13. Supply structures – Endometrial Cancer
13.1 Preliminary remarks
Endometrial carcinoma is the most common genital carcinoma in women. The age of onset is unchanged at around 70 years. The incidence and mortality are slowly increasing. For endometrial carcinoma, there is no direct primary prevention and no secondary prevention. Risk reduction is possible only indirectly through behavioral variation with weight regulation. A number of women participating in the statutory cancer screening program for cervical carcinoma are randomly diagnosed with endometrial carcinoma.In Germany, structures have been created to comprehensively regulate diagnostics, therapy and follow-up care, leading to better outcomes. These structures are continuously being developed: Goals to improve potential cancer prevention, further develop oncology care structures, ensure efficient oncology treatment and strengthen patient orientation have been included in the National Cancer Plan (http://www.bmg.bund.de/praevention/nationaler-krebsplan.html).
The need to evaluate the care situation in Germany was clearly recognized, as was the need for studies to survey long-term follow-up and the training situation.
The 10-year status quo of care data on patients with endometrial cancer treated in certified gynecologic cancer centers is now available (Kennzahlenauswertung 2020, https://www.onkozert.de/wordpress/wp-content/uploads/2020/04/qualitaetsindikatoren_gynaekologische-krebserkrankungen_2020-A1_200402.pdf?v=44353574). Based on the data now available, the strategies of the National Cancer Plan have been modified. However, there were no changes for endometrial cancer.
The data situation on the topic of care structures for women with endometrial carcinoma is still limited to a few studies. Clear evidence-based statements on the effects of care structures on patient-related outcome parameters in Germany are possible only to a limited extent.
13.2 Treatment in oncology centers
Patients with endometrial cancer should be treated by an interdisciplinary team. This team should include all necessary disciplines in a cross-sector network. This is most likely to be feasible in a certified center.
- Consensus
- Strong consensus
13.2.1 Interdisciplinary and cross-sector care
The care of patients with suspected endometrial carcinoma or diagnosed endometrial carcinoma is an interdisciplinary and cross-sectoral task. In order to achieve an optimal treatment outcome for the patient, it is necessary that the various structures and acting persons along the care chain work together in a coordinated, interdisciplinary and cooperative manner [913], [914]. The basis for this care is the definition of centers established within the framework of the National Cancer Plan: “A network of qualified and jointly certified, interdisciplinary and trans-sectoral facilities (hospitals, medical practices, rehabilitation facilities), possibly spanning multiple locations, which, if professionally required, represent as far as possible the entire care chain for affected persons, forms a center” [913].
The work of the centers is based on the relevant organ cancer guidelines as well as the relevant cross-sectional guidelines (e.g., palliative care) of the Oncology Guideline Program.
Results of surveys in certified breast and colorectal cancer centers were able to show that the implementation of the center concept described has positive effects on the quality of care for patients in the certified networks from the point of view of the service providers [915], [916] and that patient satisfaction is also very high [917], [918], [919]. In addition, evaluations of guideline-based quality indicators in certified centers show that the contents of the guidelines are well implemented and patients are treated in accordance with the guidelines [920].
In this system, the aim is to achieve high quality in prevention, diagnostics and therapy through to rehabilitation and palliation for the patient. To achieve this, processes and structures within the network must be optimized on an interdisciplinary and cross-sectoral basis. The 3-level center model with the formation of Organ Cancer Centers, Oncology Centers and Comprehensive Cancer Centers with cooperating partners (e.g. practices) at all levels of care is the basis for this high-quality care structure [913], [921].
Since 2008, Gynecologic Cancer Centers have been certified by the German Cancer Society (DKG) in cooperation with the German Society for Gynecology and Obstetrics (DGGG) and the Working Group for Gynecologic Oncology (AGO).
The 2020 key figure evaluation in the annual report of the Certified Gynecological Cancer Centers Audit Year 2019 – Key Figure Year 2018 (https://www.onkozert.de/wordpress/wp-content/uploads/2020/04/qualitaetsindikatoren_gynaekologische-krebserkrankungen_2020-A1_200402.pdf?v=44353574) shows 155 certified centers as of December 31, 2019. When the previous version was created, there were 100 certified centers (as of March 2014). This shows the continuous increase of certified centers since the beginning of certification in 2008.
