Key words breast cancer - disease management programme - quality assurance - survival - network
Schlüsselwörter Mammakarzinom - Disease-Management-Programm - Qualitätssicherung - Überleben - Netzwerk
Introduction
The first published results of the DMP breast cancer programme in Hesse were discussed
in an editorial
entitled “DMP-Mamma – Ein Reizwort” [Buzzword: DMP Breast Cancer] published in April
2009. The first
framework agreement for the DMP programme was concluded at the end of 2003. This marked
the start of one
of the most successful breast cancer quality assurance programmes in Germany. In 2012,
the first
five-year breast cancer survival rates were published, based on data obtained from
the Gemeinsame
Einrichtung (GE) in Hesse, the Hesse Breast Centres of Excellence, all DMP partners
in Hesse and the
results of the Agency for Quality Assurance (Geschäftsstelle für Qualitätssicherung,
GQH).
History of the DMP Hesse
Prior to the start of the DMP programme in Hesse and the structured dialogue programme
(Operative
Gynäkologie Hessen [Surgical Gynaecology Hesse]) for quality assurance of the GQH,
breast cancer
treatment in Hesse varied greatly. Around 4000 cases underwent surgical treatment
in one of Hesseʼs
80 hospitals every year. Facilities and equipment differed widely between hospitals.
70 % of
hospitals carried out fewer than 50 breast cancer operations per year. Only 8 % of
hospitals carried
out at least 150 operations annually. These hospitals treated almost 39 % of all new
cases.
The structured treatment programme for breast cancer patients in Hesse was approved
by the German
Federal Social Insurance Authority (Bundesversicherungsamt) on January 1, 2004. A
framework
agreement was concluded directly with the Federations of German Health Insurance Funds
(Verbände der
Krankenkassen) and supported by the Professional Association of Gynaecologists (Berufsverband
der
Frauenärzte) without involvement of the Association of Statutory Health Insurance
Physicians
(Kassenärztliche Vereinigung). The first framework agreements were concluded on September
31, 2003
with the Dr. Horst Schmidt Hospital in Wiesbaden and the University Medical Centre
in Marburg.
Coordinating and cooperating hospitals – creating the perfect network
In this model, a hospital can conclude a framework agreement and is then responsible
for coordinating
activities in a regional breast centre of excellence. The agreement ensures that surgical
standards
and standards for adjuvant therapy are complied with, that more breast-conserving
surgeries are
carried out, and that patients are comprehensively followed up and given psychosocial
support. Joint
case conferences and at least two DMP training courses per year improve quality management
(including optimising interfaces between facilities) and training. A network of interdisciplinary
healthcare services and breast centres of excellence was developed. Coordinating hospitals
were
“high-volume” hospitals with more than 150 new cases treated annually. Coordinating
and cooperating
hospitals integrated in a centre of excellence had to show that each surgeon had previously
carried
out at least 50 breast cancer operations ([Fig. 1 ]). Breast centres of
excellence also include DMP-accredited gynaecologists, who are primarily responsible
for outpatient
treatment and follow-up care ([Fig. 2 ]).
Fig. 1 Overview of breast centres of excellence in Hesse – DMP Breast Cancer Hesse –
Breast Cancer Centres of Excellence (1 coordinating + cooperating hospital per centre).
Fig. 2 Network of coordinating hospitals/cooperating hospitals.
The Gemeinsame Einrichtung (GE), a body composed of equal numbers of representatives
from hospitals
in Hesse, representatives from the breast centres of excellence and from the Professional
Association of Gynaecologists in Hesse, is responsible for quality assurance.
Common quality indicators were defined for all DMP hospitals. Comprehensive coverage
through the
creation of an intersectoral network and an annual anonymised evaluation assessing
compliance with
quality was achieved in Hesse [1 ], with GQH employees providing regular
feedback of results to healthcare providers.
Current situation
The programme kicked off on January 1, 2004. Nine breast centres of excellence with
34 participating
hospitals and more than 500 affiliated physicians in private practice were set up
across the state
of Hesse to offer comprehensive healthcare coverage. This created the basic structure
with
interdisciplinary oncological conferences and structured follow-up care provided by
local affiliated
gynaecologists. 564 gynaecologists out of a total 700 of gynaecological practices
in Hesse joined
the programme, ensuring that outpatient and follow-up care was available to every
patient enrolled
in the DMP programme (data from December 2012).
