Annals of Oncology 16: 915 – 922, 2005
doi:10.1093/annonc/mdi195
Published online 13 May 2005
Original article
Cost-effectiveness analysis of breast cancer adjuvant treatment:
FEC 50 versus FEC 100 (FASG05 study)
J. Bonneterre1*, C. Bercez2, M.-E. Bonneterre1, X. Lenne2 & B. Dervaux2
1
Centre Oscar Lambret, Lille; 2CRESGE, Lille, France
Received 29 June 2004; revised 20 September 2004 and 24 December 2004; accepted 20 January 2005
Published online 13 May 2005
Background: The aim of the study was to assess the incremental cost-effectiveness ratio (ICER) of
the FEC 100 compared with the FEC 50 in the FASG05 trial.
Materials and methods: A cost-effectiveness analysis was performed using a multi-state Markov
process model. Relevant clinical data introduced into the model were obtained from 10-year followup of the clinical trial FASG05. Survival curves for each health state were assessed by survival parametric model. The model allowed assessments from the start of adjuvant chemotherapy until death.
The costs of adjuvant treatment and follow-up were estimated. The costs of recurrence were evaluated from the medical records of 146 patients. A prospective survey was performed on a cohort of
87 patients to quantify the resources external to the hospital (including cost of transportation). The
inpatient costs were evaluated using the French diagnosis-related groups. The ambulatory costs were
assessed using the French nomenclature. Costs were expressed in 2002 Euro (e), according to the
French societal perspective. The ICER assessed the cost of one additional life year saved. A discount
rate of 5% per year was used for cost, and alternatively 0%, 3% and 5% for effectiveness. We validated the results with a probabilistic sensitivity analysis incorporating parametric and non-parametric
bootstraps, and with the acceptability curves.
Results: The mean total discounting cost of adjuvant treatments was 11 465e for FEC 50 and
13 815e for FEC 100; the mean total discounting cost of recurrences was 14 636e and 13 503e,
respectively. According to the discount rate of effectiveness, the life expectancy was 16.5, 11.4 and
9.3 years for FEC 50 and 18.4, 12.5 and 10.2 years for FEC 100. The ICER (cost per life year
saved) were 642e, 1084e and 1460e, respectively. The probability according to which FEC 50 is
strictly dominated by FEC 100 was 0.15.
Conclusion: The clinical benefit of FEC 100 generates a negligible cost increase when compared
with FEC 50.
Key words: adjuvant, breast cancer, cost, cost-effectiveness, FEC
Introduction
Breast cancer is the most frequent tumor in females in the
western world, with a lifelong risk of about one out of eight to
10 [1]. Breast cancer treatment generally combines surgery,
radiation therapy, hormone therapy in hormone-sensitive
tumors and chemotherapy. Adjuvant chemotherapy has been
recommended at several consensus conferences. Although the
recommendations are not entirely identical, adjuvant chemotherapy is frequently used. Its benefit is modest but highly significant, as described in the meta-analysis published in The
Lancet [2]. Short- and long-term toxicities may nevertheless
*Correspondence to: Dr J. Bonneterre, Centre Oscar Lambret, 3 rue
Combemale, BP 307, 59020 Lille cedex, France. Tel: + 33-320-29-55-50;
Fax: + 33-320-29-59-62; E-mail: [email protected]
q 2005 European Society for Medical Oncology
be high, as well as the cost of these treatments. Therefore,
the cost – benefit ratio of adjuvant chemotherapy needs to be
investigated.
There is no unique ‘reference’ protocol for adjuvant chemotherapy. The FEC 50 protocol is nevertheless considered to be
more effective than CMF-like regimens [3]. Moreover, the
FEC 100 regimen is associated with a higher disease-free
survival and overall survival than FEC 50 [4], the two protocols differing only in the epirubicin dose, which is respectively
100 and 50 mg/m2. These results on disease-free and overall
survival rates have also been confirmed after a median followup duration of 10 years [5]. Only one case of myeloblastic
leukemia was observed and long-term cardiotoxicity was
extensively studied on a subpopulation of patients who had not
relapsed after a minimum follow-up duration of 5 years [6]. To
our knowledge, no health-economic/pharmaco-economic study
916
on FEC 100 has been published so far. The aim of this study
was to assess the incremental cost effectiveness ratio (ICER) of
FEC 100 regimen given as adjuvant treatment of breast cancer
when compared with FEC 50.
Patients and methods
Local
recurrence
Good functional state
Death
Patients
Patients included in the analysis were those included in the clinical trial
comparing FEC 50 and FEC 100 (FASG05).
