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1. 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

Author

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

Published
2022
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2. A Prospective, Multicenter Registry Study to Evaluate the Clinical Feasibility of Targeted Axillary Dissection (TAD) in Node-positive Breast Cancer Patients

Author

Kuemmel, Sherko, Heil, Joerg, Rueland, Anna, Seiberling, Christine, Harrach, Hakima, Schindowski, Dorothea, Lubitz, Juliane, Hellerhoff, Karin, Ankel, Christine, Graßhoff, Sven-Thomas, Deuschle, Petra, Hanf, Volker, Belke, Kerstin, Dall, Peter, Dorn, Julia, Kaltenecker, Gabriele, Kuehn, Thorsten, Beckmann, Ulrike, Potenberg, Jochem, Blohmer, Jens-Uwe, Kostara, Athina, Breit, Elisabeth, Holtschmidt, Johannes, Traut, Eugen, and Reinisch, Mattea

Published
2022
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4. Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials

Author

Graeser, Monika, Schrading, Simone, Gluz, Oleg, Strobel, Kevin, Herzog, Christopher, Umutlu, Lale, Frydrychowicz, Alex, Rjosk-Dendorfer, Dorothea, Würstlein, Rachel, Culemann, Ralph, Eulenburg, Christine, Adams, Jascha, Nitzsche, Henrik, Prange, Anna, Kümmel, Sherko, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Potenberg, Jochem, von Schumann, Raquel, Aktas, Bahriye, Kolberg-Liedtke, Cornelia, Harbeck, Nadia, Kuhl, Christiane K., and Nitz, Ulrike

Published
2021
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5. A Prospective, Multicenter Registry Study to Evaluate the Clinical Feasibility of Targeted Axillary Dissection (TAD) in Node-Positive Breast Cancer Patients

Author

Kuemmel, Sherko, Heil, Joerg, Rueland, Anna, Seiberling, Christine, Harrach, Hakima, Schindowski, Dorothea, Lubitz, Juliane, Hellerhoff, Karin, Ankel, Christine, Graßhoff, Sven-Thomas, Deuschle, Petra, Hanf, Volker, Belke, Kerstin, Dall, Peter, Dorn, Julia, Kaltenecker, Gabriele, Kuehn, Thorsten, Beckmann, Ulrike, Potenberg, Jochem, Blohmer, Jens-Uwe, Kostara, Athina, Breit, Elisabeth, Holtschmidt, Johannes, Traut, Eugen, and Reinisch, Mattea

Published
2020
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6. Efficacy of Endocrine Therapy Plus Trastuzumab and Pertuzumab vs De-escalated Chemotherapy in Patients with Hormone Receptor–Positive/ERBB2-Positive Early Breast Cancer

Author

Gluz, Oleg, primary, Nitz, Ulrike A., additional, Christgen, Matthias, additional, Kuemmel, Sherko, additional, Holtschmidt, Johannes, additional, Schumacher, Johannes, additional, Hartkopf, Andreas, additional, Potenberg, Jochem, additional, Lüedtke-Heckenkamp, Kerstin, additional, Just, Marianne, additional, Schem, Christian, additional, von Schumann, Raquel, additional, Kolberg-Liedtke, Cornelia, additional, Eulenburg, Christine Zu, additional, Schinköthe, Timo, additional, Graeser, Monika, additional, Wuerstlein, Rachel, additional, Kates, Ronald E., additional, Kreipe, Hans Heinrich, additional, and Harbeck, Nadia, additional

Published
2023
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7. "Supplementary Table S5 from Impact of RNA Signatures on pCR and Survival after 12-Week Neoadjuvant Pertuzumab plus Trastuzumab with or without Paclitaxel in the WSG-ADAPT HER2+/HR− Trial

Author

Graeser, Monika, primary, Gluz, Oleg, primary, Biehl, Claudia, primary, Ulbrich-Gebauer, Daniel, primary, Christgen, Matthias, primary, Palatty, Jenci, primary, Kuemmel, Sherko, primary, Grischke, Eva-Maria, primary, Augustin, Doris, primary, Braun, Michael, primary, Potenberg, Jochem, primary, Wuerstlein, Rachel, primary, Krauss, Katja, primary, Schumacher, Claudia, primary, Forstbauer, Helmut, primary, Reimer, Toralf, primary, Stefek, Andrea, primary, Fischer, Hans Holger, primary, Pelz, Enrico, primary, zu Eulenburg, Christine, primary, Kates, Ronald, primary, Ni, Hua, primary, Kolberg-Liedtke, Cornelia, primary, Feuerhake, Friedrich, primary, Kreipe, Hans Heinrich, primary, Nitz, Ulrike, primary, and Harbeck, Nadia, primary

Published
2023
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8. Impact of RNA Signatures on pCR and Survival after 12-Week Neoadjuvant Pertuzumab plus Trastuzumab with or without Paclitaxel in the WSG-ADAPT HER2+/HR− Trial

Author

Graeser, Monika, Gluz, Oleg, Biehl, Claudia, Ulbrich-Gebauer, Daniel, Christgen, Matthias, Palatty, Jenci, Kuemmel, Sherko, Grischke, Eva-Maria, Augustin, Doris, Braun, Michael, Potenberg, Jochem, Wuerstlein, Rachel, Krauss, Katja, Schumacher, Claudia, Forstbauer, Helmut, Reimer, Toralf, Stefek, Andrea, Fischer, Hans Holger, Pelz, Enrico, Zu Eulenburg, Christine, Kates, Ronald, Ni, Hua, Kolberg-Liedtke, Cornelia, Feuerhake, Friedrich, Kreipe, Hans Heinrich, Nitz, Ulrike, Harbeck, Nadia, and WSG-ADAPT Investigators

Subjects
Cancer Research, Oncology, Medizin
Abstract

Clinical cancer research 29(4), 805-814 (2023). doi:10.1158/1078-0432.CCR-22-1587, Published by AACR, Philadelphia, Pa. [u.a.]

Published
2023
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9. Impact of RNA Signatures on pCR and Survival after 12-Week Neoadjuvant Pertuzumab plus Trastuzumab with or without Paclitaxel in the WSG-ADAPT HER2+/HR− Trial

Author

Graeser, Monika, primary, Gluz, Oleg, additional, Biehl, Claudia, additional, Ulbrich-Gebauer, Daniel, additional, Christgen, Matthias, additional, Palatty, Jenci, additional, Kuemmel, Sherko, additional, Grischke, Eva-Maria, additional, Augustin, Doris, additional, Braun, Michael, additional, Potenberg, Jochem, additional, Wuerstlein, Rachel, 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, Ni, Hua, additional, Kolberg-Liedtke, Cornelia, additional, Feuerhake, Friedrich, additional, Kreipe, Hans Heinrich, additional, Nitz, Ulrike, additional, and Harbeck, Nadia, additional

Published
2022
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10. De-Escalated Neoadjuvant Trastuzumab-Emtansine With or Without Endocrine Therapy Versus Trastuzumab With Endocrine Therapy in HR+/HER2+ Early Breast Cancer: 5-Year Survival in the WSG-ADAPT-TP Trial.