The quality indicators of the present guideline are described in Chapter 14.
Overall, between 43 to 50% of all gynecologic cancers are treated in certified centers [922]. In the meantime, due to the high treatment numbers, corresponding information on the implementation of the quality indicators of the individual guidelines is also available, so that a reflection of the individual data for the guideline commissions is possible. The gynecological tumors ovarian carcinoma, cervical carcinoma and endometrial carcinoma are all covered by S3 Guidelines from the Oncology Guidelines Program. S2k Guidelines are available for vulvar carcinoma, vaginal carcinoma and other tumors (trophoblastic tumors and sarcomas). Thus, the diagnosis, therapy and follow-up of gynecological carcinomas are very well covered by recommendations and statements from guidelines.
Analogous to the breast cancer centers, the establishment of nationwide care is also aimed at, so that the care of patients with gynecological carcinomas takes place in a quality-assured, certified, interdisciplinary and cross-sectoral form. Especially due to the increasing number of new cases at the age of > 70 years with corresponding comorbidity, the interdisciplinary collaboration of proven and certified experts is even more important. Despite the overall good prognosis of endometrial carcinoma, it has now been shown that patients with endometrial carcinoma have a treatment advantage if they are treated by specialized gynecological oncologists [923], [924].
Since an invasive endometrial carcinoma is often already present at the time of diagnosis of endometrial hyperplasia with atypia in the curettage material or endometrial biopsy, treatment should already take place at a specialized center in the case of a primary diagnosis of endometrial hyperplasia with evidence of atypia [463]. Especially in more aggressive histological type, higher grading and advanced stage, treatment by specialized gynecologic oncologists results in a significant improvement of recurrence-free interval and overall survival [925].
Therefore, in certified centers, the qualitative and quantitative expertise of the treating physicians, for example via the subspecialisation Gynecologic Oncology [926] or the number of surgical and systemic therapies performed [927]. Patients with endometrial carcinoma who are operated on at a center with a high number of cases have a lower mortality rate [927], [928]. Minimum case numbers are necessary to provide quality-assured care according to the current standard of care [927], [928]. Furthermore, a prompt start of therapy must be guaranteed in the treating gynecological cancer centers. A delay in therapy has been shown to have a negative impact on patient survival [929]. The goal must be that patients diagnosed with endometrial cancer have the opportunity to turn to centers that transparently present their quality and fulfill the corresponding criteria [913], [921], [930].
13.2.2 Center concept - Interdisciplinary tumor conferences
All patients with endometrial cancer shall be presented at an interdisciplinary tumor conference.
- Consensus
- Strong consensus
Background
The interdisciplinary tumor conference is the central element for the necessary coordination of the different levels of care and patient-related decisions on diagnostics, therapy and follow-up, involving the various treatment partners. This is where decisions are made regarding the patient's diagnostic and therapeutic course of treatment. The determination of the interdisciplinary coordinated treatment concept for a patient with initial manifestation or new recurrence/metastases of endometrial carcinoma within the framework of this interdisciplinary tumor conference is considered a central prerequisite for achieving patient-related optimal oncological treatment results with the lowest possible morbidity at the same time. Therefore, the interdisciplinary tumor conference is a central point in the certification process. The interdisciplinary tumor conference for the treatment of patients with endometrial carcinoma consists of at least one gynecological oncologist, pathologist, radiologist and radiation therapist present. Other disciplines are consulted as needed. These center structures must be funded in the health care system. Patient care should be focused on those units that offer the full spectrum of standard therapies, in order to provide comprehensive, quality-assured care for the patient here while making optimal use of limited resources. Resources should be used in a targeted manner, diagnostics and therapy should be in line with guidelines and quality should be verifiable through appropriate documentation [921], [930]. In December 2019, the G-BA (Joint Federal Committee) adopted nationwide quality requirements for the assumption of special tasks by hospitals in cutting-edge medicine. These tasks are to be financed via center surcharges, as they are services for other service providers or overarching tasks. Certified oncology centers have been a successful part of these deliberations and are thus eligible for surcharges.