Just under 3500 patients were enrolled in the DMP programme in one year. Surgical
quality assurance
data were compared and analysed using data from non-DMP hospitals as a benchmark to
evaluate whether
the objectives of the DMP programme were being achieved.
The GQH report for the years 2004–2006 (initial registration) shows the improvements
over time for
the 18 quality indicators ([Fig. 3 ]). The data from 2010 show
considerable changes ([Fig. 4 ]).
Fig. 3 Overview of GQH quality indicators for breast cancer 2004–2006.
Fig. 4 Overview of GQH quality indicators for breast cancer 2010.
In the early years of 2004–2006, there were considerable differences between DMP hospitals
and
non-DMP hospitals with regard to achieving quality indicators. When the rates of breast-conserving
surgeries for pT1 tumours were compared, the rates for non-DMP hospitals were around
10 % lower.
Since then, combined quality controls have greatly reduced this disparity. Fortunately,
the quality
indicators are distributed uniformly across all of the centres of excellence.
At the start of the DMP programme, preoperative knowledge of the definitive histology
of invasive
carcinomas was > 70 % in the centres of excellence, while the rate for this indicator
in non-DMP
hospitals was < 30 %. Today, the overall figures are > 98 % (for DMP hospitals) and
90.6 %
(for non-DMP hospitals).
Material and Method
In 2012, the Gemeinsame Einrichtung (GE) in Hesse working together with the Professional
Assocation of
Gynaecologists for the State of Hesse carried out the first analysis of survival data
from the DMP
programme in Hesse. The analysis for the period 1st January 2005–30th June 2011 included
13 973 data
sets of women enrolled in the DMP programme in Hesse. After methodical cleaning of
pseudonymised data,
datasets for 11 214 women were available for analysis. The data was obtained from
the initial records
compiled by DMP hospitals. Data on tumour size (pT1-pT4) and hormone receptor status
were additionally
included in the analysis ([Fig. 5 ]).
Fig. 5 Overview of basic data collected. n.s.: not specified.
The following treatment-relevant clinical endpoints were calculated:
Total survival
Total survival according to tumour stage at presentation
Total survival according to hormone receptor status
Total survival according to age distribution
Cox proportional hazards model and log-rank test were used for statistical analysis.
The high quality of the data is due to the fact that on 30th June 2011, the cut-off
date of the survey,
86.7 % of registered women were reported to be alive with only 8.3 % reported to have
died during survey
period. 5 % (557 women) were removed from the analysis as “lost to follow up”.
Results
5-year survival rate
Survival was calculated in months from the date of the first manifestation of the
primary tumour in
the reference period. Five-year overall survival (OS) for the evaluated 11 214 women
calculated
across all age groups and irrespective of tumour stage at diagnosis was 86.3 % ([Fig. 6 ]).
Fig. 6 Overall survival for all DMP patients whose data were available for analysis.
5-year survival rate according to tumour stage
Tumour stage or size was not specified in 1694 cases, leaving a total of 9520 cases
available for
analysis. For the evaluation period, it could be shown that when tumour diameters
were ≤ 2 cm (pT1),
there was an excellent 5-year survival rate of 92.2 %. Even for women with larger
tumours (2–5 cm;
pT2) the survival rate was still an impressive 82.3 % ([Fig. 7 ]).
Fig. 7 Overall survival according to tumour stage.
5-year survival rate according to hormone receptor status
Hormone receptor status (oestrogen and progesterone) is an important prognostic and
predictive factor
for anti-hormone treatment. The data of 11 213 women were available for analysis.
The available data
did not permit a differentiation between oestrogen receptor (ER) and progesterone
receptor (PR)
status. The analysis therefore only included the indicator “positive hormone receptor
status”. The
5-year survival rate for women with hormone receptor-positive breast cancer was 87.8
versus 78.9 %
for women with hormone receptor-negative tumours ([Fig. 8 ]). Analysis did
not take into account whether patients underwent anti-hormone therapy.
Fig. 8 Survival rate according to hormone receptor status.
5-year survival rate according to age at diagnosis
Although breast cancer is more common among older women, increasing numbers of younger
women have
also been diagnosed with this disease in the last few years. Younger age at diagnosis
is an
unfavourable prognostic factor. This makes the results presented here on survival
rates according to
age at diagnosis even more interesting. Rates were calculated based on the data of
10 657 women. The
5-year survival rate of 91 % calculated for women ≤ 35 years was particularly noteworthy
([Fig. 9 ]).
Fig. 9 Survival rate according to age at first diagnosis.