Author

Harbeck, Nadia, Nitz, Ulrike A., Christgen, Matthias, Kümmel, Sherko, Braun, Michael, Schumacher, Claudia, Potenberg, Jochem, Tio, Joke, Aktas, Bahriye, Forstbauer, Helmut, Grischke, Eva-Maria, Scheffen, Iris, Malter, Wolfram, von Schumann, Raquel, Just, Marianne, zu Eulenburg, Christine, Biehl, Claudia, Kolberg-Liedtke, Cornelia, Deurloo, Regula, and de Haas, Sanne

Published
2023
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11. Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2– Early Breast Cancer

Author

Nitz, Ulrike A., primary, Gluz, Oleg, additional, Kümmel, Sherko, additional, Christgen, Matthias, additional, Braun, Michael, additional, Aktas, Bahriye, additional, Lüdtke-Heckenkamp, Kerstin, additional, Forstbauer, Helmut, additional, Grischke, Eva-Maria, additional, Schumacher, Claudia, additional, Darsow, Maren, additional, Krauss, Katja, additional, Nuding, Benno, additional, Thill, Marc, additional, Potenberg, Jochem, additional, Uleer, Christoph, additional, Warm, Mathias, additional, Fischer, Hans Holger, additional, Malter, Wolfram, additional, Hauptmann, Michael, additional, Kates, Ronald E., additional, Gräser, Monika, additional, Würstlein, Rachel, additional, Shak, Steven, additional, Baehner, Frederick, additional, Kreipe, Hans H., additional, and Harbeck, Nadia, additional

Published
2022
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12. Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HP2-Early Breast Cancer

Author

Nitz, Ulrike A., Gluz, Oleg, Kuemmel, Sherko, Christgen, Matthias, Braun, Michael, Aktas, Bahriye, Luedtke-Heckenkamp, Kerstin, Forstbauer, Helmut, Grischke, Eva-Maria, Schumacher, Claudia, Darsow, Maren, Krauss, Katja, Nuding, Benno, Thill, Marc, Potenberg, Jochem, Uleer, Christoph, Warm, Mathias, Fischer, Hans Holger, Malter, Wolfram, Hauptmann, Michael, Kates, Ronald E., Graeser, Monika, Wuerstlein, Rachel, Shak, Steven, Baehner, Frederick, Kreipe, Hans H., Harbeck, Nadia, Nitz, Ulrike A., Gluz, Oleg, Kuemmel, Sherko, Christgen, Matthias, Braun, Michael, Aktas, Bahriye, Luedtke-Heckenkamp, Kerstin, Forstbauer, Helmut, Grischke, Eva-Maria, Schumacher, Claudia, Darsow, Maren, Krauss, Katja, Nuding, Benno, Thill, Marc, Potenberg, Jochem, Uleer, Christoph, Warm, Mathias, Fischer, Hans Holger, Malter, Wolfram, Hauptmann, Michael, Kates, Ronald E., Graeser, Monika, Wuerstlein, Rachel, Shak, Steven, Baehner, Frederick, Kreipe, Hans H., and Harbeck, Nadia

Abstract

PURPOSE To our knowledge, WSG-ADAPT-HR+/HER2- (ClinicalTrials.gov identifier: NCT01779206; n = 5,625 registered) is the first trial combining the 21-gene expression assay (recurrence score [RS]) and response to 3-week preoperative endocrine therapy (ET) to guide systemic therapy in early breast cancer. MATERIALS AND METHODS Baseline and postendocrine Ki67 (Ki67(post)) were evaluated centrally. In the en docrine trial, all patients received exclusively ET: patients with pathologic regional lymph node status (pN) 0-1 (ie, 0-3 involved lymph nodes) entered control arm if RS <= 11 and experimental arm if RS12-25 with ET response (Ki67(post) <= 10%). All other patients (including N0-1 RS12-25 without ET response) received dose-dense chemotherapy (CT) followed by ET in the CT trial. Primary end point of the endocrine trial was non-inferiority of 5-year invasive disease-free survival (5y-iDFS) in experimental (v control) arm; secondary end points included distant DFS, overall survival, and translational research. RESULTS Intention-to-treat population comprised 2,290 patients (n = 1,422 experimental v n = 868 control): 26.3% versus 34.6% premenopausal and 27.4% versus 24.0% pN1. One-sided 95% lower confidence limit of the 5y-iDFS difference was -3.3%, establishing prespecified noninferiority (P = .05). 5y-iDFS was 92.6% (95% CI, 90.8 to 94.0) in experimental versus 93.9% (95% CI, 91.8 to 95.4) in control arm; 5-year distant DFS was 95.6% versus 96.3%, and 5-year overall survival 97.3% versus 98.0%, respectively. Differences were similar in age and nodal subgroups. In N0-1 RS12-25, outcome of ET responders (ET alone) was comparable with that of ET nonresponders (CT) for age > 50 years and superior for age <= 50 years. ET response was more likely with aromatase inhibitors (mostly postmenopausal) than with tamoxifen (mostly premenopausal): 78.1% versus 41.1% (P< .001). ET response was 78.8% in RS0-11, 62.2% in RS12-25, and 32.7% in RS > 25 (n = 4,203, P < .001). CONCLUSION WSG

Published
2022

13. 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

Author

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, Harbeck, Nadia, 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

Abstract

Background Several de-escalation neoadjuvant strategies have been investigated to reduce the use of chemotherapy in HER2-positive early breast cancer using pathological complete response as a surrogate endpoint; there are few survival data from these trials. Here, we report 5-year survival data in the WSG-ADAPT-HER2+/HR- trial and address the effect of pathological complete response, early therapy response, and molecular subtype. Methods WSG-ASAPT-HER2+/ HR-, a part of the ADAPT umbrella trial performed in patients with different subtypes of early breast cancer, was an investigator-initiated, multicentre, open-label, randomised, phase 2 trial done at 40 Breast Cancer Centres in Germany. Eligible patients were aged 18 years or older with histologically confirmed, unilateral, primary invasive, non-inflammatory early breast cancer, hormone receptor-negative and HER2-positive status, and an Eastern Cooperative Oncology Group performance status of 0 or 1 or a Karnofsky performance status of at least 80%. Patients were randomly assigned (5:2, block size 21, stratified by centre and clinical nodal status) to 12 weeks of either trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks) plus pertuzumab (840 mg loading dose, then 420 mg every 3 weeks) or trastuzumab plus pertuzumab plus paclitaxel (80 mg/m (2) weekly); all drugs were administered intravenously. The primary objective of the trial was to compare the number of patients with a pathological complete response at surgery (ie, no invasive tumour cells in breast and lymph nodes [ypT0/is ypN0], the primary endpoint) in early responders (ie, low cellularity or Ki67 decrease =30% after 3 weeks) in the trastuzumab plus pertuzumab group versus all patients (irrespective of an early response) in the trastuzumab plus pertuzumab plus paclitaxel group. Non-inferiority was defined as a pathological complete response no worse than 23% lower in the early-responder proportion of patients in the trastuzumab plus pertuzumab grou

Published
2022

14. Perioperative ramucirumab in combination with FLOT versus FLOT alone for resectable esophagogastric adenocarcinoma (RAMSES/FLOT7) with high rate of signet cell component: Final results of the multicenter, randomized phase II/III trial of the German AIO and Italian GOIM.

