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PROPHYLAXIS AND CERVICAL SCREENING
IN BULGARIA- PAST, PROBLEMS AND FUTURE
Dr. Petya Kostova, PhD
Gynecology Clinic,
National Oncology Hospital, Sofia; Bulgaria
Assoc. Prof. Dr V. Zlatkov, PhD
Gynecology Clinic,
National Transport Hospital “King Boris III”, Sofia, Bulgaria
Significance of the problem (1)

Cervical cancer is one of the most
common malignant diseases in the world
with annual occurrence of 500 000 cases.
It is placed 5th with its share of 7.3% of
the total number of localizations in both
sexes.

According to the WHO, 15% of all
cancers in women belong to cervical
cancer, about 20% of which are found in
the developed countries and 80% in the
developing countries.
Significance of the problem (2)
Cancer Bulgaria
Registry
total
2002
of them cervical,
of them women еndometrial, ovarian
cancer patients
number
%
number
%
Cancer
patients
216 881
127 227
58.7
32 242
25.3
New cases
29 435
14 051
47.7
3 001
21.4
Dead
15 785
6 595
41.8
895
13.8
Structure of cancer incidence in female
Bulgaria (2001)
%
30
24.6
24.3
25
20
9.7
7.7
15
7.5
7.1
5.4
5.1
10
4.7
3.9
5
0
ea
br
st
sk
in
c
vi
er
x
d
en
e
om
um
tri
lo
co
n
ar
ov
Sites
y
re
um
ct
st
om
h
ac
ng
lu
he
ot
r
Primary prophylaxis

It requires control and elimination
etiopathogenesis of the disease.

There are no effective methods for sexual behavior
regulation.

Over the past years, the effectiveness of preventive
vaccines against HPV infections has been discussed:
Cervarix® (GlaxoSmithKline)
Gardasil® (Merck)
of
the
Secondary prophylaxis

Its aim is to detect and eliminate precancer states or
early malignancies

It is performed on women with complaints and without
clinical symptoms (screening).
Types of screening
• population based & selective
• organized & opportunistic
• multi-phase & one-procedure
The principles of secondary prophylaxis

The disease, object of screening, should be a
medico-social problem (with high incidence
and mortality);

Its clinical course should be well known,
with a preclinical phase corresponding to a
biologically less aggressive period of
development;

The screening test should be simple to use,
safe, cheap, with high sensitivity, specificity
and predictive value;

The treatment of the patients, diagnosed
during the screening, to be effective and to
reduce mortality.
Preventive effect
of cervical screening
Frequency
of screening
Reduction of
cumulative risk
Number of
tests
1 year
93.3 %
30
2 years
92.5 %
15
3 years
91.4 %
10
5 years
83.9 %
6
10 years
64.2 %
3
Possible results

When organized screening cover 70%
of the target population, it is possible
to achieve the following results:
• 30% of cancer cases to be actively
detected
• 30% of the advanced cancer cases
can be decreased
• >15% of mortality at screening
localizations can be reduced
History of the screening in
Bulgaria

Since
1956,
prophylactic
gynecological examinations
have been conducted in
Bulgaria .

K.Tsanev and D.Nikolova
(1970) - introduced cytological
screening as a routine test.
CERVICAL
SCREENING
NOC-Sofia
Past scheme
in Bulgaria
Regional DOZ
District
Ob/Gyn
Women
over 30 years
Women
under 30 years
Examination
PAP smear
(-) test
Cytological
laboratry
(+) test
Colposcopy
Normal finding
Precancer
Cancer
General principles

The screening program involves all women over 30
years of age, both married and single, and is
performed once every two years.

It is conducted by district gynecologists and
nurses. Diagnostic cytological tests are performed
in 14 laboratories based at the district oncological
centers and the National Oncological Center.

