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1.
Geburtshilfe Frauenheilkd ; 84(2): 153-163, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38344046

ABSTRACT

Introduction: Certified breast cancer centers offer specific quality standards in terms of their structure, diagnostic and treatment approaches with regards to breast surgery, drug-based cancer therapy, radiotherapy, and psychosocial support. Such centers aim to improve treatment outcomes of breast cancer patients. The question investigated here was whether patients with primary breast cancer have a longer overall survival if they are treated in a certified breast cancer center compared to treatment outside these centers. Methods: We used patient-specific data (demographics, diagnoses, treatments) obtained from data held by mandatory health insurance companies ( gesetzliche Krankenversicherung , GKV) and clinical cancer registries (KKR) for the period 2009-2017 as well as hospital characteristics recorded in standardized quality reports. Using multivariable Cox regression analysis, we investigated differences in survival between patients treated in hospitals certified as breast cancers centers by the German Cancer Society (DKG) and patients treated in hospitals which had not been certified by the DKG. Results: The sample population consisted of 143720 (GKV data) and 59780 (KKR data) patients with breast cancer, who were treated in 1010 hospitals across Germany (280 DKG-certified, 730 not DKG-certified). 63.5% (GKV data) and 66.7% (KKR data) of patients, respectively, were treated in DKG-certified breast cancer centers. Cox regression analysis for overall survival which included patient and hospital characteristics found a significantly lower mortality risk for patients treated in DKG-certified breast cancer centers (GKV data: HR = 0.77, 95% CI = 0.74-0.81; KKR data: HR = 0.88, 95% CI = 0.85-0.92). This result remained stable even after several sensitivity analyses including stratified estimates for subgroups of patients and hospitals. The effect was even more pronounced for recurrence-free survival (KKR data: HR = 0.78, 95% CI = 0.74-0.82). Conclusions: Patients who are treated by an interdisciplinary team in a DKG-certified breast cancer had clear and statistically significantly better survival rates. Certification is therefore an effective means of improving the quality of care, and more patients should be treated in certified breast cancer centers.

2.
Breast Cancer Res Treat ; 204(3): 607-615, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38238552

ABSTRACT

PURPOSE: The optimal time to initiation of adjuvant chemotherapy (TTAC) for triple negative breast cancer (TNBC) patients is unclear. This study evaluates the association between TTAC and survival in TNBC patients. METHODS: We conducted a retrospective study using data from a cohort of TNBC patients diagnosed between January 1, 2010 to December 31, 2018, registered in the Tumor Centre Regensburg was conducted. Data included demographics, pathology, treatment, recurrence and survival. TTAC was defined as days from primary surgery to first dose of adjuvant chemotherapy. The Kaplan-Meier method was used to evaluate impact of TTAC on overall survival (OS) and 5-year OS. RESULTS: A total of 245 TNBC patients treated with adjuvant chemotherapy and valid TTAC data were included. Median TTAC was 29 days. The group receiving systemic therapy within 22 to 28 days after surgery had the most favorable outcome, with median OS of 10.2 years. Groups receiving systemic therapy between 29-35 days, 36-42 days, and more than 6 weeks after surgery had significantly decreased median survival, with median OS of 8.3 years, 7.8 years, and 6.9 years, respectively. Patients receiving therapy between 22-28 days had significantly better survival compared to those receiving therapy between 29-35 days (p = 0.043), and patients receiving therapy after 22-28 days also demonstrated significantly better survival compared to those receiving therapy after more than 43 days (p = 0.033). CONCLUSION: Timing of adjuvant systemic therapy can influence OS in TNBC patients. Efforts should be made to avoid unnecessary delays in administering chemotherapy to ensure timely initiation of systemic therapy and optimize patient outcomes.


