Keywords Certified cancer center - specialized treatment - lung cancer - cohort study - survival
- quality of cancer care
Schlüsselwörter Zertifiziertes Krebszentrum - spezialisierte Behandlung - Lungenkrebs - Kohortenstudie
- Überleben - Qualität der Krebsversorgung
Introduction
With 2.21 million incident cases in 2020, lung cancer is globally the second most
frequent malignancy [1 ]. This is reflected
by the epidemiological situation in many countries like Germany: According to the
latest national cancer report [2 ], 56,577
persons were diagnosed with lung cancer in 2022 and the incidence rates, especially
among the female population, are still expected to rise.
With respect to the high complexity of lung cancer treatment [3 ]
[4 ]
[5 ], many countries have been
developing programs to promote the establishment of specialized cancer centers [6 ]
[7 ]
[8 ]
[9 ]
[10 ]. In Germany, the German Cancer Society (GCS; German: Deutsche
Krebsgesellschaft, DKG) has been offering organ-specific certifications programs
since 2003 [11 ]. Currently, there exist 18
different GCS-certification programs which are also implemented in other European
countries like Austria, Italy, and Switzerland. Among 1,960 GCS-certified centers
in
Germany [12 ], 79 are specialized in lung
cancer and 3 are currently in the application process [13 ]. To achieve GCS-certification, a
hospital must meet a wide range of requirements. These include structural measures
such as regular interdisciplinary communication, consensus decision-making in
structured tumor boards, and maintaining multi-professional outreach networks. Lung
cancer centers must regularly demonstrate their expertise in structured survey forms
regarding diagnostic procedures, radiation therapy, nuclear medicine treatments,
drug-based and surgical tumor therapy, as well as palliative care. They undergo
regular external audits, with their performance indicators published in publicly
available annual quality reports by the GCS [14 ].
However, sound evidence for better patient outcomes in certified lung cancer centers
compared to other hospitals is still missing due to a lack of studies on the topic.
Previous studies with colorectal [15 ]
[16 ]
[17 ] and prostate cancer [18 ]
[19 ] patients point towards
better functional and prognostic outcomes after treatment in GCS-certified cancer
centers but are subject to potential restrictions concerning their internal and
external validity. To overcome issues like limited regional coverage, small sample
sizes or insufficient information on patient- and hospital-level, the WiZen-study
(German Innovation Fund, grant number 01VSF17020) has been initiated. Using medical
routine data provided by the largest German statutory health insurance company and
four large clinical cancer registries, it has been the goal of this large cohort
study to compare patient survival after treatment in GCS-certified cancer centers
and non-certified hospitals for eight different tumor entities. The present
publication aims to provide an in-depth overview of the study’s lung cancer specific
results.
Patients and methods
The WiZen-study
The WiZen-study was conducted as a set of retrospective cohort studies from July
1st, 2018, to August 31st, 2021 by four distinct institutions: Zentrum für
Evidenzbasierte Gesundheitsversorgung (ZEGV)/ Hochschulmedizin Dresden,
Tumorzentrum Regensburg (TZR), Arbeitsgemeinschaft Deutscher Tumorzentren e. V.
(ADT), and Wissenschaftliches Institut der AOK (WIdO). Collaboration partners
included GCS, Klinisches Krebsregister Dresden (KKRD), Klinisches Krebsregister
Erfurt (KKE), and Klinisches Krebsregister für Brandenburg und Berlin (KKBB).
The primary objective was to investigate whether receiving treatment at
GCS-certified cancer centers for breast cancer, colorectal cancer, gynecological
cancer, head and neck cancer, lung cancer, neurooncological tumors, pancreatic
cancer, and prostate cancer is correlated with improved overall survival. To
answer this question, data from different sources was analyzed: i) statutory
health insurance (SHI) data provided Germany’s largest health insurance company
“Allgemeine Ortskrankenkassen” (AOK), ii) clinical cancer registry (CCR) data,
provided by four large population-based clinical cancer registries, iii)
GCS-certification reports. More details about these data sources can be found in
the original study protocol of the WiZen-study, which was registered on
ClinicalTrials.gov (identifier: NCT04334239) and is also available online at the
following link: https://innovationsfonds.g-ba.de/beschluesse/wizen-wirksamkeit-der-versorgung-in-onkologischen-zentren.111
and in existing publications [20 ]
[21 ]
[22 ]
[23 ]
[24 ]
[25 ]
[26 ]
[27 ]
[28 ]. The present publication focuses on the study’s lung cancer
specific results.