According to the screening program, 1.5 mill.
women are subject to examination.
Incidence of cervical cancer
in Bulgaria (1970-2002)
5
30
25
20
Crude
15
10
Standardized
5
20
02
20
00
19
98
19
96
19
94
19
92
19
90
19
88
19
86
19
84
19
82
19
80
19
78
19
76
19
74
19
72
0
19
70
10
Year
An
increase in the crude incidence was observed (12.7 to 26.9 %ооо).
The same tendency was observed for the standardized incidence from
10.0 to 19.4 %ооо women.
Incidence
according to age, residence and districts
 Incidence (1970-1996) arise in all age
groups (р<0.05), especially at 30-49 years.
 Incidence (1981-1996) is higher at towns
than in villages (р<0.05)

Standardized cervical cancer incidence
(1991-1996 г.) varies according to districts
from 6.1%ооо tо 23.1%ооо women.
Incidence of cervical cancer worldwide
Incidence
Low
Medium
High
Very high
Levels
from 3 to 9 x 10 5
Countries/regions
Scandinavian,USA,Canada,
England, Israel
Registries
(x 10 5)
Finland (3.62),
USA (4.05)
from 10 to 20 x 10 5 Parts of EC, Central Europe,
Japan, Australia and some in
Asia
from 21 to 30 x 10 5 South-East Europe, Russia
Bulgaria- (26.9)
Australia (12.5)
Japan (16.0)
Slovenia (18.5)
Poland (23.8)
Russia (28.6)
Over 30 x 10 5
Zimbabwe (67.21)
Brazil (64.78)
South America, Africa
Effect of screening on incidence
(Scandinavian countries)
M.Hakama, K.Louhivuori (1988)
40.0
per 10
5
35.0
30.0
Denmark
25.0
Norway
20.0
Iceland
15.0
Sweden
10.0
Finland
5.0
0.0
1945 1950 1955 1960 1965 1970 1975 1980 1985
Years
Mortality of cervical cancer
in Bulgaria (1970-2002)
12
5
10
10
8
6
Crude
4
Standardized
2
02
20
00
20
98
19
96
19
94
19
92
19
90
19
88
19
86
19
84
19
82
19
80
19
78
19
76
19
74
19
72
19
19
70
0
Year
An
increase in the crude mortality was observed, reaching from 3.2 tо 9.8 %ооо.
The same was tendency for the standardized index-from 3.1 to 6.2 %ооо women.
Mortality of cervical cancer worldwide
COUNTRIES
Stand. mortality
(%ооо)
Israel
1.42
Japan
1.98
USA
2.70
Finland
3.00
Germany
3.51
Bulgaria
6.2
Poland
8.23
Romania
10.01
Venezuela
10.51
Chile
14.87
Screening results
Effect on mortality in Europe
9
8
7
6
5
4
3
2
1970
1975
1980
1985
Bulgaria
United Kingdom
EUROPE
1990
1995
2000
EU average
Nordic average
2005
Ratio between the patients with CIS and cervical
cancer in Bulgaria (1975-2002)
30
10
5
25
20
15
10
CIS
5
Ca
2001
1999
1997
1993
1991
1989
1995
Years
1987
1985
1983
1981
1979
1977
1975
0
Ratio between the cancer in situ and invasive cancer for the studied period shows
bigger frequency of invasive forms and the arisal of this ratio during the study period
.
Ratio CIS / Ca (1)
100%
90%
80%
70%
60%
CIS
Ca
50%
40%
30%
20%
10%
0%
ЕС
Bulgaria
Most important is the comparison to EC countries. The ratio between CIS
and invasive cancer is 3/1 in favour of in situ forms in EC. In Bulgaria,
is the opposite. It is 5/1 due to the higher level of invasive cancer.
Ratio CIS / Ca (2)
Pe
r
ye
ar
USA
Deaths - 3800
Cancer - 10300
AGC-
180 000
HSIL
LSIL–2
ASCUS
300 000
mill. women
– 3 mill. women
In the USA 55-60 mill. Pap tests are completed every year,
the cost for them being $ 6 bln.
Stage distribution of cervical cancer
in Bulgaria (1970-2002)
Number
800
700
600
stages I+II
500
400
300
stages III+IV
200
without stage
100
20
00
19
90
19
80
0
Year
For the whole studied period we cannot observe any improvement of level of
early diagnostics with stable high level of advanced cases.
Screening coverage
About 1.5 mill women were screened annually until 1989, after which there was a
progressive drop and only 205 081 screening tests were reported in 1996.
120
100
mean for the
period
80
%
60
1980
40
20
1995
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Oncological dispensaries
Legend: 1-Blagoevgrad; 2-Burgas; 3-Varna; 4-V. Тarnovо; 5-Vratsa; 6-Pleven; 7-Plovdiv;
8-Russe; 9-Sofia-city.; 10-Sofia-reg.;11-St. Zagora; 12-Shumen; 13-Haskovo; 14-Bulgaria
Share of women with biopsy
The share of biopsies among the signalized women is low about 1/3, except 3 centers where
it is more than 50%. This means that many women do not pass the step of precise diagnostics.
Number
1000
900
800
700
600
500
400
300
200
100
0
signalized
with
biopsy
1
2
3
4
5
6
7
8
9 10 11
Oncological dispensaries
12
13
14
Legend: 1-Blagoevgrad; 2-Burgas; 3-Varna; 4-V. Тarnovо; 5-Vratsa; 6-Pleven; 7-Plovdiv;
8-Russe; 9-Sofia-city.; 10-Sofia-reg.;11-St. Zagora; 12-Shumen; 13-Haskovo; 14-Bulgaria
Faults of past screening
activity