A total of 565 patients aged <65 years with more than three positive
axillary nodes, or between one and three but with another poor prognostic
factor (tumor diameter >3 cm, histoprognostic grade III, no estradiol nor
progesterone receptor), were randomized after curative surgery between
FEC 50 (fluorouracil 500 mg/m2, cyclophosphamide 500 mg/m2 and epirubicin 50 mg/m2) and FEC 100 (epirubicin 100 mg/m2 and the same dose
for the two other drugs) for six cycles [4].
Two former independent studies were also included in the analysis to
estimate outpatient costs and the cost of relapse.
Outpatient costs were assessed by a study based on the interview of 87
consecutive patients receiving adjuvant chemotherapy for breast cancer as
outpatients in the Centre Oscar Lambret. These patients were asked about
their medical expenses outside of the hospital during the last 4 months
(visits to a general practitioner, a nurse, radiographs, biological determinations, etc.) [7].
The medical files of 146 patients whose first relapse occurred between
1983 and 1990 were reviewed to estimate the cost of relapse. A metastatic
disease was the first relapse in 99 of them. The other 47 patients had a local
relapse. All the patients had at least a 5-year follow-up since the initial
diagnosis. For those patients with local relapse only, a follow-up duration
of at least 5 years after relapse was mandatory in order not to rule out a
disseminated disease in the years following the local relapse [8, 9].
Metastatic
Figure 1. The Markov model.
the three parameters (exponential, log-normal and gamma) allowing a
better adjustment to the observed clinical data. The generalized gamma
density function is written:
f ðtÞ ¼
b t kb21 t exp 2
b
u GðkÞ u
u
where u > 0 is the scale parameter and b > 0 and k > 0 are the shape
Ð þ1
parameters and G(x) is the gamma function GðxÞ ¼ 0 e 2u u x21 du:
The survival function also estimated, the probability at 6 months to be
SðtÞ
:
in the same health state is equal to Sðt26Þ
Costs evaluation
The costs of adjuvant therapy can be split into two parts: the costs of
treatment and follow-up and the costs of relapse. In this study, only direct
costs (medical and non-medical) were considered.
The economic perspective of the study
Model
All the patients from the FASG05 study have been analyzed using a
Markov model. The model allows a representation of the different possible
outcomes for a patient, from the beginning of the adjuvant treatment until
death (Markov process) using the FASG05 patient database. The number
of events and transition from one health state to another can thus be
deduced for each strategy. The range of time has been divided into
6-month periods because of the duration of adjuvant treatment (minimum
18 weeks). The rationale for the 6-month period was for all the
chemotherapy cycles to be included in the first period.
The structure of the Markov model is showed in the Figure 1. Three
transition health states were defined: ‘good functional state’ (the patient is
still alive, free of recurrence after six cycles of chemotherapy), ‘local
recurrence’ and ‘metastatic recurrence’; and one absorbing state: ‘death’.
Patients with both ‘local’ and ‘metastatic’ recurrences were considered as
‘metastatic’.
Based on the clinical data, a multi-state model can be elaborated in
order to take into account the available information and estimate survival
over 10 years [9–11].
The probabilities of survival in each health stare were estimated by fitting a parametric survival distribution to the estimated survival curves,
whereby these may be extrapolated to converge with the x-axis, to the
point where the survival function [S(t)] is equal to zero. Many different
parametric distributions can be used. The distribution used in the model
was the generalized gamma distribution. The generalized gamma distribution includes other distributions as special cases based on the values of
The most appropriate approach is the broadest perspective, i.e. the French
societal perspective using the diagnostic-related group (DRG) in a way
that allows the inclusion of the cost of epirubicin.
The mean total cost and the mean value for each type of cost (acquisition of drugs, radiological tests, physician and nurse work, logistics,
etc.) are described for every DRG. The method identifies the DRGs
corresponding to outpatient hospitalization for the administration of adjuvant chemotherapy and integrates in these DRGs the costs of treatment
(FEC 50 or FEC 100).
Cost of adjuvant treatment and patient follow-up
Unit costs. The following items were considered as medical costs:
(i) Hospital costs: postoperative radiation therapy; patient follow-up
(mammography and specialist visits); and adjuvant treatment.
(ii) Ambulatory costs: visits at the referring physician; nurse care;
physical therapy; and hematological and radiological exams.
The cost of patient transportation from home to the hospital was the
only direct non-medical cost to be considered.
