Certified Breast Cancer Centers Research Articles

Treatment in Certified Breast Cancer Centers Improves Chances of Survival of Patients with Breast Cancer: Evidence Based on Health Care Data from the WiZen Study.

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. 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. 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). 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.

Latissimus dorsi flap for breast reconstruction: a large single-institution evaluation of surgical outcome and complications

PurposeThe use of autologous tissues is considered gold standard for patients undergoing breast reconstruction and is the preferred method in the post-radiation setting. Although the latissimus dorsi flap (LDF) has been replaced by abdominal flaps as technique of choice, it remains a valuable option in several specific clinical situations and its use has been regaining popularity in recent years. In this work, we present an 18-year retrospective analysis of a single-institution single-surgeon experience with LDF-based reconstruction with focus on early complications and reconstructive failures.MethodsHospital records of all patients undergoing breast surgery for any reason in the Certified Breast Cancer Center, Regio Klinikum Pinneberg, Germany between April, 1st 2005 and October, 31st 2022 were reviewed. 142 consecutive LDF-based reconstructive procedures were identified. Detailed information was gathered on patient characteristics, treatment-related factors, and complications.ResultsOne hundred forty patients (139 female, 1 male) received 142 LDF-based surgeries. The flap was used mainly for immediate breast reconstruction with or without implant (83% of patients), followed by defect coverage after removal of a large tumor (7%), implant-to-flap conversion with or without placement of a new implant (6%), and delayed post-mastectomy reconstruction (4%). The use of LDF decreased between 2005 and 2020 (2005: 17, 2006: 13, 2007: 14, 2008: 16, 2009: 5, 2010: 9, 2011: 8, 2012: 3, 2013: 10, 2014: 8, 2015: 8, 2016: 7, 2017: 7, 2018: 4, 2019: 4, 2020: 2, 2021: 6, 2022: 4). Surgery was performed for invasive breast cancer in 78%, ductal carcinoma in situ in 20% and other reasons such as genetic mutation in 1% of patients. Ipsilateral radiation therapy was received by 12% of patients prior to LDF surgery and by 37% after the surgery. 25% of patients were smokers. The median duration of surgery, including all procedures conducted simultaneously such as e.g., mastectomy, axillary surgery, or implant placement, was 117 min (range 56–205). Patients stayed in the hospital for a median of 7 days (range 2–23 days). The most common complication was seroma (26%), followed by wound dehiscence (8%), surgical site infection (7%), partial skin and/or nipple necrosis of any size (7%) and hematoma requiring surgical evacuation (2%). 19% of all patients required seroma aspiration or drainage, mostly at the donor site and performed under ultrasound guidance in the ambulatory setting. Flap loss due to necrosis occurred in 2% of patients.ConclusionsLatissimus dorsi flap is a well-established surgical technique commonly used for immediate breast reconstruction as well as defect coverage in locally advanced breast cancer. To the best of our knowledge, this is one of the largest single-surgeon analyses of early complications in patients receiving LDF. As expected, seroma was the most common complication observed in nearly one third of patients and requiring a therapeutic intervention in every fifth patient. Serious adverse events occurred rarely, and flap loss rate was very low.

Whitepaper: Training in Diagnostic and Interventional Breast Radiology.

Breast imaging represents an integral part of radiology and is subject to strict quality controls. Regarding this, precise diagnostics including multimodal assessment by mammography, sonography, and MRI, including image-guided biopsy and localization procedures, is often decisive and must be performed by experts with profound knowledge and skills in all of these procedures.However, due to numerous restructurings, breast imaging has been shifted more and more towards large, specialized centers, resulting in less patient exposition and training opportunities for radiologists in smaller sites. The following whitepaper summarizes the current circumstances and discusses opinions of the participating societies. Under the leadership of the German Roentgen Society (DRG) and with the participation of the DRG's AG Mammadiagnostik, the CAFRAD (Chefarztforum Radiologie), the KLR (Konferenz der Lehrstuhlinhaber für Radiologie e. V.), the DRG's Forum Junge Radiologie (FJR) and the Berufsverband der Deutschen Radiologen e. V. (BDR), possible solutions were discussed and consented for a structured training in breast radiology in the future. In addition to the teaching provided at the primary workplace, qualified training should be ensured through flexible, multi-institutional, interdisciplinary, and cross-sectoral collaboration. Furthermore, the integration of online case collections and close cooperation with certified breast cancer centers and mammography screening units is recommended. It is indispensible that online courses and case collections adhere to the standards of the national societies and include a maximum of one third of the required cases. In order to provide training in breast radiology at a high professional level, a paradigm shift with closer cooperation of all participants is necessary. This includes close collaboration of the breast imaging societies with the federal medical associations to establish new teaching concepts like e-learning in the training schedule of radiologists. · Breast diagnostics is an integral part of radiology training.. · Due to recent restructurings, smaller training centers have difficulties in meeting the case numbers demanded by the Specialist Training Regulations (WBO). Improved integration of the new structures and their adaptation to the needs of education are necessary to guarantee standardized high-quality training of young radiologists.. · The integration of certified case collections enables quality-assured training, even across regions in online-based formats. In accordance with the "blended learning principle", up to one-third of the required number of patient studies can be substituted with cases from a certified case collection.. · Legally secured short- and medium-term internships may complement training in radiology.. · Sauer ST, Bley TA, Wenkel E et al. Whitepaper: Training in Diagnostic and Interventional Breast Radiology. Fortschr Röntgenstr 2023; 195: 699 - 706.