Author

Goetze, Thorsten Oliver, primary, Hofheinz, Ralf-Dieter, additional, Schmalenberg, Harald, additional, Strumberg, Dirk, additional, Goekkurt, Eray, additional, Angermeier, Stefan, additional, Zander, Thomas, additional, Potenberg, Jochem, additional, Kopp, Hans-Georg, additional, Pink, Daniel, additional, Siegler, Gabriele Margareta, additional, Schenk, Michael, additional, De Vita, Ferdinando, additional, Maiello, Evaristo, additional, Gaiser, Timo, additional, Sookthai, Disorn, additional, Brulin, Tanita, additional, Pauligk, Claudia, additional, Homann, Nils, additional, and Al-Batran, Salah-Eddin, additional

Published
2022
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15. 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

Author

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

Published
2022
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16. The use of breast ultrasound for prediction of pathologic complete response in different subtypes of early breast cancer within the WSG-ADAPT subtrials

Author

Graeser, Monika, primary, Harbeck, Nadia, additional, Gluz, Oleg, additional, Würstlein, Rachel, additional, zu Eulenburg, Christine, additional, Schumacher, Claudia, additional, Grischke, Eva-Maria, additional, Forstbauer, Helmut, additional, Dimpfl, Moritz, additional, Braun, Michael, additional, Christgen, Matthias, additional, Kreipe, Hans Heinrich, additional, Potenberg, Jochem, additional, von Schumann, Raquel, additional, Aktas, Bahriye, additional, Kolberg-Liedtke, Cornelia, additional, Kümmel, Sherko, additional, and Nitz, Ulrike, additional

Published
2021
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17. 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)

Author

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

Published
2015
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18. Immune Markers and Tumor-Related Processes Predict Neoadjuvant Therapy Response in the WSG-ADAPT HER2-Positive/Hormone Receptor-Positive Trial in Early Breast Cancer

Author

Harbeck, Nadia, primary, von Schumann, Raquel, additional, Kates, Ronald Ernest, additional, Braun, Michael, additional, Kuemmel, Sherko, additional, Schumacher, Claudia, additional, Potenberg, Jochem, additional, Malter, Wolfram, additional, Augustin, Doris, additional, Aktas, Bahriye, additional, Forstbauer, Helmut, additional, Tio, Joke, additional, Grischke, Eva-Maria, additional, Biehl, Claudia, additional, Liedtke, Cornelia, additional, De Haas, Sanne Lysbet, additional, Deurloo, Regula, additional, Wuerstlein, Rachel, additional, Kreipe, Hans Heinrich, additional, and Gluz, Oleg, additional

Published
2021
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19. Additional file 2 of Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials

Author

Graeser, Monika, Schrading, Simone, Gluz, Oleg, Strobel, Kevin, Herzog, Christopher, Umutlu, Lale, Frydrychowicz, Alex, Rjosk-Dendorfer, Dorothea, Würstlein, Rachel, Culemann, Ralph, Eulenburg, Christine, Adams, Jascha, Nitzsche, Henrik, Prange, Anna, Sherko Kümmel, Eva-Maria Grischke, Forstbauer, Helmut, Braun, Michael, Potenberg, Jochem, Schumann, Raquel Von, Aktas, Bahriye, Kolberg-Liedtke, Cornelia, Harbeck, Nadia, Kuhl, Christiane K., and Nitz, Ulrike

Subjects
skin and connective tissue diseases, neoplasms
Abstract

Additional file 2: Figure S1. ROC curves for detecting pCR by MRI and US among patients with both imaging assessments. Data are shown for all tumors (A) and for patients with HR+/HER2+ (B), HR-/HER2- (C) and HR-/HER2+ (D) tumors.

Published
2021
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20. Additional file 4 of Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials

Author

Graeser, Monika, Schrading, Simone, Gluz, Oleg, Strobel, Kevin, Herzog, Christopher, Umutlu, Lale, Frydrychowicz, Alex, Rjosk-Dendorfer, Dorothea, Würstlein, Rachel, Culemann, Ralph, Eulenburg, Christine, Adams, Jascha, Nitzsche, Henrik, Prange, Anna, Sherko Kümmel, Eva-Maria Grischke, Forstbauer, Helmut, Braun, Michael, Potenberg, Jochem, Schumann, Raquel Von, Aktas, Bahriye, Kolberg-Liedtke, Cornelia, Harbeck, Nadia, Kuhl, Christiane K., and Nitz, Ulrike

Subjects
skin and connective tissue diseases, neoplasms
Abstract

Additional file 4: Figure S3. Difference between tumor size according to imaging and residual tumor size versus residual tumor size. Data are shown for all patients with both MRI and US (A) and for HR+/HER2+ (B), HR-/HER2- (C) and HR-/HER2+ tumors (D). Quadratic curve was fitted using the least squares method.

Published
2021
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21. Additional file 3 of Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials

Author

Graeser, Monika, Schrading, Simone, Gluz, Oleg, Strobel, Kevin, Herzog, Christopher, Umutlu, Lale, Frydrychowicz, Alex, Rjosk-Dendorfer, Dorothea, Würstlein, Rachel, Culemann, Ralph, Eulenburg, Christine, Adams, Jascha, Nitzsche, Henrik, Prange, Anna, Sherko Kümmel, Eva-Maria Grischke, Forstbauer, Helmut, Braun, Michael, Potenberg, Jochem, Schumann, Raquel Von, Aktas, Bahriye, Kolberg-Liedtke, Cornelia, Harbeck, Nadia, Kuhl, Christiane K., and Nitz, Ulrike

Abstract

Additional file 3: Figure S2. Correlation between tumor size by imaging and pathological tumor size according to breast cancer subtype. Data are shown for tumor size estimations by (A) MRI in all patients with MRI, (B) US in all patients with US, (C) MRI and (D) US in patients with both MRI and US.

Published
2021
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22. Additional file 1 of Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials

Author

Graeser, Monika, Schrading, Simone, Gluz, Oleg, Strobel, Kevin, Herzog, Christopher, Umutlu, Lale, Frydrychowicz, Alex, Rjosk-Dendorfer, Dorothea, Würstlein, Rachel, Culemann, Ralph, Eulenburg, Christine, Adams, Jascha, Nitzsche, Henrik, Prange, Anna, Sherko Kümmel, Eva-Maria Grischke, Forstbauer, Helmut, Braun, Michael, Potenberg, Jochem, Schumann, Raquel Von, Aktas, Bahriye, Kolberg-Liedtke, Cornelia, Harbeck, Nadia, Kuhl, Christiane K., and Nitz, Ulrike

Abstract

Additional file 1: Table S1. Prediction of pCR and residual tumor size in MRI and US group.