Subject(s)
Breast Neoplasms , Triple Negative Breast Neoplasms , Humans , Female , Triple Negative Breast Neoplasms/pathology , Retrospective Studies , Breast Neoplasms/pathology , Chemotherapy, Adjuvant/methods , Combined Modality Therapy , Neoplasm Staging
3.
J Cancer Res Clin Oncol ; 149(13): 11941-11950, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37418056

ABSTRACT

PURPOSE: For patients with triple negative breast cancer (TNBC), the optimal time to initiate neoadjuvant chemotherapy (TTNC) is unknown. This study evaluates the association between TTNC and survival in patients with early TNBC. METHODS: A retrospective study using data from of a cohort of TNBC patients diagnosed between January 1, 2010 to December 31, 2018 registered in the Tumor Centre Regensburg was performed. Data included demographics, pathology, treatment, recurrence, and survival. Interval to treatment was defined as days from pathology diagnosis of TNBC to first dose of neoadjuvant chemotherapy (NACT). The Kaplan-Meier and Cox regression methods were used to evaluate the impact of TTNC on overall survival (OS) and 5 year OS. RESULTS: A total of 270 patients were included. Median follow up was 3.5 years. The 5-year OS estimates according to TTNC were 77.4%, 66.9%, 82.3%, 80.6%, 88.3%, 58.3%, 71.1% and 66.7% in patients who received NACT within 0-14, 15-21, 22-28, 29-35, 36-42, 43-49, 50-56 and > 56 days after diagnosis. Patients who received systemic therapy early had the highest estimated mean OS of 8.4 years, while patients who received systemic therapy after more than 56 days survived an estimated 3.3 years. CONCLUSION: The optimal time interval between diagnosis and NACT remains to be determined. However, starting NACT more than 42 days after diagnosis of TNBC seems to reduce survival. Therefore, it is strongly recommended to carry out the treatment in a certified breast center with appropriate structures, in order to enable an adequate and timely care.


Subject(s)
Breast Neoplasms , Triple Negative Breast Neoplasms , Humans , Female , Neoadjuvant Therapy , Triple Negative Breast Neoplasms/pathology , Retrospective Studies , Breast Neoplasms/pathology , Neoplasm Staging , Antineoplastic Combined Chemotherapy Protocols , Prognosis , Chemotherapy, Adjuvant
4.
Healthcare (Basel) ; 11(11)2023 Jun 03.
Article in English | MEDLINE | ID: mdl-37297780

ABSTRACT

Generating evidence for the efficacy of an intervention is not sufficient to guarantee its implementation in real-world settings. The randomized AMBORA trial (Medication Safety with Oral Antitumor Therapy) demonstrated that an intensified clinical pharmacological/pharmaceutical care program has substantial benefits for patients, treatment teams, and the healthcare system. Thus, we are now investigating its implementation into routine care within the AMBORA Competence and Consultation Center (AMBORA Center). We perform a multicenter type III hybrid trial following the RE-AIM framework to assess the clinical effectiveness of this care program under real-world conditions, while evaluating the implementation outcomes. Semi-structured stakeholder interviews based on the Consolidated Framework for Implementation Research (CFIR) have been conducted to identify barriers and facilitators. So far, 332 patients treated with oral antitumor drugs have been referred to the AMBORA Center by 66 physicians from 13 independent clinical units. In 20 stakeholder interviews (e.g., with clinic directors), 30% (6/20) of the interviewees anticipated possible barriers which may partly hinder sustainable implementation (e.g., unavailable consultation rooms). Furthermore, important facilitators (e.g., operational processes) were identified. This methodological description adds knowledge on how to structure a hybrid effectiveness-implementation trial and proposes multilevel implementation strategies to improve the medication safety of oral antitumor therapy.

