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3. Alternating gemcitabine plus nab-paclitaxel and gemcitabine alone versus continuous gemcitabine plus nab-paclitaxel after induction treatment of metastatic pancreatic cancer (ALPACA): a multicentre, randomised, open-label, phase 2 trial

Author

Dorman, Klara, Boeck, Stefan, Caca, Karel, Reichert, Maximilian, Ettrich, Thomas J, Oettle, Helmut, Waidmann, Oliver, Modest, Dominik P, Müller, Lothar, Michl, Patrick, Kanzler, Stephan, Pink, Daniel, Reinacher-Schick, Anke, Geißler, Michael, Pelz, Henning, Kunzmann, Volker, Held, Swantje, Schichtl, Thomas, Heinemann, Volker, and Kullmann, Frank

Published
2024
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5. Nanoliposomal Irinotecan With Fluorouracil and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Cholangiocarcinoma: A Phase II Study of the AIO Hepatobiliary-YMO Cancer Groups (NIFE-AIO-YMO HEP-0315)

Author

Ettrich, Thomas J., primary, Modest, Dominik P., additional, Sinn, Marianne, additional, Striefler, Jana K., additional, Opitz, Bernhard, additional, Goetze, Thorsten, additional, Gallmeier, Eike, additional, Angermeier, Stefan, additional, Fischer von Weikersthal, Ludwig, additional, Jacobasch, Lutz, additional, Waldschmidt, Dirk, additional, Niedermeier, Michael, additional, Sohm, Michael, additional, Berger, Andreas W., additional, Manzini, Giulia, additional, Fehrenbach, Uli, additional, Auer, Timo Alexander, additional, Hosse, Clarissa, additional, Vogele, Daniel, additional, Sookthai, Disorn, additional, Schaaf, Marina, additional, Muche, Rainer, additional, Hinke, Axel, additional, Seufferlein, Thomas, additional, and Perkhofer, Lukas, additional

Published
2024
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6. Paclitaxel/Ramucirumab versus Paclitaxel in 2nd-Line Therapy of Advanced Esophageal Squamous Cell Carcinoma: Randomized Phase II IKF-AIO-RAMOS Trial.

Author

Scheck, Magdalena K., Goetze, Thorsten O., Ettrich, Thomas J., Schmalenberg, Harald, Clemens, Michael, Mahlberg, Rolf, Heeg, Steffen, Kanzler, Stephan, Hapke, Gunnar, Thuss-Patience, Peter, Kestler, Angelika, Treschl, Anne, Heidel, Stefan, Schiemer, Moritz, Sookthai, Disorn, Junge, Sabine, Pauligk, Claudia, Al-Batran, Salah-Eddin, and Lorenzen, Sylvie

Abstract

Introduction: In squamous cell carcinoma of the esophagus (ESCC), therapeutical options in 2nd-line treatment are scarce with immune checkpoint inhibition being the only approved one. Ramucirumab/paclitaxel is an approved 2nd-line treatment in metastatic esophagogastric adenocarcinoma. We assessed safety and efficacy of ramucirumab/paclitaxel for ESCC. Methods: This prospective, randomized, open-label, multicenter, phase II trial evaluated paclitaxel (80 mg/m2 days 1, 8, 15) plus ramucirumab (8 mg/kg days 1, 15) (investigational arm A) versus paclitaxel alone (80 mg/m2 days 1, 8, 15) (standard arm B), both q4w, in advanced/metastatic ESCC refractory or intolerant to fluoropyrimidine and platinum-based drugs. Primary endpoint was overall survival (OS) rate at 6 months. Results: From 3/2019 to 4/2021, 21/186 planned patients were included (arm A 11 patients; arm B 10 patients) in 9 German centers. Due to slow accrual, the study was terminated prematurely. OS at 6 months was 72.7% for ramucirumab/paclitaxel and 50.0% for paclitaxel. The study design did not allow statistical comparison of the arms. PFS (3.8 vs. 3.5 months), OS (12.1 vs. 9.2 months), ORR (18.2% vs. 20.0%) and DCR (54.5% vs. 60.0%) were comparable in both arms. Most common treatment-related adverse events (TRAEs) in arm A were leucopenia (54.5%), fatigue (27.3%), and peripheral sensory neuropathy (18.2%). 27.3% in arm A and 50.0% in arm B had TRAEs ≥ grade 3. Conclusion: Ramucirumab/paclitaxel shows an acceptable tolerability and numerically improved OS at 6 months. Due to the small number of patients, the current trial must be considered exploratory and more data are needed in this indication. Plain Language Summary: Metastatic and unresectable ESCCs still show poor prognosis. After failure or intolerance to first-line therapy, treatment options are limited and checkpoint inhibitors are the only approved therapeutic option. Our study adds further evidence to the use of antiangiogenic drugs in second-line treatment of advanced ESCC. Ramucirumab in combination with paclitaxel showed numerically improved OS and PFS compared to paclitaxel alone. However, due to the small sample size, the results have to be considered exploratory and more data are needed in this indication. We do not recommend the use of ramucirumab/paclitaxel in second-line treatment of advanced ESCC outside of clinical trials. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Adjuvant treatment with S-1 in patients after R0-resection of adenocarcinoma of the stomach and esophagogastric junction – A multicenter phase I/II feasibility study (GMBH-STO-0114)

