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  • 1
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    Breast cancer treatment with everolimus and exemestane for ER+ women: Results of the first interim analysis of the noninterventional trial BRAWO.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 15_suppl ( 2014-05-20), p. 578-578
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 578-578
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.15_suppl.578
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
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  • 2
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    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
    Georg Thieme Verlag KG ; 2023
    In:  Geburtshilfe und Frauenheilkunde Vol. 83, No. 09 ( 2023-09), p. 1127-1137
    Details
    In: Geburtshilfe und Frauenheilkunde, Georg Thieme Verlag KG, Vol. 83, No. 09 ( 2023-09), p. 1127-1137
    Abstract: Während prämenopausale Patientinnen mit einem HR+ HER2− frühen Mammakarzinom mit Tamoxifen +/− ovarielle Suppression mit einem GnRH-Analogon oder einem Aromataseinhibitor (AI) + GnRH behandelt werden, erhalten postmenopausale Frauen vorwiegend einen AI aufgrund der besseren Wirksamkeit verglichen mit Tamoxifen. Da es durch den Einzug der CDK4/6-Inhibitoren in die Behandlung des frühen Mammakarzinoms mit höherem Rückfallrisiko vermutlich zu einer Verschiebung der endokrinen Therapielandschaft kommt, ist von Interesse, wie in Deutschland potenzielle CDK4/6-Inhibitor-Kandidat*innen vor deren Markteinführung behandelt wurden. Im Rahmen einer retrospektiven, multizentrischen Analyse wurden anonymisierte Daten von Patient*innen mit einem HR+ HER2− frühen Mammakarzinom und einer im Zeitraum zwischen 10/2021–03/2022 begonnenen Antihormontherapie erhoben. Potenzielle CDK4/6-Inhibitor-Kandidat*innen wurden anhand der Einschlusskriterien der NATALEE- und monarchE-Studien in entsprechende Risikokollektive unterteilt. Insgesamt wurden Daten von 238 Patient*innen aus 29 Zentren analysiert. Während den monarchE-Kriterien 20,6% der Patient*innen zugeordnet werden konnten, enthielt das NATALEE-ähnliche Kollektiv 46,2% der Patient*innen. 53,8% der Patient*innen erfüllten weder die Einschlusskriterien der NATALEE- noch die der monarchE-Studie. Über die Hälfte der Patient*innen erhielt keine Chemotherapie. Im Gesamtkollektiv waren 28,6% der Patientinnen prämenopausal. 67,6% der prämenopausalen Frauen wurden mit einer neo-/adjuvanten Chemotherapie behandelt. 61,8% der prämenopausalen Patientinnen erhielten als adjuvante Antihormontherapie Tamoxifen, 19,1% AI + GnRH und 10,3% Tamoxifen + GnRH. Trotz des hohen Anteils prämenopausaler Patientinnen, die mit einer aggressiven Therapie im Sinne einer Chemotherapie behandelt wurden, wurde bei nur einem Drittel der prämenopausalen Patientinnen GnRH zur Antihormontherapie hinzugenommen. Untersuchungen zu einem späteren Zeitpunkt sowie Registerstudien sind nötig, um zu sehen, wie sich durch den Einzug der CDK4/6-Inhibitoren die endokrine Therapielandschaft in Deutschland verändert.