5.
J Cancer Res Clin Oncol ; 149(10): 7493-7503, 2023 Aug.
Article in English | MEDLINE | ID: mdl-36964405

ABSTRACT

PURPOSE: The aim of our study was to explore the impact of the COVID-19 pandemic on reported cancer cases in Bavaria, Germany, by comparing pre-pandemic (March 2019 to February 2020) and pandemic period (March 2020 to February 2021). METHODS: Data on incident cases were retrieved from the Bavarian Cancer Registry (until 22nd April 2022). We included patients with malignant and in situ neoplasms reported by pathology departments with consistent reporting. We calculated the number of incident cases during the COVID-19 pandemic and the pre-pandemic period with 95% confidence intervals (CI) with Bonferroni correction (α = 0.0018) based on a Poisson approach. We stratified for malignancy (malignant, in situ), tumor site, and month of year. RESULTS: Data was available for 30 out of 58 pathology departments (51.7%) from Bavaria. Incident malignant neoplasms dropped from 42,857 cases in the pre-pandemic period to 39,980 cases in the pandemic period (- 6.7%; 95% CI - 8.7%, - 4.7%). Reductions were higher for colon, rectum, skin/melanoma as well as liver (> 10.0% reduction) and less for breast cancer (4.9% reduction). No case reductions were observed for pancreas, esophagus, ovary, and cervix. Percent changes were largest for April 2020 (- 20.9%; 95% CI - 24.7%, - 16.8%) and January 2021 (- 25.2%; 95% CI - 28.8%, - 21.5%) compared to the previous year. Declines tended to be larger for in situ compared to malignant neoplasms. CONCLUSION: Detection and diagnosis of cancer were substantially reduced during the COVID-19 pandemic. Potential effects, e.g. a stage shift of tumors or an increase of cancer mortality, need to be monitored.


Subject(s)
Breast Neoplasms , COVID-19 , Melanoma , Female , Humans , Pandemics , COVID-19/epidemiology , Germany/epidemiology
6.
Arch Gynecol Obstet ; 307(5): 1573-1583, 2023 05.
Article in English | MEDLINE | ID: mdl-36282347

ABSTRACT

BACKGROUND: Several international studies reported relatively high re-excision rates due to residual tumor in breast conserving surgery (BCS). Cavity shaving (CS) is a surgical strategy to reduce re-excision rates. This study aimed to investigate the effect of circumferential cavity shaving during BCS to reduce residual tumor. MATERIAL AND METHODS: A total of 591 patients with early invasive carcinoma or carcinoma in situ of the breast (ICD-10, C50 or D05) who were diagnosed between 01/01/2017 and 31/12/2019 and underwent BCS in a certified breast cancer center of the University Regensburg were analyzed regarding surgical excision methods. Patients with CS during BCS and patients with targeted re-excision in a specific direction depending on the result of intraoperative mammography or sonography during BCS were compared. The risk of pathologic residual tumor (R1) was compared between both groups by means of a multivariable binary logistic regression model to determine if there is a benefit of a certain surgical method to avoid a second intervention for re-excision. We adjusted for age, tumor size, nodal status, histologic type, surgeon, breast side, and neoadjuvant chemotherapy. RESULTS: 80 (n = 13.54%) patients had CS and 511 (n = 86.46%) had a targeted re-excision in a specific direction during BCS according to intraoperative mammography or sonography. After comparing both techniques in a multivariable regression model, there was no significant difference regarding risk of residual tumor (p = 0.738) in the total cohort. However, CS showed a tendency to be favorable regarding rates of residual tumor in patients with invasive breast cancer between 60 and 70 years (p = 0.072) and smaller T1-tumors (p = 0.057) compared to targeted intraoperative re-excision following mammographic or sonographic assessment. CONCLUSION: CS showed a tendency to reduce residual tumor compared to the standard technique of intraoperative re-excision in specific subgroups, although no statistical significance was reached. Further studies are needed to overcome potential limitations like surgeon-based bias and missing standardized definitions of CS to reduce residual tumor rates.


Subject(s)
Breast Neoplasms , Carcinoma in Situ , Carcinoma, Ductal, Breast , Humans , Female , Mastectomy, Segmental/methods , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/surgery , Neoplasm, Residual/pathology , Reoperation , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Carcinoma in Situ/surgery , Retrospective Studies
7.
Gesundheitswesen ; 85(7): 649-656, 2023 Jul.
Article in German | MEDLINE | ID: mdl-36328158

ABSTRACT

How can we improve the interoperability of medical guidelines and the implementation and measurement of outcomes in medical health care for cancer patients as well as for care providers? This is the aim of the working group "Quality and Cross-linking". The following publication gives an overview of the targets reached in the development of guidelines together with quality indicators and documentation in cancer registries.