Unit costs are presented in Table 1.
Health care resources data sources. The management of a patient treated
for breast cancer was described by experts from the Centre Oscar Lambret
as follows: the adjuvant treatment was administered every 3 weeks in outpatient status. A blood test was performed out of the hospital the day
before chemotherapy. Patient transportation was considered within the
cost of the adjuvant strategy. The follow-up included two visits per year
917
Table 1. Unit costs
Health care resources
Sources used for the economic valorization
Outpatient costs for adjuvant treatment
Using the French DRG:
Outpatient costs:
Unit cost
GHM 681 total cost without structure
costs:
390e
structure costs:
27e
drugs and material costs:
104e
Using the French DRG: GHM
For local recurrence
608e (180–1857)a
For metastasis
588e (164–1817)a
Inpatient costs
Using the French DRG: GHM
For local recurrence
574e (131–1829)a
For metastasis
438e (44–2725)a
Blood exams
French nomenclature
11e
Radiotherapy
French nomenclature
67e per course
Specialist physician
French nomenclature
23e per visit
Mammography
French nomenclature
60e
External costs
French nomenclature
20e
General practitioner, biological tests, physical therapy,
radiological exams, nurse care
Transportation
French nomenclature
According to the tests or visit performed
French national health insurance
11 + 0.78km
Ambulatory costs
Drugs
Vidal costs
Costs were expressed in 2002 Euro (e), according the French societal perspective.
a
Mean (range).
with the specialist during the first 5 years, and one visit per year during
the following 5 years. One mammography was performed every year.
Prevention of adverse events was also described as follows: the prevention of FEC 50-induced nausea and vomiting was performed using
intravenous anti-5HT3 and 80 mg glucocorticoids. For FEC 100, the dose
of glucocorticoids was increased to 120 mg; two tablets of oral 5HT3
inhibitor per day for 3 days were added. The cost of antiemetics for FEC
50 and FEC 100 were 31.97e and 127.31e, respectively.
The cost of small equipment (e.g. single use equipment such as needles,
syringes, saline, etc.) necessary for the administration of chemotherapy
was estimated to be 19.8e in a previous study [8].
Cost of recurrence. The cost evaluation of the treatment strategy for
patients with recurrence was based on a previous study and updated using
a DRG approach.
This database gave the following information: number of visits with the
specialist, number of inpatient and outpatient hospitalizations, information
regarding radiation therapy (French nomenclature), number of transportations to the hospital and the average distance in kilometers to the hospital, number of biological and radiological exams for follow-up according
to the type of recurrence, and the costs of ambulatory treatment.
The costs of hospitalization for metastases were estimated using the
DRG. The cost of the various DRGs is weighted by the type of metastasis
(cerebral, bone, chest, etc.) according to the FASG05 database.
Incremental cost-effectiveness
The purpose of this cost-effectiveness analysis is to evaluate the cost to
consent in order to obtain a clinical benefit when using FEC 100 instead
of FEC 50 in the FASG05 trial.
A discount rate of 5% per year was used for costs, and 0%, 3% and 5%
for effectiveness.
The effectiveness with a discount rate of 0% corresponds to the estimated life expectancy without any discounting of the cohort FEC 100 or
FEC 50 patients, according to the results of the FASG05 study.
Sensitivity analysis
We conducted a probabilistic sensitivity analysis using a Bayesian secondorder Monte Carlo simulation to evaluate the uncertainty in the assumptions
and to model the distribution of effectiveness and costs. A probability distribution was assigned to all estimates and assumptions that are not fixed values
in order to capture the possible range of outcomes. After the probability
distributions were assigned, the simulation drew one value at a time from the
feasible range simultaneously for each parameter. The cost and benefit were
then calculated from the specific values of the input parameters. This process
was repeated 100 000 times, resulting in 100 000 unique estimates of
effectiveness and costs, generating a range of possible values.
Probability distributions were selected based on the expected distributions of the underlying parameters for transition probabilities, hospital
costs and resource utilization. Probabilities were assumed to follow a beta
distribution to reflect the normal distribution and restriction to values
between zero and one. Mean hospital costs were expected to follow a triangular distribution, reflecting the long right tail and restriction to positive
values according to the cost data in the French DRG (minimal, maximal
and mean costs). Mean resources utilization costs were expected to
follow a simulated multivariate distribution estimated by non-parametric
bootstrapping method using Monte Carlo simulation for 10 000 sets of
input parameters were randomly sampled.
Results
The overall survival of patients treated with FEC 50 and FEC
100 were estimated using the Markov process.