Published
2021
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23. Immune Markers and Tumor-Related Processes Predict Neoadjuvant Therapy Response in the WSG-ADAPT HER2-Positive/Hormone Receptor-Positive Trial in Early Breast Cancer

Author

Harbeck, Nadia, von Schumann, Raquel, Kates, Ronald Ernest, Braun, Michael, Kuemmel, Sherko, Schumacher, Claudia, Potenberg, Jochem, Malter, Wolfram, Augustin, Doris, Aktas, Bahriye, Forstbauer, Helmut, Tio, Joke, Grischke, Eva-Maria, Biehl, Claudia, Liedtke, Cornelia, De Haas, Sanne Lysbet, Deurloo, Regula, Wuerstlein, Rachel, Kreipe, Hans Heinrich, Gluz, Oleg, Harbeck, Nadia, von Schumann, Raquel, Kates, Ronald Ernest, Braun, Michael, Kuemmel, Sherko, Schumacher, Claudia, Potenberg, Jochem, Malter, Wolfram, Augustin, Doris, Aktas, Bahriye, Forstbauer, Helmut, Tio, Joke, Grischke, Eva-Maria, Biehl, Claudia, Liedtke, Cornelia, De Haas, Sanne Lysbet, Deurloo, Regula, Wuerstlein, Rachel, Kreipe, Hans Heinrich, and Gluz, Oleg

Abstract

Simple Summary: Patients with HER2-positive early breast cancer are treated with antibodies to the HER2 protein along with chemotherapy, regardless of whether their cancer also has hormone receptors, or of its molecular features. Because patients with HER2-positive/hormone receptor-positive disease tend to live longer than those with HER2-positive/hormone receptor-negative disease, there may be some patients who are being overtreated under current guidelines. The aim of our exploratory translational analysis of the ADAPT HER2-positive/hormone receptor-positive trial was to investigate the potential of several prognostic (outcome regardless of therapy) and predictive (effect of therapy) biomarkers as early predictors of response to treatment before surgery. Comparison of these biomarkers before and after one treatment cycle, and their effects on whether patients' cancers were completely removed at surgery, suggest that certain patients (those with treatment-induced CD8 protein-expressing cells infiltrating the cancer; without PIK3CA mutation; those with HER2-enriched tumors) may be candidates for less intensive treatment following pre-surgical therapy. Prognostic or predictive biomarkers in HER2-positive early breast cancer (EBC) may inform treatment optimization. The ADAPT HER2-positive/hormone receptor-positive phase II trial (NCT01779206) demonstrated pathological complete response (pCR) rates of similar to 40% following de-escalated treatment with 12 weeks neoadjuvant ado-trastuzumab emtansine (T-DM1) +/- endocrine therapy. In this exploratory analysis, we evaluated potential early predictors of response to neoadjuvant therapy. The effects of PIK3CA mutations and immune (CD8 and PD-L1) and apoptotic markers (BCL2 and MCL1) on pCR rates were assessed, along with intrinsic BC subtypes. Immune response and pCR were lower in PIK3CA-mutated tumors compared with wildtype. Increased BCL2 at baseline in all patients and at Cycle 2 in the T-DM1 arms was associated with lo

Published
2021

24. The use of breast ultrasound for prediction of pathologic complete response in different subtypes of early breast cancer within the WSG-ADAPT subtrials

Author

Graeser, Monika, Harbeck, Nadia, Gluz, Oleg, Wuerstlein, Rachel, zu Eulenburg, Christine, Schumacher, Claudia, Grischke, Eva -Maria, Forstbauer, Helmut, Dimpfl, Moritz, Braun, Michael, Christgen, Matthias, Kreipe, Hans Heinrich, Potenberg, Jochem, von Schumann, Raquel, Aktas, Bahriye, Kolberg-Liedtke, Cornelia, Kuemmel, Sherko, Nitz, Ulrike, Graeser, Monika, Harbeck, Nadia, Gluz, Oleg, Wuerstlein, Rachel, zu Eulenburg, Christine, Schumacher, Claudia, Grischke, Eva -Maria, Forstbauer, Helmut, Dimpfl, Moritz, Braun, Michael, Christgen, Matthias, Kreipe, Hans Heinrich, Potenberg, Jochem, von Schumann, Raquel, Aktas, Bahriye, Kolberg-Liedtke, Cornelia, Kuemmel, Sherko, and Nitz, Ulrike

Abstract

Objective: We assessed the value of breast ultrasound (US) performed at week 3 and 6 and at the end (EOT) of neoadjuvant therapy (NAT) for prediction of pathologic complete response (pCR, ypT0/is ypN0) in patients with HR+/HER2+, HR-/HER2-or HR-/HER2+ early breast cancer enrolled in the WSG-ADAPT subtrials. Methods: US was performed at week 3 and 6 of NAT and at EOT in 401, 517, and 553 patients, respec-tively. Tumors with complete or partial response by US (RECIST 1.1) were classified as responders and those with stable or progressive disease as non-responders. Results: pCR rate was higher in US responders than in non-responders. US tended to yield the highest positive predictive value in HR-/HER2+ (69%) and HR-/HER2-tumors (65%) at week 3, and the highest negative predictive value in HR+/HER2+ tumors at week 6 and at EOT (88.9% and 86.9%, respectively) and in HR-/HER2-tumors at EOT (87.9%). Multivariable analysis of patients with US at week 3 and 6 identified tumor subtype (HR-/HER2+ vs HR+/HER2+; odds ratio (OR) 2.77, 95%CI 1.45-5.29, and OR 4.17, 95%CI 2.26-7.68, respectively) and each 10% change in lesion dimension on US from baseline (OR 1.15, 95%CI 1.08-1.24, and OR 1.25, 95%CI 1.16-1.35, respectively) as parameters associated with pCR. Conclusions: Our data support the use of week 3 and EOT US for prediction of pCR in response-guided NAT and in planning of breast-conserving surgery. Change in tumor diameter on US as a continuous variable could be a valuable alternative to categorical RECIST 1.1 criteria. (c) 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Published
2021

25. Early response by MR imaging and ultrasound as predictor of pathologic complete response to 12-week neoadjuvant therapy for different early breast cancer subtypes: Combined analysis from the WSG ADAPT subtrials

Author

Graeser, Monika, Schrading, Simone, Gluz, Oleg, Strobel, Kevin, Wuerstlein, Rachel, Kuemmel, Sherko, Schumacher, Claudia, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Christgen, Matthias, Adams, Jascha, Nitzsche, Henrik, Just, Marianne, Fischer, Hans Holger, Aktas, Bahriye, Potenberg, Jochem, Von Schumann, Raquel, Kolberg-Liedtke, Cornelia, Harbeck, Nadia, Kuhl, Christiane K., Nitz, Ulrike, Graeser, Monika, Schrading, Simone, Gluz, Oleg, Strobel, Kevin, Wuerstlein, Rachel, Kuemmel, Sherko, Schumacher, Claudia, Grischke, Eva-Maria, Forstbauer, Helmut, Braun, Michael, Christgen, Matthias, Adams, Jascha, Nitzsche, Henrik, Just, Marianne, Fischer, Hans Holger, Aktas, Bahriye, Potenberg, Jochem, Von Schumann, Raquel, Kolberg-Liedtke, Cornelia, Harbeck, Nadia, Kuhl, Christiane K., and Nitz, Ulrike