Inclusion and exclusion criteria
All results reported in this paper refer to patients with diagnosis of incident
lung cancer according to the ICD-10-GM codes C33 (malignant neoplasm of
trachea), C34 (malignant neoplasm of bronchus and lung), and D38.1 (neoplasm of
uncertain behavior of trachea, bronchus, and lung, SHI data only). Moreover, the
following additional criteria had to be fulfilled to be included either in the
SHI- or the CCR-based analyses: a) patients had to be at least 18 years of age
at the time of diagnosis, b) the survival-time had to be greater than zero, c)
no previous diagnoses of lung cancer were allowed (this information was directly
available for the CCR data; concerning the SHI data, a patient was considered as
incident between 2009 and 2017 only if there was no diagnosis of lung cancer
between 2006–2008 following the guideline “good practice of secondary data
analysis” [29 ]; for this reason
patients with a cancer diagnosis between 2006 and 2008 were excluded both from
the SHI and the CCR data based analyses), d) there had to be sufficient
information concerning the certification status of the treating hospital.
In addition to this, the following criteria have been applied to the SHI-data: e)
there had to be a continuous AOK-insurance over a patient’s entire observation
period, f) there had to be at least one primary inpatient diagnosis according to
one of the above mentioned diagnostic codes, g) patients treated in a hospital
which became GCS-certified within one year subsequent to primary treatment (and,
therefore, is likely to have already fulfilled the quality standards of
certification, although it would be analyzed as part of the non-certified group)
were excluded. Concerning the CCR-dataset, patients whose histological subtype
was inconsistent with the tumor entities of interest (e. g. lymphoma or sarcoma)
were additionally excluded.
Statistical analysis
Both data sources have their advantages: While SHI data e. g. provide
comprehensive information about a patient’s comorbidities, CCR data can give
detailed insights in tumor characteristics. However, since the overlap between
the patient collectives in both data sources would have been comparatively
small, it was decided to conduct the analyses separately and interpret the
results together. Thus, the maximum amount of information could be
extracted.
Patients with incident lung cancer were considered “certified lung cancer center
patients” a) if primary tumor resection (documented by the OPS codes 5-320 –
5-325 and 5-327 – 5-329, together with a primary inpatient diagnosis according
to ICD-10-GM C33, C34, D38.1) was performed in a certified lung cancer center or
a directly associated hospital, or – in the absence of a documented primary
resection – b) if the first lung cancer specific inpatient treatment (documented
by a primary inpatient diagnosis according to ICD-10-GM C33, C34, D38.1) took
place in a certified lung cancer center or a directly associated hospital.
The primary outcome assessed was overall survival, with recurrence-free survival
(including local recurrence and recurrent distant metastases, analyzed based on
CCR data only) as the secondary outcome. Each enrolled patient was considered at
risk of death or tumor recurrence from the date of the index treatment (using
SHI data) or diagnosis (using CCR data) onward. The follow-up duration extended
until the occurrence of death or tumor recurrence. In instances where the
specified outcomes did not occur, the patient's follow-up time was
right-censored. The observation period for all patients concluded on December
31st, 2017. The survival time was expressed in years in all statistical
analyses. To compare unadjusted survival rates between GCS-certified lung cancer
centers and non-certified hospitals within the initial five years after the
index treatment, the Kaplan-Meier method was employed.