    Type of Medium: Online Resource
    ISSN: 0016-5751 , 1438-8804
    URL: Article
    DOI: 10.1055/a-2100-0643
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2023
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  • 3
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    The impact of mammalian target of rapamycin inhibition on bone health in postmenopausal women with hormone receptor-positive advanced breast cancer receiving everolimus plus exemestane in the phase IIIb 4EVER trial
    Elsevier BV ; 2019
    In:  Journal of Bone Oncology Vol. 14 ( 2019-02), p. 100199-
    Details
    In: Journal of Bone Oncology, Elsevier BV, Vol. 14 ( 2019-02), p. 100199-
    Type of Medium: Online Resource
    ISSN: 2212-1374
    URL: Article
    DOI: 10.1016/j.jbo.2018.09.010
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 2695887-9
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  • 4
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    Abstract P3-06-04: 4EVER: The impact of mTOR inhibition on bone health in postmenopausal women with hormone receptor positive (HR+) advanced breast cancer treated with everolimus (EVE) in combination with exemestane (EXE)
    American Association for Cancer Research (AACR) ; 2015
    In:  Cancer Research Vol. 75, No. 9_Supplement ( 2015-05-01), p. P3-06-04-P3-06-04
    Details
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 75, No. 9_Supplement ( 2015-05-01), p. P3-06-04-P3-06-04
    Abstract: Introduction: The BOLERO-2 study showed significant doubling of PFS benefit with the addition of EVE to EXE in postmenopausal women with hormone receptor–positive advanced breast cancer progressing after non-steroidal aromatase inhibitor (NSAI) therapy. The BOLERO-2 bone sub study indicated an immediate positive influence of EVE on bone health after 6 and 12 weeks of treatment. To further investigate the longer term effect of mTOR inhibition on bone health, we included this exploratory objective in the phase IIIb, multi-center, open label study 4EVER for postmenopausal women with hormone receptor positive advanced breast cancer treated with EVE +EXE. Methods: From May 2012 to November 2012 bone biomarker samples of 247 postmenopausal women with metastatic or locally advanced, hormone receptor positive, HER2 negative breast cancer refractory to NSAI were collected within this phase IIIb study. Here, we report the results of the planned exploratory analysis of biomarkers of bone turnover. The objective of the exploratory biomarker analysis of bone resorption and formation was to assess the effect of EVE on changes of biomarker levels of bone metabolism (CTX, P-I-NP, osteocalcin, vitamin D, testosterone, estradiol, DHEAS, SHBG, PTH,TSH and FSH) from day 1 to weeks 4, 12 and 24 to confirm potential protective effects of EVE on bone via inhibition of bone osteoclast resorption. Descriptive statistics were used to summarize the single bone resorption markers by visit and difference to baseline. Results: Trial data base lock will occur in late June 2014, therefore, the final biomarker analysis of bone resorption and formation and their influence on ORR, PFS and safety will be presented at SABCS 2014. The preliminary analysis on the changes of bone marker levels from baseline to week 24 included 247 patients. The measured changes from baseline to week 24 in biomarker levels revealed increasing levels of testosterone, DHEAS and FSH, while SHBG and PTH were significantly decreased from baseline to week 24. The combination of EVE to EXE resulted in stabilization of bone health as documented by a decrease of absolute P-I-NP levels at week 24 compared to baseline as well as a stabilization of bone resorption as measured by CTX. Conclusion: Our first preliminary results (data cut off 15 Nov 2013) on the changes in bone marker levels supported the hypothesis of EVE having direct impact on bone health, suggesting a decrease of bone turnover and a reversal of the increase in bone resorption associated with aromatase inhibitor therapy. The final analysis of the 4EVER sub study on bone marker levels in correlation with the efficacy data will provide more detailed insights into possible benefits of the combination of EVE plus EXE. Citation Format: Peyman Hadji, Hans Tesch, Oliver Stoetzer, Thomas Decker, Christian M Kurbacher, Romy Neumeister, Frederik Marmé, Andreas Schneeweiss, Christoph Mundhenke, Andrea Distelrath, Peter A Fasching, Micheal P Lux, Diana Lüftner, Wolfgang Janni, Mathias Muth, Julia Kreuzeder, Claudia Weiss, Eva-Maria Grischke. 4EVER: The impact of mTOR inhibition on bone health in postmenopausal women with hormone receptor positive (HR+) advanced breast cancer treated with everolimus (EVE) in combination with exemestane (EXE) [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-06-04.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    URL: Article
    DOI: 10.1158/1538-7445.SABCS14-P3-06-04
    RVK:
    XA 36000
    RVK:
    XA 10000
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2015
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  • 5