Author

Heinrich, Kathrin, primary, Heinemann, Volker, additional, Stintzing, Sebastian, additional, Müller, Lothar, additional, Ettrich, Thomas J., additional, Buechner-Steudel, Petra, additional, Geißler, Michael, additional, Trojan, Jörg, additional, Moosmann, Nicolas, additional, Folprecht, Gunnar, additional, Schmidt, Johannes, additional, Kanzler, Stephan, additional, Kullmann, Frank, additional, Moulin, Jean-Charles, additional, Werner, Jens, additional, Angele, Martin K., additional, Probst, Victoria, additional, Held, Swantje, additional, Schulz, Christoph, additional, and Boukovala, Myrto, additional

Published
2024
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10. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study

Author

Valle, Juan W, Vogel, Arndt, Denlinger, Crystal S, He, Aiwu Ruth, Bai, Li-Yuan, Orlova, Rashida, Van Cutsem, Eric, Adeva, Jorge, Chen, Li-Tzong, Obermannova, Radka, Ettrich, Thomas J, Chen, Jen-Shi, Wasan, Harpreet, Girvan, Allicia C, Zhang, Wei, Liu, Jiangang, Tang, Chunlao, Ebert, Philip J, Aggarwal, Amit, McNeely, Samuel C, Moser, Brian A, Oliveira, Joana M, Carlesi, Roberto, Walgren, Richard A, and Oh, Do-Youn

Published
2021
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11. Nab-paclitaxel plus gemcitabine versus nab-paclitaxel plus gemcitabine followed by FOLFIRINOX induction chemotherapy in locally advanced pancreatic cancer (NEOLAP-AIO-PAK-0113): a multicentre, randomised, phase 2 trial

Author

Hennes, Elke, Lindig, Udo, Geer, Thomas, Stahl, Michael, Senkal, Metin, Südhoff, Thomas, Egger, Matthias, Kahl, Christoph, Große-Thie, Christina, Reiser, Marcel, Mahlmann, Stefan, Fix, Peter, Schulz, Holger, Maschmeyer, Georg, Blau, Wolfgang, Kunzmann, Volker, Siveke, Jens T, Algül, Hana, Goekkurt, Eray, Siegler, Gabriele, Martens, Uwe, Waldschmidt, Dirk, Pelzer, Uwe, Fuchs, Martin, Kullmann, Frank, Boeck, Stefan, Ettrich, Thomas J, Held, Swantje, Keller, Ralph, Klein, Ingo, Germer, Christoph-Thomas, Stein, Hubert, Friess, Helmut, Bahra, Marcus, Jakobs, Ralf, Hartlapp, Ingo, and Heinemann, Volker

Published
2021
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12. Prediction of resistance to bevacizumab plus FOLFOX in metastatic colorectal cancer—Results of the prospective multicenter PERMAD trial.

Author

Seufferlein, Thomas, Lausser, Ludwig, Stein, Alexander, Arnold, Dirk, Prager, Gerald, Kasper-Virchow, Stefan, Niedermeier, Michael, Müller, Lothar, Kubicka, Stefan, König, Alexander, Büchner-Steudel, Petra, Wille, Kai, Berger, Andreas W., Kestler, Angelika M. R., Kraus, Johann M., Werle, Silke D., Perkhofer, Lukas, Ettrich, Thomas J., and Kestler, Hans A.