Impact of cavity shaving on residual tumor rates in patients with primary invasive carcinoma and carcinoma in situ in breast conserving surgery

BackgroundSeveral 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 MethodsA 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.Results80 (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.ConclusionCS 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.

Optimized process quality in certified breast centers through adherence to stringent diagnostic and therapeutic algorithms effects of structural as well as socio-demographic factors on start of therapy

PurposeAn increasing incidence of breast cancer can be observed worldwide. Since a delay of therapy can have a negative impact on prognosis, timely cancer care is an important quality indicator. By receiving treatment at a certified breast cancer center, the patient has the best chance of treatment in accordance with guidelines and the best prognosis. The identification of risk factors for a delay of therapy is of central importance and should be the basis for a continuous optimization of treatment at breast cancer centers.MethodsThis retrospective study included women with breast cancer (primary diagnosis, relapse, or secondary malignancy) at the University Hospital Würzburg in 2019 and 2020. Data were retrieved from patients’ records. Correlations and regression analyses were performed to detect potential risk factors for treatment delay.ResultsPatients who received the histological confirmation of breast cancer at an external institution experienced a later therapy start than those patients who received the histological confirmation at the University Hospital Würzburg itself. (35.7 vs. 32.2 days). The interval between histological confirmation and the first consultation at the University Hospital Würzburg correlated statistically significant with age, distress and distance to the hospital.ConclusionPatients with an in-house diagnosis of breast cancer are treated more quickly than those whose diagnosis was confirmed in an external institution. We identified factors such as increased age, greater distance to the hospital as well as increased distress to prolong the time until start of oncological treatment. Intensified patient care should be offered to these subgroups.

Use of social service counseling by cancer patients: an analysis of quality assurance data of 6339 breast cancer patients from 13 certified centers in Germany treated between 2015 and 2017

BackgroundIntegrated social care may help to mitigate social risk factors in order to achieve more equitable health outcomes. In cancer centers certified according to the criteria set out by the German Cancer Society, every patient must be given low-threshold access to qualified social workers at the center for in-house social service counseling (SSC). Previous analyses have demonstrated large variation in the utilization of these services across individual centers. Therefore, this research aims at investigating whether SSC utilization varies regarding breast cancer patient characteristics and center characteristics presenting a unique approach of using routine data.MethodsMultilevel modeling was performed using quality assurance data based on 6339 patients treated in 13 certified breast cancer centers in Germany in order to investigate whether SSC utilization varies with patient sex, age, and disease characteristics as well as over time and across centers.ResultsIn the sample, 80.3% of the patients used SSC. SSC use varies substantially between centers for the unadjusted model (ICC = 0.24). Use was statistically significantly (P < .001) more likely in women, patients with invasive (in comparison to tumor in situ/ductal carcinoma in situ) diseases (P < .001), patients with both breasts affected (P = .03), patients who received a surgery (P < .001), patients who were diagnosed in 2015 or 2017 compared to 2016 (P < .001) and patients older than 84 years as compared to patients between 55 and 64 years old (P = .002).ConclusionThe analysis approach allows a unique insight into the reality of cancer care. Sociodemographic and disease-related patient characteristics were identified to explain SSC use to some extent.

First Prospective Cross-Sectional Study on the Impact of Immigration Background and Education in Early Detection of Breast Cancer

Background: Although immigrant health is an important issue in national health policy, there is a serious shortage of data in many countries. Most studies lack information on educational status, which is a major limitation. This prospective cross-sectional study analyzed a real-world breast cancer population on the influence of immigration background and educational status on participation in breast cancer early detection programs in the federal state of Lower Saxony, Germany. Methods: Data collection was conducted from 2012 to 2016 in six certified breast cancer centers using a standardized questionnaire for patients’ interview and tumor-specific data from the patients’ medical records. Results: 2,145/3,047 primary breast cancer cases were analyzed. 17.5% of our patients had a history of immigration, including n = 202 first-generation immigrants and n = 168 second-generation immigrants. Most of them were citizens of EU27 member states. No significant difference was seen in age, tumor stage, histology, grading, Ki-67, Her2/neu-status, and hormone receptor status compared to the native cohort. 100% participation rate in the breast cancer early detection programs were seen in patients with no school graduation. With regards to the national mammography screening program, participation decreased significantly with educational status (p = 0.0003). Conclusions: No tumor biological differences were seen between immigrants and German natives. In first-generation immigrants, early detection programs were well accepted despite sociocultural and language differences. Participation rate decreased significantly with higher education levels irrespective of country of origin. Immigration background does not have a negative effect on the participation in breast cancer screening. This mainly relates to immigrants from EU27 member states.