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    4EVER: Assessment of circulating tumor cells with a novel, filtration-based method, in a phase IIIb multicenter study for postmenopausal, HER2- negative, estrogen receptor-positive, advanced breast cancer patients.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 591-591
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 591-591
    Abstract: 591 Background: The presence of circulating tumor cells (CTCs) has been shown to be of prognostic relevance for patients with early and advanced breast cancer (BC). The usefulness of CTC assessments depends on accurate cell counts and corresponding analysis of molecular targets. The aim of this sub study was to assess the feasibility of a novel, integrated CTC platform for automated cellular protein and nucleic acid analysis in a prospective multi-center study. Methods: The German 4EVER study included patients with postmenopausal, metastastic, ER positive, HER2 negative BC, who progressed after therapy with a non-steroidal aromatase inhibitor and were treated with exemestane and the mTOR inhibitor everolimus. Baseline blood samples (TransFix vaccum tubes, Cytomark, Caltag Medsystems Ltd.) were used for CTC analysis and processed on the modified Versant kPCR Sample Prep system using 8µm pore size Whatman Nuclepore track-etched membranes (GE Healthcare Piscataway, NJ). After CTC capture, immunostaining was performed for Cytokeratin 8/18/19 and CD45. CTCs were detected by image analytics after fluorescence scanning microscopy using a dedicated software solution implemented by Siemens. The data is summarized and correlated with baseline clinical characteristics. Results: CTC counts and clinical data were available for 111 blood samples (91.7%). CTCs were found in 75 patients (67,6%), 13 patients having 1 CTC, 38 having 2-9 CTCs and 24 patients having 10 or more CTCs. In an exploratory analysis the presence of CTCs was correlated with baseline patient and tumor characteristics. There were no associations with primary TNM stage, hormone receptor status or tumor type. Conclusions: CTC assessment with this novel filtration based method was feasible in a multi-center study setting. The CTC positivity rate was within the expected range. The follow-up of this study will give first insights, how the CTC measures of this platform can be used as a prognostic tool. As this CTC assessment platform was developed to perform additional automated cellular protein and nucleic acid analysis, the usefulness might derive from these analytic tools as well. Clinical trial information: NCT01626222.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.591
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 6
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    Abstract P5-19-12: Subgroup analysis on efficacy in the routine treatment - Results of the 2nd interim analysis of BRAWO, the non-interventional trial "Breast Cancer Treatment with Everolimus and Exemestane for HR+ Women"
    American Association for Cancer Research (AACR) ; 2015
    In:  Cancer Research Vol. 75, No. 9_Supplement ( 2015-05-01), p. P5-19-12-P5-19-12
    Details
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 75, No. 9_Supplement ( 2015-05-01), p. P5-19-12-P5-19-12
    Abstract: Introduction BRAWO is a German non-interventional study of 3000 patients (pts) with advanced or metastatic, hormone-receptor-positive, HER2-negative breast cancer treated with everolimus (EVE) and exemestane (EXE). We report results of the 2nd preplanned interim analysis (IA) with a data cut-off on 8th July 2014. Methods BRAWO collects data on the routine clinical treatment with EVE and EXE at about 400 sites. Main objectives are to extend the knowledge on a) the efficacy in the clinical routine and the impact of physical activity on efficacy and quality of life, b) prophylaxis and management of stomatitis, and c) the sequence of therapy in the clinical routine. The 2nd IA was defined to take place 12 months after the inclusion of the 500. patient into the documentation. Results Efficacy data will be reported for the first 500 documented pts. Apart from data on the total study population we will present the PFS results for subgroups including pts with or without prior EXE therapy, with or without prior chemotherapy for the advanced setting, with or without visceral metastasis and with regard to the line of treatment in the advanced setting and the extent of physical activity. The respective summary of adverse events for these patients will be presented as well as results on treatment compliance and dosing. Baseline characteristics and medical history as well as insights into treatment sequences before EVE and EXE will further be shown for all enrolled patients with valid baseline documentation (approx. 1200). Conclusion This subgroup analysis will provide insights into the treatment efficacy in the clinical routine and will add to a more comprehensive understanding of the treatment with EVE/EXE. Citation Format: Christian Jackisch, Eva-Maria Grischke, Andreas Schneeweiss, Thomas Decker, Christoph Uleer, Frank Förster, Oliver Tomé, Pauline Wimberger, Christian M Kurbacher, Bettina Mueller, Nadia Harbeck, Christoph Mundhenke, Sherko Kuemmel, Mathias Muth, Julia Kreuzeder, Wilhelm Bloch, Hans Tesch, Diana Lüftner, Florian Schütz, Peter A Fasching. Subgroup analysis on efficacy in the routine treatment - Results of the 2nd interim analysis of BRAWO, the non-interventional trial "Breast Cancer Treatment with Everolimus and Exemestane for HR+ Women" [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-19-12.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    URL: Article
