42 results on '"Hackmann, John"'
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2. ASO Visual Abstract: Minimally-Invasive Breast Biopsy After Neoadjuvant Systemic Treatment to Identify Breast Cancer Patients with Residual Disease for Extended Neoadjuvant Treatment—A New Concept
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Pfob, André, Cai, Lie, Schneeweiss, Andreas, Rauch, Geraldine, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Degenhardt, Tom, Rom, Joachim, Rody, Achim, van Mackelenbergh, Marion, Banys-Paluchowski, Maggie, Große, Regina, Reinisch, Mattea, Karsten, Maria Margarete, Sidey-Gibbons, Chris, Wallwiener, Markus, Golatta, Michael, and Heil, Joerg
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- 2024
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3. De-escalated neoadjuvant pertuzumab plus trastuzumab therapy with or without weekly paclitaxel in HER2-positive, hormone receptor-negative, early breast cancer (WSG-ADAPT-HER2+/HR–): survival outcomes from a multicentre, open-label, randomised, phase 2 trial
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von Schumann, Raquel, Kuhn, Walther, Polata, Silke, Bielecki, Wojciech, Meyer, Ralf, Just, Marianne, Kraudelt, Susanne, Siggelkow, Wulf, Wortelmann, Heidi, Kleine-Tebbe, Anke, Leitzen, Lena, Kirchhof, Heidrun, Krabisch, Petra, Hackmann, John, Depenbusch, Reinhard, Gnauert, Karsten, Staib, Peter, Lehnert, Antje, Hoffmann, Oliver, Briest, Susanne, Lindner, Christoph, Heyl, Volker, Bauer, Leila, Uleer, Christoph, Mohrmann, Svjetlana, Viehstaedt, Nicole, Malter, Wolfram, Link, Theresa, Buendgen, Nana, Tio, Joke, Nitz, Ulrike, Gluz, Oleg, Graeser, Monika, Christgen, Matthias, Kuemmel, Sherko, Grischke, Eva-Maria, Braun, Michael, Augustin, Doris, Potenberg, Jochem, Krauss, Katja, Schumacher, Claudia, Forstbauer, Helmut, Reimer, Toralf, Stefek, Andrea, Fischer, Hans Holger, Pelz, Enrico, zu Eulenburg, Christine, Kates, Ronald, Wuerstlein, Rachel, Kreipe, Hans Heinrich, and Harbeck, Nadia
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- 2022
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4. Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial
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Kolberg-Liedtke, Cornelia, Feuerhake, Friedrich, Garke, Madlen, Christgen, Matthias, Kates, Ronald, Grischke, Eva Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kuemmel, Sherko, Wuerstlein, Rachel, Graeser, Monika, Nitz, Ulrike, Kreipe, Hans, Gluz, Oleg, and Harbeck, Nadia
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- 2022
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5. ASO Visual Abstract: Minimally-Invasive Breast Biopsy After Neoadjuvant Systemic Treatment to Identify Breast Cancer Patients with Residual Disease for Extended Neoadjuvant Treatment—A New Concept
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Pfob, André, primary, Cai, Lie, additional, Schneeweiss, Andreas, additional, Rauch, Geraldine, additional, Thomas, Bettina, additional, Schaefgen, Benedikt, additional, Kuemmel, Sherko, additional, Reimer, Toralf, additional, Hahn, Markus, additional, Thill, Marc, additional, Blohmer, Jens-Uwe, additional, Hackmann, John, additional, Malter, Wolfram, additional, Bekes, Inga, additional, Friedrichs, Kay, additional, Wojcinski, Sebastian, additional, Joos, Sylvie, additional, Paepke, Stefan, additional, Degenhardt, Tom, additional, Rom, Joachim, additional, Rody, Achim, additional, van Mackelenbergh, Marion, additional, Banys-Paluchowski, Maggie, additional, Große, Regina, additional, Reinisch, Mattea, additional, Karsten, Maria Margarete, additional, Sidey-Gibbons, Chris, additional, Wallwiener, Markus, additional, Golatta, Michael, additional, and Heil, Joerg, additional
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- 2023
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6. Minimally Invasive Breast Biopsy After Neoadjuvant Systemic Treatment to Identify Breast Cancer Patients with Residual Disease for Extended Neoadjuvant Treatment: A New Concept
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Pfob, André, primary, Cai, Lie, additional, Schneeweiss, Andreas, additional, Rauch, Geraldine, additional, Thomas, Bettina, additional, Schaefgen, Benedikt, additional, Kuemmel, Sherko, additional, Reimer, Toralf, additional, Hahn, Markus, additional, Thill, Marc, additional, Blohmer, Jens-Uwe, additional, Hackmann, John, additional, Malter, Wolfram, additional, Bekes, Inga, additional, Friedrichs, Kay, additional, Wojcinski, Sebastian, additional, Joos, Sylvie, additional, Paepke, Stefan, additional, Degenhardt, Tom, additional, Rom, Joachim, additional, Rody, Achim, additional, van Mackelenbergh, Marion, additional, Banys-Paluchowski, Maggie, additional, Große, Regina, additional, Reinisch, Mattea, additional, Karsten, Maria Margarete, additional, Sidey-Gibbons, Chris, additional, Wallwiener, Markus, additional, Golatta, Michael, additional, and Heil, Joerg, additional
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- 2023
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7. Diagnosing Pathologic Complete Response in the Breast After Neoadjuvant Systemic Treatment of Breast Cancer Patients by Minimal Invasive Biopsy: Oral Presentation at the San Antonio Breast Cancer Symposium on Friday, December 13, 2019, Program Number GS5-03
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Heil, Joerg, Pfob, André, Sinn, Hans-Peter, Rauch, Geraldine, Bach, Paul, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Ditsch, Nina, Rody, Achim, Große, Regina, van Mackelenbergh, Marion, Reinisch, Mattea, Karsten, Maria, and Golatta, Michael
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- 2020
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8. Supplementary Figure from De-escalated Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC): Impact of Molecular Markers and Final Survival Analysis of the WSG-ADAPT-TN Trial
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Gluz, Oleg, primary, Nitz, Ulrike, primary, Kolberg-Liedtke, Cornelia, primary, Prat, Aleix, primary, Christgen, Matthias, primary, Kuemmel, Sherko, primary, Mohammadian, Mohammad Parsa, primary, Gebauer, Daniel, primary, Kates, Ronald, primary, Paré, Laia, primary, Grischke, Eva-Maria, primary, Forstbauer, Helmut, primary, Braun, Michael, primary, Warm, Mathias, primary, Hackmann, John, primary, Uleer, Christoph, primary, Aktas, Bahriye, primary, Schumacher, Claudia, primary, Wuerstlein, Rachel, primary, Graeser, Monika, primary, Pelz, Enrico, primary, Jóźwiak, Katarzyna, primary, zu Eulenburg, Christine, primary, Kreipe, Hans Heinrich, primary, and Harbeck, Nadia, primary
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- 2023
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9. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto—GBG 69): a randomised, phase 3 trial
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Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Conrad, Bettina, Aktas, Bahriye, Denkert, Carsten, Eidtmann, Holger, Wiebringhaus, Hermann, Kümmel, Sherko, Hilfrich, Jörn, Warm, Mathias, Paepke, Stefan, Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Clemens, Michael, Darb-Esfahani, Silvia, Schmitt, Wolfgang Daniel, Dan Costa, Serban, Gerber, Bernd, Engels, Knut, Nekljudova, Valentina, Loibl, Sibylle, and von Minckwitz, Gunter
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- 2016
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10. A systematic and sensitive method for critical reagent antibody evaluation with PCA technology
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Gong, Jian, primary, Wang, Xing, additional, and Hackmann, John, additional
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- 2022
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11. Efficacy and safety of nab-paclitaxel 125 mg/m2 and nab-paclitaxel 150 mg/m2 compared to paclitaxel in early high-risk breast cancer. Results from the neoadjuvant randomized GeparSepto study (GBG 69)
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Furlanetto, Jenny, Jackisch, Christian, Untch, Michael, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Wiebringhaus, Hermann, Kümmel, Sherko, Warm, Mathias, Paepke, Stefan, Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens Uwe, Clemens, Michael, Costa, Serban Dan, Gerber, Bernd, Nekljudova, Valentina, Loibl, Sibylle, and von Minckwitz, Gunter
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- 2017
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12. RESPONDER – diagnosis of pathological complete response by vacuum-assisted biopsy after neoadjuvant chemotherapy in breast Cancer - a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial
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Heil, Joerg, Sinn, Peter, Richter, Hannah, Pfob, André, Schaefgen, Benedikt, Hennigs, André, Riedel, Fabian, Thomas, Bettina, Thill, Marc, Hahn, Markus, Blohmer, Jens-Uwe, Kuemmel, Sherko, Karsten, Maria Margarete, Reinisch, Mattea, Hackmann, John, Reimer, Toralf, Rauch, Geraldine, and Golatta, Michael
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- 2018
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13. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery
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Pfob, André, primary, Sidey-Gibbons, Chris, additional, Rauch, Geraldine, additional, Thomas, Bettina, additional, Schaefgen, Benedikt, additional, Kuemmel, Sherko, additional, Reimer, Toralf, additional, Hahn, Markus, additional, Thill, Marc, additional, Blohmer, Jens-Uwe, additional, Hackmann, John, additional, Malter, Wolfram, additional, Bekes, Inga, additional, Friedrichs, Kay, additional, Wojcinski, Sebastian, additional, Joos, Sylvie, additional, Paepke, Stefan, additional, Degenhardt, Tom, additional, Rom, Joachim, additional, Rody, Achim, additional, van Mackelenbergh, Marion, additional, Banys-Paluchowski, Maggie, additional, Große, Regina, additional, Reinisch, Mattea, additional, Karsten, Maria, additional, Golatta, Michael, additional, and Heil, Joerg, additional
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- 2022