13.2.3 Interdisciplinary supply chain
The first link in the care chain is the gynecologist in private practice, who identifies a patient with endometrial cancer either by an abnormal cytological or clinical finding in the course of the statutory cancer screening examinations or by the abnormal symptoms.
On April 3, 2013, the Act for the Further Development of Early Cancer Detection and for Quality Assurance through Clinical Cancer Registries (Krebsfrüherkennungs- und –Registergesetz (Cancer Early Detection and Register Act) – KFRG) was passed. As part of the law, among other objectives, two screening programs – namely for cervical carcinoma and colon carcinoma/rectal carcinoma – were established. As a result, people with statutory health insurance are entitled to participate in organized screening free of charge. After a gynecological examination and in the presence of a conspicuous cytological smear, a patient is given further histological clarification either on site or in a certified gynecological dysplasia consultation/unit, if appropriate expertise is available.
13.2.3.1 Consensus care algorithm of the Guideline Group
Background
With histological confirmation of the suspected diagnosis and assessment of the clinical tumor stage, the patient is referred to a unit that ensures the appropriate diagnostic and therapeutic options. For this purpose, the German Cancer Society (DKG), in cooperation with the German Society of Gynecology and Obstetrics (DGGG) and the Working Group for Gynecological Oncology (AGO), has established the certified Gynecological Cancer Centers [914], [913]. Certification ensures that interdisciplinary and intersectoral cooperation takes place, which determines the diagnostic and therapeutic algorithm for patients within the framework of the Interdisciplinary Tumor Conference. At present, only those units are certified and subsequently audited annually that present their treatment quality transparently and publicly.
If neoadjuvant or adjuvant drug therapy concepts are pursued, implementation is also possible within the certified network in the outpatient setting by specialized gynecologic oncologists (BNGO) or hematooncologists and internal oncologists (BNHO).
13.2.4 “Outpatient Specialized Medical Care”
Not all regions of Germany have a certified Gynecological Cancer Center. However, in order to ensure quality-assured care in such areas as well, so-called outpatient specialist care was created, in short “ASV” (from the German, “Ambulante Spezialfachärztliche Versorgung“). Here, too, specialized physicians from different disciplines work together in a team and jointly take over diagnostics and treatment. ASV is offered by hospitals, specialists in private practice and medical care centers.
13.2.5 Longitudinal documentation of patient history
The decisive factor in the entire care chain is that the information from the individual areas of care is collected and systematically documented in order to be able to make statements on process, structural and outcome quality that are relevant to care.
This approach is pursued by the Cancer Early Detection and Registry Act (KFRG), since a central data pooling is to take place here and thus data is collected both across sectors and across locations in order to then use it for the presentation of the quality of outcomes.
For this purpose, a basic data set is defined via the Data Efficient Uniform Tumor Documentation (DET) working group, initiated by the Federal Ministry of Health (BMG), with which the data are documented across sectors. This data set is revised on a regular basis. The basic data set also contains the data fields required for mapping the quality indicators relevant to planning, as well as quality assurance measures from the Joint Federal Committee (G-BA) or from the various sectors of the healthcare system's providers.
After the data has been entered by the providers, the necessary information is to be made available to the treating physicians and patients through central data documentation and evaluation by the clinical cancer registries of the federal states.
Due to the quality of the S3 Guidelines, it is possible to create corresponding quality indicators for the certification system and thus the verification for everyday care. Within the certification system of the gynecological cancer centers, corresponding quality indicators were taken from the Guidelines, which have been continuously reviewed over the past years. These results are fed back to the certification commission to see if any improvement or implementation has taken place in the context of day-to-day clinical care. In addition, however, recommendations for deletion or integration of new quality indicators into the certification system may be made by the Guideline Commission. The former, for example, in the case of standard value fulfillment over several years, at which point no further improvement in the quality of care can be achieved. The latter, if new current findings should be integrated into the daily patient care.