918
Table 2. Costs of adjuvant treatment and follow-up per patient without recurrence
Costs of acquisition and administration of treatment
Year 1
Years 2–5
GHM 681 without drug cost
312.64e6 cycles = 1876e
5-Fluorouracil (500 mg/m2)
4e6 cycles = 24e
Epirubicin (50 mg/m2)
265e6 cycles = 1590e
2
Epirubicin (100 mg/m )
530e6 cycles = 3180e
Cyclophosphamide (500 mg/m2)
10e6 cycles = 60e
Material
28.62e6 cycles = 172e
Antiemetics FEC 50
31.97e6 cycles = 192e
Antiemetics FEC 100
127.31e6 cycles = 764e
Total cost for FEC 50
652.23e6 cycles = 3913e (2493.39– 8326.04)a
Total cost for FEC 100
1012.57e6 cycles = 6075e (4655.43– 10 488.08)a
Years 6–10
Annual other costs
Blood tests (10.80e)
65e
Radiotherapy (66.50e)
1596e
Visits (22.87e)
46e
46e
23e
External costs (360.27e)
360e
360e
360e
Transportation (101.68e)
3152e
203e
102e
Total other costs
5219e
609e
485e
Total cost for FEC 50b
9132e
11 570e
13 994e
Total cost for FEC 100b
11 294e
13 732e
16 156e
a
Mean (range).
Not discounted.
b
Costs of the adjuvant treatment and its follow-up
The costs of the various adjuvant strategies after 10 years per
patient without recurrence are presented in Table 2. Regarding
the acquisition and the administration of treatment, the costs
of one administration of FEC 50 and of FEC 100 were 652e
(416e–1388e) and 1013e (776e– 1748e), respectively. The
difference was essentially due to the acquisition cost of epirubicin and less to the management of emesis. There was no
difference in the other costs between the two strategies. The
costs of follow-up from years 2–5 and years 6–10 were 609e
and 485e, respectively.
In total, after 10 years, the discount acquisition, administration and follow-up costs for each patient without recurrence
receiving FEC 50 was 13 020e (11 600e–17 433e), and
15 182e (13 762e–19 595e) for those receiving FEC 100.
Cost of recurrence
The costs of local and metastatic recurrence per patient are
shown respectively in Table 3.
After 10 years, the total discount cost of local recurrence
was 21 236e (9939e –53 338e). Over half of the cost appears
during the first year of local recurrence.
Table 3. Costs (in e) of local recurrence and metastasis
Local recurrence (cost in e)
Year 1
Physician visit
Outpatient
72
At 5 years
325
Metastasis (cost in e)
At 10 years
325
Year 1
89
At 5 years
461
At 10 years
610
865
2133
2133
2499
7700
12 570
8407
13 350
13 350
9461
20 334
29 076
Radiotherapy
245
376
376
468
1317
1512
Transportation
1205
3379
3864
1915
8044
10 361
269
1189
1189
232
2183
2823
Inpatient
Ambulatory treatment
Medical assessment
Mean total cost
Discount rate of 5%.
587
914
1323
1763
8815
14 105
11 650
20 599
21 236
16 428
45 103
61 965
919
Table 4. Cost-effectiveness results
Cost of adjuvant
treatment in e (C) 5%
Cost of recurrences
in e (B) 5%
Effectiveness in years (E)
0%*
3%
5%
Mean hypotheses:
FEC 100
13 815
13 503
18.4
12.5
10.2
Mean (SD 95%)
13 815 (9775; 17 337)
13 503 (4747; 41 872)
18.35 (16.54; 20.04)
12.45 (11.39; 13.41)
10.14 (9.37; 10.84)
Mean hypotheses:
FEC 50
11 465
14 636
16.5
11.4
9.3
Mean (SD 95%)
11 466 (10 123; 14 838)
14 636 (5291; 45 755)
16.55 (14.88; 18.36)
11.38 (10.41; 12.43)
9.35 (8.63; 10.12)
Mean hypotheses:
DFEC 100 – FEC 50
2350
1134
1.9
1.1
0.8
Mean (SD 95%)
2349 (717; 2780)
1134 (5921; 2220)
1.81 (0.82; 4.15)
1.07 (0.46; 2.42)
0.79 (0.34; 1.78)
1084e per life year
saved
1460e per life year
saved
Discount rate:
D(C –B)
1216
SD 95%
(3296; 3368)
ICER = D(C– B)/DE
642e per life year
saved
The total cost of metastatic recurrence was 61 965e
(31 062e–218 964e). Over one-quarter of the cost appears
during the first year of metastatic recurrence.