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14. De-escalated neoadjuvant pertuzumab plus trastuzumab therapy with or without weekly paclitaxel in HER2-positive, hormone receptor-negative, early breast cancer (WSG-ADAPT-HER2+/HR–): survival outcomes from a multicentre, open-label, randomised, phase 2 trial
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Nitz, Ulrike, primary, Gluz, Oleg, additional, Graeser, Monika, additional, Christgen, Matthias, additional, Kuemmel, Sherko, additional, Grischke, Eva-Maria, additional, Braun, Michael, additional, Augustin, Doris, additional, Potenberg, Jochem, additional, Krauss, Katja, additional, Schumacher, Claudia, additional, Forstbauer, Helmut, additional, Reimer, Toralf, additional, Stefek, Andrea, additional, Fischer, Hans Holger, additional, Pelz, Enrico, additional, zu Eulenburg, Christine, additional, Kates, Ronald, additional, Wuerstlein, Rachel, additional, Kreipe, Hans Heinrich, additional, Harbeck, Nadia, additional, von Schumann, Raquel, additional, Kuhn, Walther, additional, Polata, Silke, additional, Bielecki, Wojciech, additional, Meyer, Ralf, additional, Just, Marianne, additional, Kraudelt, Susanne, additional, Siggelkow, Wulf, additional, Wortelmann, Heidi, additional, Kleine-Tebbe, Anke, additional, Leitzen, Lena, additional, Kirchhof, Heidrun, additional, Krabisch, Petra, additional, Hackmann, John, additional, Depenbusch, Reinhard, additional, Gnauert, Karsten, additional, Staib, Peter, additional, Lehnert, Antje, additional, Hoffmann, Oliver, additional, Briest, Susanne, additional, Lindner, Christoph, additional, Heyl, Volker, additional, Bauer, Leila, additional, Uleer, Christoph, additional, Mohrmann, Svjetlana, additional, Viehstaedt, Nicole, additional, Malter, Wolfram, additional, Link, Theresa, additional, Buendgen, Nana, additional, and Tio, Joke, additional
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- 2022
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15. De-escalated Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC): Impact of Molecular Markers and Final Survival Analysis of the WSG-ADAPT-TN Trial
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Gluz, Oleg, Nitz, Ulrike, Kolberg-Liedtke, Cornelia, Prat, Aleix, Christgen, Matthias, Kuemmel, Sherko, Mohammadian, Mohammad Parsa, Gebauer, Daniel, Kates, Ronald, Pare, Laia, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Wuerstlein, Rachel, Graeser, Monika, Pelz, Enrico, Jozwiak, Katarzyna, Zu Eulenburg, Christine, Kreipe, Hans Heinrich, Harbeck, Nadia, Gluz, Oleg, Nitz, Ulrike, Kolberg-Liedtke, Cornelia, Prat, Aleix, Christgen, Matthias, Kuemmel, Sherko, Mohammadian, Mohammad Parsa, Gebauer, Daniel, Kates, Ronald, Pare, Laia, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Wuerstlein, Rachel, Graeser, Monika, Pelz, Enrico, Jozwiak, Katarzyna, Zu Eulenburg, Christine, Kreipe, Hans Heinrich, and Harbeck, Nadia
- Abstract
Purpose: Although optimal treatment in early triple-negative breast cancer (TNBC) remains unclear, de-escalated chemother-apy appears to be an option in selected patients within this aggressive subtype. Previous studies have identified several pro -immune factors as prognostic markers in TNBC, but their predictive impact regarding different chemotherapy strategies is still controversial.Experimental Design: ADAPT-TN is a randomized neoadju-vant multicenter phase II trial in early patients with TNBC (n = 336) who were randomized to 12 weeks of nab-paclitaxel 125 mg/m2 thorn gemcitabine or carboplatin d 1,8 q3w. Omission of further (neo-) adjuvant chemotherapy was allowed only in patients with patho-logical complete response [pCR, primary endpoint (ypT0/is, ypN0)]. Secondary invasive/distant disease-free and overall survival (i/dDFS, OS) and translational research objectives included quantification of a predictive impact of markers regard-ing selection for chemotherapy de-escalation, measured by gene expression of 119 genes (including PAM50 subtype) by nCounter platform and stromal tumor-infiltrating lymphocytes (sTIL).Results: After 60 months of median follow-up, 12-week-pCR was favorably associated (HR, 0.24; P = 0.001) with 5y-iDFS of 90.6% versus 62.8%. No survival advantage of carboplatin use was observed, despite a higher pCR rate [HR, 1.04; 95% confidence interval (CI), 0.68-1.59]. Additional anthracycline-containing che-motherapy was not associated with a significant iDFS advantage in pCR patients (HR, 1.29; 95% CI, 0.41-4.02). Beyond pCR rate, nodal status and high sTILs were independently associated with better iDFS, dDFS, and OS by multivariable analysis.Conclusions: Short de-escalated neoadjuvant taxane/platinum-based combination therapy appears to be a promising strategy in early TNBC for using pCR rate as an early decision point for further therapy (de-) escalation together with node-negative status and high sTILs.
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- 2022
16. Diagnosing Pathologic Complete Response in the Breast After Neoadjuvant Systemic Treatment of Breast Cancer Patients by Minimal Invasive Biopsy: Oral Presentation at the San Antonio Breast Cancer Symposium on Friday, December 13, 2019, Program Number GS5-03
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Heil, Joerg, Pfob, Andre, Sinn, Hans-Peter, Rauch, Geraldine, Bach, Paul, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Ditsch, Nina, Rody, Achim, Grosse, Regina, van Mackelenbergh, Marion, Reinisch, Mattea, Karsten, Maria, Golatta, Michael, Heil, Joerg, Pfob, Andre, Sinn, Hans-Peter, Rauch, Geraldine, Bach, Paul, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Ditsch, Nina, Rody, Achim, Grosse, Regina, van Mackelenbergh, Marion, Reinisch, Mattea, Karsten, Maria, and Golatta, Michael
- Abstract
Objective:We evaluated the ability of minimally invasive, image-guided vacuum-assisted biopsy (VAB) to reliably diagnose a pathologic complete response in the breast (pCR-B).Summary Background Data:Neoadjuvant systemic treatment (NST) elicits a pathologic complete response in up to 80% of women with breast cancer. In such cases, breast surgery, the gold standard for confirming pCR-B, may be considered overtreatment.Methods:This multicenter, prospective trial enrolled 452 women presenting with initial stage 1-3 breast cancer of all biological subtypes. Fifty-four women dropped out; 398 were included in the full analysis. All participants had an imaging-confirmed partial or complete response to NST and underwent study-specific image-guided VAB before guideline-adherent breast surgery. The primary endpoint was the false-negative rate (FNR) of VAB-confirmed pCR-B.Results:Image-guided VAB alone did not detect surgically confirmed residual tumor in 37 of 208 women [FNR, 17.8%; 95% confidence interval (CI), 12.8-23.7%]. Of these 37 women, 12 (32.4%) had residual DCIS only, 20 (54.1%) had minimal residual tumor (<5mm), and 19 of 25 (76.0%) exhibited invasive cancer cellularity of
10%. In 19 of the 37 cases (51.4%), the false-negative result was potentially avoidable. Exploratory analysis showed that performing VAB with the largest needle by volume (7-gauge) resulted in no false-negative results and that combining imaging and image-guided VAB into a single diagnostic test lowered the FNR to 6.2% (95% CI, 3.4%-10.5%).Conclusions:Image-guided VAB missed residual disease more often than expected. Refinements in procedure and patient selection seem possible and necessary before omitting breast surgery. - Published
- 2022
17. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery
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Pfob, Andre, Sidey-Gibbons, Chris, Rauch, Geraldine, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Degenhardt, Tom, Rom, Joachim, Rody, Achim, van Mackelenbergh, Marion, Banys-Paluchowski, Maggie, Grosse, Regina, Reinisch, Mattea, Karsten, Maria, Golatta, Michael, Heil, Joerg, Pfob, Andre, Sidey-Gibbons, Chris, Rauch, Geraldine, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Degenhardt, Tom, Rom, Joachim, Rody, Achim, van Mackelenbergh, Marion, Banys-Paluchowski, Maggie, Grosse, Regina, Reinisch, Mattea, Karsten, Maria, Golatta, Michael, and Heil, Joerg
- Abstract
PURPOSE Neoadjuvant systemic treatment (NST) elicits a pathologic complete response in 40%-70% of women with breast cancer. These patients may not need surgery as all local tumor has already been eradicated by NST. However, nonsurgical approaches, including imaging or vacuum-assisted biopsy (VAB), were not able to accurately identify patients without residual cancer in the breast or axilla. We evaluated the feasibility of a machine learning algorithm (intelligent VAB) to identify exceptional responders to NST. METHODS We trained, tested, and validated a machine learning algorithm using patient, imaging, tumor, and VAB variables to detect residual cancer after NST (ypT+ or in situ or ypN+) before surgery. We used data from 318 women with cT1-3, cN0 or +, human epidermal growth factor receptor 2-positive, triple-negative, or high-proliferative Luminal B-like breast cancer who underwent VAB before surgery (ClinicalTrials.gov identifier: , RESPONDER trial). We used 10-fold cross-validation to train and test the algorithm, which was then externally validated using data of an independent trial (ClinicalTrials.gov identifier: ). We compared findings with the histopathologic evaluation of the surgical specimen. We considered false-negative rate (FNR) and specificity to be the main outcomes. RESULTS In the development set (n = 318) and external validation set (n = 45), the intelligent VAB showed an FNR of 0.0%-5.2%, a specificity of 37.5%-40.0%, and an area under the receiver operating characteristic curve of 0.91-0.92 to detect residual cancer (ypT+ or in situ or ypN+) after NST. Spiegelhalter's Z confirmed a well-calibrated model (z score -0.746, P = .228). FNR of the intelligent VAB was lower compared with imaging after NST, VAB alone, or combinations of both. CONCLUSION An intelligent VAB algorithm can reliably exclude residual cancer after NST. The omission of breast and axillary surgery for these exceptional responders may be evaluated in future trials.