Subjects
BEVACIZUMAB, MACHINE learning, COLORECTAL cancer, ANTINEOPLASTIC combined chemotherapy protocols, ENDOTHELIAL growth factors, METASTASIS
Abstract

Background: Anti-vascular endothelial growth factor (VEGF) monoclonal antibodies (mAbs) are widely used for tumor treatment, including metastatic colorectal cancer (mCRC). So far, there are no biomarkers that reliably predict resistance to anti-VEGF mAbs like bevacizumab. A biomarker-guided strategy for early and accurate assessment of resistance could avoid the use of non-effective treatment and improve patient outcomes. We hypothesized that repeated analysis of multiple cytokines and angiogenic growth factors (CAFs) before and during treatment using machine learning could provide an accurate and earlier, i.e., 100 days before conventional radiologic staging, prediction of resistance to first-line mCRC treatment with FOLFOX plus bevacizumab. Patients and methods: 15 German and Austrian centers prospectively recruited 50 mCRC patients receiving FOLFOX plus bevacizumab as first-line treatment. Plasma samples were collected every two weeks until radiologic progression (RECIST 1.1) as determined by CT scans performed every 2 months. 102 pre-selected CAFs were centrally analyzed using a cytokine multiplex assay (Luminex, Myriad RBM). Results: Using random forests, we developed a predictive machine learning model that discriminated between the situations of "no progress within 100 days before radiological progress" and "progress within 100 days before radiological progress". We could further identify a combination of ten out of the 102 CAF markers, which fulfilled this task with 78.2% accuracy, 71.8% sensitivity, and 82.5% specificity. Conclusions: We identified a CAF marker combination that indicates treatment resistance to FOLFOX plus bevacizumab in patients with mCRC within 100 days prior to radiologic progress. [ABSTRACT FROM AUTHOR]

Published
2024
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13. ADJUBIL: phase II study of adjuvant immunotherapy with STRIDE regimen with/without capecitabine in biliary tract cancers

Author

Goetze, Thorsten, primary, Gonzalez-Carmona, Maria A, additional, Kochen, Lisa, additional, Agaoglu, Nihat Bugra, additional, Al-Batran, Salah-Eddin, additional, Habibzada, Timorshah, additional, Pons, Miriam, additional, Brunner, Marius, additional, Ettrich, Thomas J, additional, Köhne, Claus-Henning, additional, Roderburg, Christoph, additional, and Modest, Dominik, additional

Published
2024
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17. Regorafenib

Author

Ettrich, Thomas J., Seufferlein, Thomas, Schlag, Peter-Michael, Series Editor, Senn, Hans-Jörg, Series Editor, and Martens, Uwe M., editor

Published
2018
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20. Community-driven development of a modified progression-free survival ratio for precision oncology

Author

Mock, Andreas, Heilig, Christoph E, Kreutzfeldt, Simon, Huebschmann, Daniel, Heining, Christoph, Schröck, Evelin, Brors, Benedikt, Stenzinger, Albrecht, Jäger, Dirk, Schlenk, Richard, Glimm, Hanno, Fröhling, Stefan, Horak, Peter, Apostolidis, Leonidas, Augustin, Marinela, Aust, Daniela, Bhatti, Irfan Ahmed, Bloehdorn, Johannes, Brendel, Cornelia, Britschgi, Christian, Braess, Jan, Burdach, Stefan, Busch, Elena, Casuscelli, Jozefina, Desuki, Alexander, Deutsch, Thomas, Dietrich, Mareike, Ehmer, Ursula, Ettrich, Thomas J, Falkenhorst, Johanna, Fehm, Tanja, Flörcken, Anne, Forschner, Andrea, Fuxius, Stefan, Gonzales-Carmona, Maria, Griesinger, Frank, Grill, Sabine, Gröschel, Stefan, Haag, Georg Martin, Haag, Ulrich, Halama, Niels, Hebart, Holger, Heidger, Nina, Hermes, Barbara, Hess, Georg, Hettmer, Simone, Hoechstetter, Manuela, Hoffmann, Martin, Hüttner, Felix J, Illert, Anna L, Jenzer, Maximilian, Kasper, Bernd, Kasper-Virchow, Stefan, Kindler, Thomas, Koscielniak, Ewa, Krönke, Jan, Kühn, Michael, Kunzmann, Volker, Lang, Alois, Leichsenring, Jonas, Livingstone, Elisabeth, Liotta, Lucia, Luley, Kim, Mack, Elisabeth, Martens, Uwe M, Metzeler, Klaus, Middeke, Jan Moritz, Möhrmann, Lino, Jayarama-Naidu, Roopa, Pape, Ulrich-Frank, Perkhofer, Lukas, Pfeufer, Arne, Pixberg, Constantin, Quante, Michael, Rendenbach, Bernhard, Rieke, Damian, Rothermundt, Christian, Sagerer, Andre Norbert, Salzmann, Martin, Saur, Dieter, Schilling, Bastian, Schleicher, Jan, Schlenska-Lange, Anke, Schmidt, Thomas, Schmitz, Sophia, Schölch, Sebastian, Shah, Rajiv, Shoumariyeh, Khalid, Siebenhüner, Alexander, Singh, Martin, Siveke, Jens, Springfeld, Christoph, Starke, Helen, Strobel, Sophia, Teleanu, Veronica, Thon, Niklas, Wagner, Sebastian, Walle, Thomas, Westphalen, Benedikt, Whitlock, Bettina, Winkler, Eva, Wirsik, Naita Maren, Woydack, Lena, Bois, Angelika Zabel-du, and Zschäbitz, Stefanie

