Breast Cancer In Germany Research Articles

Palbociclib in combination with either aromatase inhibitors or fulvestrant for patients with advanced HR+/HER2- breast cancer in Germany - Final results of the phase 2 multicohort INGE-B trial

Palbociclib in combination with either aromatase inhibitors or fulvestrant for patients with advanced HR+/HER2- breast cancer in Germany - Final results of the phase 2 multicohort INGE-B trial

Cost consequence model of the MammaPrint (70-gene signature) and 21-gene signature in patients with primary HR+HER2-, N1 early-stage breast cancer in Germany.

534 Background: The MammaPrint 70-gene and Oncotype DX 21-gene signatures serve to stratify breast cancer tumors, distinguishing between those with low or high risk of distant metastasis. Patients with a low genomic risk tumor have the option to avoid overtreatment by omitting chemotherapy and minimize associated toxicities. This analysis evaluates the economic impact of implementing MammaPrint, Oncotype DX (ODx), or no gene signature testing for patients with HR+ HER2- early breast cancer with 1 to 3 positive lymph nodes (N1) in Germany. Methods: We constructed a cost-consequence model to assess the budget implications of MammaPrint, ODx, and not employing a gene signature, considering both the healthcare payers and societal perspective. The model focuses on patients with HR+/HER2-/N1 breast tumors who, in the absence of a gene expression analysis, would receive chemotherapy in 63% of cases according to the data of the certified breast cancers in Germany. Input data were sourced from MINDACT, RxPONDER, literature, the EBM, the DRG system. The healthcare payer perspective covers testing, direct/indirect costs of chemotherapy, and disease recurrence costs. The societal perspective adds transport costs and productivity losses to these. Results: A projected 9,207 HR+/HER2-/N1 breast cancer patients were candidates for genomic testing. In MINDACT, patients were classified as MammaPrint Low Risk in 73% of cases, and in RxPONDER 83% of patients were categorized as ODx Low Risk (RS 0-25). The model demonstrated per patient savings from a healthcare payer perspective of €3.766 for MammaPrint and €900 for ODx compared to not using any gene signature for N1 breast cancer patients in Germany. Importantly, the savings are even more substantial from a societal perspective, reaching €11.815 for MammaPrint and €11.243 for ODx. When limiting the population to women >50 years, similar results were observed with per patient savings from a payer perspective of €3.766 and €1.549, and from a societal perspective of €9.826 and €9.349, for MammaPrint and ODx, respectively. Conclusions: These data demonstrate that personalized treatment planning with genomic testing for breast cancer with HR+/HER2-/LN1 breast cancer, leads to a reduction in chemotherapy use and associated costs in Germany. Although MammaPrint designates a smaller proportion of genomically high risk patients compared to ODx, MammaPrint Low Risk patients without chemotherapy demonstrate higher survival outcomes. Consequently, any increased chemotherapy costs are offset by lower testing and distant recurrence expenses, making MammaPrint a cost-conscious option.

Correction: Cost-effectiveness of talazoparib for patients with locally advanced or metastasized breast cancer in Germany

Correction: Cost-effectiveness of talazoparib for patients with locally advanced or metastasized breast cancer in Germany

Regulatory gaps and research waste in clinical trials involving women with metastatic breast cancer in Germany

Background Non-publication, incomplete publication and excessively slow publication of clinical trial outcomes contribute to research waste and can harm patients. While research waste in German academic trials is well documented, research waste in Germany related to a specific disease area across non-commercial and commercial sponsors has not previously been assessed. Methods In this cohort study, we used public records from three clinical trial registries to identify 70 completed or terminated clinical trials involving women with metastatic breast cancer with trial sites in Germany. We then searched registries and the literature for trial outcomes and contacted sponsors about unreported studies. Results We found that 66/70 trials (94.3%) had made their results public. Only 13/70 (18.6%) trials had reported results within one year of completion as recommended by the World Health Organisation (WHO). The outcomes of 4/70 trials (5.7%) had not been made public at all, but only one of those trials had recruited a significant number of patients. Conclusions Discussions about research waste in clinical trials commonly focus on weakly designed or unreported trials. We believe that late reporting of results is another important form of research waste. In addition, a discussion regarding the appropriate ethical and legal rules for reporting the results of terminated trials might add value. German legislation now requires sponsors to upload the results of some clinical trials onto a trial registry within one year of trial completion, but these laws only cover around half of all trials. Our findings highlight the potential benefits of extending the scope of national legislation to cover all interventional clinical trials involving German patients.

