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Sherko Kümmel,1 Christian Jackisch,2 Volkmar Müller,3 Andreas Schneeweiss,4 Sandra Klawitter,5 Michael P Lux6 1Breast Unit Essen, Kliniken Essen-Mitte, Essen, Germany; 2Department of Obstetrics and Gynecology, Sana Klinikum Offenbach, Offenbach, Germany; 3Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 4Division of Gynecologic Oncology, National Center for Tumor Diseases, University Hospital, Heidelberg, Germany; 5Medical Affairs – Biostatistics and Epidemiology, Roche Pharma AG, Grenzach-Wyhlen, Germany; 6Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany Purpose: Although several trials have demonstrated improved progression-free survival (PFS) with first-line regimens for HER2-negative metastatic breast cancer (mBC), overall survival (OS) benefit is elusive. We calculated required sample sizes to power for OS using published data from recent mBC trials.Patients and methods: Randomized superiority trials of first-line chemotherapy/targeted therapy for HER2-negative mBC including >150 patients, meeting the primary efficacy objective, and published in 2000–2018 were identified. The sample sizes required to power for PFS and OS were calculated retrospectively for each trial using observed results and study/recruitment follow-up durations (α=0.05, two-sided log-rank test, 80% power), and summarized as a factor (x) relative to actual sample size.Results: Nine of 13 identified trials reported all information required for retrospective sample size calculation. Six had sample sizes larger than required to demonstrate a significant PFS benefit but all would have required larger sample sizes to demonstrate significant OS benefit with the observed results. In ten trials, the required sample size was ≥5-fold larger to power for OS than PFS.Conclusion: Designing trials to test potential new treatments for HER2-negative mBC is challenging, requiring a balance of regulatory acceptability, feasibility, and realistic medical assumptions to calculate sample sizes. Powering for OS is particularly difficult in heterogeneous populations with long postprogression survival, potential crossover, heterogeneous poststudy therapy, and evolving treatment standards. Validated surrogate endpoints are critical. Ongoing trials of cancer immunotherapy (new mode of action) in triple-negative mBC (more homogeneous, shorter OS and postprogression survival, fewer treatment options) may show a new pattern. Keywords: progression-free survival, overall survival, endpoint, metastatic breast cancer, clinical trial, regulatory authorities

Hintergrund: Krankenhauseinweisungen und -entlassungen haben oftmals negative Auswirkungen auf die Versorgungskontinuität. Durch unzureichende oder verspätete Kommunikation kommt es zu Informationsverlusten, Ergebnis ist häufig eine mangelnde Koordination der Vor- und Nachsorge. Ein strukturiertes[zum vollständigen Text gelangen Sie über die oben angegebene URL], 53. Kongress für Allgemeinmedizin und Familienmedizin

Hintergrund: Krankenhauseinweisungen und -entlassungen haben oftmals negative Auswirkungen auf die Versorgungskontinuität. Es kommt beispielsweise zu Verzögerungen oder Informationsverlusten, was mitunter auf einen Mangel an Kommunikation und Koordination der Vor- und Nachsorge zurückzuführen[zum vollständigen Text gelangen Sie über die oben angegebene URL], 17. Deutscher Kongress für Versorgungsforschung (DKVF)