To account for the potentially unbalanced distribution of important confounders,
multivariable Cox-regression models were developed. In the CCR-based analyses,
it was possible to adjust for age (categorized in groups based on
epidemiological considerations: 18-59, 60-79, 80+), sex, year of diagnosis,
histological subtype, UICC-stage, grade, lymphatic, and venous invasion. For the
SHI-based analyses, the following covariates were included in the model: age
(categorized in groups based on epidemiological considerations: 18-59, 60-79,
80+), sex, year of index treatment, distant metastasis, relevant comorbidities
selected by a panel of independent clinical experts (categorized according to
Elixhauser [30 ]), and hospital
characteristics (case-loads, academic status, ownership). Moreover, a shared
frailty term was included in the model to account for correlation between
outcomes of patients treated in the same hospital [31 ].
All significance tests were conducted as two-sided tests with a significance
level set at 0.05. The reported results include the associated p-value and/or
the upper and lower boundaries of the 95% confidence interval. R, version 3.6.3,
was utilized for the analyses based on SHI data. IBM SPSS 25 (IBM SPSS
Statistics for Windows, Version 25.0. Armonk, NY, USA: IBM Corp.) was employed
for the analyses based on CCR data. The findings of this survey are presented in
strict compliance with the Strengthening the Reporting of Observational studies
in Epidemiology (STROBE) statement [32 ] (supplementary table S1, online). The study was also listed at
ClinicalTrials.gov (identifier: NCT04334239).
Data protection and ethics
Information related to GCS-certification, patient details, tumor characteristics,
and hospital attributes underwent pseudonymization at WIdO and the collaborating
cancer registries. The pseudonymized data were subsequently analyzed at ZEGV
(SHI) and TZR (CCR). The WiZen-study received approval from the ethics committee
of TU Dresden (approval number: EK95022019). Data processing and analyses
adhered to the principles outlined in the Declaration of Helsinki and the
General Data Protection Regulation of the European Union.
Results
Inclusion process
Between 2009 and 2017, the SHI- and the CCR-dataset contained 304,751 and 36,069
patients, respectively, with the ICD-10-GM diagnoses C33, C34, or D38.1. After
the application of all inclusion criteria, 173,999 patients (57.1%) from the SHI
and 35,702 patients from the CCR-dataset (99.0%) met all eligibility criteria
and were included in the study. ([Fig.
1 ]).
Fig. 1 Inclusion and exclusion of patients (a ) SHI data,
b ) CCR data).
Share of patients treated in GCS-certified colorectal cancer centers
According to the SHI data, the share of patients treated in GCS-certified lung
cancer centers was 3.9% in 2009. It gradually rose to 29.3% in 2017 ([Fig. 2 ]; analyzing the CCR data, a
gradient from 0.9% in 2009 to 43.1% in 2017 was seen.). Moreover, the rate of
center treatment over the whole observation period differed substantially
between the different regions (defined by German federal states): It ranged
between 1.9% and 64.1% (supplementary Table S2, online).
Fig. 2 Share of patients treated in GCS-certified lung cancer
centers (SHI and CCR data).
Description of collectives
While age groups were distributed almost equally among the patients of certified
and non-certified hospitals in the CCR-dataset, a slightly higher share of
patients aged 80 and older was seen in the non-certified group of the
SHI-dataset (16.5% vs. 11.5%, [Table
1 ]). An overview of Elixhauser comorbidities of the patients in the
SHI dataset considered relevant by independent clinical experts is provided in
online supplementary Table S3. Within the SHI dataset, more patients of
non-certified hospitals already had distant metastases at the time of diagnosis
([Table 1 ]). Concerning further
tumor characteristics, the CCR-dataset provides deeper insights: Again, there
was a higher share of UICC stage IV tumors among patients of non-certified
hospitals (49.7% vs. 43.8%) and patients of certified hospitals were more likely
to have low stages (UICC I/0: 19.2% vs. 12.4%; [Table 2 ]). Generally, GCS-certified
cancer centers had more hospital beds, were slightly less often privately owned,
and had more frequently the status of a teaching or even university hospital
than non-certified hospitals ([Table
3 ]).
Table 1 Patient characteristics (SHI and CCR
data).