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- 2022
18. Abstract PD7-02: Intelligent vacuum-assisted breast biopsy to identify breast cancer patients with pathologic complete response after neoadjuvant systemic treatment for omission of breast and axillary surgery
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Pfob, André, primary, Sidey-Gibbons, Chris, additional, Rauch, Geraldine, additional, Thomas, Bettina, additional, Schaefgen, Benedikt, additional, Kuemmel, Sherko, additional, Reimer, Toralf, additional, Hahn, Markus, additional, Thill, Marc, additional, Blohmer, Jens-Uwe, additional, Hackmann, John, additional, Malter, Wolfram, additional, Bekes, Inga, additional, Friedrichs, Kay, additional, Wojcinski, Sebastian, additional, Joos, Sylvie, additional, Paepke, Stefan, additional, Degenhardt, Tom, additional, Rom, Joachim, additional, Rody, Achim, additional, Große, Regina, additional, van Mackelenbergh, Marion, additional, Reinisch, Mattea, additional, Karsten, Maria, additional, Golatta, Michael, additional, and Heil, Joerg, additional
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- 2022
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19. Additional file 4 of Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial
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Kolberg-Liedtke, Cornelia, Feuerhake, Friedrich, Garke, Madlen, Christgen, Matthias, Kates, Ronald, Grischke, Eva Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kuemmel, Sherko, Wuerstlein, Rachel, Graeser, Monika, Nitz, Ulrike, Kreipe, Hans, Gluz, Oleg, and Harbeck, Nadia
- Abstract
Additional file 4. Table S1. Mediation analysis for raw sTIL-0 and sTIL-3 measurements as continuous variables. Table S2. Mediation analysis for categorized sTIL-0 and sTIL-3 measurements.
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- 2022
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20. Additional file 2 of Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial
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Kolberg-Liedtke, Cornelia, Feuerhake, Friedrich, Garke, Madlen, Christgen, Matthias, Kates, Ronald, Grischke, Eva Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kuemmel, Sherko, Wuerstlein, Rachel, Graeser, Monika, Nitz, Ulrike, Kreipe, Hans, Gluz, Oleg, and Harbeck, Nadia
- Abstract
Additional file 2. Figure S2. Distribution of semi quantitative measurements of A sTIL-0 and B sTIL-3 (n = 336).
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- 2022
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21. Additional file 3 of Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial
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Kolberg-Liedtke, Cornelia, Feuerhake, Friedrich, Garke, Madlen, Christgen, Matthias, Kates, Ronald, Grischke, Eva Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kuemmel, Sherko, Wuerstlein, Rachel, Graeser, Monika, Nitz, Ulrike, Kreipe, Hans, Gluz, Oleg, and Harbeck, Nadia
- Abstract
Additional file 3. Figure S3. ROC curves and AUC in all patients regarding. A sTIL-0 and B sTIL-3
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- 2022
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22. A Randomized Phase 2 Study Comparing EC or CMF Versus Nab-Paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Nonfrail Elderly Patients With Moderate to High-Risk Early Breast Cancer (ICE II-GBG 52)
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von Minckwitz, Gunter, Conrad, Bettina, Reimer, Toralf, Decker, Thomas, Eidtmann, Holger, Eiermann, Wolfgang, Hackmann, John, Möbus, Volker, Marmé, Frederik, Potenberg, Jochem, Stickeler, Elmar, Simon, Eike, Thomssen, Christoph, Huober, Jens, Denkert, Carsten, Alfer, Joachim, Jackisch, Christian, Nekljudova, Valentina, Burchardi, Nicole, and Loibl, Sibylle
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- 2015
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23. Therapy response and prognosis of patients with early breast cancer with low positivity for hormone receptors – An analysis of 2765 patients from neoadjuvant clinical trials
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Villegas, Sonia L., primary, Nekljudova, Valentina, additional, Pfarr, Nicole, additional, Engel, Jutta, additional, Untch, Michael, additional, Schrodi, Simone, additional, Holms, Frank, additional, Ulmer, Hans U., additional, Fasching, Peter A., additional, Weber, Karsten E., additional, Albig, Christian, additional, Heinrichs, Clemens, additional, Marmé, Frederik, additional, Hartmann, Arndt, additional, Hanusch, Claus, additional, Schmitt, Wolfgang D., additional, Huober, Jens, additional, Lederer, Bianca, additional, van Mackelenbergh, Marion, additional, Tesch, Hans, additional, Jackisch, Christian, additional, Rezai, Mahdi, additional, Sinn, Peter, additional, Sinn, Bruno V., additional, Hackmann, John, additional, Kiechle, Marion, additional, Schneeweiss, Andreas, additional, Weichert, Wilko, additional, Denkert, Carsten, additional, and Loibl, Sibylle, additional
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- 2021
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24. Immune cell composition and functional marker dynamics from multiplexed immunohistochemistry to predict response to neoadjuvant chemotherapy in the WSG-ADAPT-TN trial
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Graeser, Monika, primary, Feuerhake, Friedrich, additional, Gluz, Oleg, additional, Volk, Valery, additional, Hauptmann, Michael, additional, Jozwiak, Katarzyna, additional, Christgen, Matthias, additional, Kuemmel, Sherko, additional, Grischke, Eva-Maria, additional, Forstbauer, Helmut, additional, Braun, Michael, additional, Warm, Mathias, additional, Hackmann, John, additional, Uleer, Christoph, additional, Aktas, Bahriye, additional, Schumacher, Claudia, additional, Kolberg-Liedtke, Cornelia, additional, Kates, Ronald, additional, Wuerstlein, Rachel, additional, Nitz, Ulrike, additional, Kreipe, Hans Heinrich, additional, and Harbeck, Nadia, additional
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- 2021
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25. Immune cell composition and functional marker dynamics from multiplexed immunohistochemistry to predict response to neoadjuvant chemotherapy in the WSG-ADAPT-TN trial
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Graeser, Monika, Feuerhake, Friedrich, Gluz, Oleg, Volk, Valery, Hauptmann, Michael, Jozwiak, Katarzyna, Christgen, Matthias, Kuemmel, Sherko, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kolberg-Liedtke, Cornelia, Kates, Ronald, Wuerstlein, Rachel, Nitz, Ulrike, Kreipe, Hans Heinrich, Harbeck, Nadia, Graeser, Monika, Feuerhake, Friedrich, Gluz, Oleg, Volk, Valery, Hauptmann, Michael, Jozwiak, Katarzyna, Christgen, Matthias, Kuemmel, Sherko, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kolberg-Liedtke, Cornelia, Kates, Ronald, Wuerstlein, Rachel, Nitz, Ulrike, Kreipe, Hans Heinrich, and Harbeck, Nadia
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Background The association of early changes in the immune infiltrate during neoadjuvant chemotherapy (NACT) with pathological complete response (pCR) in triple-negative breast cancer (TNBC) remains unexplored. Methods Multiplexed immunohistochemistry was performed in matched tumor biopsies obtained at baseline and after 3 weeks of NACT from 66 patients from the West German Study Group Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer (WSG-ADAPT-TN) trial. Association between CD4, CD8, CD73, T cells, PD1-positive CD4 and CD8 cells, and PDL1 levels in stroma and/or tumor at baseline, week 3 and 3-week change with pCR was evaluated with univariable logistic regression. Results Compared with no change in immune cell composition and functional markers, transition from 'cold' to 'hot' (below-median and above-median marker level at baseline, respectively) suggested higher pCR rates for PD1-positive CD4 (tumor: OR=1.55, 95% CI 0.45 to 5.42; stroma: OR=2.65, 95% CI 0.65 to 10.71) and PD1-positive CD8 infiltrates (tumor: OR=1.77, 95% CI 0.60 to 5.20; stroma: OR=1.25, 95% CI 0.41 to 3.84; tumor+stroma: OR=1.62, 95% CI 0.51 to 5.12). No pCR was observed after 'hot-to-cold' transition in PD1-positive CD8 cells. pCR rates appeared lower after hot-to-cold transitions in T cells (tumor: OR=0.26, 95% CI 0.03 to 2.34; stroma: OR=0.35, 95% CI 0.04 to 3.25; tumor+stroma: OR=0.00, 95% CI 0.00 to 1.04) and PD1-positive CD4 cells (tumor: OR=0.60, 95% CI 0.11 to 3.35; stroma: OR=0.22, 95% CI 0.03 to 1.92; tumor+stroma: OR=0.32, 95% CI 0.04 to 2.94). Higher pCR rates collated with 'altered' distribution (levels below-median and above-median in tumor and stroma, respectively) of T cell (OR=3.50, 95% CI 0.84 to 14.56) and PD1-positive CD4 cells (OR=4.50, 95% CI 1.01 to 20.14). Conclusion Our exploratory findings indicate that comprehensive analysis of early immune infilt
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- 2021
26. Efficacy of deescalated chemotherapy according to PAM50 subtypes, immune and proliferation genes in triple-negative early breast cancer: Primary translational analysis of the WSG-ADAPT-TN trial
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Gluz, Oleg, Kolberg-Liedtke, Cornelia, Prat, Aleix, Christgen, Matthias, Gebauer, Daniel, Kates, Ronald, Pare, Laia, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kuemmel, Sherko, Wuerstlein, Rachel, Pelz, Enrico, Nitz, Ulrike, Kreipe, Hans Heinrich, Harbeck, Nadia, Gluz, Oleg, Kolberg-Liedtke, Cornelia, Prat, Aleix, Christgen, Matthias, Gebauer, Daniel, Kates, Ronald, Pare, Laia, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Kuemmel, Sherko, Wuerstlein, Rachel, Pelz, Enrico, Nitz, Ulrike, Kreipe, Hans Heinrich, and Harbeck, Nadia
- Abstract
In the neoadjuvant WSG-ADAPT-TN trial, 12-week nab-paclitaxel + carboplatin (nab-pac/carbo) was highly effective and superior to nab-paclitaxel + gemcitabine (nab-pac/gem) in triple-negative breast cancer regarding pathological complete response (pCR). Predictive markers for deescalated taxane/carbo use in TNBC need to be identified. Patients received 4 x nab-pac 125 mg/m(2) (plus carbo AUC2 or gem 1,000 mg/m(2) d1,8 q21). Expression of 119 genes and PAM50 scores by nCounter were available in 306/336 pretherapeutic samples. Interim survival analysis was planned after 36 months median follow-up. Basal-like (83.3%) compared to other subtypes was positively associated with pCR (38% vs. 20%, p = 0.015), as was lower HER2 score (p < 0.001). Proliferation biomarkers were positively associated with pCR, that is, PAM50 proliferation, ROR scores (all p < 0.004), higher Ki-67 (IHC; p < 0.001). For nab-pac/carbo, expression of immunological (CD8, PD1 and PFDL1) genes and proliferation markers (proliferation and ROR scores, MKI67, CDC20, NUF2, KIF2C, CENPF, EMP3 and TYMS) were positively associated with pCR (p < 0.05 for all). For nab-pac/gem, angiogenesis genes were negatively associated with pCR (ANGPTL4: p = 0.05; FGFR4: p = 0.02; VEGFA: p = 0.03). pCR after 12 weeks was strongly associated with favorable outcome (3y event-free survival: 92% vs. 71%, p < 0.001). In early TNBC, basal-like subtype, higher Ki-67 (IHC) and lower HER2 score were, associated with chemosensitivity. Chemoresistance pathways differed between the two taxane based combinations. Combination of proliferation/immune markers and PAM50 subtype could allow patient selection for further deescalated chemotherapy and/or immune treatment approaches.