Subject(s)
Medical Oncology , Neoplasms , Humans , Germany , Neoplasms/therapy , Registries , Quality Control
8.
J Cancer Res Clin Oncol ; 148(3): 719-726, 2022 Mar.
Article in English | MEDLINE | ID: mdl-33914125

ABSTRACT

PURPOSE: Since 2008, guidelines recommend that patients with HER2-positive early breast cancer (BC) should receive adjuvant chemotherapy in combination with trastuzumab in Germany. However, recent studies highlight that a substantial share of patients do not receive trastuzumab. We investigate which patient characteristics are associated with a tumor board recommendation for trastuzumab in Breast Cancer Centers (BCC) certified by the German Cancer Society (DKG) and the German Society for Senology, and if the recommendation differs between BCCs. MATERIALS AND METHODS: Multi-level modeling was performed using quality assurance data based on 3052 HER2-positive, operated patients with a first diagnosis of early BC treated between 2006 and 2019 in 17 BCCs in Germany to investigate whether trastuzumab recommendation varies with patient sex, age, and disease characteristics, as well as over time and across BCCs. RESULTS: Tumor board recommendations for trastuzumab differ substantially between BCCs (intraclass correlation coefficient [ICC] null model: 0.11). Our final model (ICC 0.17, Akaike Information Criterion [AIC], 1328.0, R2 0.69) shows that physicians in BCCs more often recommend trastuzumab to patients who are younger than 60 years and those with a recommendation for any additional therapy (chemotherapy, radiation or endocrine therapy) (all p < 0.05). Furthermore, there is a significant time-dependent increase of trastuzumab recommendations (odds ratio [OR] = 1.38, 95% confidence interval [CI] = 1.31-1.46, p < 0.05). CONCLUSION: In certified BCCs in Germany, guideline concordant trastuzumab recommendation is increasing since 2006 (positive cohort effect). Recommendation of trastuzumab for HER2-positive BC patients in BCCs is significantly associated with patients' age and the recommendations for other additional therapy strategies, apart from surgery. The quality assurance data analyzed do not include potentially relevant confounders, such as socioeconomic status or comorbidities.


Subject(s)
Antineoplastic Agents, Immunological/therapeutic use , Breast Neoplasms/drug therapy , Practice Guidelines as Topic/standards , Practice Patterns, Physicians'/statistics & numerical data , Receptor, ErbB-2/metabolism , Trastuzumab/therapeutic use , Adult , Aged , Breast Neoplasms/immunology , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Female , Follow-Up Studies , Humans , Middle Aged , Prognosis
9.
Arch Gynecol Obstet ; 305(1): 203-213, 2022 01.
Article in English | MEDLINE | ID: mdl-34223974

ABSTRACT

PURPOSE: Treatment according to guidelines has been demonstrated to improve survival in a number of different cancer entities. Deviations from guidelines depend on several factors, including the patient's preferences, age and comorbidities. The aim of this study was to assess the adherence to guideline recommendations concerning surgical and adjuvant treatment in endometrial cancer. Furthermore, we sought to evaluate the reasons for non-adherence to guidelines by further examining the influence of comorbidities and age. METHODS: The influence of age, comorbidities, tumor stage and histological subtype on guideline adherence was evaluated by multivariable logistic regression in a cohort of 353 high-grade endometrial cancer patients. High-grade endometrial cancer was defined as carcinosarcoma, Type II (serous, clear cell, mixed cell carcinoma) and Type I G3 histology. RESULTS: Extensive surgical procedures, particularly systematic LNE, were less frequently applied in patients with comorbidities (p = 0.015) or higher age (p < 0.01). Guideline adherence was not affected by comorbidities (p = 0.563), but was significantly reduced with higher age (p < 0.01). In a multivariable model, higher age (p < 0.01), obesity (p = 0.011), higher FIGO Stage (p < 0.01) and histologic subtype (p < 0.01) significantly decreased OS. Surgery (p < 0.001), chemotherapy (p < 0.01) and systematic LNE (p = 0.011) were associated with higher OS. CONCLUSION: Age seems to be the strongest independent factor leading to guideline deviation. Comorbidities were associated with less aggressive treatment, but not with deviations from guidelines.