SHI data
CCR data
treatment in GCS-certified centers
yes
no
yes
no
n
%
n
%
n
%
n
%
sex
female
11,953
34.3
45,876
33.0
2,814
30.8
7,696
29.0
male
22,931
65.7
93,239
67.0
6,325
69.2
18,867
71.0
age
mean (median)
67.5 (68.0) years
69.1 (70.0) years
68.0 (68.8) years
68.4 (69.6) years
18 – 59
7,919
22.7
27,375
19.7
2,083
22.8
6,088
22.9
60 – 79
22,962
65.8
88,745
63.8
6,063
66.4
17,088
64.3
80+
4,003
11.5
22,995
16.5
993
10.9
3,387
12.8
distant metastasis
yes
13,513
38.7
68,427
49.2
4,003
43.8
13,191
49.7
total
34,884
100.0
139,115
100.0
9,139
100.0
26,563
100.0
Table 2 Tumor characteristics (CCR data).
Treatment in GCS-certified centers
yes
no
n
%
n
%
histological entity
SCLC
1,366
14.9
4,433
16.7
NSCLC
7,773
85.1
22,130
83.3
UICC stage
I/0
1,757
19.2
3,294
12.4
II
870
9.5
1,681
6.3
III
2,202
24.1
4,715
17.8
IV
4,003
43.8
13,191
49.7
X
307
3.4
3,682
13.9
grade
G1
300
3.3
658
2.5
G2
2,491
27.3
6,343
23.9
G3/4
3,216
35.2
9,204
34.6
GX
3,132
34.3
10,358
39.0
lymphatic invasion
L0
1,701
18.6
3,292
12.4
L1
673
7.4
1,293
4.9
LX
6,765
74.0
21,978
82.7
venous invasion
V0
1,965
21.5
3,806
14.3
V1/2
402
4.4
751
2.8
VX
6,772
74.1
22,006
82.8
total
9,139
100.0
26,563
100.0
Table 3 Hospital characteristics (SHI
data).
Treatment in GCS-certified centers
yes
no
n
%
n
%
hospital beds
1 – 299
21
34.4
631
57.8
300 – 499
13
21.3
269
24.7
500 – 999
17
27.9
150
13.7
1000+
10
16.4
41
3.8
hospital ownership
public
20
32.8
399
36.6
non-profit
32
52.5
459
42.1
private
9
14.8
233
21.4
academic status
university hospital
6
9.8
25
2.3
teaching hospital
47
77.0
605
55.5
total
61
100.0
1,091
100.0
Overall survival, Kaplan-Meier analyses
The median follow-up time over all patients without an event regardless of
certification status was 2.6 years (SHI data, CCR data 3.4). Within the SHI
data, the 5-year Kaplan-Meier survival rate over all patients was 28.0% (95%CI
27.4%, 28.6%) for GCS-center patients and 16.9% (95%CI 16.7%, 17.1%) for
patients from other hospitals ([Fig.
3a ]). The difference between the two survival curves was highly
significant (p<0.001). Similar results were seen in the CCR dataset: Here,
the 5-year survival rates were 21.4% (95%CI 20.0%, 22.9%) for center and 13.6%
(95%CI 13.1%, 14.1%) for non-center patients (p<0.001, [Fig. 3b ] and supplementary table S4,
online).
Fig. 3 Kaplan-Meier curves and Cox regression analysis for overall
survival (OAS). (a ) Kaplan-Meier survival curves OAS (SHI data).
(b ) Kaplan-Meier survival curves OAS (CCR data). (c )
Unadjusted and adjusted hazard ratios with 95%CI for all-cause mortality
(SHI and CCR data) following treatment in GCS-certified lung cancer
centers compared to treatment in non-certified hospitals. * adjusted for
age, sex, year of index treatment, distant metastasis, Elixhauser
comorbidities, and hospital characteristics ** adjusted for age, sex,
year of diagnosis, histological subtype, UICC-stage, grade, lymphatic,
and venous invasion.
Overall survival, Cox-regression analyses
Within the SHI data, the unadjusted hazard ratio (HR) over all patients for
all-cause mortality with shared frailty on hospital level was 0.90 (95%CI 0.87,
0.93) for treatment in a GCS-certified cancer center. After adjustment for age,
sex, year of index treatment, distant metastasis, Elixhauser comorbidities, and
hospital characteristics, it rose to 0.97 (95%CI 0.94, 1.00, [Fig. 3c ]), missing significance
slightly. The results for all covariates contained in the adjusted
Cox-regression model can be found in online supplementary Table S5. Analyzing
patients without distant metastases separately, significant advantages for
center-based treatment were seen (HR 0.92, 95%CI 0.88, 0.96). These and further
sensitivity analyses with stratification for age and sex can be found in online
supplementary Table S6.