Published
2019
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27. Integrated Analysis of the RASH Study with the Use of the “Burden of Therapy” (BOTh®TM) Methodology—A Novel Tool for Assessing Adverse Events in Metastatic Pancreatic Cancer

Author

Dorman, Klara, primary, Boeck, Stefan, additional, Snijder, Robert J., additional, Siveke, Jens T., additional, Schenk, Michael, additional, Mayerle, Julia, additional, Caca, Karel, additional, Freiberg-Richter, Jens, additional, Fischer von Weikersthal, Ludwig, additional, Kullmann, Frank, additional, Reinacher-Schick, Anke, additional, Fuchs, Martin, additional, Kanzler, Stephan, additional, Kunzmann, Volker, additional, Ettrich, Thomas J., additional, Zhang, Danmei, additional, Held, Swantje, additional, Abdul-Ahad, Ayad, additional, von Bergwelt-Baildon, Michael, additional, Heinemann, Volker, additional, and Haas, Michael, additional

Published
2023
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28. Supplementary Data from RINT1 Regulates SUMOylation and the DNA Damage Response to Preserve Cellular Homeostasis in Pancreatic Cancer

Author

Arnold, Frank, primary, Gout, Johann, primary, Wiese, Heike, primary, Weissinger, Stephanie E., primary, Roger, Elodie, primary, Perkhofer, Lukas, primary, Walter, Karolin, primary, Scheible, Jeanette, primary, Prelli Bozzo, Caterina, primary, Lechel, André, primary, Ettrich, Thomas J., primary, Azoitei, Ninel, primary, Hao, Li, primary, Fürstberger, Axel, primary, Kaminska, Ewa K., primary, Sparrer, Konstantin M.J., primary, Rasche, Volker, primary, Wiese, Sebastian, primary, Kestler, Hans A., primary, Möller, Peter, primary, Seufferlein, Thomas, primary, Frappart, Pierre-Olivier, primary, and Kleger, Alexander, primary

Published
2023
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29. Data from RINT1 Regulates SUMOylation and the DNA Damage Response to Preserve Cellular Homeostasis in Pancreatic Cancer

Author

Arnold, Frank, primary, Gout, Johann, primary, Wiese, Heike, primary, Weissinger, Stephanie E., primary, Roger, Elodie, primary, Perkhofer, Lukas, primary, Walter, Karolin, primary, Scheible, Jeanette, primary, Prelli Bozzo, Caterina, primary, Lechel, André, primary, Ettrich, Thomas J., primary, Azoitei, Ninel, primary, Hao, Li, primary, Fürstberger, Axel, primary, Kaminska, Ewa K., primary, Sparrer, Konstantin M.J., primary, Rasche, Volker, primary, Wiese, Sebastian, primary, Kestler, Hans A., primary, Möller, Peter, primary, Seufferlein, Thomas, primary, Frappart, Pierre-Olivier, primary, and Kleger, Alexander, primary

Published
2023
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30. Regorafenib

Author

Ettrich, Thomas J., Seufferlein, Thomas, Schlag, Peter M., Series editor, Senn, Hans-Jörg, Series editor, and Martens, Uwe M., editor

Published
2014
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31. Immunotherapy: Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

Author

Perkhofer, Lukas, Beutel, Alica K., and Ettrich, Thomas J.