Thus, the system of certified gynecologic cancer centers, high-quality guidelines with their quality indicators and cancer registration in a quality cycle oncology functions in an exemplary manner. Through the progress of continuous development, this system supports the high-quality care of the patient with endometrial cancer.
These high-quality indicators also form the basis for IQTiG within the framework of the statutory quality assurance measures (see special Chapter 14).
13.2.6 Possibility for education and training
Physician education and training in the treatment of the patient with endometrial cancer should be provided at a Gynecologic Cancer Center/Oncology Center.
- Consensus
- Strong consensus
The Guideline Group is not aware of any meta-analyses, randomized trials or observational studies on the specific training and continuing education situation for endometrial cancer in Germany. Training and continuing education generally take place as a specialist in the field or in specialized training. The overall comprehensive topic is the treatment of gynecological malignancies, for which treatment principles are often similar.
The training of physicians treating patients with endometrial carcinoma should focus on certified networks in order to ensure a high quality of training with regard to the implementation of the Guideline and the latest standards through high case numbers, interdisciplinarity and bundling of competencies [913], [921], [930]. The basic prerequisite is the guidelines laid down in the 2004 regulations for further training on the number of services that must be provided as part of specialist further training, specialist further training and/or facultative further training. The performance of major surgical interventions as part of the advanced training in gynecological oncology or the disease-specific chemotherapies as part of the additional training in drug-based tumor therapy can be provided only where a minimum number of patients with this clinical picture are treated on an interdisciplinary basis by physicians with corresponding further training or qualification requirements and proven oncological experience. The current high number of specialists and focal point holders in the various areas of care currently makes comprehensive care possible. However, the number of further training authorizations is stagnating or has declined slightly in recent years. It is becoming apparent that in the future the number of persons in specialized training will be smaller and thus the future care of patients with gynecological carcinomas will become more difficult [926], [930].
References
[913] B, e, c, k, m, a, et.al. Gynäkologische Krebszentren – Kompetenzbündelung zur Qualitätsverbesserung, Frauenheilkunde up2date, 2009. 3: p. 71-74.
[914] Wesselmann, S., Beckmann, M. W., Winter, A., The concept of the certification system of the German Cancer Society and its impact on gynecological cancer care, Arch Gynecol Obstet, 2013. 289: p. 7-12., https://www.ncbi.nlm.nih.gov/pubmed/24220845
[915] Kowalski, C., Wesselmann, S., Ansmann, L., Kreienberg, R., Pfaff, H., Zertifizierte Brustkrebszentren aus Sicht der Zentrumsleitungen: Ergebnisse einer Schlüsselpersonenbefragung, Geburtsh Frauenheilk, 2012. 72: p. 235-242.
[916] Huthmann, D., Seufferlein, T., Post, S., Benz, S., Stinner, B., Wesselmann, S., Zertifizierte Darmkrebszentren aus Sicht der Zentrumsleitungen: Ergebnisse einer Schlüsselpersonenbefragung, Gastroenterol, 2012. 50: p. 753-759.
[917] Kowalski, C., Wesselmann, S., Ansmann, L., Kreienberg, R., Pfaff, H., Zertifizierte Brustkrebszentren aus Sicht der Patientinnen: Stärken und Verbesserungspotenziale, Geburtsh Frauenheilk, 2012. 71: p. 137-143.
[918] Thiel, F. C., Scharl, A., Hildebrandt, T., Kotziabassis, E., Schrauder, M. G., Bani, M. R., et.al. Financing of certified centers: a willingness-to-pay analysis, Arch Gynecol Obstet, 2012. 287: p. 495-509., https://www.ncbi.nlm.nih.gov/pubmed/23080545
[919] Lux, M. P., Fasching, P. A., Bani, M. R., Schrauder, M., Marketing von Brust- und Perinatalzentren – Sind Patientinnen mit dem Produkt „zertifiziertes Zentrum“ vertraut?, Geburtsh Frauenheilk, 2009. 69: p. 321-327.