Abstract

We evaluated the role of early response after 3 weeks of neoadjuvant treatment (NAT) assessed by ultrasound (US), magnetic resonance imaging (MRI) and Ki-67 dynamics for prediction of pathologic complete response (pCR) in different early breast cancer subtypes. Patients with HR+/HER2+, HR-/HER2- and HR-/HER2+ tumors enrolled into three neoadjuvant WSG ADAPT subtrials underwent US, MRI and Ki-67 assessment at diagnosis and after 3 weeks of NAT. Early response was defined as complete or partial response (US, MRI) and >= 30% proliferation decrease or <500 invasive tumor cells (Ki-67). Predictive values and area under the receiver operating characteristic (AUC) curves for prediction of pCR (ypT0/is ypN0) after 12-week NAT were calculated. Two hundred twenty-six had MRI and 401 US; 107 underwent both MRI and US. All three methods yielded a similar AUC in HR+/HER2+ (0.66-0.67) and HR-/HER2- tumors (0.53-0.63), while MRI and Ki-67 performed better than US in HR-/HER2+ tumors (0.83 and 0.79 vs 0.56). Adding MRI+/-Ki-67 increased AUC of US in HR-/HER2+ tumors to 0.64 to 0.75. MRI and Ki-67 demonstrated highest sensitivity in HR-/HER2- (0.8-1) and HR-/HER2+ tumors (1, both). Negative predictive value was similar for all methods in HR+/HER2+ (0.71-0.74) and HR-/HER2- tumors (0.85-1), while it was higher for MRI and Ki-67 compared to US in HR-/HER2+ subtype (1 vs 0.5). Early response assessed by US, MRI and Ki-67 is a strong predictor for pCR after 12-week NAT. Strength of pCR prediction varies according to tumor subtype. Adding MRI+/-Ki-67 to US did not improve pCR prediction in majority of our patients.

Published
2021

26. The PLATON pilot-study “Platform for analyzing targetable tumor mutations”: A PLATON network study.

Author

Vogel, Arndt, primary, Zäpf, Bianca, additional, Goetze, Thorsten Oliver, additional, Westphalen, Benedikt, additional, Müller, Lothar, additional, Broeckling, Sebastian, additional, Moulin, Jean-Charles, additional, Potenberg, Jochem, additional, Sohm, Michael, additional, Gabrysiak, Thomas, additional, Heuer, Vera, additional, Klump, Bodo, additional, Chater, Jack, additional, Zeth, Matthias, additional, Saborowski, Anna, additional, Quader, Facher, additional, Michael, Felicia, additional, Pauligk, Claudia, additional, Amstein, Leonie, additional, and Al-Batran, Salah-Eddin, additional

Published
2021
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27. Perioperative ramucirumab in combination with FLOT versus FLOT alone for resectable esophagogastric adenocarcinoma (RAMSES/FLOT7): Results of the phase II-portion-A multicenter, randomized phase II/III trial of the German AIO and Italian GOIM.

Author

Al-Batran, Salah-Eddin, Hofheinz, Ralf Dieter, Schmalenberg, Harald, Strumberg, Dirk, Goekkurt, Eray, Angermeier, Stefan, Zander, Thomas, Potenberg, Jochem, Kopp, Hans Georg, Pink, Daniel, Siegler, Gabriele Margareta, Schenk, Michael, De Vita, Ferdinando, Maiello, Evaristo, Gaiser, Timo, Sookthai, Disorn, Bankstahl, Ulli Simone, Pauligk, Claudia, Goetze, Thorsten Oliver, Homann, Nils, Al-Batran, Salah-Eddin, Hofheinz, Ralf Dieter, Schmalenberg, Harald, Strumberg, Dirk, Goekkurt, Eray, Angermeier, Stefan, Zander, Thomas, Potenberg, Jochem, Kopp, Hans Georg, Pink, Daniel, Siegler, Gabriele Margareta, Schenk, Michael, De Vita, Ferdinando, Maiello, Evaristo, Gaiser, Timo, Sookthai, Disorn, Bankstahl, Ulli Simone, Pauligk, Claudia, Goetze, Thorsten Oliver, and Homann, Nils

Published
2020

28. De-escalated chemotherapy versus endocrine therapy plus pertuzumab plus trastuzumab for HR+/HER2+early breast cancer (BC): First efficacy results from the neoadjuvant WSG-TP-II study.

Author

Gluz, Oleg, Nitz, Ulrike, Christgen, Matthias, Kuemmel, Sherko, Holtschmidt, Johannes, Priel, Jan, Hartkopf, Andreas, Potenberg, Jochem, Luedtke-Heckenkamp, Kerstin, Just, Marianne, Wuelfing, Pia, Von Schumann, Raquel, Graeser, Monika, Wuerstlein, Rachel, Kates, Ronald E., Kreipe, Hans Heinrich, Harbeck, Nadia, Gluz, Oleg, Nitz, Ulrike, Christgen, Matthias, Kuemmel, Sherko, Holtschmidt, Johannes, Priel, Jan, Hartkopf, Andreas, Potenberg, Jochem, Luedtke-Heckenkamp, Kerstin, Just, Marianne, Wuelfing, Pia, Von Schumann, Raquel, Graeser, Monika, Wuerstlein, Rachel, Kates, Ronald E., Kreipe, Hans Heinrich, and Harbeck, Nadia

Published
2020

29. Early response byMRimaging and ultrasound as predictor of pathologic complete response to 12‐week neoadjuvant therapy for different early breast cancer subtypes: Combined analysis from theWSG ADAPTsubtrials

Author

Graeser, Monika, primary, Schrading, Simone, additional, Gluz, Oleg, additional, Strobel, Kevin, additional, Würstlein, Rachel, additional, Kümmel, Sherko, additional, Schumacher, Claudia, additional, Grischke, Eva‐Maria, additional, Forstbauer, Helmut, additional, Braun, Michael, additional, Christgen, Matthias, additional, Adams, Jascha, additional, Nitzsche, Henrik, additional, Just, Marianne, additional, Fischer, Hans Holger, additional, Aktas, Bahriye, additional, Potenberg, Jochem, additional, Schumann, Raquel, additional, Kolberg‐Liedtke, Cornelia, additional, Harbeck, Nadia, additional, Kuhl, Christiane K., additional, and Nitz, Ulrike, additional

Published
2021
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30. Randomized multicenter phase II/III study with adjuvant gemcitabine versus neoadjuvant/adjuvant FOLFIRINOX in resectable pancreatic cancer: The NEPAFOX trial.