Cost-benefit evaluation of advanced therapy lines in metastatic triple-negative breast cancer in Germany

BackgroundTriple-negative breast cancer (TNBC) is responsible for 10–20% cases of breast cancer and is resulting in rising healthcare costs. Thus, health-economic evaluations are needed to relate clinical outcomes and costs of treatment options and to provide recommendations of action from a health-economic perspective.MethodsWe investigated the cost-benefit-ratio of approved treatment options in metastatic TNBC in Germany by applying the efficiency frontier approach. These included sacituzumab-govitecan (SG), eribulin, vinorelbine, and capecitabine. Clinical benefit was measured as (i) median overall survival (mOS) and (ii) health-related quality of life (HRQoL) in terms of time to symptom worsening (TSW). To assess medical benefits, literature was systematically reviewed in PubMed for (i) and (ii), respectively. Treatment costs were calculated considering annual direct outpatient treatment costs from a statutory healthcare payer perspective. It was intended that both, (i) and (ii), yield an efficiency frontier.ResultsAnnual direct outpatient treatment costs amounted to EUR 176,415.21 (SG), EUR 47,414.14 (eribulin), EUR 13,711.35 (vinorelbine), and EUR 3,718.84 (capecitabine). Systematic literature review of (i) and statistical analysis resulted in OS values of 14.3, 9.56, 9.44, and 7.46 months, respectively. Capecitabine, vinorelbine, and SG are part of the efficiency frontier including OS. The highest additional benefit per additional cost was determined for vinorelbine, followed by SG. Systematic review of (ii) revealed that no TSW data of TNBC patients receiving vinorelbine were available, preventing the presentation of an efficiency frontier including HRQoL.ConclusionsVinorelbine is most cost-effective, followed by SG. Health-economic evaluations support decision-makers to assess treatment options within one indication area. In Germany, the efficiency frontier can provide decision support for the pricing of innovative interventions. Results of our analysis may thus guide reimbursement determination.

Patient Preferences Influencing Treatment Decision-Making in Early-Stage Breast Cancer in Germany, Italy, and Japan.

Patients with early breast cancer (eBC) are increasingly provided with different options, which may involve a sequence of different treatments and treatment modalities, and eligibility for certain adjuvant treatments depending upon pre-surgical and surgical outcomes. This study examined patient preferences around aspects of treatment decision-making in eBC. A total of 452 patients with self-reported eBC in Germany (n=151), Italy (n=151), and Japan (n=150) completed an online survey about physician interactions and treatment side effects. The survey included best-worst scaling (BWS) to assess prioritization of 13 statements reflecting aspects of treatment decision-making. In a series of choice tasks, participants chose their most and least preferred options among subsets of 4 statements. Hierarchical Bayesian modeling was used to estimate BWS preference scores for each statement. BWS scores were based on the number of times a statement was chosen as most versus least preferred; scores total 100 for each patient. The most preferred aspects of treatment decision-making were "treatment aggressiveness matches personal risk" (mean BWS score = 13.49), "being told about what is coming" (13.18), deciding based on "own surgical outcome" (11.90), "avoiding unnecessary treatment" (10.35), and "involving in treatment decisions" (9.44). The least preferred aspects were "not being asked about treatment decisions along the way" (3.27) and "receiving the same treatment as other patients" (3.41). Patients in Japan preferred "being told about what is coming", "deciding based on own surgical outcome", "avoiding unnecessary treatment", and being "involved in decisions" more than patients in Italy and Germany. Patients in Germany were more satisfied with their physician interactions and care, although their outcomes were not always better than those in Italy and Japan. Patients value individualized treatment tailored to their risk of recurrence and tolerance of side effects, highlighting the need for focused patient education about options, to encourage their engagement.