[920] Wesselmann, S., Winter, A., Ferencz, J., Seufferlein, T., Post, S., Documented quality of care in certified colorectal cancer centers in Germany: German Cancer Society benchmarking report for 2013, Int J Colorectal Dis, 2014. 29: p. 511-8., https://www.ncbi.nlm.nih.gov/pubmed/24584335
[921] Beckmann, M. W., Adler, G., Albers, P., Bruns, J., Dreistufenmodell optimiert Behandlung unter Kostendeckung Wie die künftigen Strukturen der onkologischen Versorgung in Deutschland aussehen sollten, Dtsch Arztebl, 2007. 104: p. 3004-3009., https://www.aerzteblatt.de/archiv/57409/Onkologie-Dreistufenmodell-optimiert-Behandlung-unter-Kostendeckung-Wie-die-kuenftigen-Strukturen-der-onkologischen-Versorgung-in-Deutschland-aussehen-sollten
[922] O, n, k, o, z, e, et.al. Kennzahlenauswertung 2020 - Jahresbericht der zertifizierten Gynäkologischen Krebszentren - Auditjahr 2019 / Kennzahlenjahr 2018, 2020., https://www.onkozert.de/wordpress/wp-content/uploads/2020/04/qualitaetsindikatoren_gynaekologische-krebserkrankungen_2020-A1_200402.pdf?v=44353574
[923] Roland, P. Y., Kelly, F. J., Kulwicki, C. Y., Blitzer, P., Curcio, M., Orr, J. W., Jr., The benefits of a gynecologic oncologist: a pattern of care study for endometrial cancer treatment, Gynecol Oncol, 2004. 93: p. 125-30., https://www.ncbi.nlm.nih.gov/pubmed/15047225
[924] Macdonald, O. K., Sause, W. T., Lee, R. J., Dodson, M. K., Zempolich, K., Gaffney, D. K., Does oncologic specialization influence outcomes following surgery in early stage adenocarcinoma of the endometrium?, Gynecol Oncol, 2005. 99: p. 730-5., https://www.ncbi.nlm.nih.gov/pubmed/16139348
[463] Antonsen, S. L., Ulrich, L., Hogdall, C., Patients with atypical hyperplasia of the endometrium should be treated in oncological centers, Gynecol Oncol, 2011. 125: p. 124-8., https://www.ncbi.nlm.nih.gov/pubmed/22198048
[925] Chan, J. K., Sherman, A. E., Kapp, D. S., Zhang, R., Osann, K. E., Maxwell, L., et.al. Influence of gynecologic oncologists on the survival of patients with endometrial cancer, J Clin Oncol, 2011. 29: p. 832-8., https://www.ncbi.nlm.nih.gov/pubmed/21263082
[926] Beckmann, M. W., et al., Der neue Schwerpunkt Gynäkologische Onkologie: nationale und internationale Chance?, Geburtsh Frauenheilk, 2006. 66: p. 123-127.
[927] Ioka, A., Tsukuma, H., Ajiki, W., Oshima, A., Influence of hospital procedure volume on uterine cancer survival in Osaka, Japan, Cancer Sci, 2005. 96: p. 689-94., https://www.ncbi.nlm.nih.gov/pubmed/16232201
[928] Diaz-Montes, T. P., Zahurak, M. L., Giuntoli, R. L., 2nd, Gardner, G. J., Bristow, R. E., Uterine cancer in Maryland: impact of surgeon case volume and other prognostic factors on short-term mortality, Gynecol Oncol, 2006. 103: p. 1043-7., https://www.ncbi.nlm.nih.gov/pubmed/16876234
[929] Elit, L. M., O'Leary, E. M., Pond, G. R., Seow, H. Y., Impact of wait times on survival for women with uterine cancer, J Clin Oncol, 2013. 32: p. 27-33., https://www.ncbi.nlm.nih.gov/pubmed/24276779
[930] Beckmann, M. W.,, Frauenarzt/-ärztin der Zukunft: müssen die Kliniken neu strukturiert werden?, Der Gynäkologe, 2010. 43: p. 748-756., https://www.springermedizin.de/frauenarzt-aerztin-der-zukunft-muessen-die-kliniken-neu-struktur/8104622