Author

Al-Batran, Salah-Eddin, primary, Reichart, Alexander, additional, Bankstahl, Ulli Simone, additional, Pauligk, Claudia, additional, Kraus, Thomas Werner, additional, Bechstein, Wolf Otto, additional, Trojan, Jorg, additional, Behrend, Matthias, additional, Potenberg, Jochem, additional, Homann, Nils, additional, Venerito, Marino, additional, Bohle, Wolfram, additional, Varvenne, Michael, additional, Bolling, Claus, additional, Behringer, Dirk M., additional, Kratz-Alber, Karsten, additional, Siegler, Gabriele Margareta, additional, Hozaeel, Wael, additional, and Goetze, Thorsten Oliver, additional

Published
2021
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31. Perioperative ramucirumab in combination with FLOT versus FLOT alone for resectable esophagogastric adenocarcinoma (RAMSES/FLOT7): Results of the phase II-portion—A multicenter, randomized phase II/III trial of the German AIO and Italian GOIM.

Author

Al-Batran, Salah-Eddin, primary, Hofheinz, Ralf Dieter, additional, Schmalenberg, Harald, additional, Strumberg, Dirk, additional, Goekkurt, Eray, additional, Angermeier, Stefan, additional, Zander, Thomas, additional, Potenberg, Jochem, additional, Kopp, Hans Georg, additional, Pink, Daniel, additional, Siegler, Gabriele Margareta, additional, Schenk, Michael, additional, De Vita, Ferdinando, additional, Maiello, Evaristo, additional, Gaiser, Timo, additional, Sookthai, Disorn, additional, Bankstahl, Ulli Simone, additional, Pauligk, Claudia, additional, Goetze, Thorsten Oliver, additional, and Homann, Nils, additional

Published
2020
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32. De-escalated chemotherapy versus endocrine therapy plus pertuzumab+ trastuzumab for HR+/HER2+ early breast cancer (BC): First efficacy results from the neoadjuvant WSG-TP-II study.

Author

Gluz, Oleg, primary, Nitz, Ulrike, additional, Christgen, Matthias, additional, Kuemmel, Sherko, additional, Holtschmidt, Johannes, additional, Priel, Jan, additional, Hartkopf, Andreas, additional, Potenberg, Jochem, additional, Luedtke-Heckenkamp, Kerstin, additional, Just, Marianne, additional, Wuelfing, Pia, additional, von Schumann, Raquel, additional, Graeser, Monika, additional, Wuerstlein, Rachel, additional, Kates, Ronald E., additional, Kreipe, Hans Heinrich, additional, and Harbeck, Nadia, additional

Published
2020
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33. Abstract P4-10-05: Predictive value of HER2 expression, early response and tumor infiltrating lymphocytes (TILs) on efficacy of de-escalated pertuzumab+trastuzumab in the neoadjuvant WSG-ADAPT-HER2+/HR- trial

Author

Gluz, Oleg, primary, Kolberg-Liedtke, Cornelia, additional, Biehl, Claudia, additional, Christgen, Matthias, additional, Kuemmel, Sherko, additional, Grischke, Eva-Maria, additional, Augustin, Doris, additional, Braun, Michael, additional, Potenberg, Jochem, additional, Graeser, Monika, additional, Kates, Ronald, additional, Wuerstlein, Rachel, additional, Feuerhake, Friedrich, additional, Nitz, Ulrike, additional, Kreipe, Hans, additional, Harbeck, Nadia, additional, and Group, West German Study, additional

Published
2020
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34. De-Escalation Strategies in Human Epidermal Growth Factor Receptor 2 (HER2)–Positive Early Breast Cancer (BC): Final Analysis of the West German Study Group Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early BC HER2- and Hormone Receptor–Positive Phase II Randomized Trial—Efficacy, Safety, and Predictive Markers for 12 Weeks of Neoadjuvant Trastuzumab Emtansine With or Without Endocrine Therapy (ET) Versus Trastuzumab Plus ET

Author

Harbeck, Nadia, Gluz, Oleg, Christgen, Matthias, Kates, Ronald Ernest, Braun, Michael, Kümmel, Sherko, Schumacher, Claudia, Potenberg, Jochem, Kraemer, Stefan, Kleine-Tebbe, Anke, Augustin, Doris, Aktas, Bahriye, Forstbauer, Helmut, Tio, Joke, Von Schumann, Raquel, Liedtke, Cornelia, Grischke, Eva-Maria, Schumacher, Johannes, Wuerstlein, Rachel, Kreipe, Hans Heinrich, and Nitz, Ulrike Anneliese

Subjects
Adult, Cancer Research, Receptor, ErbB-2, Medizin, Breast Neoplasms, Middle Aged, Trastuzumab, Ado-Trastuzumab Emtansine, Antibodies, Monoclonal, Humanized, Neoadjuvant Therapy, 03 medical and health sciences, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Humans, Female, Maytansine, Prospective Studies, 030212 general & internal medicine, Precision Medicine
Abstract

Purpose Human epidermal growth factor receptor 2 (HER2)–positive/hormone receptor (HR)–positive breast cancer is a distinct subgroup associated with lower chemotherapy sensitivity and slightly better outcome than HER2-positive/HR-negative disease. Little is known about the efficacy of the combination of endocrine therapy (ET) with trastuzumab or with the potent antibody-cytotoxic, anti-HER2 compound trastuzumab emtansine (T-DM1) with or without ET for this subgroup. The West German Study Group trial, ADAPT (Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer) compares pathologic complete response (pCR) rates of T-DM1 versus trastuzumab with ET in early HER2-positive/HR-positive breast cancer. Patients and Methods In this prospective, neoadjuvant, phase II trial, 375 patients with early breast cancer with HER2-positive and HR-positive status (n = 463 screened) were randomly assigned to 12 weeks of T-DM1 with or without ET or to trastuzumab with ET. The primary end point was pCR (ypT0/is/ypN0). Early response was assessed in 3-week post-therapeutic core biopsies (proliferation decrease ≥ 30% Ki-67 or cellularity response). Secondary end points included safety and predictive impact of early response on pCR. Adjuvant therapy followed national standards. Results Baseline characteristics were well balanced among the arms. More than 90% of patients completed the therapy per protocol. pCR was observed in 41.0% of patients treated with T-DM1, 41.5% of patients treated with T-DM1 and ET, and 15.1% with trastuzumab and ET ( P < .001). Early responders (67% of patients with assessable response) achieved pCR in 35.7% compared with 19.8% in nonresponders (odds ratio, 2.2; 95% CI, 1.24 to 4.19). T-DM1 was associated with a significantly higher prevalence of grade 1 to 2 toxicities, especially thrombocytopenia, nausea, and elevation of liver enzymes. Overall toxicity was low; seventeen therapy-related severe adverse events (T-DM1 arms v trastuzumab plus ET; 5.3% v 3.1%, respectively) were reported. Conclusion The ADAPT HER2-positive/HR-positive trial demonstrates that neoadjuvant T-DM1 (with or without ET) given for only 12 weeks results in a clinically meaningful pCR rate. Thus, a substantial number of patients are spared the adverse effects of systemic chemotherapy.

Published
2017
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35. Impact of PIK3CA mutation status on immune marker response and pCR in the WSG-ADAPT HER2+/HR+ phase II trial.