Effect of adjuvant radiotherapy in elderly patients with breast cancer.

Radiotherapy (RT) is of critical importance in the locoregional management of early breast cancer. Although RT is routinely used following breast conserving surgery (BCS), patients may occasionally be effectively treated with BCS alone. Currently, the selection of patients undergoing BCS who do not need breast irradiation is under investigation. With the advancement of personalized medicine, there is an increasing interest in reduction of aggressive treatments especially in older women. The primary objective of this study was to identify elderly patients who may forego breast irradiation after BCS without measurable consequences on local tumor growth and survival. We analyzed 2384 early breast cancer patients aged 70 and older who were treated in 17 German certified breast cancer centers between 2001 and 2009. We compared RT versus no RT after guideline adherent (GA) BCS. The outcomes studied were breast cancer recurrence (RFS) and breast cancer-specific survival (BCSS). Low-risk patients were defined by luminal A, tumor size T1 or T2 and node-negative whereas higher-risk patients were defined by patients with G3 or T3/T4 or node-positive or other than Luminal A tumors. To test if there is a difference between two or more survival curves, we used the Gp family of tests of Harrington and Fleming. The median age was 77 yrs (mean 77.6±5.6 y) and the median observation time 46 mths (mean 48.9±24.8 mths). 950 (39.8%) patients were low-risk and 1434 (60.2%) were higher-risk. 1298 (54.4%) patients received GA BCS of which 85.0% (1103) received GA-RT and only 15% (195) did not. For low-risk patients with GA-BCS there were no significant differences in RFS (log rank p = 0.651) and in BCSS (p = 0.573) stratified by GA-RT. 5 years RFS in both groups were > 97%. For higher-risk patients with GA-BCS we found a significant difference (p<0.001) in RFS and tumor-associated OS stratified by GA-RT. The results remain the same after adjusting by adjuvant systemic treatment (AST) and comorbidity (ASA and NYHA). Patients aged 70 years and older suffering from low-risk early breast cancer with GA-BCS can avoid breast irradiation with <3% chance of relapse. In the case of higher-risk, breast irradiation should be used routinely following GA-BCS. As a side effect of these results, removing the entire breast of elderly low risk patients to spare them from breast irradiation seems to be not necessary.

Abstract P6-11-12: Access to certified breast cancer centers in the mainly rural state of Bavaria, Germany: A structural health geographical analysis

Abstract Background: In Germany, evidence- and consensus-based recommendations for the treatment of breast cancer patients are available from the national guideline. To ensure implementation of these standards in clinical routine care, two different certification programs for breast cancer exist in Germany: 1) accreditation ‘Organ Cancer Center’ of the German Cancer Society (“Deutsche Krebsgesellschaft” DKG); 2) Disease Management Program (DMP) developed by Health Insurance Companies. For our analysis we focused on Bavaria due to its mainly rural character, which can lead to challenges in patients’ medical supply with long travel distances. We aimed to investigate the accessibility of certified Breast Cancer Centers (cBCC) in rural and urban areas of Bavaria and to estimate how many inhabitants and potentially breast cancer patients might be affected. Methods: Accessibility of cBCC was defined according to travel time by car (or taxi) within 30 minutes. Addresses of cBCCs were identified through the homepages of the DKG, the Bavarian Association of Statutory Health Insurance Physicians (KVB), and a health insurance company. Data collection took place between August and December 2018. Only cBCC located in Bavaria with valid certification at point of search were eligible. Using ArcGIS, a routing network was created to identify clear catchment areas for each facility. The modeled speeds on which the traffic is based are street specific and consider the average regional traffic situations. The latter was then combined with the disaggregated 100 × 100 meters population data for the Census 2011, which allowed analyzing absolute population on a fine spatial resolution. Aggregated data on incident and prevalent breast cancer rates (women only) were obtained from the Epidemiological Bavarian Cancer Registry and merged on district level. As only aggregated data from the Bavarian Cancer Registry were utilized, a formal ethics committee (EC) review was not required. A declaration of no objection by the EC of the University of Würzburg is available (#2019042402). Results: A total of 58 cBCC (both DKG/DMP: n=44, DMP only: n=14) were identified and included in our analysis. The predefined accessibility coverage comprises 76% of Bavaria. Focusing on all Bavarian administrative areas (n=96) we identified following categories: n=38 had full access, n=56 partial access and n=2 no access. On population level, n=5,533,166 (87.5%) females reach a cBCC within 30min travel time. Whereas about 800.000 (12.5%) women have hampered access with about 3/4 living in rural regions. Data from the Bavarian Cancer Registry reveal that non-accessibility might affect ca. 5.000 prevalent and ca. 1.500 newly-diagnosed female breast cancer patients - based on a hypothetical stable age-standardized (EU) incidence and 5-yrs prevalence rate. Conclusion: Our analysis revealed that there is no Bavaria-wide accessibility to cBCC and that disparities between rural and urban areas exist. Integrating GIS methods to health care service research allows 1) identifying regions with limited access to evidence-based structures (e.g. cBCC) and 2) planning of structures needed from a public health point of view. Our findings can be used to inform policy makers about injustice regarding health care accessibility. Furthermore, results can serve for developing and evaluating telemedical strategies to deliver high quality health care to all inhabitants regardless of residence. Citation Format: Stephanie Stangl, Sebastian Rauch, Jürgen Rauh, Martin Meyer, Jacqueline Müller-Nordhorn, Manfred Wildner, Peter U. Heuschmann, Achim Wöckel. Access to certified breast cancer centers in the mainly rural state of Bavaria, Germany: A structural health geographical analysis [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P6-11-12.