Subject(s)
Carcinosarcoma , Endometrial Neoplasms , Carcinosarcoma/pathology , Endometrial Neoplasms/pathology , Female , Humans , Neoplasm Staging , Radiotherapy, Adjuvant , Retrospective Studies
11.
Geburtshilfe Frauenheilkd ; 81(6): 612-636, 2021 Jun.
Article in English | MEDLINE | ID: mdl-34168377

ABSTRACT

Aim The aim of the interdisciplinary S3-guideline Perimenopause and Postmenopause - Diagnosis and Interventions is to provide help to physicians as they inform women about the physiological changes which occur at this stage of life and the treatment options. The guideline should serve as a basis for decisions taken during routine medical care. This short version lists the statements and recommendations given in the long version of the guideline together with the evidence levels, the level of recommendation, and the strength of consensus. Methods The statements and recommendations are largely based on methodologically high-quality publications. The literature was evaluated by experts and mandate holders using evidence-based medicine (EbM) criteria. The search for evidence was carried out by the Essen Research Institute for Medical Management (EsFoMed). To some extent, this guideline also draws on an evaluation of the evidence used in the NICE guideline on Menopause and the S3-guidelines of the AWMF and has adapted parts of these guidelines. Recommendations Recommendations are given for the following subjects: diagnosis and therapeutic interventions for perimenopausal and postmenopausal women, urogynecology, cardiovascular disease, osteoporosis, dementia, depression, mood swings, hormone therapy and cancer risk, as well as primary ovarian insufficiency.

12.
Breast Cancer Res Treat ; 187(3): 715-727, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33721148

ABSTRACT

BACKGROUND: The axillary lymph node status is one of the most important prognostic factors in patients with early breast cancer. However, the impact of axillary lymph node micrometastases on survival remains unclear. There are no consistent recommendations for adjuvant chemotherapy (CHT). In this context, we aimed to investigate the impact of micrometastases on the clinical outcome of breast cancer patients according to the adjuvant CHT performed. PATIENTS AND METHODS: We conducted a retrospective population-based registry study of 26,465 patients aged between 24 and 97 years with primary breast cancer diagnosed between 2003 and 2017. Of these patients, 8856 with early breast cancer were eligible for analysis: 8316 (93.9%) were node negative and 540 (6.1%) had lymph node micrometastases. RESULTS: The median follow-up was 7.2 years, with a confidence interval (CI) of 7.1-7.3 years. Patients with lymph node micrometastases (pN1mi) without adjuvant CHT have reduced 10-year overall survival (OS) and recurrence-free survival (RFS) compared to patients who had axillary lymph node micrometastases and received an adjuvant CHT. However, this effect disappeared after adjustment for age, tumor size and tumor grading. Furthermore, in the group of patients with lymph node micrometastases, the administration of adjuvant CHT did not improve OS or RFS, compared to patients with lymph node micrometastases without adjuvant CHT: hazard ratio for treated patients was 1.51 (95% CI 0.80-2.85, p = 0.208) for OS and 1.12 (95% CI 0.63-1.97, p = 0.705) for RFS. CONCLUSION: Patients with axillary lymph node micrometastases showed a comparable outcome to node negative patients and their outcome was not significantly improved with CHT. Thus, axillary lymph node micrometastases should not be considered in the treatment decision.


Subject(s)
Breast Neoplasms , Neoplasm Micrometastasis , Adult , Aged , Aged, 80 and over , Axilla , Breast Neoplasms/drug therapy , Breast Neoplasms/surgery , Chemotherapy, Adjuvant , Female , Humans , Lymph Nodes , Lymphatic Metastasis , Middle Aged , Retrospective Studies , Sentinel Lymph Node Biopsy , Young Adult
14.
Arch Gynecol Obstet ; 304(3): 759-771, 2021 09.
Article in English | MEDLINE | ID: mdl-33575846