Author

Harbeck, Nadia, Nitz, Ulrike, Christgen, Matthias, Kates, Ronald E., Braun, Michael Wilhelm, Kummel, Sherko, Schumacher, Claudia, Potenberg, Jochem, Malter, Wolfram, Augustin, Doris, Aktas, Bahriye, Forstbauer, Helmut, Tio, Joke, Kleine-Tebbe, Anke, Liedtke, Cornelia, de Haas, Sanne, Deurloo, Regula, Wuerstlein, Rachel, Kreipe, Hans Heinrich, Gluz, Oleg, Harbeck, Nadia, Nitz, Ulrike, Christgen, Matthias, Kates, Ronald E., Braun, Michael Wilhelm, Kummel, Sherko, Schumacher, Claudia, Potenberg, Jochem, Malter, Wolfram, Augustin, Doris, Aktas, Bahriye, Forstbauer, Helmut, Tio, Joke, Kleine-Tebbe, Anke, Liedtke, Cornelia, de Haas, Sanne, Deurloo, Regula, Wuerstlein, Rachel, Kreipe, Hans Heinrich, and Gluz, Oleg

Published
2018

36. Comparison of Neoadjuvant Nab-Paclitaxe plus Carboplatin vs Nab-Paclitaxe plus Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results

Author

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

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/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

Published
2018

37. Sorafenib plus topotecan versus placebo plus topotecan for platinum-resistant ovarian cancer (TRIAS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

Author

Chekerov, Radoslav, Hilpert, Felix, Mahner, Sven, El-Balat, Ahmed, Harter, Philipp, De Gregorio, Nikolaus, Fridrich, Claudius, Markmann, Susanne, Potenberg, Jochem, Lorenz, Ralf, Oskay-Oezcelik, Guelten, Schmidt, Marcus, Krabisch, Petra, Lueck, Hans-Joachim, Richter, Rolf, Braicu, Elena Ioana, du Bois, Andreas, Sehouli, Jalid, Chekerov, Radoslav, Hilpert, Felix, Mahner, Sven, El-Balat, Ahmed, Harter, Philipp, De Gregorio, Nikolaus, Fridrich, Claudius, Markmann, Susanne, Potenberg, Jochem, Lorenz, Ralf, Oskay-Oezcelik, Guelten, Schmidt, Marcus, Krabisch, Petra, Lueck, Hans-Joachim, Richter, Rolf, Braicu, Elena Ioana, du Bois, Andreas, and Sehouli, Jalid

Abstract

Background Antiangiogenic therapy has known activity in ovarian cancer. The investigator-initiated randomised phase 2 TRIAS trial assessed the multi-kinase inhibitor sorafenib combined with topotecan and continued as maintenance therapy for platinum-resistant or platinum-refractory ovarian cancer. Methods We did a multicentre, double-blind, placebo-controlled, randomised, phase 2 trial at 20 sites in Germany. Patients (>= 18 years) with platinum-resistant ovarian cancer previously treated with two or fewer chemotherapy lines for recurrent disease were stratified (first vs later relapse) in block sizes of four and randomly assigned (1: 1) using a web-generated response system to topotecan (1.25 mg/m(2) on days 1-5) plus either oral sorafenib 400 mg or placebo twice daily on days 6-15, repeated every 21 days for six cycles, followed by daily maintenance sorafenib or placebo for up to 1 year in patients without progression. Investigators and patients were masked to allocation of sorafenib or placebo; topotecan treatment was open label. The primary endpoint was investigator-assessed progression-free survival, analysed in all patients who received at least one dose of study drug. This completed trial is registered with ClinicalTrials.gov, number NCT01047891. Findings Between Jan 18, 2010, and Sept 19, 2013, 185 patients were enrolled, 174 of whom were randomly assigned: 85 to sorafenib and 89 to placebo. Two patients in the sorafenib group had serious adverse events before treatment and were excluded from analyses. 83 patients in the sorafenib group and 89 in the placebo group started treatment. Progression-free survival was significantly improved with sorafenib versus placebo (hazard ratio 0.60, 95% CI 0.43-0.83; p=0.0018). Median progression-free survival was 6.7 months (95% CI 5.8-7.6) with sorafenib versus 4.4 months (3.7-5.0) with placebo. The most common grade 3-4 adverse events were leucopenia (57 [69%] of 83 patients in the sorafenib group vs 47 [53%] of 89 in th

Published
2018

38. Sorafenib plus topotecan versus placebo plus topotecan for platinum-resistant ovarian cancer (TRIAS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

Author

Chekerov, Radoslav, primary, Hilpert, Felix, additional, Mahner, Sven, additional, El-Balat, Ahmed, additional, Harter, Philipp, additional, De Gregorio, Nikolaus, additional, Fridrich, Claudius, additional, Markmann, Susanne, additional, Potenberg, Jochem, additional, Lorenz, Ralf, additional, Oskay-Oezcelik, Guelten, additional, Schmidt, Marcus, additional, Krabisch, Petra, additional, Lueck, Hans-Joachim, additional, Richter, Rolf, additional, Braicu, Elena Ioana, additional, du Bois, Andreas, additional, Sehouli, Jalid, additional, Lichtenegger, Werner, additional, Yalcinkaya, Isil, additional, Kittner, Marion, additional, Konwert, Ellen, additional, Keller, Maren, additional, Mustea, Alexander, additional, Koensgen-Mustea, Dominique, additional, Pietzner, Klaus, additional, Camara, Oumar, additional, Wimberger, Pauline, additional, Elser, Gabriele, additional, and Polleis, Sandra, additional

Published
2018
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39. Impact of PIK3CA mutation status on immune marker response and pCR in the WSG-ADAPT HER2+/HR+ phase II trial.

Author

Harbeck, Nadia, primary, Nitz, Ulrike, additional, Christgen, Matthias, additional, Kates, Ronald E., additional, Braun, Michael Wilhelm, additional, Kummel, Sherko, additional, Schumacher, Claudia, additional, Potenberg, Jochem, additional, Malter, Wolfram, additional, Augustin, Doris, additional, Aktas, Bahriye, additional, Forstbauer, Helmut, additional, Tio, Joke, additional, Kleine-Tebbe, Anke, additional, Liedtke, Cornelia, additional, de Haas, Sanne, additional, Deurloo, Regula, additional, Wuerstlein, Rachel, additional, Kreipe, Hans Heinrich, additional, and Gluz, Oleg, additional

Published
2018
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40. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results

Author

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

Published
2017
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41. Panitumumab in platinum-sensitive epithelial ovarian cancer patients with KRAS wild-type: The PROVE-study, a phase II randomized multicenter study of the North-Eastern German Society of Gynaecologic Oncology.