Abstract

Pancreatic ductal adenocarcinoma (PDAC) and extrahepatic biliary tract cancer (BTC) are among the malignancies with the highest morbidity and mortality. Despite increasing knowledge on biology and novel therapies, outcome remains poor in these patients. Recent progress in immunotherapies created new hopes in the treatment of PDAC and extrahepatic BTC. Several trials tested immunotherapies in various therapeutic situations as monotherapies or in combinations. Although responses were seen in some of the trials, the value of immunotherapy in PDAC and extrahepatic BTC remains unclear in the current situation, especially regarding the complex biological characteristics with a high stroma component, intrinsic resistance mechanisms and an immunosuppressive, hypoxic microenvironment. These major hurdles have to be taken into account and overcome if immunotherapies should be successful in these tumor entities. Thereby, combinational approaches that allow on the one hand targeted therapy and on the other restore or boost the function of immune cells are promising.

Published
2024
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32. Translational analysis and final efficacy of the AVETUX trial – Avelumab, cetuximab and FOLFOX in metastatic colorectal cancer

Author

Tintelnot, Joseph, primary, Ristow, Inka, additional, Sauer, Markus, additional, Simnica, Donjete, additional, Schultheiß, Christoph, additional, Scholz, Rebekka, additional, Goekkurt, Eray, additional, von Wenserski, Lisa, additional, Willscher, Edith, additional, Paschold, Lisa, additional, Lorenzen, Sylvie, additional, Riera-Knorrenschild, Jorge, additional, Depenbusch, Reinhard, additional, Ettrich, Thomas J., additional, Dörfel, Steffen, additional, Al-Batran, Salah-Eddin, additional, Karthaus, Meinolf, additional, Pelzer, Uwe, additional, Hinke, Axel, additional, Bauer, Marcus, additional, Massa, Chiara, additional, Seliger, Barbara, additional, Wickenhauser, Claudia, additional, Bokemeyer, Carsten, additional, Hegewisch-Becker, Susanna, additional, Binder, Mascha, additional, and Stein, Alexander, additional

Published
2022
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33. Integrated Analysis of the RASH Study with the Use of the 'Burden of Therapy' (BOTh®TM) Methodology : A Novel Tool for Assessing Adverse Events in Metastatic Pancreatic Cancer

Author

Dorman, Klara, Boeck, Stefan, Snijder, Robert J., Siveke, Jens, Schenk, Michael, Mayerle, Julia, Caca, Karel, Freiberg-Richter, Jens, Fischer von Weikersthal, Ludwig, Kullmann, Frank, Reinacher-Schick, Anke, Fuchs, Martin, Kanzler, Stephan, Kunzmann, Volker, Ettrich, Thomas J., Zhang, Danmei, Held, Swantje, Abdul-Ahad, Ayad, von Bergwelt-Baildon, Michael, Heinemann, Volker, and Haas, Michael

Subjects
Medizin
Abstract

CA extern This analysis of the RASH trial (NCT01729481) aimed at gaining a better understanding of the "Burden of Therapy" (BOTh & REG;TM) in pancreatic ductal adenocarcinoma (PDAC). In the RASH study, 150 patients with newly diagnosed metastatic PDAC were treated with gemcitabine plus erlotinib (gem/erlotinib) for four weeks. Patients who developed a skin rash during this four-week run-in phase continued with the gem/erlotinib treatment, while rash-negative patients were switched to FOLFIRINOX. The study demonstrated a 1-year survival rate of rash-positive patients who received gem/erlotinib as first-line treatment that was comparable to previous reports of patients receiving FOLFIRINOX. To understand whether these comparable survival rates may be accompanied by better tolerability of the gem/erlotinib treatment compared to FOLFIRINOX, the BOTh & REG;TM methodology was used to continuously quantify and depict the burden of therapy generated by treatment emergent events (TEAEs). Sensory neuropathy was significantly more common in the FOLFIRINOX arm, and prevalence as well as severity increased over time. In both arms, the BOTh & REG;TM associated with diarrhea decreased over the course of treatment. The BOTh & REG;TM caused by neutropenia was comparable in both arms but decreased in the FOLFIRINOX arm over time, possibly due to chemotherapy dose reductions. Overall, gem/erlotinib was associated with a slightly higher overall BOTh & REG;TM, but the difference was not statistically significant (p = 0.6735). In summary, the BOTh & REG;TM analysis facilitates the evaluation of TEAEs. In patients fit for intense chemotherapeutic regimens, FOLFIRINOX is associated with a lower BOTh & REG;TM than gem/erlotinib.