In the CCR data set, the unadjusted hazard ratio for all-cause mortality across
all patients was 0.73 (95% CI 0.71, 0.75) when treated in a GCS-certified cancer
center. Following adjustment for variables including age, sex, year of
diagnosis, exact ICD-10-GM diagnosis, UICC stage, grade, lymphatic and venous
invasion, this ratio changed to 0.85 (95% CI 0.82, 0.88, as shown in [Fig. 3c ]; detailed results for all
covariates in the adjusted Cox-regression model are available in supplementary
Table S7, online). These findings indicate a statistically significant advantage
in overall survival for those treated in a GCS-certified lung cancer center
(p<0.001). This result remained stable in the sensitivity analyses: After the
exclusion of patients with unknown UICC-stage, the hazard ratio for all-cause
mortality was still 0.85 (95%CI 0.82, 0.88) in favor of treatment in
GCS-certified cancer centers. Concentrating on stage I to III patients only, the
effect was even more pronounced (HR 0.83; 95%CI 0.78, 0.88). Generally, the
effect of center-treatment was stronger in lower (UICC I/0: HR 0.77, UICC II HR
0.70) than in higher stages (UICC III: 0.89, UICC IV: 0.97). Analyzing NSCLC-
and SCLC patients separately, the hazard ratio for all-cause mortality was 0.84
(95%CI 0.81, 0.88) and 0.87 (95%CI 0.81, 0.94), respectively. The detailed
results of these and further sensitivity analyses can be found in online
supplementary Table S6.
Recurrence-free survival, Cox-regression analyses
Using the CCR data it was also possible to analyze recurrence free survival of
R0-resected stage I – III patients; the adjusted hazard ratio for death or tumor
recurrence was 0.82 (95%CI 0.75, 0.90). Further subgroup analyses concerning
recurrence free survival can be found in online supplementary Table S8.
Discussion
Summary
The analyses based on SHI and CCR data yielded significantly higher survival
rates for patients treated in GCS-certified lung cancer centers. After
adjustment for important covariates like age, comorbidities, or the year of
index treatment in the SHI-based analyses, the hazard of death was 5% lower in
patients treated in certified lung cancer centers, although this difference
missed the pre-defined significance level of 0.05 slightly. In the CCR-based
analyses, the hazard of death after treatment at a GCS-certified lung cancer
center was significantly lower by 15% after adjustment for a variety of patient-
and tumor characteristics.
The observed divergence of the certification effect between the country-wide
SHI-based analyses and the CCR-based analyses for four regions from the
South-East is most likely to be attributed to regional heterogeneity on
different levels: Analyzing epidemiological data from the observation period
reveals substantial differences concerning incidence, mortality and relative
survival rates for lung cancer between the different federal states [33 ]. For example, the 5-year relative
survival rate of male lung cancer patients was 13.8% in the federal state of
Mecklenburg-Vorpommern in 2009 compared to 25.2% in the federal state of Bavaria
in 2017. At the same time, the rate of patients treated in certified
institutions observed in the present study differed substantially between the
federal states. This might be attributed to substantial structural differences
between the federal states. While the accessibility of certified institutions is
very high in urban states like Berlin or Hamburg, there are other states like
Mecklenburg-Vorpommern or Bavaria with a high proportion of rural regions and a
consecutively lower accessibility to certified institutions. Considerable
socioeconomic differences between the different federal states might also play a
role in this context. While certified cancer centers are already well
established in the treatment of other tumor entities like breast or colorectal
cancer, the number of lung cancer centers is comparatively low: In 2012 only 34
certified institutions existed, rising to a number of 49 in 2017 [13 ]. Currently, there are 79 lung
cancer centers in Germany and the majority of lung cancer treatment still takes
place outside of certified hospitals. Taking also into account the very low
median life expectancy of lung cancer patients in general it becomes obvious
that regional differences concerning epidemiological or structural aspects might
have influenced the presented analyses substantially. Future research should
therefore aim to analyze lung cancer treatment with special respect to regional
disparities.