ABSTRACT

PURPOSE: Due to insufficient and conflicting prospective evidence, the recommendations on when to apply adjuvant radiochemotherapy in early-stage cervical cancer vary between international guidelines. In this population-based study, we evaluated the outcome of patients with early-stage cervical cancer based on risk factors and the adjuvant therapy they received. METHODS: The effect of primary therapy (surgery and radiochemotherapy RCT, surgery and radiotherapy RT, and surgery alone) on overall survival (OS) and recurrence-free survival (RFS) was evaluated in the complete cohort of 442 patients and in subgroups according to risk profile and nodal status. RESULTS: In low-risk patients, there was no difference in OS (p = 0.276) depending on whether patients received adjuvant therapy or not. Concerning RFS, patients with RT (including one patient with RCT) exhibited a significantly worse outcome compared to the group with surgery alone (p = 0.015). In intermediate-risk patients, the administration of adjuvant RT significantly benefited RFS when compared to surgery only in multivariate analysis (p = 0.031). Concerning OS, no significant influence for adjuvant treatment could be seen (p = 0.354). Though trends towards better OS and RFS could be observed in patients of the high-risk group-both in RCT and RT groups compared to surgery alone-the effects did not prove to be significant. CONCLUSION: Our study reaffirms the evidence against the use of adjuvant radio(chemo)therapy in low-risk early-stage cervical cancer. In intermediate-, and less pronounced in high-risk patients, however, it seems to be beneficial. The role of adjuvant radio(chemo)therapy in early cervical cancer should be further investigated in prospective randomized trials.


Subject(s)
Antineoplastic Agents/therapeutic use , Combined Modality Therapy/methods , Uterine Cervical Neoplasms/drug therapy , Uterine Cervical Neoplasms/radiotherapy , Adult , Aged , Aged, 80 and over , Chemotherapy, Adjuvant , Female , Humans , Kaplan-Meier Estimate , Middle Aged , Neoplasm Staging , Radiotherapy Dosage , Radiotherapy, Adjuvant , Survival Rate , Treatment Outcome , Uterine Cervical Neoplasms/mortality , Uterine Cervical Neoplasms/pathology
15.
J Cancer Res Clin Oncol ; 147(6): 1813-1823, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33230583

ABSTRACT

PURPOSE: The usage of radioactive Technetium99m (Tc99m) colloid for the purpose of sentinel lymph node biopsy (SLNB) in early breast cancer is considered the gold standard in Germany. However, new tracers, such as near-infrared (NIR) imaging agents like indocyanine green (ICG) could offer an alternative in future, as they overcome drawbacks associated with radioactive Technetium99m (Tc99m) like limited availability, high costs and radioactivity exposure for both patients and surgeons. METHODS: In this double-arm retrospective study, we sought to establish the usefulness of indocyanine green as an alternative or an addition to the conventional Technetium99m (Tc99m) in the identification of the SLN in early breast cancer. RESULTS: Among the 161 patients who underwent primary SLNB, 34 patients had at least 1 SLN with metastasis. Among these patients with SLN metastasis, 33 had the SLN detected by ICG; while 31 had the SLN detected by Tc99m. The conventional Technetium99m radiotracer failed to detect 2 patients with metastasis in this Arm of the study. Among the 87 patients who underwent SLNB after NACT, 13 patients had at least 1 SLN with metastasis. Among these 13 patients with SLN metastasis, ICG and Tc99m had detected the SLN among 12 patients, while 1 patient had been detected by ICG alone. CONCLUSIONS: Our results show that ICG is as effective as the radioisotope for SLNB even among patients who have undergone NACT. This trial is registered with the German Clinical Trial Register, ID: DRKS00013606.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/pharmacology , Breast Neoplasms/pathology , Sentinel Lymph Node Biopsy , Sentinel Lymph Node/drug effects , Sentinel Lymph Node/diagnostic imaging , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Coloring Agents/analysis , Coloring Agents/pharmacokinetics , Diagnostic Imaging/instrumentation , Diagnostic Imaging/methods , Female , Fluorescence , Humans , Indocyanine Green/analysis , Indocyanine Green/pharmacokinetics , Lymphatic Metastasis , Middle Aged , Neoadjuvant Therapy , Optical Imaging/instrumentation , Optical Imaging/methods , Predictive Value of Tests , Retrospective Studies , Sentinel Lymph Node/metabolism , Sentinel Lymph Node/pathology , Sentinel Lymph Node Biopsy/instrumentation , Sentinel Lymph Node Biopsy/methods , Technetium/analysis , Technetium/pharmacokinetics
16.
Gesundheitswesen ; 82(8-09): e108-e121, 2020 Sep.
Article in German | MEDLINE | ID: mdl-32858754