Author

Chekerov, Radoslav, primary, Klare, Peter, additional, Krabisch, Petra, additional, Potenberg, Jochem, additional, Heinrich, Georg, additional, Mueller, Lothar, additional, Kurbacher, Christian M., additional, Grischke, Eva-Maria, additional, Braicu, Elena Ioana, additional, Wimberger, Pauline, additional, and Sehouli, Jalid, additional

Published
2017
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42. Distinct early proliferation response to neoadjuvant anti-HER2 antibody drug conjugate +/- endocrine therapy in early breast cancer in the WSG ADAPT HER2+/HR+ trial

Author

Gluz, Oleg, Nitz, Ulrike, Kuemmel, Sherko, Krämer, Stefan, Braun, Michael, Schumacher, Claudia, Aktas, Bahriye, Forstbauer, Helmut, Reimer, Toralf, Fasching, Peter, Potenberg, Jochem, Hofmann, Daniel, Kates, Ronald E., Wuerstlein, Rachel, Christgen, Matthias, Kreipe, Hans, and Harbeck, Nadia

Subjects
Medizin
Published
2015

43. Topotecan (T) ± sorafenib (S) in platinum-resistant ovarian cancer (PROC): A double-blind placebo-controlled randomized NOGGO–AGO intergroup Trial—TRIAS.

Author

Sehouli, Jalid, primary, Hilpert, Felix, additional, Mahner, Sven, additional, Neunhoeffer, Tanja, additional, Harter, Philipp, additional, de Gregorio, Nikolaus, additional, Fridrich, Claudius, additional, Markmann, Susanne, additional, Richter, Rolf, additional, Potenberg, Jochem, additional, Lorenz, Ralf, additional, Klare, Peter, additional, Schmidt, Marcus, additional, Krabisch, Petra, additional, Groell, Isolde, additional, Doering, Gabriele, additional, Belau, Antje, additional, Lueck, Hans-Joachim, additional, Du Bois, Andreas, additional, and Chekerov, Radoslav, additional

Published
2016
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44. Final analysis of WSG-ADAPT HER2+/HR- trial: Efficacy, safety, and predictive markers for 12-weeks of neoadjuvant dual blockade with trastuzumab + pertuzumab ± weekly paclitaxel in HER2+/HR- early breast cancer (EBC).

Author

Nitz, Ulrike, primary, Gluz, Oleg, additional, Christgen, Matthias, additional, Grischke, Eva-Maria, additional, Augustin, Doris, additional, Kümmel, Sherko, additional, Braun, Michael Wilhelm, additional, Potenberg, Jochem, additional, Kohls, Andreas, additional, Krauss, Katja, additional, Stefek, Andrea, additional, Schumacher, Claudia, additional, Forstbauer, Helmut, additional, Reimer, Toralf, additional, Fischer, Hans Holger, additional, Liedtke, Cornelia, additional, Wuerstlein, Rachel, additional, Kreipe, Hans Heinrich, additional, and Harbeck, Nadia, additional

Published
2016
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45. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results.

Author

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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46. Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group

Author

Hofheinz, Ralf-Dieter, primary, Gencer, Deniz, additional, Schulz, Holger, additional, Stahl, Michael, additional, Hegewisch-Becker, Susanna, additional, Loeffler, Luisa Mantovani, additional, Kronawitter, Ursula, additional, Bolz, Georg, additional, Potenberg, Jochem, additional, Tauchert, Felix, additional, Al-Batran, Salah-Eddin, additional, and Schneeweiss, Andreas, additional

Published
2015
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47. Pazopanib and 5-FU/oxaliplatin as first-line treatment in advanced gastric cancer: PaFLO, a randomized phase II study from the AIO (Arbeitsgemeinschaft Internistische Onkologie).

Author

Thuss-Patience, Peter C., primary, Al-Batran, Salah-Eddin, additional, Siveke, Jens T, additional, Homann, Nils, additional, Malfertheiner, Peter, additional, Glaeser, Dietrich, additional, Stein, Alexander, additional, Tamm, Ingo, additional, Daum, Severin, additional, Potenberg, Jochem, additional, Florschütz, Axel, additional, Vogel, Arndt, additional, Ridwelski, Karsten, additional, Ritgen, Matthias, additional, Geissler, Michael, additional, Schmalenberg, Harald, additional, Schlattmann, Peter, additional, Lorenz, Mario, additional, Breithaupt, Kirstin, additional, and Pichlmeier, Uwe, additional

Published
2015
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48. Abstract P4-15-01: Distinct early proliferation response to neoadjuvant anti-HER2 antibody drug conjugate +/- endocrine therapy in early breast cancer in the WSG ADAPT HER2+/HR+ trial

Author

Gluz, Oleg, primary, Nitz, Ulrike, additional, Sherko, Kuemmel, additional, Stefan, Kraemer, additional, Braun, Michael, additional, Schumacher, Claudia, additional, Aktas, Bahriye, additional, Forstbauer, Helmut, additional, Reimer, Toralf, additional, Fasching, Peter, additional, Potenberg, Jochem, additional, Hofmann, Daniel, additional, Kates, Ronald E, additional, Wuerstlein, Rachel, additional, Christgen, Matthias, additional, Kreipe, Hans H, additional, and Harbeck, Nadia, additional

Published
2015
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49. Efficacy of 12-weeks of neoadjuvant TDM1 with or without endocrine therapy in HER2-positive hormone-receptor-positive early breast cancer: WSG-ADAPT HER2+/HR+ phase II trial

Author

Harbeck, Nadia, Gluz, Oleg, Christgen, Matthias, Braun, Michael, Kummel, Sherko, Potenberg, Jochem, Aktas, Bahriye, Schumacher, Claudia, Forstbauer, Helmut, Augustin, Doris, Kraemer, Stefan, Just, Marianne, Tio, Joke, Kleine-Tebbe, Anke, Liedtke, Cornelia, Kates, Ronald, Hofmann, Daniel, Wuerstlein, Rachel, Kreipe, Hans, Nitz, Ulrike, and West German Study Grp ADAPT HER2

Subjects
Gynecology, Oncology, Cancer Research, medicine.medical_specialty, business.industry, medicine.medical_treatment, Medizin, Endocrine therapy, Targeted therapy, Hormone receptor, Internal medicine, medicine, skin and connective tissue diseases, business, neoplasms, Early breast cancer
Abstract

506 Background: Evidence suggests differential efficacy of standard neoadjuvant chemo- + targeted therapy in HER2+ early breast cancer (eBC) according to hormone-receptor (HR) status. ADAPT HER2+/H...

Published
2015
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50. Gene expression signatures, stromal tumor infiltrating lymphocytes (sTILs), and change in tumor cellularity to predict pathological complete response (pCR) after 12 week de-escalated neoadjuvant endocrine therapy (ET) vs paclitaxel + dual HER2...

Author

Graeser, Monika Karla, Gluz, Oleg, Nitz, Ulrike, Biehl, Claudia, Berg, Angela, Christgen, Matthias, Kuemmel, Sherko, Holtschmidt, Johannes, Schumacher, Johannes, Hartkopf, Andreas D., Potenberg, Jochem, Luedtke-Heckenkamp, Kerstin, Just, Marianne, Schem, Christian, zu Eulenburg, Christine, Schinkoethe, Timo, Wuerstlein, Rachel, Kates, Ronald E., Kreipe, Hans Heinrich, and Harbeck, Nadia

Published
2023
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