Budget Impact of the Oncotype DX Breast Recurrence Score® Test in Patients with Early Primary Hormone-Receptor-Positive, HER2-Negative, Node-Positive Breast Cancer in Germany

Background: Gene expression tests can inform decisions on whether to recommend or omit chemotherapy for patients with early HR+, HER2− breast cancer. The benefit of these tests is well established and fully reimbursed by sickness funds for lymph node-negative (pN0) patients in Germany. A budget impact model was built to evaluate the effect of using the Oncotype DX Breast Recurrence Score^® test also for node-positive (pN1: 1–3 positive lymph nodes) patients. Methods: The prospective randomized clinical trial, RxPONDER, defined conditions (Recurrence Score result 0–25 for postmenopausal patients with 1–3 positive lymph nodes) under which omitting chemotherapy does not significantly impact invasive disease-free survival with results currently reported for 5-year follow-up. The present budget impact model calculates average total cost per node-positive patient versus no testing from a sickness funds perspective, taking into account not only the budgetary impact of avoiding chemotherapy and associated side effects, but also the costs of treating those patients who develop distant metastasis. The stability of the results was investigated by probabilistic multivariate sensitivity analysis. Results: After deducting testing cost, applying the Oncotype DX Breast Recurrence Score test yielded an average savings per node-positive patient of EUR 4,272. Without the test costs, the greatest savings resulted from reductions in direct treatment costs and costs arising from the treatment of chemotherapy-related side effects, which together averaged EUR 6,677. The targeted use of chemotherapy after testing also resulted in slightly lower costs for treatment of distant metastasis, if it did occur. The multivariate sensitivity analysis also almost exclusively resulted in cost savings. Conclusion: Analogous to the pN0 situation, this budget impact model demonstrates that the Oncotype DX Breast Recurrence Score test can also reduce healthcare costs in Germany in treatment of node-positive (pN1: 1–3 positive lymph nodes) patients by minimizing both unnecessary chemotherapy and undertreatment. Additional benefits to patients would include reduced morbidity and improved quality of life for those patients who can safely avoid chemotherapy or undertreatment.

Clinical Impact of Polygenic Risk Score for Breast Cancer Risk Prediction in 382 Individuals with Hereditary Breast and Ovarian Cancer Syndrome.

Single nucleotide polymorphisms are currently not considered in breast cancer (BC) risk predictions used in daily practice of genetic counselling and clinical management of familial BC in Germany. This study aimed to assess the clinical value of incorporating a 313-variant-based polygenic risk score (PRS) into BC risk calculations in a cohort of German women with suspected hereditary breast and ovarian cancer syndrome (HBOC). Data from 382 individuals seeking counselling for HBOC were analysed. Risk calculations were performed using the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm with and without the inclusion of the PRS. Changes in risk predictions and their impact on clinical management were evaluated. The PRS led to changes in risk stratification based on 10-year risk calculations in 13.6% of individuals. Furthermore, the inclusion of the PRS in BC risk predictions resulted in clinically significant changes in 12.0% of cases, impacting the prevention recommendations established by the German Consortium for Hereditary Breast and Ovarian Cancer. These findings support the implementation of the PRS in genetic counselling for personalized BC risk assessment.

The Endocrine Treatment Landscape for Patients with HR+ HER2− Early-stage Breast Cancer in Germany Before the Introduction of CDK4/6 Inhibitor Therapy – A Real-World Analysis

AbstractWhile premenopausal patients with HR+ HER2− early breast cancer are treated with tamoxifen +/− ovarian suppression with a GnRH analog or an aromatase inhibitor (AI) + GnRH, the majority of postmenopausal women receive an AI due to its higher efficacy compared to tamoxifen. As the introduction of CDK4/6 inhibitors into the treatment of early-stage breast cancer with a higher risk of recurrence will probably result in a shift in the endocrine treatment landscape, the question is what treatment did potential candidates for CDK4/6 inhibitors in Germany receive before CDK4/6 inhibitors were available.As part of a retrospective multicenter analysis, anonymized data were collected of patients with HR+ HER2− early-stage breast cancer who received endocrine therapy in the period between 10/2021 and 03/2022. Potential candidates for CDK4/6 inhibitor treatment were classified into different risk cohorts using the inclusion criteria of the NATALEE and monarchE trials.The data of 238 patients from 29 different centers were analyzed. While 20.6% of patients met the monarchE criteria, the subgroup which met the NATALEE inclusion criteria consisted of 46.2% of patients. 53.8% of patients did not meet the inclusion criteria for either the NATALEE or the monarchE trial. More than half of the patients did not receive chemotherapy. 28.6% of patients in the whole cohort were premenopausal. 67.6% of premenopausal women received neo-/adjuvant chemotherapy. 61.8% of premenopausal patients received tamoxifen as adjuvant endocrine therapy, 19.1% received an AI + GnRH and 10.3% were treated with tamoxifen + GnRH.Despite the high percentage of premenopausal patients who received aggressive treatment in the form of chemotherapy, only one third of premenopausal patients received GnRH in addition to their standard endocrine therapy. Studies carried out at a later point in time and registry studies will be necessary to see how the endocrine therapy landscape in Germany has changed following the introduction of CDK4/6 inhibitors.