Claudia M Witt,1–3 Marion Pérard,2 Brian Berman,3,4 Susan Berman,4 Timothy C Birdsall,5 Horst Defren,6 Sherko Kümmel,7 Gary Deng,8 Gustav Dobos,9 Atje Drexler,10 Christine Holmberg,2 Markus Horneber,11 Robert Jütte,9 Lori Knutson,12 Christopher Kummer,13 Susanne Volpers,14 David Schweiger15 1University Hospital Zurich, Institute for Complementary and Integrative Medicine, Zurich, Switzerland; 2Institute for Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin, Berlin, Germany; 3University of Maryland School of Medicine, Center for Integrative Medicine, Baltimore, Maryland, USA; 4The Institute for Integrative Health, Baltimore, USA; 5Cancer Treatment Centers of America, Goodyear, Arizona, USA, 6Kliniken Essen Mitte, Evang, Huyssen-Stiftung/Knappschaft GmbH Patientenmanagement, Essen, Germany; 7Department of Senology, Breast Center, Kliniken Essen-Mitte, Evang. Huyssens Stiftung, Knappschaft GmbH, Essen, Germany; 8Memorial Sloan-Kettering Cancer Center, New York, USA; 9Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Academic Teaching Hospital of the University of Duisburg-Essen, Germany; 10Robert Bosch Foundation GmbH, Stuttgart, Germany; 11Department of Internal Medicine, Division of Oncology and Hematology, Paracelsus Medical University, Klinikum Nürnberg, Germany; 12Integrative Healthcare Solutions, Minneapolis, Minnesota, USA; 13Institute of Mergers, Acquisitions and Alliances (IMAA), Zurich, Switzerland; 14Frauenselbsthilfe nach Krebs, Bonn, Germany; 15Schweiger, Schweiger & Associates, Hilton Head Island, South Carolina, USA Background: An increasing number of clinics offer complementary or integrative medicine services; however, clear guidance about how complementary medicine could be successfully and efficiently integrated into conventional health care settings is still lacking. Combining conventional and complementary medicine into integrative medicine can be regarded as a kind of merger. In a merger, two or more organizations - usually companies - are combined into one in order to strengthen the companies financially and strategically. The corporate culture of both merger partners has an important influence on the integration.Purpose: The aim of this project was to transfer the concept of corporate culture in mergers to the merging of two medical systems.Methods: A two-step approach (literature analyses and expert consensus procedure) was used to develop practical guidance for the development of a cultural basis for integrative medicine, based on the framework of corporate culture in “mergers,” which could be used to build an integrative medicine department or integrative medicine service.Results: Results include recommendations for general strategic dimensions (definition of the medical model, motivation for integration, clarification of the available resources, development of the integration team, and development of a communication strategy), and recommendations to overcome cultural differences (the clinic environment, the professional language, the professional image, and the implementation of evidence-based medicine).Conclusion: The framework of mergers in corporate culture provides an understanding of the difficulties involved in integrative medicine projects. The specific recommendations provide a good basis for more efficient implementation. Keywords: integrative medicine, mergers, corporate culture

Background: TAC (docetaxel/doxorubicin/cyclophosphamide) is associated with high incidences of grade 4 neutropenia and febrile neutropenia (FN). This analysis compared the efficacies of four regimens for primary prophylaxis of FN and related toxic effects in breast cancer patients receiving neoadjuvant TAC. Patients and methods: Patients with stage T2-T4 primary breast cancer were scheduled to receive 6-8 cycles of TAC. Primary prophylaxis was: ciprofloxacin 500 mg orally twice daily on days 5-14 (n = 253 patients; 1478 cycles), daily granulocyte colony-stimulating factor (G-CSF) (filgrastim 5 μg/kg/day or lenograstim 150 μg/m2/day) on days 5-10 (n = 377; 2400 cycles), pegfilgrastim 6 mg on day 2 (n = 305; 1930 cycles), or pegfilgrastim plus ciprofloxacin (n = 321; 1890 cycles). Results: Pegfilgrastim with/without ciprofloxacin was significantly more effective than daily G-CSF or ciprofloxacin in preventing FN (5% and 7% versus 18% and 22% of patients; all P

The neoadjuvant phase III GeparSepto study showed that substituting nab-paclitaxel for standard solvent-based paclitaxel significantly improved the pathologic complete response (pCR) rate achieved with a sequential neoadjuvant chemotherapy regimen of paclitaxel, epirubicin, and cyclophosphamide for high-risk primary breast cancer. Recent trials demonstrated that in HER2+ breast cancer pCR can be increased by using pertuzumab in addition to trastuzumab and chemotherapy. The present analysis focuses on efficacy and safety data from the subset of patients with HER2+ tumors from the GeparSepto trial (n = 396) in comparison to the HER2- cohort.Patients with histologically confirmed breast cancer (n = 1206) received four cycles of weekly paclitaxel [either solvent-based (Pac) or nab-paclitaxel (nab-Pac), according to randomization] followed by 4 cycles of epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 q3w, with concurrent trastuzumab and pertuzumab q3w for those with HER2+ tumors. The primary endpoint was pCR defined as ypT0 ypN0.Higher rates of pCR were achieved in HER2+ than in HER2- tumors (57.8% versus 22.0%, P 0.0001), with the highest rate in the HER2+/HR- cohort (71.0%; 66.7% Pac, 74.6% nab-Pac). In HER2+/HR+ tumors, the pCR rate was 52.9% (49.7% Pac, 56.4% nab-Pac). Grade ≥3 toxic effects were significantly more common in HER2+ than in HER2- patients, with grade 3-4 diarrhea in 7.6% versus 0.9% (P 0.001) and febrile neutropenia in 6.3% versus 3.3% (P = 0.023) of patients. Left ventricular ejection fraction decreases from baseline were uncommon, with 2.0% versus 0.4% of patients showing decreases to 50% along with a ≥10% decrease from baseline.In HER2+ early breast cancer, a dual HER2-targeted combination of pertuzumab and trastuzumab, together with taxane-epirubicin-cyclophosphamide neoadjuvant chemotherapy, achieved high rates of pCR.