Analysis of Changes in Cancer-Related Fatigue of Breast Cancer Patients Receiving an Integrative Medicine Program.

Introduction:Cancer-related fatigue (CRF) occurs frequently in breast cancer patients. The aim of this real-world study was to analyze the longitudinal changes of CRF in breast cancer patients receiving an integrative medicine program, which includes the application of non-pharmacological interventions (NPIs) and Viscum album L. (VA) extracts.Methods:All data were collected from the clinical register of the Network Oncology of a German certified breast cancer center of the Gemeinschaftskrankenhaus Havelhöhe (GKH). Primary breast cancer patients, treated upon initial diagnosis with integrated NPIs, comprising art and exercise therapy, nursing interventions, and educational components, during their hospital stay, and who had answered the German Cancer-Fatigue Scale (CFS-D) questionnaire at first diagnosis and 12 months later, were included. The associations between NPIs and CFS-D changes were analyzed with adjusted multivariable regression analyses, considering received treatment regimens and demographic variables, using the software R.Results:231 female breast cancer patients of all tumor stages were evaluated. While chemotherapy exhibited significant severe deterioration, add-on VA applications seem to partially mitigate this impairment on CRF. 36 separate multivariable regression analyses for all NPIs showed that in particular significant associations between CFS-D improvements and the interventions nursing compresses (6 point change; P = .0002; R² = 28%) or elaborate consultations and life review (ECLR) (4 point change; P = .0002; R² = 25%) were observed.Conclusions:Breast cancer patients benefit from a hospital-based integrative medicine program. To alleviate fatigue symptoms during oncological therapy, an expansion of this concept should be developed in the future.

Recommendation of adjuvant trastuzumab treatment in HER-2-positive breast cancer patients: insights from quality indicator data collected in certified breast cancer centers in Germany, Italy, Austria, and Switzerland.

In 2003, a certification system was introduced to ensure high standards of oncological care in breast cancer patients in Germany. Certified breast cancer centers (BCCs) must fulfill specific requirements including quality indicators (QI) derived from the clinical guidelines that are evaluated in annual audits. When target values for QIs are not fulfilled, centers need to give explanations. We analyzed data from BCCs for a selected indicator: the recommendation of trastuzumab for patients with early HER-2-positive invasive breast cancer. We investigated explanations given in cases when trastuzumab was not recommended to see whether this was justified. Patient data from 274 BCCs treating 53,777 primary cases in 2015 were analyzed using descriptive statistics. In the 274 BCC sites, 5700 primary patients with early HER-2-positive breast cancer were treated in 2015. 128 sites (46.7%) did not reach the target value of 95% trastuzumab recommendation and thus had to give explanations. In these 128 sites, 2663 primary HER-2-positive breast cancer patients were treated, 343 (12.9%) of whom did not receive a recommendation for adjuvant trastuzumab treatment. All 128 sites delivered explanations. Overall, 450 explanations were given, allowing multiple explanations for single patients. No explanation was given for 8 of the 343 patients (2.3%). The most common given explanation was multi-/comorbidity (45.5%). The analysis suggests thorough decision-making when quality indicator target values for a trastuzumab recommendation were not fulfilled. Our data do not provide information on whether such decisions have an impact on treatment outcome for these patients.

B2 Prognostic Score: External Validation of a Clinical Decision-making Tool for Metastatic Breast Cancer

BackgroundThe B2 Prognostic Score (B2PS) is a clinical decision-making tool in metastatic breast cancer (MBC) that provides risk classification based on routine parameters. This study validates the B2PS in an independent series of MBC for the whole study group and for each intrinsic subtype. Patients and MethodsWe analyzed 641 metastasized patients, treated in 17 German certified breast cancer centers between 2001 and 2009. They were classified into low, intermediate, and high-risk groups according to B2PS. Overall survival (OS) curves for the various B2PS groups were compared with Kaplan-Meier method. ResultsAccording to the B2PS formula, 42.3% of patients were classified as low risk, 25.4% as intermediate risk and 32.3% as high risk. Intermediate- and high-risk patients had a statistically significant decreased OS compared with B2PS low-risk patients: (intermediate-risk: hazard ratio, 1.36; 95% confidence interval, 1.04-1.77; P = .023; high-risk: hazard ratio, 2.62; 95% confidence interval, 2.06-3.32; P < .001). The 5-year survival rates of low-, intermediate-, and high-risk patients were 41.3%, 26.9%, and 10.2%, respectively. The distribution of B2PS risk groups varied significantly within the intrinsic subtypes. For each intrinsic subtype, B2PS gives an additional risk classification. ConclusionsThis study demonstrates the reproducibility of the B2PS based on routinely assessable parameters and confirms its prognostic value in an independent entire cohort of MBC as well as in the separate intrinsic subtypes. It therefore can help in counseling and individualizing the therapeutic regimens of those patients.