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- 2020
27. Diagnosing Pathologic Complete Response in the Breast After Neoadjuvant Systemic Treatment of Breast Cancer Patients by Minimal Invasive Biopsy: Oral Presentation at the San Antonio Breast Cancer Symposium on Friday, December 13, 2019, Program Number...
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Heil, Joerg, Pfob, Andre, Sinn, Hans-Peter, Rauch, Geraldine, Bach, Paul, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, and Ditsch, Nina
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Objective: We evaluated the ability of minimally invasive, image-guided vacuum-assisted biopsy (VAB) to reliably diagnose a pathologic complete response in the breast (pCR-B). Summary Background Data: Neoadjuvant systemic treatment (NST) elicits a pathologic complete response in up to 80% of women with breast cancer. In such cases, breast surgery, the gold standard for confirming pCR-B, may be considered overtreatment. Methods: This multicenter, prospective trial enrolled 452 women presenting with initial stage 1-3 breast cancer of all biological subtypes. Fifty-four women dropped out; 398 were included in the full analysis. All participants had an imaging-confirmed partial or complete response to NST and underwent study-specific image-guided VAB before guideline-adherent breast surgery. The primary endpoint was the false-negative rate (FNR) of VAB-confirmed pCR-B. Results: Image-guided VAB alone did not detect surgically confirmed residual tumor in 37 of 208 women [FNR, 17.8%; 95% confidence interval (CI), 12.8-23.7%]. Of these 37 women, 12 (32.4%) had residual DCIS only, 20 (54.1%) had minimal residual tumor (<5 mm), and 19 of 25 (76.0%) exhibited invasive cancer cellularity of <=10%. In 19 of the 37 cases (51.4%), the false-negative result was potentially avoidable. Exploratory analysis showed that performing VAB with the largest needle by volume (7-gauge) resulted in no false-negative results and that combining imaging and image-guided VAB into a single diagnostic test lowered the FNR to 6.2% (95% CI, 3.4%-10.5%). /p> Conclusions: Image-guided VAB missed residual disease more often than expected. Refinements in procedure and patient selection seem possible and necessary before omitting breast surgery. [ABSTRACT FROM AUTHOR]
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- 2022
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28. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto
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Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kuemmel, Sherko, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Rhiem, Kerstin, Schmitt, Wolfgang D., Furlanetto, Jenny, Gerber, Bernd, Huober, Jens, Nekljudova, Valentina, von Minckwitz, Gunter, Loibl, Sibylle, Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kuemmel, Sherko, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Rhiem, Kerstin, Schmitt, Wolfgang D., Furlanetto, Jenny, Gerber, Bernd, Huober, Jens, Nekljudova, Valentina, von Minckwitz, Gunter, and Loibl, Sibylle
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PURPOSE The GeparSepto trial demonstrated that weekly nanoparticle albumin-bound (NAB)-paclitaxel significantly improves the pathologic complete remission rate compared with weekly solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide as neoadjuvant treatment in patients with primary breast cancer (BC). Here, we report data on long-term outcomes. METHODS Patients with histologically confirmed primary BC were randomly assigned in a 1: 1 ratio to 12 times weekly NAB-paclitaxel 150 mg/m(2) (after study amendment, 125 mg/m(2)) or weekly sb-paclitaxel 80 mg/m(2) followed in both arms by four times epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks. Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received dual antibody treatment with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) concurrently to chemotherapy and continued for 1 year. RESULTS A total of 1,206 patients started treatment, 606 with NAB-paclitaxel and 600 with sb-paclitaxel. After a median follow-up of 49.6 months (range, 0.5 to 64.0 months), 243 invasive disease-free survival (iDFS) events were reported (143 in the sb-paclitaxel and 100 in the NAB-paclitaxel arm). At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m(2) compared with NAB-paclitaxel 150 mg/m(2). CONCLUSION The significantly higher pathologic complete response rate with NAB-paclitaxel translated into a significantly improve
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- 2019
29. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69–GeparSepto
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Untch, Michael, primary, Jackisch, Christian, additional, Schneeweiss, Andreas, additional, Schmatloch, Sabine, additional, Aktas, Bahriye, additional, Denkert, Carsten, additional, Schem, Christian, additional, Wiebringhaus, Hermann, additional, Kümmel, Sherko, additional, Warm, Mathias, additional, Fasching, Peter A., additional, Just, Marianne, additional, Hanusch, Claus, additional, Hackmann, John, additional, Blohmer, Jens-Uwe, additional, Rhiem, Kerstin, additional, Schmitt, Wolfgang D., additional, Furlanetto, Jenny, additional, Gerber, Bernd, additional, Huober, Jens, additional, Nekljudova, Valentina, additional, von Minckwitz, Gunter, additional, and Loibl, Sibylle, additional
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- 2019
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30. Efficacy of deescalated chemotherapy according to PAM50 subtypes, immune and proliferation genes in triple‐negative early breast cancer: Primary translational analysis of the WSG‐ADAPT‐TN trial
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Gluz, Oleg, primary, Kolberg‐Liedtke, Cornelia, additional, Prat, Aleix, additional, Christgen, Matthias, additional, Gebauer, Daniel, additional, Kates, Ronald, additional, Paré, Laia, additional, Grischke, Eva‐Maria, additional, Forstbauer, Helmut, additional, Braun, Michael, additional, Warm, Mathias, additional, Hackmann, John, additional, Uleer, Christoph, additional, Aktas, Bahriye, additional, Schumacher, Claudia, additional, Kuemmel, Sherko, additional, Wuerstlein, Rachel, additional, Pelz, Enrico, additional, Nitz, Ulrike, additional, Kreipe, Hans Heinrich, additional, and Harbeck, Nadia, additional
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- 2019
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31. Low Positivity for Hormone Receptors in Early Breast Cancer: Therapy-Response and Prognosis -A Systematic Analysis of a Total of 9027 Patients
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Villegas, Sonia Lorena, primary, Nekljudova, Valentina, additional, Engel, Jutta, additional, Untch, Michael, additional, Schrodi, Simone, additional, Holms, Frank, additional, Ulmer, Hans-Ulrich, additional, Fasching, Peter Andreas, additional, Ernst Weber, Karsten, additional, Heinrichs, Clemens, additional, Marmé, Frederik, additional, Hartmann, Arndt, additional, Hanusch, Claus Alexander, additional, Schmitt, Wolfgang Daniel, additional, Huober, Jens, additional, Lederer, Bianca, additional, van Mackelenbergh, Marion, additional, Tesch, Hans, additional, Jackisch, Christian, additional, Rezai, Mahdi, additional, Sinn, Peter, additional, Valentin Sinn, Bruno, additional, Hackmann, John, additional, Kiechle, Marion, additional, Schneeweiss, Andreas, additional, Weichert, Wilko, additional, Denkert, Carsten, additional, and Loibl, Sibylle, additional
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- 2019
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32. Survival analysis of the prospectively randomized phase III GeparSepto trial comparing neoadjuvant chemotherapy with weekly nab-paclitaxel with solvent-based paclitaxel followed by anthracycline/cyclophosphamide for patients with early breast cancer-GBG69
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Schneeweiss, Andreas, Jackisch, Christian, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kummel, Sherko, Rhiem, Kerstin, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens Uwe, Gerber, Bernd, Furlanetto, Jenny, von Minckwitz, Gunter, Nekljudova, Valentina, Loibl, Sibylle, Untch, Michael, Schneeweiss, Andreas, Jackisch, Christian, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kummel, Sherko, Rhiem, Kerstin, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens Uwe, Gerber, Bernd, Furlanetto, Jenny, von Minckwitz, Gunter, Nekljudova, Valentina, Loibl, Sibylle, and Untch, Michael
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- 2018
33. Comparison of Neoadjuvant Nab-Paclitaxe plus Carboplatin vs Nab-Paclitaxe plus Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results
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Gluz, Oleg, Nitz, Ulrike, Liedtke, Cornelia, Christgen, Matthias, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Bangemann, Nikola, Lindner, Christoph, Kuemmel, Sherko, Clemens, Michael, Potenberg, Jochem, Staib, Peter, Kohls, Andreas, von Schumann, Raquel, Harbeck, Nadia, Gluz, Oleg, Nitz, Ulrike, Liedtke, Cornelia, Christgen, Matthias, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Bangemann, Nikola, Lindner, Christoph, Kuemmel, Sherko, Clemens, Michael, Potenberg, Jochem, Staib, Peter, Kohls, Andreas, von Schumann, Raquel, and Harbeck, Nadia