Cost-effectiveness results
According to the hypotheses, the life expectancy without discounting with FEC 100 was 18.4 years, 12.5 years with a 3%
discount rate and 10.2 years with a 5% discount rate. With
FEC 50, the life expectancy was 16.5, 11.4 and 9.3 years,
respectively. The number of additional life years saved was
then 1.9, 1.1 and 0.8 years.
Using a 5% discount rate, the acquisition, administration
and follow-up costs for FEC 100 were 13 815e, and for FEC
50 were 11 465e.
The discount cost of local and metastatic recurrence was
13 503e for FEC 100 and 14 636e for FEC 50. The FEC 100
strategy was more costly regarding acquisition, administration
of treatment and monitoring (difference of 2350e), but less
costly regarding the cost of recurrence (difference of 1134e).
The incremental cost was 1216e.
The FEC 100 strategy was both more effective and slightly
more expensive than the FEC 50 strategy. The incremental
cost effectiveness ratio was respectively 642e, 1084e and
1460e per life year saved for a discount rate, respectively, of
0%, 3% and 5%. However, it is not possible to calculate the
standard deviation of the incremental cost-effectiveness ratio
because of negative data to the denominator (Table 4).
Sensitivity analysis
The results of the descriptive analysis of the probabilistic sensitivity analysis (mean and standard deviation) (Table 4) are
extremely close to those obtained from the mean hypotheses
(mean costs of DRG, external expenses and relapse and death
probabilities). It allows to conclude that the number of simulations performed (100 000) was sufficient. Figures 2–4 show
the plot of the 100 000 estimates of the ICER (DC, DE) points
on the incremental cost-effectiveness plane for the different
discount rate for effectiveness (0%, 3% and 5%). In terms of
dominance of one strategy over another, the probability that
FEC 100 strictly dominated FEC 50 (less costly and more
effective) was 0.15, the probability to be strictly dominated
(more costly and less effective) was 0.04.
Figure 5 presents the cost-effectiveness acceptability curve
derived from the plot replicates in the (DC, DE) planes corresponding to three different discount rates for effectiveness
[12]. It shows, as a function of hypothetical threshold values
of the decision maker’s willingness to accept an increase in
costs, the proportion of the estimated ICER replicates that will
be considered acceptable. Thus, if the critical threshold values
are assumed to be equal to 642e, 1084e and 1460e, the probability that FEC 100 is cost-effective is equal to 42.2%,
41.9% and 41.8%, respectively. If the acceptable threshold is
10 000e, the probability is 90%.
Discussion
Our results show that the incremental cost per life year saved
was 642e without any discount, 1084e with a 3% discount rate
and 1460e with a 5% discount rate when patients were treated
with FEC 100 instead of FEC 50. This incremental cost is very
low when compared to the National Institute for Clinical Excellence proposals, which consider that £35 000 ( 45 500e) is an
acceptable cost for a life year saved. The probabilistic sensitivity analysis allows the conclusion that the probability for
FEC 100 to be strictly dominant was 15% (more effective and
less expensive), the reverse being 4%. The acceptability curves
show that the likelihood for the price to pay per life year saved
to be less than the amount seen above was 41%. Longterm side effects are rare. Any cardiac toxicity is essentially
asymptomatic, and in most cases not treated [5]. In our study,
only one case of acute myeloblastic leukemia, which was probably related to chemotherapy, was observed. After 10 years of
follow-up, it can be concluded that the cost between the two
treatments is nearly identical with a significant number of life
years saved for FEC 100.
2 000
0
∋
–1
–2 000
∋
–4 000
∋
–6 000
∋
–8 000
∋
–10 000
∋
FEC 100 less costly
and less effective than FEC50
(p = 0.0050)
4 000
∋
–2
6 000
∋
–3
8 000
∋
–4
10 000
∋
–5
FEC 100 more costly
and less effective than FEC 50
(p = 0.0352)
∋
Incremental costs
920
FEC 100 more costly
and more effective than FEC 50
(p = 0.8145)
RCEI = 642
0
1
2
3
4
5
6
FEC 100 less costly
and more effective than FEC 50
Incremental effectiveness
(p = 0.1453)
2 000
∋
0
∋
–2 000
∋
–4 000
∋
–6 000
∋
–8 000
∋
–10 000
∋
FEC 100 more costly
and less effective than FEC 50
(p = 0.0051)
4 000
∋
–2.00
6 000
∋
–3.00
8 000
–1.00
FEC 100 more costly
and more effective than FEC 50
(p = 0.8118)
RCEI = 1 084
0.00
1.00
2.00
3.00
4.00
5.00
∋
–4.00
10 000
∋
–5.00
FEC 100 more costly
and less effective than FEC 50
(p = 0.0379)
∋
Incremental costs
Figure 2. Incremental cost-effectiveness plane (discount rate for effectiveness 0%).