    DOI: 10.1158/1538-7445.SABCS14-P5-19-12
    RVK:
    XA 36000
    RVK:
    XA 10000
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2015
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  • 7
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    Abstract P4-01-05: Machine learning to predict treatment response and tolerability in HR+, HER2– advanced breast cancer: German study AI4ANNA
    American Association for Cancer Research (AACR) ; 2023
    In:  Cancer Research Vol. 83, No. 5_Supplement ( 2023-03-01), p. P4-01-05-P4-01-05
    Details
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 83, No. 5_Supplement ( 2023-03-01), p. P4-01-05-P4-01-05
    Abstract: Background: Predicting the probability of tumor progression and tolerability with sufficient accuracy remains a significant challenge in advanced breast cancer. The objective of AI4ANNA study was to assess the predictive potential of machine learning (ML) methods with respect to tumor control and safety outcomes using German study data (RIBECCA, RIBANNA) and to identify the most relevant baseline factors for prediction. Methods: Anonymized study data from two studies of ribociclib and endocrine therapy in patients with advanced HR+, HER2– breast cancer were used for predictive analysis. RIBECCA (N=487) was a multicenter, open-label, single-arm, phase 3b trial, and RIBANNA (N=1904) is an ongoing non-interventional study evaluating the real-world efficacy and safety of first-line ribociclib in combination with aromatase inhibitor/fulvestrant, endocrine monotherapy or chemotherapy. Study baseline features were used to develop prediction models for a variety of tumor control (including progression-free survival (PFS), overall response rate (ORR) at week 24, death) and safety outcomes (including general number of adverse events (AEs) as well as selected AEs belonging to blood system, cardiac, hepatobiliary, and gastrointestinal disorders). LASSO (Least Absolute Shrinkage and Selection Operator) and XGBoost (eXtreme Gradient Boosting) ML algorithms were employed to train prediction models. LASSO was selected as a representative of fully interpretable, linear models and XGBoost as a representative of highly flexible, nonlinear models. Predictive performance of these two algorithms was compared and predictive value of single baseline features was assessed using feature permutation importance method. Results were validated internally within the training study (10 times repeated 5-fold stratified cross-validation) as well as externally, ie, implementation and training of the prediction models on one study and validation on the other and vice versa. Results: Moderate predictive signal (at baseline) could be identified for the following two outcomes: ORR (area under the curve [AUC] mean 0.628 [RIBANNA] and 0.626 [RIBECCA]) and PFS (AUC mean 0.626 [RIBANNA] , 0.604 [RIBECCA]). Model performance could be validated with very similar AUCs by cross-study evaluation. Patients could be assigned to one of three risk groups. The most important features for ORR prediction included the presence of locally ad vanced cancer and metastases presenting as bone only disease and for PFS the presence of liver metastases, histological grade and prior (neo)adjuvant treatment. For three safety endpoints, a predictive signal (AUC & gt;0.6) was identified only in one study but not in the other (AEs “QT prolongation”, “leukopenia grade 3/4” and serious AE “vomiting”). However, insufficient predictive signals were found for all other outcomes. Conclusion: Prediction models for tumor control and safety outcomes were trained on a broad number of clinical baseline features. Moderate predictive signals could be identified for ORR and PFS. Even though the predictive performance (AUC) seems to be limited, patients could be assigned to one of three differently behaving risk groups at the baseline. The key predictive features for PFS included clinically known prognostic factors like liver metastasis, histological grade and prior (neo)adjuvant treatment. Citation Format: Peter A. Fasching, Achim Wöckel, Hans Tesch, Bernhard Volz, Uwe Pritzsche, Marc Bachmann, Asmir Vodencarevic, Julia Kreuzeder, Diana Lüftner. Machine learning to predict treatment response and tolerability in HR+, HER2– advanced breast cancer: German study AI4ANNA [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-01-05.