P35 Real-World Evidence of Incidence, Initial Treatment, and Survival of Female Breast Cancer in Germany

P35 Real-World Evidence of Incidence, Initial Treatment, and Survival of Female Breast Cancer in Germany

233P Decision-making criteria for the choice of 1st line CDK4/6-inhibitor therapy for HR+/Her2- breast cancer in Germany: DECISIONext

German AGO breast recommendations 2021 propose endocrine-based therapy as the 1st therapy option for HR+, MBC, if there is no threat of organ failure. Since 2016, CDK4/6i + endocrine therapy (ET) is an option for 1st L therapy. This data collection intends to show which therapy decisions are made and why in different patient groups with 1st L MBC. Subsequent therapy may require molecular tumor characterization. How often molecular testing is done with MBC is largely unknown.

Budget impact of the Oncotype DX® test compared to other gene expression tests in patients with early breast cancer in Germany

PurposeGene expression tests can inform decisions on whether to recommend chemotherapy for patients with HR+, HER2- early breast cancer. The goal of this analysis was to compare treatment costs by an expanded budget impact model of reimbursed gene expression tests in Germany. MethodsA cost comparison was constructed as an expanded budget impact model to calculate average total costs per patient covered by public health insurance. Based on the strong clinical evidence from the prospective randomized controlled trial TAILORx including more than 10,000 patients with HR+ and node negative breast cancer, the assumption was made that the Oncotype DX® test accurately predicts chemotherapy benefit and clinical outcomes. For the further reimbursed tests (EndoPredict®, MammaPrint®, Prosigna®), results from comparative studies – aligned with prognosis studies – as analyzed in IQWiG Rapid Report D19–01 were applied. ResultsThe use of the Oncotype DX test led to estimated average savings per patient of 2,500 € vs. EndoPredict, 1,936 € vs. MammaPrint, and 649 € vs. Prosigna. Savings were achieved by reduction of unnecessary chemotherapy use, a consequence of false-positive test results (EndoPredict 73%, MammaPrint 42%, Prosigna 20%). False-negative test results (EndoPredict 5%, MammaPrint 22%, Prosigna 49%) reduced necessary chemotherapies, which initially results in cost savings, but may lead to increased long-term costs associated with management of progressive disease. ConclusionThe results from this model suggest that the use of the Oncotype DX test reduces the cost of health care in Germany making it the most cost effective test compared to the further tests.

1126P Budget impact of Oncotype DX test compared to further gene expression tests in patients with early breast cancer in Germany

Biomarker tests can support informed decision whether to use chemotherapy in patients with HR+, HER2- early breast cancer. Goal of this analysis was to compare treatment costs of various reimbursed biomarker tests within a budget impact model for Germany.

P038 - Scenarios of cost-savings associated with Oncotype DX® test-guided decisions for adjuvant chemotherapy in early breast cancer in Germany

P038 - Scenarios of cost-savings associated with Oncotype DX® test-guided decisions for adjuvant chemotherapy in early breast cancer in Germany

Awareness and Availability of Routine Germline BRCA1/2 Mutation Testing in Patients with Advanced Breast Cancer in Germany