6.00
FEC 100 more costly
and less effective than FEC 50
Incremental effectiveness
(p = 0.1452)
Figure 3. Incremental cost-effectiveness plane (discount rate for effectiveness 3%).
The database for this study is sound. The clinical data of
the 565 patients included in the FASG05 study were reviewed,
with a median follow-up duration of 10 years; the number of
events was very high in this poor prognosis patient population.
Similarly, the consumed resources, either out of the hospital
during the adjuvant treatment or after relapse, have been
measured from the observation of important patient populations, using a questionnaire for the ambulatory study, or
–2 000
∋
–4 000
∋
–6 000
∋
–8 000
∋
–10 000
∋
FEC 100 less costly
and less effective than FEC 50
(p = 0.0052)
0
∋
–1
2 000
∋
–2
4 000
∋
–3
6 000
∋
–4
8 000
∋
–5
10 000
FEC 100 more costly
and more effective than FEC 50
(p = 0.8102)
RCEI = 1 460
0
1
2
3
4
∋
FEC 100 more costly
and less effective than FEC 50
(p = 0.0395)
∋
Incremental costs
921
5
6
FEC 100 less costly
and more effective than FEC 50
Incremental effectiveness
(p = 0.1451)
Figure 4. Incremental cost-effectiveness plane (discount rate for effectiveness 5%).
1.0
0.9
Cost-effectiveness probability
0.8
0.7
Discount rate for cost: 5%
Discount rate for effectiveness: 5%
0.6
0.5
Discount rate for cost: 5%
Discount rate for effectiveness: 3%
0.4
0.3
Discount rate for cost: 5%
Discount rate for effectiveness: 0%
0.2
0.1
0.0
0
2 000
4 000
6 000
8 000
10000
12 000
14 000
16 000
Ceiling ratio
Figure 5. Cost-effectiveness acceptability curve (the probability that the incremental cost-effectiveness is 5000e is <90%).
18 000
20000
922
reviewing the clinical files of patients who relapsed. An
advantage of the study is that it has been carried out in a well
defined population of patients in whom the indication of adjuvant chemotherapy is not discussed according to the published
consensus. The perspective of the study was the societal one,
which is probably the most realistic approach that could be
used. Very few studies have been published on the cost-effectiveness or cost-utility of adjuvant treatment in breast cancer.
In addition, the methods that have been used are different, and
thus the results difficult to compare. The incremental cost
effectiveness of adjuvant CMF versus no treatment has been
found to be US$447 (1e is about US$1.2 in September 2004)
per life year saved [13]; it is important to note that in Messori’s study, only the costs of chemotherapy administration
were considered. Based on literature data incorporated with
Norwegian standard adjuvant chemotherapy, Norum [14]
found that the cost per life year saved was between £2365 and
£6253, depending on the method used. Similarly, the cost per
quality-adjusted life year saved was estimated to be between
£2973 and £5737 (1e is about £0.7 in September 2004). In
Irvin et al.’s study [15], the ICE was estimated at US$1510
per life year saved with CMF and at US$1208 and US$1967,
respectively, for stage II and III breast cancer patients. The
cost of treatment and follow-up of breast cancer has been studied in a French group [16]; the mean cost was 10 072e, with
extremes at 6384e and 12 351e, depending on the treatments
used; the median follow-up duration was 4 years and 4
months. When taking into account the differences between
the costs that were considered and the methods of evaluation
used, our results are very similar. In a worldwide evaluation
of the cost of breast cancer, Radice et al. [17] found that the
cost of initial care for stage I and II breast cancers are,
respectively, US$10 835 and US$12 273, which is very similar to the previous one. The highest cost is for terminal care in
patients with distant disease (about US$20 000). The 10-year
cumulative cost per patient has been found to be 31 774e in a
Belgium group [18].
Based on our results, we can therefore conclude that the
clinical benefit of FEC 100 generates a negligible cost
increase when compared with FEC 50.
Acknowledgements
This study was supported by an unrestricted grant from Pfizer
France.
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