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Background: Pathological complete response (pCR) is associated with improved prognosis in triple-negative breast cancer (TNBC). The optimal chemotherapy regimen is unclear. Weekly nab-paclitaxel vs conventional paclitaxel or addition of carboplatin to anthracycline-taxane results in higher pCR rates with uncertain survival impact. We evaluated carboplatin vs gemcitabine with a nab-paclitaxel backbone as a short 12-week A-free regimen with a focus on early response. Methods: Patients with TNBC (estrogen receptor/progesterone receptor < 1%, human epidermal growth factor receptor 2-negative, cT1c-cT4c, cN0/+) were randomly assigned to A: nab-paclitaxel 125 mg/m(2)/gemcitabine 1000 mg/m(2) d1,8 three times weekly (q3w); vs B: nab-paclitaxel 125 mg/m(2)/carboplatin AUC2 day 1,8 q3w. The trial was powered for a pCR (ypT0/is ypN0) comparison by therapy arm and early response (defined as Ki-67 decrease >30% or < 500 invasive tumor cells in the three-week serial biopsy). All statistical tests were two-sided. Results: A total of 336 patients were enrolled (48 centers, arms A/B: n = 182/154). The median age was 50 years. At baseline (A vs B), 62.6% and 62.9% had cT2-4c tumors; 86.8% and 90.9% completed therapy per protocol, respectively. pCR favored arm B (28.7%, 95% CI = 0.22 to 0.36, vs 45.9%, 95% CI = 0.38 to 0.54; 95% CI(d(BA)) = 6.2% to 27.9%, P = .002) and was lower in nonresponders than in early responders (19.5% vs 44.4%, P < .001) or in patients with unclassifiable early response (50.0%). The nab-paclitaxel/gemcitabine was associated with more frequent dose reductions (20.6% vs 11.9%, P = .04), treatment-related serious adverse events (11.1% vs 5.3%, P = .07), grade 3-4 infections (7.2% vs 2.6%, P = .07), and grade 3-4 ALAT elevations (11.7 vs 3.3%, P = .01). Conclusions: This first large randomized trial suggests high efficacy and excellent tolerability of a neoadjuvant nabpaclitaxel/carboplatin regimen, superior to nab-paclitaxel/gemcitabine in TNBC. De-escalation o
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- 2018
34. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results
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Gluz, Oleg, primary, Nitz, Ulrike, additional, Liedtke, Cornelia, additional, Christgen, Matthias, additional, Grischke, Eva-Maria, additional, Forstbauer, Helmut, additional, Braun, Michael, additional, Warm, Mathias, additional, Hackmann, John, additional, Uleer, Christoph, additional, Aktas, Bahriye, additional, Schumacher, Claudia, additional, Bangemann, Nikola, additional, Lindner, Christoph, additional, Kuemmel, Sherko, additional, Clemens, Michael, additional, Potenberg, Jochem, additional, Staib, Peter, additional, Kohls, Andreas, additional, von Schumann, Raquel, additional, Kates, Ronald, additional, Schumacher, Johannes, additional, Wuerstlein, Rachel, additional, Kreipe, Hans Heinrich, additional, and Harbeck, Nadia, additional
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- 2017
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35. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial
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Martin, Miguel, primary, Holmes, Frankie A, additional, Ejlertsen, Bent, additional, Delaloge, Suzette, additional, Moy, Beverly, additional, Iwata, Hiroji, additional, von Minckwitz, Gunter, additional, Chia, Stephen K L, additional, Mansi, Janine, additional, Barrios, Carlos H, additional, Gnant, Michael, additional, Tomašević, Zorica, additional, Denduluri, Neelima, additional, Šeparović, Robert, additional, Gokmen, Erhan, additional, Bashford, Anna, additional, Ruiz Borrego, Manuel, additional, Kim, Sung-Bae, additional, Jakobsen, Erik Hugger, additional, Ciceniene, Audrone, additional, Inoue, Kenichi, additional, Overkamp, Friedrich, additional, Heijns, Joan B, additional, Armstrong, Anne C, additional, Link, John S, additional, Joy, Anil Abraham, additional, Bryce, Richard, additional, Wong, Alvin, additional, Moran, Susan, additional, Yao, Bin, additional, Xu, Feng, additional, Auerbach, Alan, additional, Buyse, Marc, additional, Chan, Arlene, additional, Harvey, Vernon, additional, Tomek, Rudolf, additional, Robert, Nicholas J., additional, Gore, Ira, additional, Smith, John W., additional, Masuda, Norikazu, additional, Di Sean Kendall, S., additional, Harker, William Graydon, additional, Petrakova, Katarina, additional, Guerrero Zotano, Angel, additional, Simon, Amparo Ruiz, additional, Konstantinovic, Zora Neskovic, additional, Iannotti, Nicholas O., additional, Tassone, Pierfrancesco, additional, Rodriguez, Gladys I., additional, Jáñez Martinez, Noelia, additional, Crespo Massieu, Carmen, additional, Smickoska, Snezana, additional, Somali, Isil, additional, Yilmaz, Ugur, additional, Alonso, Mirta Garcia, additional, Rosales, Adolfo Murias, additional, Cold, Soeren, additional, Knoop, Ann Soegaard, additional, Patt, Debra, additional, Hellerstedt, Beth A., additional, Morales Murillo, Serafin, additional, Mayer, Ingrid A., additional, Means-Powell, Julie Ann, additional, Hui, Rina, additional, Senecal, Francis M., additional, De Boer, Richard Hendry, additional, Shen, Zhenzhou, additional, Luczak, Adam Andrzej, additional, Chui, Joanna W.Y., additional, Tsang, Janice Wing-hang, additional, Lang, Istvan, additional, Rai, Yoshiaki, additional, Hozumi, Yasuo, additional, Ten Tije, Albert J., additional, Bhandari, Manish, additional, Osborne, Cynthia R.C., additional, Ohtani, Shoichiro, additional, Higaki, Kenji, additional, Watanabe, Kenichi, additional, Taguchi, Kazunori, additional, Takahashi, Masato, additional, Filipovic, Sladjana, additional, Hansen, Vincent L., additional, Rao, Vijayarama Phooshkooru, additional, Gupta, Manish, additional, Petrov, Petar, additional, Coudert, Bruno, additional, Vojnovic, Zeljko, additional, Polya, Zsofia, additional, Miyaki, Toshiko, additional, Yamamoto, Naohito, additional, Brincat, Stephen, additional, Lesniewski-Kmak, Krzysztof, additional, Chmielowska, Ewa, additional, Birhiray, Ruemu E., additional, Citron, Marc L., additional, Papish, Steven William, additional, Berry, William R., additional, Langkjer, Sven Tyge, additional, Garcia Sáenz, José Angel, additional, Arance, Ana Maria, additional, Efrat, Noa, additional, Sarosiek, Tomasz, additional, Grzeda, Lukasz, additional, Manalo, Yvonne, additional, Smith, Julie C., additional, Vaziri, Irfan, additional, Healey, Tabitha, additional, Rahim, Yasmin, additional, Luk, Cynthia, additional, Dingle, Brian, additional, Franco, Sandra, additional, Sorensen, Peter Grundtvig, additional, Anand, Anjana, additional, Khan, Sarah, additional, Fountzilas, George, additional, Aogi, Kenjiro, additional, Shimizu, Satoru, additional, Mikulova, Milada, additional, Spanik, Stanislav, additional, Somer, Robert A., additional, Flynn, Patrick J., additional, Coward, Jermaine, additional, Mainwaring, Paul, additional, Jerusalem, Guy, additional, Segura-Ojezzar, Carine, additional, Levy, Christelle, additional, Delozier, Thierry, additional, Khayat, David, additional, Coleman, Robert E., additional, Rolles, Martin J., additional, Maisano, Robert, additional, Nardi, Mario, additional, Ito, Yoshinori, additional, Yumuk, Perran Fulden, additional, Basaran, Gul, additional, Serdar Turhal, Nazim, additional, Wilkinson, Mary J., additional, Green, Nathan B., additional, Sidrys, Algis P., additional, Hallmeyer, Sigrun, additional, Testori, Douglas J., additional, Sridhar, Srikala, additional, Chang, Jose, additional, Sun, Qiang, additional, Jara-Sanchez, Carlos, additional, Rubio, Xabier, additional, Garrido, Maria Lomas, additional, De La Haba Rodriguez, Juan Rafael, additional, Perello Martorell, Antonia, additional, Avelia Mestre, Antoni, additional, Rifa Ferrer, Julio, additional, del Barco Berron, Sonia, additional, Nagy, Zsuzsanna, additional, Tanaka, Maki, additional, Im, Young-Hyuck, additional, Carroll, Robert R., additional, Dickerson, Laura C., additional, Mace, Joseph R., additional, Rivera, Ragene, additional, Klein, Leonard M., additional, Ruxer, Robert, additional, Wilks, Sharon T., additional, Kotasek, Dusan, additional, Popov, Vasil, additional, Taskova, Violina, additional, Marinova-Venkova, Violetka, additional, Timcheva, Constanta, additional, Desbiens, Christine, additional, Ayoub, Jean-Pierre, additional, Grenier, Debjani, additional, Marschner, Norbert, additional, Tesch, Hans, additional, Lueck, Hans-Joachim, additional, Janssen, Jan, additional, Schwaner, Ingo, additional, Wahlstrom, Stine, additional, Brix, Eva Harder, additional, Vallentin, Susanne, additional, Kristensen, Dan, additional, Andreeva, Anna, additional, Glavicic, Vesna, additional, Calvo Plaza, Isabel, additional, Anton Torres, Antonio, additional, Veyret, Corinne, additional, Bergerat, Jean-Pierre, additional, Bourbouloux, Emmanuelle, additional, Ella, Wendy Ann, additional, Algurafi, Hafiz, additional, Robinson, Anne, additional, Kim, Seung Jin, additional, Taguchi, Tetsuya, additional, Juozaityte, Elona, additional, Madretsma, Stanley, additional, Radema, Sandra, additional, Czerniawska-Meier, Malgorzata, additional, Rogowski, Wojciech, additional, Wagnerova, Maria, additional, Richards, Donald A., additional, Tan-Chiu, Elizabeth, additional, Vasileios, Asskikis, additional, Henderson, Charles