Introduction: Diagnostic testing of germline mutations in breast cancer susceptibility genes 1 or 2 (gBRCA1/2) in patients with human epidermal growth factor receptor 2 negative (HER2–) advanced breast cancer (ABC; locally advanced or metastatic breast cancer) is necessary to assess eligibility for poly(ADP-ribose) polymerase inhibitors (PARPi). We investigated awareness, clinical practice, and the availability of gBRCA1/2 mutation testing in the German outpatient oncology setting. Methods: Office-based oncologists completed a 23-item online survey. Responses were evaluated collectively and by center type. Results: Of 50 oncologists, 33 and 17 were medical and gynecological oncologists, respectively. Oncologists treated a median of 65 (range 14–350) patients with ABC per year. The strongest decision factors to initiate gBRCA1/2 mutation testing were: patient’s known family history of gBRCA1/2 mutation-related cancer(s), guideline recommendations, and triple-negative breast cancer (TNBC). In routine practice, 86% of oncologists tested for gBRCA1/2 mutations. Most oncologists (76–98%) reported testing patients with a known family history of gBRCA1/2 mutation-related cancer(s) irrespective of receptor status. For unknown family history, 92% of oncologists reported testing patients with advanced TNBC versus 30% for HR+/HER2– ABC. Oncologists (66%) rated the awareness of therapeutic relevance of gBRCA1/2 mutation testing for targeted treatment selection as good to satisfactory; 22% rated awareness as poor to in­sufficient. Conclusion: Diagnostic gBRCA1/2 mutation testing in patients with HER2– ABC is available and routinely performed in Germany’s outpatient oncology setting. However, specific patient subgroups were not routinely tested despite therapeutic indications. Given PARPi availability, opportunities exist to improve testing rates especially for patients with HR+/HER2– ABC without a known family history of gBRCA1/2 mutation-related cancer(s).

PCN98 Scenarios of Cost-Savings Associated with Oncotype DX® Test - Guided Decisions for Adjuvant Chemotherapy in EARLY Breast Cancer in Germany

PCN98 Scenarios of Cost-Savings Associated with Oncotype DX® Test - Guided Decisions for Adjuvant Chemotherapy in EARLY Breast Cancer in Germany

Long-term Incidence and Mortality Trends for Breast Cancer in Germany.

Introduction Changes in risk factors and the introduction of mammography screening in 2005 have led to dramatic changes in the breast cancer-associated burden of disease in Germany. This study aimed to investigate long-term disease-related incidence and mortality trends in women from East and West Germany since the reunification of Germany. Methods Total and stage-specific incidence rates were evaluated based on data obtained from selected cancer registries. Sufficiently complete data going back to 1995 were available for 4 East German and 3 West German regions. The figures were weighted for population size, and rates were calculated for the whole of Germany based on the rates for East and West Germany. The study particularly focused on 3 different age groups: women eligible for mammography screening (50 – 69 years), younger women (30 – 49 years) and older women (70+ years). All rates were standardised for age. The mortality rates obtained from the official statistics on cause of death since 1990 were processed accordingly. Results Incidence rates in the observation period increased, as they were affected by the increasing number of cases with early-stage cancers being diagnosed in the screening age group. The total incidence for this group, which included the incidence of non-invasive breast cancers, increased by 14.5% between 2005 and 2016. Early-stage cancers (UICC stages 0 and I) increased by 48.1% while late-stage diagnoses (UICC stages III and IV) decreased by 31.6%. Qualitatively similar changes were noted for the other age groups, although they were less pronounced. The decrease in breast cancer mortality observed since the mid-1990s ended around 2008 for the group of younger women but continued in the screening age group. After 2008, an increase in mortality was observed in the group of older women. The differences in disease burden between East and West Germany (in favour of East Germany) decreased in younger women during the observation period but tended to increase in the group of older women. Conclusion The analysis suggests that the introduction of mammography screening contributed to a decrease in the incidence of advanced-stage breast cancers and in breast cancer-related mortality rates but also resulted in a substantial number of overdiagnoses. The relatively unfavourable incidence trend in the group of younger women, particularly in East Germany, should be interpreted in the context of lifestyle changes. The slight increase in mortality observed in the group of older women after 2008 requires further analysis.

Distribution of the 21-Gene Breast Recurrence Score in Patients with Primary Breast Cancer in Germany.

Background Multigene assays are being used increasingly to aid in decision-making about chemotherapy in breast cancer. Here, we present the 21-gene recurrence score (RS) of patients tested in routine clinical practice in Germany. Patients and Methods In a retrospective analysis, 4695 patients with hormone receptor-positive and HER2-negative early breast cancer (pT1 – 3, pN0 – 1, M0) were included in whom RS testing was conducted in Germany between November 2015 and July 2018. RS groups as defined in the TAILORx trial (RS result 0 – 10; 11 – 25; 26 – 100) were used. Results Of these patients, 21% were assigned to the low RS group, 63% to the midrange RS group, and 15% to the high RS group. 1772 (81%) of 2175 node-negative patients over 50 years of age were grouped either into the low RS group or the midrange RS group. The portion of patients with a low or midrange RS was 90% among node-positive patients (1284 of 1432 patients), 79% among patients with Ki-67-high (≥ 20%) tumors (1829 of 2310 patients), 86% vs. 70% among patients with G2 and G3 tumors (3244 of 3762 patients and 368 of 522 patients), respectively, 88% among patients with a tumor size of > 5 cm (140 of 159 patients), and 82% among node-negative patients at high clinical risk (1110 of 1352). Conclusions The distribution of the 21-gene RS in German patients that were tested in routine clinical practice indicates that, according to the results of the TAILORx trial, chemotherapy may not be beneficial in most of these.