Published
2023

34. S3-Leitlinie zum exokrinen Pankreaskarzinom – Langversion 2.0 – Dezember 2021 – AWMF-Registernummer: 032/010OL

Author

Seufferlein, Thomas, additional, Mayerle, Julia, additional, Böck, Stefan, additional, Brunner, Thomas, additional, Ettrich, Thomas J., additional, Grenacher, Lars, additional, Gress, Thomas Mathias, additional, Hackert, Thilo, additional, Heinemann, Volker, additional, Kestler, Angelika, additional, Sinn, Marianne, additional, Tannapfel, Andrea, additional, Wedding, Ulrich, additional, and Uhl, Waldemar, additional

Published
2022
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35. Integrated Analysis of the RASH Study with the Use of the "Burden of Therapy" (BOTh ®TM) Methodology—A Novel Tool for Assessing Adverse Events in Metastatic Pancreatic Cancer.

Author

Dorman, Klara, Boeck, Stefan, Snijder, Robert J., Siveke, Jens T., Schenk, Michael, Mayerle, Julia, Caca, Karel, Freiberg-Richter, Jens, Fischer von Weikersthal, Ludwig, Kullmann, Frank, Reinacher-Schick, Anke, Fuchs, Martin, Kanzler, Stephan, Kunzmann, Volker, Ettrich, Thomas J., Zhang, Danmei, Held, Swantje, Abdul-Ahad, Ayad, von Bergwelt-Baildon, Michael, and Heinemann, Volker

Subjects
PANCREATIC cancer, METASTASIS, PANCREATIC duct, CANCER chemotherapy, ERLOTINIB
Abstract

This analysis of the RASH trial (NCT01729481) aimed at gaining a better understanding of the "Burden of Therapy" (BOTh®TM) in pancreatic ductal adenocarcinoma (PDAC). In the RASH study, 150 patients with newly diagnosed metastatic PDAC were treated with gemcitabine plus erlotinib (gem/erlotinib) for four weeks. Patients who developed a skin rash during this four-week run-in phase continued with the gem/erlotinib treatment, while rash-negative patients were switched to FOLFIRINOX. The study demonstrated a 1-year survival rate of rash-positive patients who received gem/erlotinib as first-line treatment that was comparable to previous reports of patients receiving FOLFIRINOX. To understand whether these comparable survival rates may be accompanied by better tolerability of the gem/erlotinib treatment compared to FOLFIRINOX, the BOTh®TM methodology was used to continuously quantify and depict the burden of therapy generated by treatment emergent events (TEAEs). Sensory neuropathy was significantly more common in the FOLFIRINOX arm, and prevalence as well as severity increased over time. In both arms, the BOTh®TM associated with diarrhea decreased over the course of treatment. The BOTh®TM caused by neutropenia was comparable in both arms but decreased in the FOLFIRINOX arm over time, possibly due to chemotherapy dose reductions. Overall, gem/erlotinib was associated with a slightly higher overall BOTh®TM, but the difference was not statistically significant (p = 0.6735). In summary, the BOTh®TM analysis facilitates the evaluation of TEAEs. In patients fit for intense chemotherapeutic regimens, FOLFIRINOX is associated with a lower BOTh®TM than gem/erlotinib. [ABSTRACT FROM AUTHOR]

Published
2023
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36. S3-Leitlinie zum exokrinen Pankreaskarzinom – Kurzversion 2.0 – Dezember 2021, AWMF-Registernummer: 032/010OL

Author

Seufferlein, Thomas, additional, Mayerle, Julia, additional, Böck, Stefan, additional, Brunner, Thomas, additional, Ettrich, Thomas J., additional, Grenacher, Lars, additional, Gress, Thomas Mathias, additional, Hackert, Thilo, additional, Heinemann, Volker, additional, Kestler, Angelika, additional, Sinn, Marianne, additional, Tannapfel, Andrea, additional, Wedding, Ulrich, additional, and Uhl, Waldemar, additional

Published
2022
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37. Pancreatic cancer Clinical research projects of the German oncology groups (ACO, AIO, and ARO)

