor,
Department
of
Medicine
Toronto-Sunnybrook
Regional
Cancer
Centre.
Intended
Audiences:
Oncology
clinicians
In
Conversation
with:
For
the
Canadian
Eprex
Study
Group
Jose
Chang,
Durham
Regional
Cancer
Centre,
Oshawa,
Ontario;
Félix
Couture
Hôtel-Dieu
de
Lévis,
Lévis,
Québec
and
Hôtel-Dieu
de
Québec,
Quebec
City,
Québec
A
study
demonstrating
that
once
weekly
Epoetin
Alfa
maintains
hemoglobin,
improves
Quality
of
Life
and
Reduces
Transfusion
in
Breast
Cancer
Patients
Receiving
Chemotherapy
J.
Chang(1),
F.
Couture(2) for
Canadian
Eprex
Study
Group
(1)
Durham
Regional
Cancer
Centre,
Oshawa,
Ontario
(2)
Hôtel-Dieu
de
Lévis,
Lévis,
Québec
and
Hôtel-Dieu
de
Québec,
Quebec
City,
Québec
Abstract:
Epoetin alfa (E) has been shown
to significantly increase
hemoglobin (Hb), reduce transfusion
and improve quality of life
(QOL) in anemic cancer patients.
An open-label randomized
study to evaluate the efficacy
of epoetin alfa 40,000 IU
once-weekly (QW) for 16 weeks
versus Best Supportive Care
(BSC) in preventing anemia,
reducing transfusions and
improving QOL in 350 breast
cancer patients was recently
completed (Interim analysis
of 110 patients presented
at ASCO 2002). The baseline
characteristics (N=174 for
E and N=176 for BSC) including
baseline Hb level [E = 11.16±0.85
g/dL; BSC = 11.23±0.77
g/dL, P=0.41], disease status
(Adjuvant: E= 75.3%,BSC =74.4%;
Metastatic: E = 19.5%.BSC
= 22.7%, P=0.56), chemotherapy
administered mainly (CEF:E=48.24%,
BSC = 49.43; CMF: E=8.62%,
BSC = 10.80%), FACT-An scores
[E = 54.3±14.68; BSC
= 53.9±13.44, P=0.79]
and Cancer Linear Analogue
Scale (CLAS) [overall QOL:
E = 61.5±25.10;BSC
= 62.2±24.46, P=0.784]
were balanced between the
2 groups.
A
interim
review
of
261
patients
(E=131,
BSC=130)
identified
a
statistically
significant
(P<.0001)
increase
in
Hb
at
week
12
(E=12.33 ±1.4
g/dL
and
BSC
=
10.71 ±11.66
g/dL)
and
a
significant
improvement
in
CLAS
and
reduction
in
the
incidence
of
transfusion
shown
below:
Change
from baseline to week 12 (primary
evaluation time point) |
| Hematologic
responses |
Epoetin
alfa (n=131) |
BSC
(n=130) |
P-value |
| %
Hb response1 |
52 |
6 |
<0.001 |
| %Transfusion |
6.9
(n=9) |
24.02
(n=32) |
0.0001 |
| QOL(CLAS) |
|
|
|
| -
Energy |
3.25 ±27.10 |
-3.98 ±31.90 |
0.050 |
| -
Daily activity |
3.42 ±27.30 |
-3.20 ±30.64 |
0.066 |
| -
Overall QOL |
4.02 ±28.19 |
-3.98±27.26 |
0.020 |
|
|
|
|
1Mean
AUC >12
g/dL wk 4 - wk 12
These
results suggest early administration
of epoetin alfa maintains hemoglobin,
significantly reduces transfusion
rate and improves QOL in breast
cancer patients receiving chemotherapy.
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