Supportive effect of Viscum album L. extracts on the sense of coherence in non-metastasized breast cancer patients

IntroductionViscum album L. extracts (VA) are frequently used in integrative oncology to enhance health-related quality of life. As a central aspect of well-being is associated with feeling warm or cold the internal coherence scale (ICS) questionnaire including the thermo coherence measurement was utilized. MethodsA prospective observational longitudinal cohort study was conducted, using data from the Network Oncology clinical registry. Primary non-metastasized breast cancer patients diagnosed in a German certified breast cancer center and treated either with standard anti-hormonal therapy alone (control) or in combination with VA-extracts (VA-group) were included. At first diagnosis, 6 months and 12 months later, the ICS-questionnaire was administered and analysed. ResultsIn total, 72 patients (56 control and 16 VA-patients; median age 62.1 years, IQR: 52.3–70.6) were evaluated. 6 months after first diagnosis, only for the VA-group a considerable increase of the total ICS and particularly the thermo coherence score was observed (p (d) < 0.01). Furthermore, after 12 months in a subgroup of 45 patients, 69% of the VA-group, felt an advancement of warmth, while only 25% of the controls had this feeling. This significant effect remained consistent in a multivariable regression analysis (p = 0.006). ConclusionsOur findings suggest that concomitant VA is positively associated with an impact on the thermo coherence of breast cancer patients and VA-applications might be an option to harmonize discomfort symptoms during anti-cancer therapy. However, results should be interpreted with caution in light of the study´s observational character.

Abstract P1-15-10: A prospective multicenter real-world study on neoadjuvant treatment and clinical outcome in TNBC patients

Abstract Introduction Controversy exists with regards to the optimal regimen for neoadjuvant chemotherapy (NAC) of TNBC. Platinum-based regimens seem to be more active in TNBC improving pCR rates significantly. But adding platinum to an anthracycline/taxane chemotherapy regime comes at the expense of greater toxicity. Its impact on survival and long-term-outcomes remains undetermined. Practical guidelines vary across leading international professional societies. In this real-world multicenter study neoadjuvant regimens, pCR rates and survival were evaluated. Material and methods This study was conducted from 2012-2017 in six certified breast cancer centers in the region of Hanover, Germany, including rural and urban populations by using a personal questionnaire and data from the medical records. All patients with primary TNBC (ER&amp;lt;1%, PR&amp;lt;1%, Her2/neu 0, 1+ or 2+ FISH/CISH negative) and no evidence of distant disease were eligible. Results 143/217 patients (66%) received NAC and 74/217patients (34%) adjuvant chemotherapy. 63/143 (44%) patients achieved pCR. 23/63 (35%) received platinum-based NAC and 40/63 (65%) received chemotherapy without platinum. In 80 patients pCR was not achieved. 12/80 patients received platinum and 68/80 non platinum-based NAC. pCR was significantly higher among patients with platinum-based chemotherapy (chi-square, p &amp;lt; 0.003). 20/23 patients who achieved pCR received NAC containing anthracycline/taxane/carboplatin, 3/23 patients received a taxane/carboplatin-based regime. Treatment discontinuation was seen in 12/35 (34%) patients receiving platinum-based NAC vs 15/108 (14%) in non-platinum-based NAC. Mean follow up was 17 months (1-70months). A significant difference in OS (p=0.007) and DFS (p=0.001) was seen for patients with a pCR. Conclusion Our trial confirms that platinum based NAC achieves significantly higher rates of pCR in patients with TNBC. pCR was associated with significantly longer DFS and OS. The CALBG protocol (CALBG 40603) was the preferred choice of treatment regimen followed by the GeparSixto protocol. In our study the pCR rate was comparable to that of both trials in which pCR rates of 60% (CALBG 40603) and 53% (GeparSixto) were achieved. However, in our trial 34% of the patients discontinued treatment due to toxicity. Therefore these protocols should be used in carefully selected patients. In a real world setting less toxic chemotherapy regimens achieved a pCR rate of 37%. In terms of toxicity and adherence to chemotherapy, these regimens are reasonable alternative options. In daily care close monitoring of treatment response is essential during NAC. In patients who have a rapid clinical response to platinum-free NAC the benefit of adding platinum is questionable. In contrast, the addition of platinum seems to be appropriate in those patients who show only limited response under NAC. Citation Format: Kuehnle E, Kaur P, Siggelkow W, Luebbe K, Schrader I, Uleer C, Noeding S, Noeding K-H, Noesselt T, Arfsten M, Busch C, Krentel N, Hillemanns P, Dörk T, Park-Simon T-W. A prospective multicenter real-world study on neoadjuvant treatment and clinical outcome in TNBC patients [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-15-10.