Author

Striefler, Jana K., Reissig, Timm M., Kunzmann, Volker, Westphalen, C. Benedikt, Boeck, Stefan, Ettrich, Thomas J., Lutz, Manfred P., Waldschmidt, Dirk T., Brunner, Thomas, Uhl, Waldemar, Sinn, Marianne, Siveke, Jens T., Striefler, Jana K., Reissig, Timm M., Kunzmann, Volker, Westphalen, C. Benedikt, Boeck, Stefan, Ettrich, Thomas J., Lutz, Manfred P., Waldschmidt, Dirk T., Brunner, Thomas, Uhl, Waldemar, Sinn, Marianne, and Siveke, Jens T.

Abstract

Background: The incidence of pancreatic cancer (PC) is increasing. Due to a combination of therapeutic resistance and to advanced disease already at diagnosis, PC remains one of the most fatal malignant solid tumors with a 5-year survival rate of only 8-9%. Objectives: The German oncology study groups offer a broad portfolio of clinical trials. We present the most current projects of Arbeitsgemeinschaft Chirurgische Onkologie (ACO), Arbeitsgemeinschaft Internistische Onkologie (AIO), and Arbeitsgemeinschaft Radiologische Onkologie (ARO) in PC including recruiting studies as well as those envisaged or recently completed. Results: Combination chemotherapy is still the backbone of PC therapy. In localized disease, curatively intended resection followed by adjuvant chemotherapy remains standard in fit patients (e.g., modified FOLFIRINOX, gemcitabine-based). In addition, clinical trial activities focus on the role of perioperative therapy in PC. Recent clinical trials analyze the benefit in the (borderline) resectable (NEONAX), locally advanced (NEOLAP), and oligometastatic (METAPANC, HOLIPANC) setting. In metastatic PC, intensified chemotherapeutic protocols and combined epigenetic and immune targeting concepts are currently being evaluated. Conclusion: Taking into account the relevant therapeutic resistance of PC, new therapeutic concepts are needed to further ameliorate the prognosis. The role of perioperative therapy needs to be further clarified and is the objective of recent studies.

Published
2022

39. Comparative panel sequencing of DNA variants in cf-, ev- and tumorDNA for pancreatic ductal adenocarcinoma patients

Author

Waldenmaier, Mareike, Schulte, Lucas, Schönfelder, Jonathan, Fürstberger, Axel, Kraus, Johann M., Daiss, Nora, Seibold, Tanja, Morawe, Mareen, Ettrich, Thomas J., Kestler, Hans A., Kahlert, Christoph, Seufferlein, Thomas, Eiseler, Tim, and Wong, David

Subjects
Cancer Research, liquid biopsy, PDAC, extracellular vesicles, exosomes, cfDNA, next-generation sequencing, Pancreatic neoplasms, Liquid biopsy, Extracellular vesicles, Exosomes, DDC 570 / Life sciences, Oncology, ddc:570, High throughput screening, Biopsie, ddc:610, Exosom, Bauchspeicheldrüsenkrebs, %22">Exosom , DDC 610 / Medicine & health, Cell-free nucleic acids, High-throughput nucleotide sequencing
Abstract

Simple Summary Pancreatic ductal adenocarcinoma (PDAC) has still a dismal prognosis. To improve treatment, personalized medicine uses next-generation DNA sequencing to monitor disease and guide treatment decisions. Tumor samples for sequencing are usually obtained by invasive fine-needle biopsy. Recently, the focus has been increasingly shifting to blood-based liquid biopsies, including circulating free (cf)DNA or DNA isolated from extracellular vesicles (evDNA). To evaluate the detection performance of DNA alterations, we directly compared tumor-, cf- and evDNA from patients with advanced PDAC upon panel sequencing. Copy number variations (CNVs), single nucleotide variants (SNVs) and insertions and deletions (indels) were compared for their concordance with tumorDNA. Compared to cfDNA, evDNA contained significantly larger DNA fragments, which improved the concordance of SNVs and indels with tumorDNA. In line with previous observations, CNV detection was mostly uninformative for cf- and evDNA. However, the combination of both liquid biopsy analytes was clearly superior for SNV detection, pointing to potentially improved actionable variant prediction. Abstract Pancreatic ductal adenocarcinomas (PDACs) are tumors with poor prognosis and limited treatment options. Personalized medicine aims at characterizing actionable DNA variants by next-generation sequencing, thereby improving treatment strategies and outcomes. Fine-needle tumor biopsies are currently the gold standard to acquire samples for DNA profiling. However, liquid biopsies have considerable advantages as they are minimally invasive and frequently obtainable and thus may help to monitor tumor evolution over time. However, which liquid analyte works best for this purpose is currently unclear. Our study aims to directly compare tumor-, circulating free (cf-) and extracellular vesicle-derived (ev)DNA by panel sequencing of matching patient material. We evaluated copy number variations (CNVs), single nucleotide variants (SNVs) and insertions and deletions (indels). Our data show that evDNA contains significantly larger DNA fragments up to 5.5 kb, in line with previous observations. Stringent bioinformatic processing revealed a significant advantage of evDNA with respect to cfDNA concerning detection performance for SNVs and a numerical increase for indels. A combination of ev- and cfDNA was clearly superior for SNV detection, as compared to either single analyte, thus potentially improving actionable variant prediction upon further optimization. Finally, calling of CNVs from liquid biopsies still remained challenging and uninformative., publishedVersion