ABSTRACT

Health services research in oncology deals with all situations which cancer patients face. It looks at the different phases of care, i. e. prevention / early detection, prehabilitation, diagnostics, therapy, rehabilitation and palliative care as well as the various actors, including those affected, the carers and self-help. It deals with healthy people (e. g. in the context of prevention / early detection), patients and cancer survivors. Due to the nature of cancer and the existing care structures, there are a number of specific contents for health services research in oncology compared to general health services research while the methods remain essentially identical. This memorandum describes the subject, illustrates the care structures and identifies areas of health services research in oncology. This memorandum has been prepared by the Oncology Section of the German Network for Health Services Research and is the result of intensive discussions.


Subject(s)
Health Services Research , Medical Oncology , Medicine , Germany , Humans , Palliative Care
17.
Arch Gynecol Obstet ; 302(3): 763-777, 2020 09.
Article in English | MEDLINE | ID: mdl-32661753

ABSTRACT

This short version of the interdisciplinary S3 guideline "Peri- and Postmenopause-Diagnosis and Interventions" is intended as a decision-making instrument for physicians who counsel peri- and postmenopausal women. It is designed to assist daily practice. The present short version summarizes the full version of the guideline which contains detailed information on guideline methodology, particularly regarding the critical appraisal of the evidence and the assignment of evidence levels. The statements and recommendations of the full version of the guideline are quoted completely in the present short version including levels of evidence (LoE) and grades of recommendation. The classification system developed by the Centre for Evidence-based Medicine in Oxford was used in this guideline.


Subject(s)
Societies, Medical , Evidence-Based Medicine/methods , Female , Germany , Guidelines as Topic , Humans , Middle Aged , Perimenopause , Postmenopause
18.
Arch Gynecol Obstet ; 301(3): 787-792, 2020 03.
Article in English | MEDLINE | ID: mdl-32048031

ABSTRACT

PURPOSE: Lymph node metastasis is a significant predictive factor for disease recurrence and survival in cervical cancer patients and relevant for therapeutic strategies. We evaluated the clinical value of indocyanine green (ICG) by measuring the sensitivity and negative predictive value of sentinel lymph node mapping compared with the gold standard of complete lymphadenectomy in detecting lymph node metastases for cervical cancer. METHODS: We utilized the near-infrared imaging agent ICG to detect tumor-infested lymph nodes in the pelvis analogue to a classical sentinel lymph node procedure by analyzing data from 20 patients who had undergone surgery for cervical cancer at our institution. A laparoscopic lymph node mapping procedure by means of ICG, followed by a complete pelvic lymphadenectomy with or without paraaortic lymphadenectomy was done in all patients. RESULTS: Histological examination identified seven patients with tumor-positive pelvic nodes, whereas mapping with ICG identified only five of these patients. Detection rate of positive nodes by ICG mapping and false negative rate was 71.4% and 28.6%, respectively; bilateral detection rate was 83.3%. One of the two false negative patients additionally suffered from deep infiltrating endometriosis. CONCLUSIONS: Our results indicate that ICG can identify the relevant pelvic nodes independent of tumor size, provided bilateral detection is achieved and additional, related diseases are excluded. TRIAL REGISTRATION: This trial is registered within the German Clinical Trial Register (DRKS-ID: DRKS00014692).