Adherence to guidelines and benefit of adjuvant radiotherapy in patients with invasive breast cancer: results from a large population-based cohort study of a cancer registry.

According to German S3 guidelines, radiotherapy (RT) is indicated in patients with invasive breast cancer after breast-conserving therapy (BCT). The aim of this analysis was to assess adherence to guidelines, long-term survival, recurrence rates, and recurrence-free survival after adjuvant RT in patients with BCT in daily clinical practice. This retrospective cohort study comprised data from the population-based clinical cancer registry of the Tumor Centre Regensburg (Bavaria, Germany). 6370 patients with non-metastatic invasive breast cancer and UICC tumor stages I, II, and III who were treated in certified breast cancer centers by BCT and diagnosed between 2003 and 2013 were included in the study. 6184 (97.1%) breast cancer patients received guideline concordant RT and showed a 3-year overall survival (OAS) of 96.8% in contrast to 90.9% in patients without RT (5-year OAS of 93.1% vs. 79.0%, p < 0.001). In multivariable Cox regression models, better overall survival was confirmed for the RT group (HR 0.64, 95% CI 0.46-0.88, p = 0.007). The 5-year local recurrence-free survival rate (RFS) in the irradiated patients was 92.1% vs. 62.0% in the comparison group (p < 0.001). The 10-year RFS was 80.5% vs. 36.0% (p < 0.001). This difference persisted after adjusting in multivariable analysis (HR 0.20, 95% CI 0.16-0.26, p < 0.001). This population-based analysis showed that the implementation of German guidelines in clinical routine was successful and guideline concordant adjuvant radiotherapy after BCT leads to better overall and recurrence-free survival and lower local recurrence rates.

Highly significant improvement in guideline adherence, relapse-free and overall survival in breast cancer patients when treated at certified breast cancer centres: An evaluation of 8323 patients

ObjectivesCertified multi-disciplinary breast cancer centres (CBCs) have been established worldwide. Development of CBCs, guideline-adherent systemic therapy and surgical management should now show an impact on outcomes. This analysis aimed to investigate whether guideline adherence (GA) rates, relapse-free survival (RFS) and overall survival (OS) have significantly improved at CBCs compared to the pre-certification period. Materials and methods8323 patients with primary breast cancer were treated in 17 German CBCs, which had been certified between 2003 and 2007 [2003 (n = 1), 2004 (n = 6), 2005 (n = 3), 2006 (n = 6) and 2007 (n = 1)]. 3544 patients (42.6%) were treated before certification and 4779 patients (57.4%) after certification. Results and conclusionA highly significant (p < 0.001) difference in 100%-GA was found between the various hospitals before certification (min 25.0%; max 54.6%). In 2008, when all participating hospitals were certified, the GA rate was 61.8% (min 39.5%, max 74.4%) and 69.2% (min 45.9%, max 86.4%) for patients <75 y (n = 6675). The difference between pre-certification 100%-GA (46.9%) and post-certification (57.2%) was highly significant (p < 0.001). RFS and OS were both significantly better after certification compared to the pre-certification period (RFS: HR = 0.79; 95% CI: 0.68–0.92; p = 0.003; OS: HR = 0.75; 95% CI: 0.65–0.85; p < 0.001). 5-year RFS (OS) of patients <75 y was 89.6% (85.4%) pre-certification and 91.4% (89.5%) post-certification.Since improvement in GA and outcomes correlated as well, GA remains a highly significant prognostic factor for RFS and OS regardless of NPI, intrinsic subtype and adjuvant systemic therapy. This suggests that the certification process is strongly associated with improvements in outcome.

Implementation of an Integrative Oncological Concept in the Daily Care of a German Certified Breast Cancer Center

Background: In recent decades the concept of integrative medicine has attracted growing interest in patients and professionals. At the Gemeinschaftskrankenhaus Havelhöhe (GKH), a hospital specialized in anthroposophical medicine, a breast cancer center (BCC) has been successfully certified for more than 5 years. The objective of the present study was to analyze how integrative strategies were implemented in the daily care of primary breast cancer patients. Methods: Clinical, demographic, and follow-up data as well as information on non-pharmacological interventions were analyzed. In addition, BCC quality measures were compared with data of the National Breast Cancer Benchmarking Report 2016. Results: Between 2011 and 2016, 741 primary breast cancer patients (median age 57.4 years) were treated at the GKH BCC. 91.5% of the patients showed Union for International Cancer Control (UICC) stage 0, I, II, or III and 8.2% were in UICC stage IV. 97% of the patients underwent surgery, 53% radiation, 38% had hormone therapy, and 25% received cytostatic drugs. 96% of the patients received non-pharmacological interventions and 32% received Viscum album L. therapy. Follow-up was performed in up to 93% of the patients 2 years after first diagnosis. Compared to nationwide benchmarking BCCs, the GKH BCC met the requirements in central items. Conclusions: The results of the present study show that integrative therapies offered by the concept of anthroposophical medicine can be implemented in the daily care and treatment of a certified BCC. However, as national guidelines on integrative concepts in oncology are missing, further studies are needed for a systematic evaluation of integrative treatment and care concepts in this field.