Abstract P5-11-14: Palbociclib in combination with anastrozole or exemestane as first-line therapy for patients with locally advanced, inoperable or metastatic HR+/HER2- breast cancer in Germany: Interim results of the INGE-B phase 2 study

Abstract Background: The pivotal PALOMA trials investigated the combination of the cyclin-dependent kinase 4/6 inhibitor palbociclib with letrozole as first-line treatment or with fulvestrant after prior endocrine therapy in patients with advanced HR+/HER2- breast cancer. Based on these trials, extended European approval was granted for this patient population to receive palbociclib in combination with any aromatase inhibitor or with fulvestrant after prior endocrine therapy. Methods: The prospective, multicenter phase 2 INGE-B trial was designed for patients with locally advanced or metastatic HR+/HER2- breast cancer to generate efficacy, safety and quality of life data on the combination of palbociclib with letrozole (first line) or fulvestrant (first and later line after prior endocrine therapy) in accordance with the PALOMA trials and to generate so far lacking trial data on the combination of palbociclib with letrozole (later line) and the combination of palbociclib with anastrozole or exemestane (first line) in Germany. This pre-planned interim analysis was conducted to evaluate data on patients receiving palbociclib plus anastrozole or exemestane as first-line therapy. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Key secondary endpoints included the overall response rate (ORR), the CBR for all patients, the disease control rate (DCR), quality of life (QoL) and safety. Data will be analyzed for each group separately with descriptive statistics. Results: At the cut-off date of the interim analysis (June 30, 2019), 66 patients (pts) have been enrolled to receive palbociclib plus anastrozole (palbo+ana) and 64 pts have been enrolled to receive palbociclib plus exemestane (palbo+exe). Thereof, 60 and 58 pts were evaluable, respectively. Median age was 63.5 years (palbo+ana) and 65.0 years (palbo+exe), 100% (n=60) and 94.8% (n=55) of pts had an ECOG performance score of 0 or 1, respectively. 35% (n=21, palbo+ana) and 22.4% (n=13, palbo+exe) of pts presented with non-measurable bone-only disease. The primary endpoint CBR in pts with measurable disease was 73% with palbo+ana (27 of 37 pts) and 70% with palbo+exe (31 of 44 pts).Selected outcome data are depicted in Table 1. Grade 3/4 adverse events experienced by at least 10% of pts were neutropenia (n=20, 33.3%) and leukopenia (n=9, 15.0%) in pts treated with palbo+ana and neutropenia (n=23, 39.7%), leukopenia and infections (both n=6, 10.3%) in pts treated with palbo+exe. Conclusions: This interim analysis of the INGE-B study will provide so far lacking trial data on the treatment of palbociclib in combination with anastrozole or exemestane. The data will be discussed with respect to results of the PALOMA trials and already published interim analysis results of the INGE-B trial. Palbociclib + anastrozolePalbociclib + exemestaneMeasurable disease (RECIST v1.1) All pts (investigator assessment)Measurable disease (RECIST v1.1) All pts (investigator assessment)(N=37)(N=60)(N=44)(N=58)n% (95% CI)n% (95% CI)n% (95% CI)n% (95% CI)Overall response rate (ORR)1849 (32-66)2033 (22-47)1841 (26-57)1933 (21-46)Clinical benefit rate (CBR)2773 (56-86)4880 (68-89)3170 (55-83)4171 (57-82)Disease control rate (DCR)3081 (65-92)5388 (77-95)3784 (70-93)4679 (67-89)ORR=CR+PR, CBR=CR+PR+SD ≥ 24 weeks, DCR=CR+PR+SD Citation Format: Manfred Welslau, Norbert Marschner, Ulrike Söling, Cosima Brucker, Oliver J. Stoetzer, Johannes Meiler, Pauline Wimberger, Steffen Dörfel, Jörg Sahlmann, Leonora Houet, Corinne Vannier, Karin Potthoff. Palbociclib in combination with anastrozole or exemestane as first-line therapy for patients with locally advanced, inoperable or metastatic HR+/HER2- breast cancer in Germany: Interim results of the INGE-B phase 2 study [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 P5-11-14.