Notwithstanding this, the results of the present study show that after the
exclusion of patients with distant metastases the survival benefit following
center treatment was more pronounced and also significant in the SHI data-based
analyses. This might be explained by the fact that prolonging survival might not
always be the primary goal of the treatment of UICC-stage IV patients and the
spectrum of possible treatment modalities is limited in the presence of distant
metastases; at the same time, these patients represent approximately 50% of all
lung cancer patients which could explain the absence of a significant survival
benefit in the SHI-based main analysis.
Strengths and limitations
Unlike smaller previous studies on the topic, the WiZen-study’s analyses are
based on a truly comprehensive patient cohort. In total, more than one million
patients with eight tumor entities were included. While many studies exclude
patients with unfavorable characteristics like high age or advanced tumor stages
[34 ]
[35 ], all these patients remained part
of the study collective. Thus, the reported results are truly population-based.
This is also reflected by the fact that the population characteristics (age-,
sex-, and stage-distribution) and the observed survival rates reported in this
paper are consistent with the figures presented in the national epidemiological
cancer report of Germany [36 ].
Ideally, one would like to conduct a randomized controlled trial to analyze the
effectiveness of center-based cancer treatment. Obviously, such a study design
cannot be realized in this specific context: Patients select their hospital
based on a variety of factors like referral by other health professionals,
advice from fellow-patients, regional accessibility, individual preferences, and
many more [37 ]. A patient’s
socioeconomic status and her or his health literacy are also an important factor
in this context. Subjecting people to a random allocation process would
represent a severe restriction of their right of self-determination and has to
be regarded as highly unethical. Therefore, the selected observational study
design with independent standardized controlled prospective data collection in a
large health insurance database and several comprehensive clinical cancer
registries can be regarded as most adequate [25 ]
[38 ]. However, future
studies on the topic could try to reconstruct the patients’ and their treating
ambulatory physicians’ preferences by means of artificial intelligence and
implement them in the analyses [39 ].
With observational data and non-randomized group allocation, it is always
important to correct for a potentially imbalanced distribution of potential
confounders. Since data from two different sources was available, it was
possible to integrate an extraordinarily large amount of different patient- and
tumor-associated factors in the multivariable analyses. The reported results can
be expected to reflect the cause-specific certification effect, although this
assumption cannot be tested empirically. For certain variables, especially tumor
characteristics in the CCR dataset, information was missing – predominantly in
patients from non-certified hospitals. However, in the performed sensitivity
analyses patients with incomplete information were excluded and the results
remained stable.
To achieve reliable and valid results, the WiZen-study followed a conservative
approach: In the detailed results of the SHI-based Cox-regression analysis (cf.
supplementary table S5, online) one can see that the regression models
attributed the certification effect partially to other confounders like hospital
size (300-499 beds: HR 0.93, 500-999 beds: HR 0.86, 1000+beds: HR 0.87) , status
as a teaching hospital (HR 0.99), or university hospital (HR 0.83), whose
distribution is highly collinear to the status of certification. Due to the fact
that the share of center-treatments rose over time, it is possible that
adjusting for the year of index treatment eliminated part of the
certification-effect, too. The center-effect might have been further
under-estimated since patients treated in a hospital which forms part of an
association with a GCS-certified cancer center have been regarded as
center-treated although their treatment might still not have met
center-standard.
The value of certification
The question whether concentrating (lung) cancer treatment in specialized centers
or hospitals with large caseloads has been subject to international research for
many years: In 2001, Bach et al. [40 ]
analyzed over 2,000 patients from the US National Inpatient Sample and found
that receiving a lung-resection in large-volume hospitals is associated with a
45%-reduction of postoperative complications, postoperative mortality (-50%),
and better 5-year overall survival (+33%). Similar results were obtained from a
national cohort analysis in England: In 2015, Møller et al. [41 ] showed that patients who received
lung cancer surgery in a hospital belonging to the highest quintile concerning
surgical volume “had about half the odds of death within 30 days than patients
from the lowest quintile.” A recent nation-wide analysis from South Korea also
showed that short- and long-term survival is significantly better for patients
treated in high-volume hospitals [42 ].