Abstract OT1-06-02: Oncotype DX®-REMAR(Rhein-Main-Registry)-study: Use of the oncotype DX® assay in early breast cancer in certified breast cancer centers in Rhine-Main Region, Germany

Abstract A brief background discussion: The OncotypeDX® multigene assay is recommended by several international guidelines as a predictive and prognostic factor for HR+/HER2- early breast cancer (EBC). Several trials have shown the necessity of OncotypeDX® Recurrence Score (RS) as a decision tool for HR+/HER2- EBC with 0-3 lymph nodes (LN) involved. At present, though, only limited data from the routine setting are available on the impact of treatment decision making process based on the usage of classical proliferation marker Ki67 with or without knowing the individual RS prior and after a treatment decision from a multidisciplinary tumor board (MTB) for the decision making of the adjuvant therapy of EBC. The Oncotype DX® assay is still not reimbursed by every insurance, therefore we expect that this registry will have an impact on reimbursement in Germany. Trial design: The OncotypeDX®-REMAR(Rhein-Main-Registry) study is a prospective, non-interventional, multicenter and non-randomized, study. 13 certified breast cancer (BC) centers in the Rhine-Main region in Germany participate. The sponsor of this trial is the AGAPLESION, Markus Hospital Frankfurt, Genomic Health provides the financial support. After registration, the patient´s case will be discussed in the respective institution's MTB, before and after the RS result. The adjuvant treatment will be recommended based on available clinical and histopathological data according to the guidelines and the RS result. After each meeting, the physician and patient will fill in a questionnaire. In addition to the local determination of Ki67 and nuclear grading, a central pathology assessment of these two markers will be provided in a blinded fashion. Only the sponsor has access to these results. Consequently, this independent test has no influence both on the local histopathology result and on the recommended treatment. Eligibility criteria: Inclusion criteria: Female patients, ≥18 years, with a hormone-receptor positive, HER2-negative EBC and 0-3 positive LN, T1-3, nuclear grading 1-3, Ki67:10-40%, cM0. Specific aims: Primary endpoint is the decision impact of the RS result in patients with mid-range Ki67 on adjuvant chemotherapy in EBC. Secondary endpoints include the correlation of Ki67 with tumor grade and RS result. Moreover, an economic subanalysis will be done. Statistical methods: The change in physicians' treatment recommendations will be measured pre-assay vs. post-assay. The proportion of patients for whom the treatment recommendation changed and the 95% confidence interval will be reported overall and by select groups. McNemar's test will be used to compare the proportion of patients' recommended chemo-hormonal therapy pre-assay vs. post-assay. Present accrual and target accrual: Thirteen participating centers recruited 97 patients by the end of April 2017. 600 patients are planned in total. Contact information for people with a specific interest in the trial: In case of interest you can contact Ms. Louiza Anastasiadou, Tel: +4969-9533-66395, Fax: +4969-9533-2385, email: louiza.anastasiadou@fdk.info Citation Format: Anastasiadou L, Aulmann S, Falk S, Baier P, Giesecke D, Buchen S, Hurst U, Krapfl E, Moebus V, Mosch D, Schulmeyer E, Solbach C, Ackermann S, Gabriel B, Jackisch C, Thill M. Oncotype DX®-REMAR(Rhein-Main-Registry)-study: Use of the oncotype DX® assay in early breast cancer in certified breast cancer centers in Rhine-Main Region, Germany [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT1-06-02.

Abstract P4-11-07: Shared decision making (SDM) in routine care treatment of breast cancer patients – a survey of patients following surgery