Subject(s)
Indocyanine Green/therapeutic use , Sentinel Lymph Node Biopsy/methods , Sentinel Lymph Node/diagnostic imaging , Uterine Cervical Neoplasms/surgery , Adult , Aged , Female , Humans , Indocyanine Green/pharmacology , Middle Aged , Retrospective Studies , Uterine Cervical Neoplasms/pathology
19.
J Cancer Res Clin Oncol ; 146(4): 961-969, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31901975

ABSTRACT

OBJECTIVE: The primary therapy for intermediate- and high-risk endometrial cancer includes pelvic and paraaortic lymph node evaluation. Laparoscopic surgery is an increasingly popular intervention due to decreased risk and better short-term morbidity; however, a recent study casts doubt on the benefit of this approach in terms of oncological safety. In this cancer registry study, we sought to evaluate the benefit of laparoscopy versus laparotomy and retrospectively compared overall survival, recurrence rates, and recurrence-free survival among patients with intermediate- and high-risk endometrial cancer who underwent either laparoscopic or open surgery. METHODS: This observational study included 419 patients who have been treated from 2011 to 2017. We employed Kaplan-Meier method, and univariable and multivariable Cox-regression to compare overall survival, recurrence rates, and recurrence-free survival in 110 patients, who underwent laparoscopic, with 309 patients, who underwent open surgery. To address the confounding bias in this retrospective study, we also performed a propensity score matching (PSM) analysis including 357 patients (laparoscopy: n = 107; open surgery: n = 250). RESULTS: We found a benefit for laparoscopic over open surgery in patients with intermediate- and high-risk endometrial cancer for overall survival in both univariable (p = 0.002; PSM: p = 0.016) and multivariable analyses (p = 0.019; PSM: p = 0.007). In contrast, there was no statistically significant difference between both patient groups regarding the cumulative recurrence rates. A univariable analysis identified a significant benefit for laparoscopy regarding recurrence-free survival (p = 0.003; PSM: p = 0.029) but a multivariable analysis failed to confirm this finding (p = 0.108; PSM: p = 0.118). CONCLUSIONS: Our study provides evidence that laparoscopic systematic lymphadenectomy does not present a lower oncological efficacy than open surgery in the treatment of patients with endometrial cancer.


Subject(s)
Endometrial Neoplasms/surgery , Lymph Node Excision/methods , Lymph Nodes/surgery , Aged , Cohort Studies , Disease-Free Survival , Endometrial Neoplasms/pathology , Female , Humans , Kaplan-Meier Estimate , Laparoscopy/methods , Laparoscopy/statistics & numerical data , Lymph Node Excision/statistics & numerical data , Lymph Nodes/pathology , Middle Aged , Neoplasm Staging , Propensity Score , Proportional Hazards Models , Retrospective Studies , Treatment Outcome
20.
Arch Gynecol Obstet ; 301(2): 573-583, 2020 02.
Article in English | MEDLINE | ID: mdl-31749031

ABSTRACT

PURPOSE: The German guideline for breast cancer recommends using chemotherapy (CHT) in patients with hormone receptor-positive and node-positive, invasive breast cancer. The aim of this study was to analyse the effects of CHT in this patient group on overall survival (OS) and distant metastases-free survival (DMFS), especially considering the 70-year threshold. METHODS: 1772 patients from the clinical cancer registry Regensburg (Germany) with hormone receptor-positive and node-positive, invasive breast cancer diagnosed between 2003 and 2013 were analysed in a retrospective cohort study. OS and DMFS were evaluated by means of Kaplan-Meier and multivariable Cox-regression method. Results were further examined according to age at diagnosis. RESULTS: The comparison of 1544 patients with CHT to 228 patients without CHT showed a significant benefit for CHT regarding 5-year OS (91.3% vs. 76.8%) and 5-year DMFS (86.7% vs. 74.4%, both p < 0.001). Likewise, better OS and DMFS were seen in patients aged < 70 years using CHT compared to patients without CHT of the same age. Patients aged ≥ 70 years with CHT had a minimal benefit regarding 5-year OS compared to patients without CHT, but no advantage considering DMFS. All results were confirmed in multivariable analyses except for patients being ≥ 70 years of age. CONCLUSION: Patients with hormone receptor-positive and node-positive, invasive breast cancer benefit from chemotherapy with regard to a significantly better overall and distant metastases-free survival, although chemotherapy use in patients aged ≥ 70 years results in a smaller benefit considering OS and no benefit considering DMFS.


Subject(s)
Breast Neoplasms/drug therapy , Chemotherapy, Adjuvant/methods , Aged , Breast Neoplasms/mortality , Disease-Free Survival , Female , Humans , Middle Aged
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