While these findings generally support the results of this study, it has to be
stated, though, that the GCS-certification goes far beyond a simple case-load
based classification of hospitals and of course the treatment of lung cancer,
especially of advanced stages, encompasses far more than just surgery.
Therefore, it is very interesting to compare the results of this study to the
findings of several studies from the US concentrating on the treatment in NCI
(National Cancer Institute)-designated cancer centers, which have been
established from 1971 onwards [9 ]. In
2005, Birkmeyer et al. [43 ] analyzed
63,860 patients aged 65-99 years with lung, esophageal, gastric, pancreatic,
bladder, and colon carcinoma. They compared the patients from 51 NCI-designated
cancer centers to patients from 51 high-volume hospitals without designation; in
this retrospective cohort study treatment in designated centers was associated
with lower adjusted surgical short-term mortality rates (pulmonary resection:
6.3% vs. 7.9%; p=0.010), although no significant difference in terms of
long-term survival could be observed. In contrast to this, Onega et al. [44 ] found out that treatment for lung,
breast, colorectal and prostate cancer in an NCI-designated cancer center is
associated with “a significant reduction in the odds of 1- and 3-year all-cause
and cancer-specific mortality”. In 2021, Okawa et al. [45 ] published their registry-based
observational study about the situation in Japan: There also exist accredited
high-capacity, high experience cancer care hospitals; treatment at these
intuitions has been associated with the higher adjusted all-site 3-year survival
probabilities (86.6%) in contrast to non-designated hospitals (78.8%). A
systematic review informing the recently published “European Respiratory Society
Guideline on various aspects of quality in lung cancer care” could also show
that treatment in specialized lung cancer centers leads to lower 30- and 90-day
morbidity and mortality and better long-term survival [46 ], which is absolutely in-line with
the results of the present study.
Furthermore, it is essential to acknowledge that the landscape of metastatic lung
cancer care has undergone a profound transformation in recent years following
the introduction and widespread utilization of immunotherapy as well as
second/third-generation targeted agents. It's noteworthy that these
advancements occurred after the completion of data collection for the present
study in 2017. Given this evolving scenario, it appears probable that the
significance of certified lung cancer centers specializing in these innovative
therapies will experience a notable escalation and the survival benefit
associated with center-treatment will probably increase further. However, this
assumption should be tested in a follow-up study on the topic based on recent
clinical routine data.
In summary, the lung-cancer specific results of the Wizen-study presented in this
publication contribute to a constantly growing international evidence base
pointing towards the additional value of cancer treatment in designated centers.
In concordance with research results from other countries with similar
certification programs, the observed survival benefit associated with treatment
in GCS-certified lung cancer centers seems to be not just a consequence of
hospital size or large caseloads but also of structural and procedural
improvements, like the reception of different consultations, early and dedicated
image controls, availability of radiotherapy facilities, palliative care etc.,
induced by the certification. This information should be actively transported to
patients, referring outpatient physicians, and decision makers. From a
regulatory perspective, certification based on the criteria of the GCS could be
defined as a structural requirement for billing corresponding healthcare
services, leading to a potential shift of more treatment cases to certified
centers.
Statement of Ethics
The WiZen-study was approved by the ethics committee of the TU Dresden (approval
number: EK95022019, IRB 00001473, OHRP IORG0001076). Data processing and analyses
was conducted in line with the Declaration of Helsinki and the General Data
Protection Regulation of the European Union.
Registration
The study was listed at ClinicalTrials.gov (identifier: NCT04334239).
Data Availability Statement
Data Availability Statement
The authors confirm that the data utilized in this study cannot be made available
in
the manuscript, the supplemental files, or in a public repository due to German data
protection laws (‘Bundesdatenschutzgesetz’, BDSG).
Fundref Information
Gemeinsamer Bundesausschuss — 01VSF17020