Arthur, additional, Holden, Viran Roger, additional, Wang, Xiaojia, additional, Tong, Zhongsheng, additional, Yang, Junlan, additional, Gonzalez, Manuel Enrique, additional, Rezai, Mahdi, additional, Hackmann, John, additional, de Dueñas, Eduardo Martinez, additional, de las Heras, Begoña Bermejo, additional, Dourthe, Louis Marie, additional, Chocteau-Bouju, Dorothee, additional, Bougnoux, Philippe, additional, Kakolyris, Stylianos, additional, Kalofonos, Haralabos, additional, Pectasidis, Dimitrios, additional, Ng, Ting Ying, additional, Pajkos, Gabor, additional, Somogyine, Eva Ezer, additional, Tonini, Giuseppe, additional, Giuffrida, Dario, additional, Takao, Shintaro, additional, Ishitobi, Makoto, additional, Inaji, Hideo, additional, Tokuda, Yutaka, additional, Wozniak, Katarzyna, additional, Lungulescu, Dan, additional, Lu, Yen-Shen, additional, Chang, King-Jen, additional, Hill, Julian, additional, Croot, Christopher Charles, additional, Dekker, Albert, additional, Belman, Neil D., additional, Conde, Miguel, additional, Michaelson, Richard A., additional, Kemmer, Kathleen, additional, Chui, Stephen, additional, Luoh, Shiuh-Wen, additional, Nahum, Kenneth, additional, Greenspan, Andrew R., additional, Nichols, Joni C., additional, Encarnacion, Carlos A., additional, Niederman, Thomas M.J., additional, Lee, Theresa, additional, Alexander, Roland, additional, Gordon, Robert, additional, Tomova, Antoanet, additional, Rauch, Daniel, additional, Popescu, Razvan Andrei, additional, Rojas, Gustavo Adolfo, additional, Vanasek, Jaroslav, additional, Neunhoeffer, Tanja, additional, Barinoff, Jana, additional, Graffunder, Gerd, additional, Wolfgang, Abenhardt, additional, Bojko, Peter, additional, Heinrich, Bernhard, additional, von der Assen, Albert, additional, Antonovic, Bogovic Jurij, additional, Adrian, Lene, additional, Ramos Vazquez, Manuel, additional, Gonzalez Santiago, Santiago, additional, Dieras, Veronique, additional, Bishop, Jill Mercia, additional, Perren, Timothy John, additional, Varthalitis, Ioannis, additional, Mavroudis, Dimitris, additional, Georgoulias, Vassilis, additional, Chow, Louis W.C., additional, Yau, Chung Cheung Thomas, additional, Liang, Raymond Hin-Suen, additional, Pikó, Béla, additional, Wéber, Agnes, additional, Kaufman, Bella, additional, Drumea, Karen, additional, Nuzzo, Francesco, additional, De Matteis, Andrea, additional, Carteni, Giacomo, additional, Tokunaga, Eriko, additional, Ishida, Mayumi, additional, Ohno, Shinji, additional, Sato, Nobuaki, additional, Kuroi, Katsumasa, additional, Nishimura, Reiki, additional, Watanabe, Junichiro, additional, Choi, Yoon Ji, additional, Park, Kyong Hwa, additional, Wojtukiewicz, Marek, additional, Jassem, Jacek, additional, Loman, Niklas, additional, Askoy, Sercan, additional, Altundag, Mustafa Kadri, additional, Saip, Pinar, additional, Ali, Muhammad Amjad, additional, Wade, James Lloyd, additional, Chien, Amy Jo, additional, Brandt, Debra, additional, Novik, Yelena, additional, Jani, Chirag, additional, Rice, Robert L., additional, Gaffar, Yousuf A. R, additional, Keaton, Mark R., additional, Bajaj, Rajesh, additional, Kimmick, Gretchen, additional, Campbell, David, additional, Turnquest, Theodore, additional, Lucas, Sideras, additional, Dube, Pierre, additional, Xu, Binghe, additional, Schilling, Joerg, additional, Apel, Klaus, additional, Vestlev, Peter Michael, additional, Jensen, Brita Bjerregaard, additional, Haahr, Vera, additional, Lescure, Alvaro Rodriguez, additional, Grana Suarez, Begona, additional, Saura Manich, Cristina, additional, Jacquin, Jean-Philippe, additional, Samreen, Ahmed, additional, Boiangiu, Ion, additional, Dank, Magdolna, additional, Falci, Cristina, additional, Jirillo, Antonio, additional, Cinieri, Saverio, additional, Ueno, Takayuki, additional, Sato, Fumiaki, additional, Yamashiro, Hiroyasu, additional, Sugie, Tomoharu, additional, Lee, Keun Seok, additional, Ro, Jung Sil, additional, Park, In Hae, additional, Bustam, Anita Zarina, additional, Suszko-Kazarnowicz, Malgorzata, additional, Piktel, Artur, additional, Krzemieniecki, Krzysztof, additional, Iorga, Polizenia Georgeta, additional, Yap, Yoon Sim, additional, Kakalejcik, Marian, additional, Sevinc, Alper, additional, Ozguroglu, Mustafa, additional, Chen, Shin-Cheh, additional, Greenberg, Richard H., additional, Eisemann, Allan Daniel, additional, Droder, Robert, additional, Abbasi, M. Rashid, additional, Vaysburd, Marina, additional, Caldera, Humberto Jose, additional, Haley, Barbara Bacsik, additional, Robin, Erwin, additional, Inhorn, Roger C., additional, Hufnagel, David, additional, Kenyon, Peter D., additional, Spremulli, Ellen, additional, Silverman, Paula, additional, Jain, Sharad, additional, Weigand, Robert, additional, Mebis, Jeroen, additional, Koynova, Tatyana, additional, Lesperance, Bernard, additional, Prausova, Jana, additional, Kohne, Claus-Henning, additional, Schneeweiss, Andreas, additional, Jackisch, Christian, additional, Fuxius, Stefan, additional, Cubedo Cervera, Ricardo, additional, Urruticoechea Ribate, Ander, additional, Pernas Simon, Sonia, additional, Valero Gallego, Jose, additional, Arcusa Lanza, Angels, additional, del Pilar Alvarez, Maria, additional, Florian Gerico, Jesus, additional, Cany, Laurent, additional, Stebbing, Justin, additional, Labudovic, Dejan, additional, Gugic, Damir, additional, Vrbanec, Damir, additional, Roila, Fausto, additional, Barni, Sandro, additional, Bidoli, Paolo, additional, Mukai, Hirofumi, additional, Bermudez, Vanessa, additional, Eniu, Alexandru, additional, Mirtsching, Barry C., additional, Ibrahim, Emad, additional, Trey, Joan, additional, Hergenroeder, Paul Francis, additional, Mahmood, Aftab, additional, Gonzalez, Anneliese, additional, Kaplan, Edward H., additional, Ban, Stacy, additional, Patel, Dhimant, additional, Clowney, Billy, additional, Hoelzer, Karen, additional, Schwartz, Garry H., additional, Salkeni, Mohamed, additional, Abraham, Jame, additional, Narula, Sunil, additional, Jabboury, Khaled, additional, Mocharnuk, Robert Scott, additional, McDonough, Richard H., additional, Sikes, David H., additional, Kawanchi, Ronald H., additional, Schlabach, Larry, additional, McCachren, Samuel Spence, additional, Cosgriff, Thomas M., additional, Dreisbach, Luke, additional, DeMichele, Angela, additional, Pawl, Lawrence, additional, Lucas, Jennifer, additional, Shinn, Lowell C., additional, Alkhouri, Nabiel, additional, Monga, Manish, additional, Lindquist, Deborah L., additional, Anderson, Thomas C., additional, Khurshid, Humera, additional, Witherby, Sabrina, additional, Erickson, Nicholette, additional, Traynor, Ann, additional, Bose, Ron, additional, Pluard, Timothy J., additional, Jones, Michael C., additional, Prakash, Sucharu, additional, Volterra, Fabio, additional, Capo, Gerardo, additional, Flaherty, Lawrence E., additional, Gartner, Elaina, additional, Baidas, Said, additional, Okazaki, Ian, additional, Nguyen, Bichlien, additional, Rakowski, Thomas, additional, Oliff, Ira, additional, Leach, Joseph W., additional, Anderson, Daniel, additional, Kubiak, Kendra, additional, Tsai, Michaela, additional, Vroman, Philippe, additional, Deleu, Ines, additional, Lybaert, Willem, additional, Borms, Marleen, additional, Couture, Felix, additional, Wilson, Jonathan J., additional, Hunt, Gordon, additional, Holland, David R., additional, Mingrone, Walter, additional, Wang, Shusen, additional, Liu, Donggeng, additional, Jiang, Zefei, additional, Benesova, Vera, additional, Smakal, Martin, additional, Garnolova, Petra, additional, Vesper, Anne-Sophie, additional, Neumann, Monika, additional, Janni, Wolfgang, additional, Liedtke, Cornelia, additional, Fischer, Dorothea, additional, Grischke, Eva-Maria, additional, Seeger, Dietmar, additional, Moebus, Volker, additional, Prechtl, Anita, additional, Carlos Camara Toral, Juan, additional, Sanchez Munoz, Alfonso, additional, Gonzalez Jimenez, Sonia, additional, Cassinello Espinosa, Javier, additional, Cirauqui, Beatriz, additional, Margeli Vila, Mireia, additional, Batista Lopez, Norberto, additional, Chacon Lopez-Muniz, Jose Ignacio, additional, de la Cruz Mora, Miguel Angel, additional, Mailliez, Audrey, additional, Vanlemmens, Laurence, additional, Pouessel, Damien, additional, Espie, Marc, additional, Conibear, John, additional, Roylance, Rebecca, additional, Harnett, Adrian, additional, Geffen, David, additional, Ruggeri, Enzo Maria, additional, Gamucci, Teresa, additional, Van Groeningen, Cees J., additional, Banas, Renata, additional, Alkis, Necati, additional, Hou, Ming-Feng, additional, Krie, Amy K., additional, Vrindavanam, Nandagopal S., additional, Howard, Orion M., additional, Citrin, Dennis, additional, Morginstin, Mark S., additional, Desai, Ajit, additional, Sanchez, Ines J., additional, Nixon, David Allen, additional, Beatty, Patrick G., additional, Edmiston, Kathryn, additional, McLaughlin, Marilyn, additional, Eneman, Jonathan D., additional, Lynch, Cynthia A., additional, O'Brien, Edward, additional, Call, Justin A., additional, Lanier, Keith S., additional, Conlin, Alison, additional, Brooks, Donald J., additional, McIntyre, Kristi, additional, Saltzman, Marc A., additional, Castine, Michael J., additional, Ortega, Gregory L., additional, Choi, Young M., additional, Reynolds, Craig H., additional, Brescia, Frankie