Discussion
In an age of evidence-based medicine, comparatively little information is available
on routine medical
care available for oncological disease [2 ]. Particularly for breast cancer,
the most common malignant disease affecting the female population with an incidence
of almost 72 000 new
cases every year, there are only limited reliable data. Only the Robert Koch Institute
(RKI) with its
current summary of epidemiological data for the years 2007/8 offers a good overview
[3 ]. The current RKI review reports an absolute overall 5-year survival rate of 78.0 %
for
2007/8 [3 ]. This means that our figure of 86.3 % for Hesse was significantly
higher than the national average for Germany. A similarly good outcome with a 5-year
survival rate of
87 % can also be found in the Bavarian Cancer Registry for the period 2007/8 [9 ]. If we compare the 5-year survival rates for Hesse and Bavaria according to tumour
stage
(T1: 92 vs. 98 %, T2: 82 vs. 86 %, T3: 68 vs. 68 %, T4 56 vs. 51 %), then the data
for Bavaria are
better for early stages of disease, which may be due to early implementation of a
mammography screening
programme in Bavaria. When the 5-year survival rates are compared according to age
group, the data
paints a better picture for younger patients living in Hesse (≤ 35 years: 91 vs. 86 %;
40–50 years: 89
vs. 92 %). In contrast, the rates are more favourable in the Bavarian population for
women older than 60
years of age [9 ].
The continued increase in the incidence of breast cancer in women has been variously
ascribed to the
adoption of an “urban lifestyle”, possible in combination with a fundamental change
in the reproductive
behaviour of the female population. As mammography screening has become increasingly
common and systemic
adjuvant therapy – mainly the use of tamoxifen – has begun to have an impact, there
has been a so-called
“stage shift” of tumour stage at diagnosis, and mortality has dropped. This shift
has been particularly
noticeable in women with breast cancer and a positive oestrogen receptor status (ER
pos.) and women
younger than 70 years of age at the time of diagnosis. It would appear that oestrogen
receptor-negative
(ER neg.) breast cancers are more common at a younger age than ER-positive tumours.
The incidence of
ER-negative cancer first plateaus at around 50 years of age, and at around 70 years
for ER-positive
cancers. Loco-regional control has also improved as investigation of surgical specimens
has improved and
use of radiation therapy has become more common [4 ].
Analysis of parameters was deliberately limited to data collected for the classic
prognostic factors
(age, tumour size and hormone receptor status). No attempt was made to collect therapy-relevant
data or
other more modern prognostic factors as the expected heterogeneity of the data and
the different
documentation statuses would not have led to any meaningful results.
Treatment results were obtained from DMP Breast Cancer. This data is available for
the first time for the
German federal state of Hesse. Analysis of the period 2005–2011 provided excellent
data on survival
rates according to age group, tumour size and hormone receptor status; the data on
smaller tumours and
cancers in younger women up until the age of 36 must be among the best in Germany.
Data of around 10 000
women was collected, providing a large volume of data for Hesse not previously available.
This data can
now be used as a basis for a more detailed analysis of treatment results after breast
cancer therapy and
can be compared with comparative national and international studies. It could also
be shown that
intersectoral cooperation between the clinical sectors offering acute care and gynaecologists
who
provide diagnosis and follow-up outside the hospitals has improved the quality of
outcomes. It is well
known that the quality of treatment and care provided to women with breast cancer
is positively
correlated to structures, specialisation and experience. When this was measured using
the numbers of
patients receiving surgery after their first diagnosis for every hospital (“hospital”
or “surgeonsʼ
volume”), data for the state of New York – which has a similarly heterogeneous population
distribution
and hospitals with a wide variability in cases with primary disease – clearly proved
the connection
between the number of patients with primary disease who underwent surgery and 5-year
survival rates
[5 ]. With regard to 5-year survival, Roohan et al. were able to show that
hospitals with more than 150 primary cases every year had an advantage of 30 % compared
to hospitals
which cared for fewer than 50 primary cases per year. This still applied for co-morbidities
and lymph
node involvement after adjusted multivariate analysis [5 ].