Johannes Wohlrab,1 Nikola Bangemann,2 Anke Kleine-Tebbe,3 Marc Thill,4,5 Sherko Kümmel,6 Eva-Maria Grischke,7 Rainer Richter,8 Sophie Seite,9 Diana Lüftner10 1Martin Luther University Halle-Wittenberg, Department of Dermatology and Venereology, Halle (Saale), 2Interdisciplinary Breast Centre, University Hospital Charité Berlin, Campus Benjamin Franklin, Berlin, Germany, 3Breast Centre DRK Hospital, Berlin, 4Breast Centre University of Lübeck, Department of Gynaecology and Obstetrics, Lübeck, 5Department of Gynaecology and Obstetrics, Agaplesion Markus Hospital, Frankfurt am Main, 6Breast Centre and Clinic of Senology, Hospital Essen-Mitte, Essen, 7Breast Centre University of Tübingen, Department of Gynaecology, Tübingen, 8L'Oréal, Deutschland GmbH, Düsseldorf, 9La Roche-Posay, Dermatological Laboratories, Asnières, France; 10University Hospital Charité Berlin, Campus Benjamin Franklin, Department of Hematology, Oncology and Tumour Immunology, Berlin, Germany Purpose: Chemotherapy with anthracyclines, taxanes, or alkylating agents often causes cutaneous side effects. Nonspecific inhibition of the proliferative activity of keratinocytes has antidifferentiation effects that lead to defects in the barrier function and, thus, to dry, itchy, and irritable skin. These cutaneous symptoms reduce the quality of life of the patients considerably. Conditioning with topical application of niacinamide uses the cytoprotective and barrier stabilizing effect of vitamin B3. Patients and methods: A multicenter randomized crossover study investigated the influence of the test preparation on the quality of life compared to standard care for 73 patients with breast cancer undergoing adjuvant or neoadjuvant cytostatic therapy. Primary target parameter was the Dermatology Life Quality Index with its respective subscales after 6 weeks of a twice-daily application of the respective preparations. Additionally, specific symptoms such as pruritus, dryness, and irritability have been assessed using visual analog scales. Results: Regarding the total score of the Dermatology Life Quality Index, no relevant differences could be observed. However, the results for the "symptoms and feelings" subscale show a significant advantage in favor of the test preparation. Significant superiority of the test preparation could also be observed in the secondary target parameters, the visual analog scales (P

Poster Abstract

Poster Abstract

Contains fulltext : 72531.pdf (Publisher’s version ) (Open Access) 6 p.

The aim of this study was to investigate the expression and prognostic influence of HER1 (EGFR), HER2 (c-erb-B2), HER3 (c-erb-B3) and HER4 (cerb-B4) in squamous cell cervical carcinomas (SCC) and the importance of receptor correlations.78 SCC were stained immunohistochemically for HER1-HER4. HER2 gene amplification was determined using fluorescence in situ hybridization (FISH). Parametric correlations were performed between the four receptors and tumor characteristics. Overall survival was evaluated by uni- and multivariate analyses.Overexpression was found in 63% of SCC for HER1, in 21.8% for HER2, in 74.4% for HER3 and in 79.5% for HER4. Correlations were observed between HER1 and HER4 (p = 0.019). Survival analyses revealed a significant association of HER1 overexpression with favorable outcome (p = 0.016), while overexpression of HER2 and HER3 was associated with poor prognosis (p = 0.006; p = 0.05, respectively). HER1 remained significant in multivariate analysis.These data suggest that the prognostic relevance of the different HER receptors is influenced by the balance between the various receptors, especially of HER4.