Ann, additional, Kramer, Rita, additional, Kohn, Aimee D., additional, Micha, John P., additional, Rhee, Jessica M., additional, Shah, Satish, additional, Riseberg, David A., additional, Patterson, William Kevin, additional, Salmon, Jean-Paul, additional, Andre, Chantal, additional, Bols, Alain, additional, D'hondt, Randal, additional, Luce, Sylvie, additional, Nouwynck, Claire, additional, Pelgrims, Gino, additional, Richard, Vincent, additional, Verschuere, Johan, additional, Geldhof, Kurt, additional, Caspar, Clemens, additional, Luo, Rongcheng, additional, Bednarik, Otakar, additional, Schwedler, Kathrin, additional, Schmidt, Marcus, additional, Neumeister, Romy, additional, Bischoff, Joachim, additional, Rack, Brigitte, additional, Repp, Roland, additional, Fries, Stefan, additional, Adrion, Ralf, additional, Schulz, Volker, additional, Klare, Peter, additional, Danei, Mahmoud, additional, Ossenbuhl, Dirk, additional, Kusche, Jakob Manfred, additional, Griesinger, Frank, additional, Baena Canada, Jose Manuel, additional, Martinez del Prado, Purificacion, additional, Machover, David, additional, Mayeur, Didier, additional, Trufflandier, Nathalie, additional, Delecroix, Valerie, additional, Mousseau, Mireille, additional, Mouret-Reynier, Marie-Ange, additional, Nabholtz, Jean-Marc, additional, Chetiyawardana, Anula D., additional, Papandreou, Christos, additional, Hornyak, Lajos, additional, Faluhelyi, Zsolt, additional, Simo, Erzsebet, additional, Di Palma, Mario, additional, Cognetti, Francesco, additional, Gorzegno, Gabriella, additional, Dogliotti, Luigi, additional, Gridelli, Cesare, additional, Falcone, Alfredo, additional, Soto Parra, Hector, additional, Buscarino, Calogero, additional, Im, Seock-Ah, additional, Sanchez Llamas, Benito, additional, Dercksen, Wouter, additional, Erdkamp, Franciscus, additional, Ruit, Jan B., additional, Braun, Hans, additional, Portielje, Joanneke E.A., additional, Ciltas, Aydin, additional, Buyukberber, Suleyman, additional, Benekli, Mustafa, additional, Zahalsky, Andrew J., additional, Jaslow, Rebecca, additional, Thomas, Gary W., additional, Maini, Archana, additional, Wiznitzer, Israel, additional, Khojasteh, Ali, additional, Francisco Gonzalez, Manuel, additional, Kong, Lynn R., additional, Padmanabhan, Aruna, additional, Conkright, William A., additional, Swain, Sandra M., additional, Faig, Douglas E., additional, Jain, Kirti, additional, Yanagihara, Ronald H., additional, Ottaviano, Yvonne, additional, Delmas, Andrew, additional, Steele, Heather A., additional, Rainey, Gordon K., additional, Harris, Penelope J., additional, Burris, Jason K., additional, Rupard, Erik J., additional, Tan, Esther, additional, Whitworth, Pat W., additional, Bova, Abby R., additional, Anderson, Ian C., additional, Shirinian, Mihran, additional, Tin-u, Caesar, additional, O'Rourke, Timothy J., additional, Roberts, Michael S., additional, Francisco, Michael, additional, Pierson, A. Scott, additional, Byeff, Peter D., additional, Kovach, Peter A., additional, Caton, John R., additional, Rarick, Mark Urban, additional, Schimidt, William G., additional, Stopeck, Alison T., additional, Swart, Rachel, additional, Carrillo Flores, Maria Regina, additional, Alemany, Carlos A., additional, Lozada, Brennely, additional, Weinstein, Paul L., additional, Wang, Wei, additional, Porubcin, Michael, additional, Ellison, David M., additional, Geils, George F., additional, Rivera, Edgardo, additional, and Charif, Mahmoud, additional
- Published
- 2017
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36. A randomized phase III trial comparing neoadjuvant chemotherapy with weekly nanoparticle-based paclitaxel with solvent-based paclitaxel followed by anthracyline/cyclophosphamide for patients with early breast cancer (GeparSepto) : GBG 69
- Author
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Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Conrad, Bettina, Aktas, Bahriye, Denkert, Carsten, Eidtmann, Holger, Wiebringhaus, Hermann, Kuemmel, Sherko, Hilfrich, Joern, Warm, Mathias, Paepke, Stefan, Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Clemens, Hans, Costa, Serban Dan, Gerber, Bernd, Nekljudova, Valentina, Loibl, Sibylle, and von Minckwitz, Gunter
- Subjects
Medizin - Published
- 2015
37. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results.
- Author
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Gluz, Oleg, Nitz, Ulrike, Liedtke, Cornelia, Christgen, Matthias, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Warm, Mathias, Hackmann, John, Uleer, Christoph, Aktas, Bahriye, Schumacher, Claudia, Bangemann, Nikola, Lindner, Christoph, Kuemmel, Sherko, Clemens, Michael, Potenberg, Jochem, Staib, Peter, Kohls, Andreas, and von Schumann, Raquel
- Subjects
CARBOPLATIN ,ANTINEOPLASTIC agents ,BREAST cancer ,ESTROGEN receptors ,STEROID receptors ,BREAST tumors ,COMBINED modality therapy ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,METASTASIS ,PACLITAXEL ,PROGNOSIS ,RESEARCH ,EVALUATION research ,ALBUMINS ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,DEOXYCYTIDINE - Abstract
Background: Pathological complete response (pCR) is associated with improved prognosis in triple-negative breast cancer (TNBC). The optimal chemotherapy regimen is unclear. Weekly nab-paclitaxel vs conventional paclitaxel or addition of carboplatin to anthracycline-taxane results in higher pCR rates with uncertain survival impact. We evaluated carboplatin vs gemcitabine with a nab-paclitaxel backbone as a short 12-week A-free regimen with a focus on early response.Methods: Patients with TNBC (estrogen receptor/progesterone receptor < 1%, human epidermal growth factor receptor 2-negative, cT1c-cT4c, cN0/+) were randomly assigned to A: nab-paclitaxel 125 mg/m2/gemcitabine 1000 mg/m2 d1,8 three times weekly (q3w); vs B: nab-paclitaxel 125 mg/m2/carboplatin AUC2 day 1,8 q3w. The trial was powered for a pCR (ypT0/is ypN0) comparison by therapy arm and early response (defined as Ki-67 decrease >30% or < 500 invasive tumor cells in the three-week serial biopsy). All statistical tests were two-sided.Results: A total of 336 patients were enrolled (48 centers, arms A/B: n = 182/154). The median age was 50 years. At baseline (A vs B), 62.6% and 62.9% had cT2-4c tumors; 86.8% and 90.9% completed therapy per protocol, respectively. pCR favored arm B (28.7%, 95% CI = 0.22 to 0.36, vs 45.9%, 95% CI = 0.38 to 0.54; 95% CI(dBA) = 6.2% to 27.9%, P = .002) and was lower in nonresponders than in early responders (19.5% vs 44.4%, P < .001) or in patients with unclassifiable early response (50.0%). The nab-paclitaxel/gemcitabine was associated with more frequent dose reductions (20.6% vs 11.9%, P = .04), treatment-related serious adverse events (11.1% vs 5.3%, P = .07), grade 3-4 infections (7.2% vs 2.6%, P = .07), and grade 3-4 ALAT elevations (11.7 vs 3.3%, P = .01).Conclusions: This first large randomized trial suggests high efficacy and excellent tolerability of a neoadjuvant nab-paclitaxel/carboplatin regimen, superior to nab-paclitaxel/gemcitabine in TNBC. De-escalation of further chemotherapy in patients with early pCR after a short anthracycline-free regimen is a promising field of future research. Early necrotic morphological changes and/or proliferation decrease after the first therapy cycle seem to be associated with subsequent pCR. [ABSTRACT FROM AUTHOR]- Published
- 2018
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- View/download PDF
38. Abstract S2-07: A randomized phase III trial comparing neoadjuvant chemotherapy with weekly nanoparticle-based paclitaxel with solvent-based paclitaxel followed by anthracyline/cyclophosphamide for patients with early breast cancer (GeparSepto); GBG 69
- Author
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Untch, Michael, primary, Jackisch, Christian, additional, Schneeweiß, Andreas, additional, Conrad, Bettina, additional, Aktas, Bahriye, additional, Denkert, Carsten, additional, Eidtmann, Holger, additional, Wiebringhaus, Hermann, additional, Kümmel, Sherko, additional, Hilfrich, Jörn, additional, Warm, Mathias, additional, Paepke, Stefan, additional, Just, Marianne, additional, Hanusch, Claus, additional, Hackmann, John, additional, Blohmer, Jens-Uwe, additional, Clemens, Michael, additional, Costa, Serban Dan, additional, Gerber, Bernd, additional, Nekljudova, Valentina, additional, Loibl, Sibylle, additional, and von Minckwitz, Gunter, additional
- Published
- 2015
- Full Text
- View/download PDF
39. Hormone receptor discordance between local and central pathology with RT-PCR analysis: Results from multicenter Phase III WSG-PlanB trial
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Von Schumann, Raquel, Gluz, Oleg, Nitz, Ulrike, Clemens, Michael, Luebbe, Kristina, Aktas, Bahriye, Just, Marianne, Noesselt, Thomas, Henschen, Stephan, Hackmann, John, Lorenz-Salehi, Fatemeh, Freese, Kristin, Svedman, Christer, Kates, Ronald E., Kreipe, Hans, Harbeck, Nadia, Liedtke, Cornelia, and West German Study Grp PlanB
- Subjects
Cancer Research ,Pathology ,medicine.medical_specialty ,Oncology ,Rt pcr analysis ,Hormone receptor ,business.industry ,Medizin ,medicine ,business - Abstract
e11555 Background: Discordances between local and central pathology regarding ER, PR, and HER2 status may occur at varying frequencies, which may be attributable to technical factors (tissue handli...