Another positive side effect was that compliance with quality indicators also improved
in non-DMP
hospitals in Hesse. In one of the first analyses on the effect of the DMP project
in Hesse, du Bois et
al. were able to show already in 2004 that the quality of outcomes after treatment
offered to breast
cancer patients in Hesse varied greatly with regard to rates of breast-conserving
surgeries. One of the
original DMP criteria was a figure of at least 50 primary operations in every DMP
hospital [6 ]. These structural conditions are also a basic requirement of
guidelines-based systemic therapy [7 ], [8 ]. A lot
has been achieved with the DMP in Hesse in the last few years; all parties participating
in the
intersectoral network must maintain this motivation when providing care to women with
breast cancer in
hospitals and in doctorsʼ practices. Patients and their families and the general population
without
disease have a right to know where high-quality evidence-based medical care is available
[10 ], [11 ]. Cooperations between different
facilities to implement and improve quality indicators and guidelines are instruments
which can be used
to continually optimise therapy [12 ]. Certified breast centres have been
established in Germany since many years as models which show how care can be optimised
[13 ].
Appendix
Coordinating hospitals in DMP Breast Cancer in Hesse
Johann Wolfgang Goethe Universität Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe,
Theodor-Stern-Kai 7, 60590 Frankfurt am Main
Universitätsklinikum Gießen und Marburg – Standort Marburg, Klinik für Gynäkologie,
Gynäkologische Endokrinologie und Onkologie, Baldingerstraße, 35033 Marburg (Lahn)
Dr.-Horst-Schmidt-Kliniken, Klinik für Gynäkologie und gynäkologische Onkologie,
Ludwig-Erhard-Straße 100, 65199 Wiesbaden
Klinikum Offenbach GmbH, Klinik für Gynäkologie und Geburtshilfe, Starkenburgring
66, 63069
Offenbach
Klinikum Hanau, Frauenklinik, Leimenstraße 20, 63450 Hanau
Interdisziplinäres Brustzentrum am Klinikum Kassel, Mönchebergstraße 41–43, 34125
Kassel
Klinikum Fulda, Frauenklinik, Pacelliallee 4, 36043 Fulda
Klinikum Darmstadt, Frauenklinik, Grafenstraße 9, 64283 Darmstadt
Hochwaldkrankenhaus Bad Nauheim, Abteilung für Gynäkologie, Chaumont-Platz 1, 61231
Bad
Nauheim
Cooperating hospitals in DMP Breast Cancer in Hesse
St. Vincenz-Krankenhaus, Auf dem Schafsberg, 65549 Limburg
Kreiskrankenhaus Eschwege, Elsa-Brandström-Straße 1, 37269 Eschwege
Klinikum Wetzlar, Forsthausstraße 1, 35578 Wetzlar
Asklepios Paulinen Klinik, Geisenheimerstraße 10, 65197 Wiesbaden
Frauenklinik Erbach, Albert-Schweitzer-Straße 10, 64711 Erbach
Kreiskrankenhaus Groß-Umstadt, Krankenhausstraße 11, 64823 Groß-Umstadt
Katharina Kasper GmbH, Richard-Wagner-Straße 14, 60318 Frankfurt am Main
Main-Kinzig-Kliniken, Herzbachweg 14, 63571 Gelnhausen
St. Josefs Hospital, Solmsstraße 15, 65159 Wiesbaden
Markus-Krankenhaus (FDK), Wilhelm-Epstein-Straße 2, 60431 Frankfurt am Main
Kreiskrankenhaus Bergstraße, Viernheimer Straße 2, 64646 Heppenheim
Asklepios Klinik Langen-Seligenstadt, Röntgenstraße 20, 63225 Langen
Krankenhaus Nordwest, Steinbacher Hohl 2–26, 60488 Frankfurt am Main
St. Josefs-Krankenhaus Gießen, Liebigstraße 24, 35394 Gießen
Klinikum Bad Hersfeld, Seilerweg 29, 36251 Bad Hersfeld
Deutsche Klinik für Diagnostik, Aukammallee 33, 65191 Wiesbaden
Hochtaunus-Kliniken, Urselerstraße 33, 61348 Bad Homburg
Kliniken des Main-Taunus-Kreises, Kronbergerstraße 36, 65812 Bad Soden
Asklepios Klinik, Goethestraße 4, 35423 Lich
Städtische Kliniken Höchst, Gotenstraße 6–8, 65929 Frankfurt am Main
Elisabeth-Krankenhaus, Weinbergstraße 7, 34117 Kassel
Herz-Jesu-Krankenhaus Fulda GmbH, Buttlarstraße 74, 36039 Fulda
DRK-Krankenhaus, Hainstraße 77, 35216 Biedenkopf
Ketteler Krankenhaus, Lichtenplattenweg 85, 63071 Offenbach
Kreiskrankenhaus Frankenberg, Forststraße 9, 35066 Frankenberg