    Type of Medium: Online Resource
    ISSN: 1538-7445
    URL: Article
    DOI: 10.1158/1538-7445.SABCS22-P4-01-05
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
    detail.hit.zdb_id: 2036785-5
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  • 8
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    Abstract P5-19-06: 4EVER - Final efficacy analysis of the phase IIIb, multi-center, open label study for postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer (BC) treated with everolimus (EVE) in combination with exemestane (EXE)
    American Association for Cancer Research (AACR) ; 2015
    In:  Cancer Research Vol. 75, No. 9_Supplement ( 2015-05-01), p. P5-19-06-P5-19-06
    Details
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 75, No. 9_Supplement ( 2015-05-01), p. P5-19-06-P5-19-06
    Abstract: Introduction: The phase III BOLERO-2 trial showed a significant doubling of PFS benefit with EVE + EXE over EXE alone in postmenopausal women with hormone receptor positive advanced BC progressing after non-steroidal aromatase inhibitor (NSAI) therapy. The 4EVER trial further evaluated the combination of EVE+EXE with regard to efficacy and safety, quality of life and health resources utilization in a broader patient population, i.e. without limitations as to the number of previous chemotherapy lines, the time point of progression after NSAI therapy, and the previous EXE therapy. Methods: From May 2012 to November 2012 a total of 299 postmenopausal women with metastatic or locally advanced, hormone receptor positive, HER2 negative breast cancer, refractory to NSAI were recruited to this phase IIIb study. Here we report the results of the planned analysis of the primary and secondary endpoints. The primary endpoint was the overall response rate (ORR) at week 24. The secondary endpoints included: Progression-free survival (PFS), ORR at week 48, overall survival (OS), and quality of life. This study includes a broad exploratory translational research program e.g. changes in serum bone turnover biomarkers, the correlation of Interleukin-6 with anxiety and depression, presence and molecular characteristics of circulating tumor cells, the correlation of response to EXE+EVE with pharmacogenomics. Results: Trial database lock will occur in late June 2014, therefore, the final data concerning the primary and secondary efficacy and safety endpoints will be presented at SACBS 2014. The preliminary baseline analysis included 299 patients (data cut off 15 Nov 2013): HR status: ER+/PgR+ 78.1%, ER+/PgR- 20.9%, 0.7% ER-/PgR+, 0.3% ER-/PgR-. Tissue for receptor status analysis: 71.0% primary tumor, 29.0% metastasis. The mean time since initial diagnosis was 9.6 years, the mean time since first relapse/metastasis was 4.3 years. The mean time since last relapse/metastasis was 2.8 months. 68.1% of patients had bone lesions. Last anti-neoplastic therapy had been administered in the adjuvant (23.9%) and metastatic setting (73.0%). 25.9% of patients had no prior antineoplastic therapy in the metastatic setting, 16.3% had one, 12.2% two and 47.4% three or more prior therapies. Conclusion: The final analysis of the 4EVER study provides more important information on disease patterns and benefits of the combined treatment with EVE and EXE. Citation Format: Hans Tesch, Oliver J Stoetzer, Thomas Decker, Christian M Kurbacher, Romy Neumeister, Frederik Marmé, Andreas Schneeweis, Christoph Mundhenke, Andrea Distelrath, Peter A Fasching, Michael P Lux, Diana Lueftner, Peyman Hadji, Wolfgang Janni, Mathias Muth, Julia Kreuzeder, Claudia Weiss, Diethelm Wallwiener. 4EVER - Final efficacy analysis of the phase IIIb, multi-center, open label study for postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer (BC) treated with everolimus (EVE) in combination with exemestane (EXE) [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-19-06.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    URL: Article