Abstract P2-17-01: Therapy of advanced breast cancer for patients with hormone receptor-positive/HER2-negative and HER2-positive tumors is changing in real life: First results from the prospective, national research platform OPAL for patients with advanced breast cancer in Germany

Abstract Introduction Tumor Registries give insight into routine treatment and complement the knowledge derived from randomized controlled trials (RCT), since characteristics of patients from RCTs often differ from those of patients in routine care. Furthermore, follow-up of patients in registries is generally longer which gives the possibility to analyze sequential treatments. Since 2007 the Tumor Registry Breast Cancer (TMK, NCT01351584) has prospectively collected data on treatment and outcome of patients with breast cancer in Germany. Among other topics, insights into “real-world” treatment and outcome and long-term observation of quality of life have been published. Since 2017 the registry platform OPAL (NCT03417115) has extended the work of the TMK by recruiting patients with advanced breast cancer (ABC) from all specialties (medical and gynecologic oncologists). The main aims are to observe the impact of novel treatments on patient outcome, and to identify areas for improvement of quality of care. Methods OPAL started in December 2017. Patients are prospectively recruited at start of their first systemic treatment for ABC. Follow-up continues until death or up to 5 years. There is no treatment specification. Detailed information on all (sequential) treatments, patient and tumor characteristics, physician-reported factors regarding treatment decision making, biomarker testing, outcomes (e.g. best response, progression-free and overall survival) are collected in a web-based data capture system with implemented checks for completeness and plausibility. Data are monitored by data management and on-site. Patient-reported outcomes (PROs) are collected at start of treatment and every 3 months thereafter. Patients can also give informed consent for their tumor samples to be used in future translational research (virtual biobank). All patient data remain in Germany. Here, first combined data from the TMK and OPAL (database as of 01.04.2019) are presented. Results Since 2007, 5076 patients have been recruited. Patients with ABC (n=2105, 434 since the start of OPAL) have a median age of over 60 years at start of treatment; about 60% have comorbidities. For patients with hormone-receptor positive (HRpos)/HER2 negative (HER2neg) ABC, first-line treatment has changed over the years. From 2007-11 (n=458) 60% of patients started with chemotherapy, decreasing to 48% in 2012-16 (n=528) and to 23% in 2018-19 (n=170) with 58% of patients now being treated with CDK4/6-inhibitor. First-line of HER2pos ABC has also changed from 79% of patients receiving trastuzumab (TRA) between 2007-12 (n=268) to 78% of patients receiving dual-blockade with TRA/pertuzumab in 2018-19 (n=97) and 10% receiving TRA only. About 25% of patients treated with TRA in 2018-19 received a biosimilar. Median overall survival (OS) of patients with start of first-line therapy between 2007-16 is currently 15 months for triple-neg (74% events), 34 months for HRpos/HER2neg (59% events), 40 months for HER2pos (52% events); median OS has not yet been reached for patients in OPAL. Conclusions For patients with HRpos/HER2neg ABC, a shift towards more endocrine therapy in the first-line setting, and a quick implementation of CDK4/6-inhibitors after their approval can be observed. In patients with HER2pos ABC, integration of trastuzumab biosimilars into routine care has started. Prognosis for patients with triple-negative ABC remains poor and new treatment options are urgently needed. OPAL together with TMK will allow to follow changes in treatment of patients with ABC in a “real world” setting in Germany, the application of sequential treatments, and their impact on clinical as well as patient-reported outcome. Citation Format: Elmar Stickeler, Nadia Harbeck, Marc Thill, Arnd Nusch, Marco Chiabudini, Lisa Kruggel, Martina Jänicke, Norbert Marschner, Mark-Oliver Zahn, Anja Welt, Achim Wöckel, Thomas Decker, OPAL Study Group. Therapy of advanced breast cancer for patients with hormone receptor-positive/HER2-negative and HER2-positive tumors is changing in real life: First results from the prospective, national research platform OPAL for patients with advanced breast cancer in Germany [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 P2-17-01.