- Published
- 2015
40. De-escalated Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC): Impact of Molecular Markers and Final Survival Analysis of the WSG-ADAPT-TN Trial.
- Author
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Gluz O, Nitz U, Kolberg-Liedtke C, Prat A, Christgen M, Kuemmel S, Mohammadian MP, Gebauer D, Kates R, Paré L, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Wuerstlein R, Graeser M, Pelz E, Jóźwiak K, Zu Eulenburg C, Kreipe HH, and Harbeck N
- Subjects
- Humans, Neoadjuvant Therapy adverse effects, Carboplatin administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Survival Analysis, Triple Negative Breast Neoplasms drug therapy, Triple Negative Breast Neoplasms genetics, Triple Negative Breast Neoplasms pathology
- Abstract
Purpose: Although optimal treatment in early triple-negative breast cancer (TNBC) remains unclear, de-escalated chemotherapy appears to be an option in selected patients within this aggressive subtype. Previous studies have identified several pro-immune factors as prognostic markers in TNBC, but their predictive impact regarding different chemotherapy strategies is still controversial., Experimental Design: ADAPT-TN is a randomized neoadjuvant multicenter phase II trial in early patients with TNBC (n = 336) who were randomized to 12 weeks of nab-paclitaxel 125 mg/m2 + gemcitabine or carboplatin d 1,8 q3w. Omission of further (neo-) adjuvant chemotherapy was allowed only in patients with pathological complete response [pCR, primary endpoint (ypT0/is, ypN0)]. Secondary invasive/distant disease-free and overall survival (i/dDFS, OS) and translational research objectives included quantification of a predictive impact of markers regarding selection for chemotherapy de-escalation, measured by gene expression of 119 genes (including PAM50 subtype) by nCounter platform and stromal tumor-infiltrating lymphocytes (sTIL)., Results: After 60 months of median follow-up, 12-week-pCR was favorably associated (HR, 0.24; P = 0.001) with 5y-iDFS of 90.6% versus 62.8%. No survival advantage of carboplatin use was observed, despite a higher pCR rate [HR, 1.04; 95% confidence interval (CI), 0.68-1.59]. Additional anthracycline-containing chemotherapy was not associated with a significant iDFS advantage in pCR patients (HR, 1.29; 95% CI, 0.41-4.02). Beyond pCR rate, nodal status and high sTILs were independently associated with better iDFS, dDFS, and OS by multivariable analysis., Conclusions: Short de-escalated neoadjuvant taxane/platinum-based combination therapy appears to be a promising strategy in early TNBC for using pCR rate as an early decision point for further therapy (de-) escalation together with node-negative status and high sTILs. See related commentary by Sharma, p. 4840., (©2022 American Association for Cancer Research.)
- Published
- 2022
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41. Efficacy of deescalated chemotherapy according to PAM50 subtypes, immune and proliferation genes in triple-negative early breast cancer: Primary translational analysis of the WSG-ADAPT-TN trial.
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Gluz O, Kolberg-Liedtke C, Prat A, Christgen M, Gebauer D, Kates R, Paré L, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Kuemmel S, Wuerstlein R, Pelz E, Nitz U, Kreipe HH, and Harbeck N
- Subjects
- Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers, Tumor metabolism, Dose-Response Relationship, Drug, Early Detection of Cancer, Female, Humans, Middle Aged, Triple Negative Breast Neoplasms genetics, Triple Negative Breast Neoplasms immunology, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Cell Proliferation genetics, Translational Research, Biomedical, Triple Negative Breast Neoplasms drug therapy
- Abstract
In the neoadjuvant WSG-ADAPT-TN trial, 12-week nab-paclitaxel + carboplatin (nab-pac/carbo) was highly effective and superior to nab-paclitaxel + gemcitabine (nab-pac/gem) in triple-negative breast cancer regarding pathological complete response (pCR). Predictive markers for deescalated taxane/carbo use in TNBC need to be identified. Patients received 4 × nab-pac 125 mg/m
2 (plus carbo AUC2 or gem 1,000 mg/m2 d1,8 q21). Expression of 119 genes and PAM50 scores by nCounter were available in 306/336 pretherapeutic samples. Interim survival analysis was planned after 36 months median follow-up. Basal-like (83.3%) compared to other subtypes was positively associated with pCR (38% vs. 20%, p = 0.015), as was lower HER2 score (p < 0.001). Proliferation biomarkers were positively associated with pCR, that is, PAM50 proliferation, ROR scores (all p < 0.004), higher Ki-67 (IHC; p < 0.001). For nab-pac/carbo, expression of immunological (CD8, PD1 and PFDL1) genes and proliferation markers (proliferation and ROR scores, MKI67, CDC20, NUF2, KIF2C, CENPF, EMP3 and TYMS) were positively associated with pCR (p < 0.05 for all). For nab-pac/gem, angiogenesis genes were negatively associated with pCR (ANGPTL4: p = 0.05; FGFR4: p = 0.02; VEGFA: p = 0.03). pCR after 12 weeks was strongly associated with favorable outcome (3y event-free survival: 92% vs. 71%, p < 0.001). In early TNBC, basal-like subtype, higher Ki-67 (IHC) and lower HER2 score were, associated with chemosensitivity. Chemoresistance pathways differed between the two taxane based combinations. Combination of proliferation/immune markers and PAM50 subtype could allow patient selection for further deescalated chemotherapy and/or immune treatment approaches., (© 2019 UICC.)- Published
- 2020
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42. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results.
- Author
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Gluz O, Nitz U, Liedtke C, Christgen M, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Bangemann N, Lindner C, Kuemmel S, Clemens M, Potenberg J, Staib P, Kohls A, von Schumann R, Kates R, Kates R, Schumacher J, Wuerstlein R, Kreipe HH, and Harbeck N
- Subjects
- Adult, Aged, Albumins adverse effects, Carboplatin adverse effects, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Disease-Free Survival, Female, Humans, Lymphatic Metastasis, Middle Aged, Neoadjuvant Therapy methods, Paclitaxel adverse effects, Treatment Outcome, Triple Negative Breast Neoplasms pathology, Gemcitabine, Albumins administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin administration & dosage, Deoxycytidine analogs & derivatives, Paclitaxel administration & dosage, Triple Negative Breast Neoplasms drug therapy
- Abstract
Background: Pathological complete response (pCR) is associated with improved prognosis in triple-negative breast cancer (TNBC). The optimal chemotherapy regimen is unclear. Weekly nab-paclitaxel vs conventional paclitaxel or addition of carboplatin to anthracycline-taxane results in higher pCR rates with uncertain survival impact. We evaluated carboplatin vs gemcitabine with a nab-paclitaxel backbone as a short 12-week A-free regimen with a focus on early response., Methods: Patients with TNBC (estrogen receptor/progesterone receptor < 1%, human epidermal growth factor receptor 2-negative, cT1c-cT4c, cN0/+) were randomly assigned to A: nab-paclitaxel 125 mg/m2/gemcitabine 1000 mg/m2 d1,8 three times weekly (q3w); vs B: nab-paclitaxel 125 mg/m2/carboplatin AUC2 day 1,8 q3w. The trial was powered for a pCR (ypT0/is ypN0) comparison by therapy arm and early response (defined as Ki-67 decrease >30% or < 500 invasive tumor cells in the three-week serial biopsy). All statistical tests were two-sided., Results: A total of 336 patients were enrolled (48 centers, arms A/B: n = 182/154). The median age was 50 years. At baseline (A vs B), 62.6% and 62.9% had cT2-4c tumors; 86.8% and 90.9% completed therapy per protocol, respectively. pCR favored arm B (28.7%, 95% CI = 0.22 to 0.36, vs 45.9%, 95% CI = 0.38 to 0.54; 95% CI(dBA) = 6.2% to 27.9%, P = .002) and was lower in nonresponders than in early responders (19.5% vs 44.4%, P < .001) or in patients with unclassifiable early response (50.0%). The nab-paclitaxel/gemcitabine was associated with more frequent dose reductions (20.6% vs 11.9%, P = .04), treatment-related serious adverse events (11.1% vs 5.3%, P = .07), grade 3-4 infections (7.2% vs 2.6%, P = .07), and grade 3-4 ALAT elevations (11.7 vs 3.3%, P = .01)., Conclusions: This first large randomized trial suggests high efficacy and excellent tolerability of a neoadjuvant nab-paclitaxel/carboplatin regimen, superior to nab-paclitaxel/gemcitabine in TNBC. De-escalation of further chemotherapy in patients with early pCR after a short anthracycline-free regimen is a promising field of future research. Early necrotic morphological changes and/or proliferation decrease after the first therapy cycle seem to be associated with subsequent pCR.
- Published
- 2018
- Full Text
- View/download PDF
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