Faults in organization
 Faults in test
 Faults in interpretation
Problems of organization
They are connected with the following :

No team for
programme

No screening registry

Lack of call and recall system

No unified system for diagnostics of
signalized women

No quality control on all screening levels.
management
of
the
Problems of test




Monitoring quality of cervical smears
Adequate preparation and storage of smears at
laboratories
Timely cytological answer to clinicians
Registration of results in screening registry
Problems of interpretation
1
4

The need of unified
cytological classification

The introduction of internal
and external quality control
at cytological laboratories

The continuous training and
education of staff
2
3
What’s happened
over the last 10 years?
Attempts at change

Over the past 10 years, different teams of the Ministry of
Health have initiated the development of new cervical
screening programme.

One of these teams, under the guidance of prof.
Chernozemski and with our participation, created “The
National Strategy for Prophylactic Oncological Screening
in Bulgaria for the period 2001-2006” for the three main
screening localizations - breast, uterine cervix and
prostate.

It was accepted by a decree of the Council of Ministers №
880 / 22.12.2000, but it could not be realized in practice.
Recent
situation
Secondary
prophylaxis
?
Selective
opportunistic
screening
Opportunistic
screening
Gynecologist
Cash
Payment
(? Women)
Gynecologist
Health
Insurance
system
Population
screening
GP / Gynecologist
Health
Insurance
system
80 000 women
Necessary changes





Restoration of the organized population
cervical screening as a component of the
health system.
Building a structure for management and
screening registry.
Introduction of unified terminological
system.
Establishment of quality control at
cytological laboratories.
System for continuous education.
The basic components of the future
cervical screening programme
Management
Qualification
Education
Cervical
screening
Efficiency &
effectiveness
Quality
control
Target and interval

Recommended target population is 1.8 mill.
women (25-60 years)

The screening interval should be 3 years.
Potential prices of cervical
screening

According to world standards the
mean value of one conventional
screening examination is 10 €.

In our country this price is lower,
around 10 leva (5 €), because of
lack of realistic assessment of
human labor, overheads, and
equipment value.
Prices of cervical cancer treatment according
to stage for one year
Prices according to EU data
Cervical cancer Number of cases in
Stages
Bulgaria (2001)
(Andrae Bengt - 2004)
Per item
Total
St. III – IV
347
30 000 €
10 410 000 €
St. I – II
670
9 000 €
6 030 000 €
CIS
275
300 €
83 500 €
Total
1292
-
16 522 500 €
Which price is better ?
If
the target population
(25 - 60 years) is 1.8 mill,
its full coverage will cost
9 mill €.
If
screening interval
is 3 years, it will cost
3 mill € yearly.
Treatment
of
cancer cases
for one year –
about 16 mill €.
Finally, we would like to
recall the aphorism used
by J. Bokhman ( 1989 ) :
"... If a woman dies
of uterine cancer, there is
someone else beside the
cancer itself, who is to be
blamed for her death...".