    DOI: 10.1158/1538-7445.SABCS14-P5-19-06
    RVK:
    XA 36000
    RVK:
    XA 10000
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2015
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  • 9
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    Efficacy and safety of everolimus plus exemestane in postmenopausal women with hormone receptor‐positive, human epidermal growth factor receptor 2‐negative locally advanced or metastatic breast cancer: Results of the single‐arm, phase IIIB 4EVER trial
    Wiley ; 2019
    In:  International Journal of Cancer Vol. 144, No. 4 ( 2019-02-15), p. 877-885
    Details
    In: International Journal of Cancer, Wiley, Vol. 144, No. 4 ( 2019-02-15), p. 877-885
    Abstract: What's new? Current treatment guidelines for HR+, HER2– advanced breast cancer support continued endocrine therapy after progression on first‐line treatment, including the use of everolimus and exemestane combined. Here, the authors report on the phase IIIB 4EVER trial, which evaluated the efficacy, safety and quality of life effects of everolimus plus exemestane in postmenopausal women with pretreated, HR+, HER2– advanced breast cancer. The patient population was broader than that evaluated in previous major trials, and thus more reflective of real‐world practice. Overall, the results confirm the clinical benefits and known safety profile of everolimus plus exemestane in this patient population.
    Type of Medium: Online Resource
    ISSN: 0020-7136 , 1097-0215
    URL: Issue
    URL: Article
    DOI: 10.1002/ijc.v144.4
    DOI: 10.1002/ijc.31738
    RVK:
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    Language: English
    Publisher: Wiley
    Publication Date: 2019
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  • 10
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    Systemic Therapy of Premenopausal Patients with Early Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer – Controversies and Standards in Healthcare
    Georg Thieme Verlag KG ; 2023
    In:  Geburtshilfe und Frauenheilkunde Vol. 83, No. 06 ( 2023-06), p. 673-685
    Details
    In: Geburtshilfe und Frauenheilkunde, Georg Thieme Verlag KG, Vol. 83, No. 06 ( 2023-06), p. 673-685
    Abstract: Die adjuvante endokrine Behandlung von prämenopausalen Patientinnen mit einem hormonrezeptorpositiven, HER2-negativen (HR-pos./HER2-neg.) Mammakarzinom unterliegt bei bestehender Ovarialfunktion einigen Besonderheiten. Als therapeutische Optionen stehen Tamoxifen mit oder ohne GnRH-Analogon und Aromatasehemmer mit GnRH-Analogon zur Verfügung. Des Weiteren wird die Ovarialfunktion durch eine vorherige Chemotherapie beeinflusst. Sowohl die Indikation für GnRH-Analoga in Kombination mit Tamoxifen als auch die Indikation für Aromatasehemmer (+GnRH-Analoga) sind für Patientinnen mit einem erhöhten Rückfallrisiko vorgesehen. In nationalen und internationalen Leitlinien und Therapieempfehlungen ist jedoch keine klare Grenze für ein mittleres oder hohes Risiko definiert, sodass viele Therapieentscheidungen für jede Patientin individuell getroffen werden. Dies spiegelt sich auch in einer großen nationalen und internationalen Variabilität z. B. beim Einsatz von Aromatasehemmern + GnRH-Analoga wider. Diese Übersichtsarbeit fasst die Datenlage zu den abgeschlossenen Studien (z. B. SOFT, TEXT, EBCTCG-Metaanalysen), den aktuellen Multigentest-Studien (TailorX, RxPonder, ADAPT) zusammen, diskutiert die Rationale für aktuell durchgeführte Studien (z. B. CLEAR-B) und gibt einen Ausblick auf künftige Fragestellungen.
    Type of Medium: Online Resource
    ISSN: 0016-5751 , 1438-8804
    URL: Article
    DOI: 10.1055/a-2073-1887
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2023
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