Abstract Introduction: The aim of shared decision making (SDM), defined as an interaction between patient and attending physician(s), is a treatment decision in which patients are meaningfully involved. Based on mutual agreement and active participation the awareness of a choice should be created and the choice respected. Many preference-sensitive decisions have to be made in breast cancer treatment. However, little is known about the implementation of SDM in German breast cancer care. We therefore investigated the process of SDM from the patients' perspective. Methods: All breast cancer patients who underwent surgery in one of four certified breast cancer centers in Germany between 07/2016 and 12/2016 were invited by mail to participate in the survey. The experienced decision-making process was assessed using the 9-item Shared Decision Making Questionnaire (SDM-Q-9). SDM-Q-9 items were rated on a 6-point scale ranging from "completely disagree" to "completely agree", added together and transformed into a scale ranging from 0 to 100. The higher the total score the higher the experienced degree of participation in the decision-making process. The survey also assessed patients' satisfaction with treatment, satisfaction with decisions and decisional control preferences, and included a range of demographic and clinical questions. For most items we asked the participants to separately rate decision-making consultations with their inpatient hospital doctors, outpatient gynecologists, outpatient oncologists and primary care providers (PCP). The project is still ongoing, data of approximately 300 patients will be presented at the meeting in December. Results: Of 289 patients approached by mail, 143 filled in the survey (response rate: 49%). Median age at the time of the survey was 62 years (36-89). 83% had breast conserving surgery, 17% mastectomy. 74% were treated with radiation, 31% received neo-/adjuvant chemotherapy. 14% were off-treatment at the time of survey participation, 67% still received antihormonal therapy, 9% anti HER2 treatment, 7% chemotherapy and 2% radiation. Inpatient hospital doctors achieved the highest SDM-Q-9 score (mean of 75, standard deviation of 22) indicating the highest degree of SDM. Oncologists, gynecologists and PCP were rated quite comparable with a mean score of 72 each and standard deviations (SD) of 27, 22 and 31. The mean score for all groups of doctors was 73. For items concerning satisfaction with quality and amount of doctors' information and participation in medical decisions patients showed a high degree of satisfaction, resulting in mean values of 3.6 and 3.5 with SD of 0.6 on a 4-point scale ranging from "1" "very unsatisfied" to "4" "very satisfied". Conclusions: A considerable number of patients took part in the survey. Overall, patients reported to have experienced SDM in many situations where treatment decisions were necessary. Patients were quite satisfied with the quality of information and their participation in medical decisions. However, we do not know whether non-respondents might have had different experiences regarding their treatment decision-making. Further research should include SDM expert observations of breast cancer treatment decisions to validate these findings. Citation Format: Feiten S, Scholl I, Schmidt M, Dünnebacke J, Franzen A, Ernst W, Weide R. Shared decision making (SDM) in routine care treatment of breast cancer patients – a survey of patients following surgery [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-11-07.

Abstract P6-11-07: Effectiveness and adverse events of DigniCap® scalp cooling system

Abstract Background Chemotherapy-induced alopecia (CIA) is able to affect a patient's self-image and confidence negatively. A decade ago scalp cooling failed to avoid chemotherapy- induced hairloss in women who underwent chemotherapy as only thermal packs were used. The DigniCap® scalp cooling system consists of a silicon cap that includes two sensor controlled cooling cycles. These cycles regulate the scalp temperature to lead to a continuous vasoconstriction in the scalp. Thus, it is indicated to reduce the likelihood of CIA. Reduced temperature results in a reduced blood flow to the scalp area so that less chemotherapy reaches the hair cells. Therefore, these are not exposed to the full dose of chemotherapy and may be able to survive the treatment. The purpose of this study was to evaluate the effectiveness and adverse events of DigniCap® scalp cooling system. Patients and Methods Since October 2015, 48 of 60 planned breast cancer patients undergoing chemotherapy were prospectively included in a unicentric cohort study in the certified breast cancer center at AGAPLESION Markus Hospital, Frankfurt, Germany. The average age of the women was 52.7 years (range 33 – 76). The chemotherapy regimen included 4x EC q3w -&amp;gt; 12x paclitaxel q1w (60.4%), 4x TC q3w (8.3%), 6x carboplatin plus paclitaxel q3w (8.3%), 6x docetaxel, carboplatin, trastuzumab (TCbH) q3w + pertuzumab (4.1%), 4x nab-paclitaxel m 3 q4 (2.1%), 4x paclitaxel q2w -&amp;gt; 4x EC q2w (2.1%), 18x paclitaxel q1w (2.1%), 18x paclitaxel q1w plus myocet q1w (2.1%), eribulin d1, 8 q3 (2.1%), 4x EC q3w -&amp;gt; 12x paclitaxel q1w plus trastuzumab plus pertuzumab (2.1%), 6x carboplatin plus paclitaxel q3w plus bevacizumab (2.1%), 4x nab-paclitaxel3 q4 plus bevacizumab (2.1%), 4x nab-paclitaxel 3 q4 -&amp;gt; 4x EC q3w (2.1%). Our aim was to quantify the grade of alopecia, satisfaction and side effects of the scalp cooling system. Alopecia quantification was done by a standardized questionnaire and photo documentation. Final results of the whole cohort of 60 patients will be presented at SABCS 2017. Results The interim analysis showed a success rate of complete hair loss avoidance of 8.0%. Hair loss of less than 20% was documented in 60.0% (29 patients). In 19/ 48 patients (39.6%) adverse reactions caused by the DigniCap® Scalp Cooling System, like headache (12.5%) or CIA (27.1%) were reported. Conclusion Our evaluation shows that DigniCap® Scalp Cooling Systemhas a minimal rate of adverse events (39.6%) and reduces the likelihood of chemotherapy-induced alopecia (&amp;lt; 20% hair loss)effectively by 60.0%, even in anthracycline-based regimen. Citation Format: Traub L, Brandi C, Khandan F, Thill M. Effectiveness and adverse events of DigniCap® scalp cooling system [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-07.