Published
2022
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40. Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial

Author

Seufferlein, Thomas, primary, Ettrich, Thomas J., additional, Menzler, Stefan, additional, Messmann, Helmut, additional, Kleber, Gerhard, additional, Zipprich, Alexander, additional, Frank-Gleich, Stefanie, additional, Algül, Hana, additional, Metter, Klaus, additional, Odemar, Frank, additional, Heuer, Theodor, additional, Hügle, Ulrich, additional, Behrens, Rüdiger, additional, Berger, Andreas W., additional, Scholl, Catharina, additional, Schneider, Katharina L., additional, Perkhofer, Lukas, additional, Rohlmann, Friederike, additional, Muche, Rainer, additional, and Stingl, Julia C., additional

Published
2022
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41. Comparative Panel Sequencing of DNA Variants in cf-, ev- and tumorDNA for Pancreatic Ductal Adenocarcinoma Patients

Author

Waldenmaier, Mareike, primary, Schulte, Lucas, additional, Schönfelder, Jonathan, additional, Fürstberger, Axel, additional, Kraus, Johann M., additional, Daiss, Nora, additional, Seibold, Tanja, additional, Morawe, Mareen, additional, Ettrich, Thomas J., additional, Kestler, Hans A., additional, Kahlert, Christoph, additional, Seufferlein, Thomas, additional, and Eiseler, Tim, additional

Published
2022
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42. Das Pankreaskarzinom

Author

Striefler, Jana K., primary, Reissig, Timm M., additional, Kunzmann, Volker, additional, Westphalen, C. Benedikt, additional, Böck, Stefan, additional, Ettrich, Thomas J., additional, Lutz, Manfred P., additional, Waldschmidt, Dirk T., additional, Brunner, Thomas, additional, Uhl, Waldemar, additional, Sinn, Marianne, additional, and Siveke, Jens T., additional

Published
2022
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47. PD-L1 targeting and subclonal immune escape mediated by PD-L1 mutations in metastatic colorectal cancer

Author

Stein, Alexander, primary, Simnica, Donjete, additional, Schultheiß, Christoph, additional, Scholz, Rebekka, additional, Tintelnot, Joseph, additional, Gökkurt, Eray, additional, von Wenserski, Lisa, additional, Willscher, Edith, additional, Paschold, Lisa, additional, Sauer, Markus, additional, Lorenzen, Sylvie, additional, Riera-Knorrenschild, Jorge, additional, Depenbusch, Reinhard, additional, Ettrich, Thomas J, additional, Dörfel, Steffen, additional, Al-Batran, Salah-Eddin, additional, Karthaus, Meinolf, additional, Pelzer, Uwe, additional, Waberer, Lisa, additional, Hinke, Axel, additional, Bauer, Marcus, additional, Massa, Chiara, additional, Seliger, Barbara, additional, Wickenhauser, Claudia, additional, Bokemeyer, Carsten, additional, Hegewisch-Becker, Susanna, additional, and Binder, Mascha, additional

Published
2021
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48. Quality of life and outcome of patients with metastatic pancreatic cancer receiving first‐line chemotherapy with nab‐paclitaxel and gemcitabine: Real‐life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry

Author

Al‐Batran, Salah‐Eddin, Hofheinz, Ralf‐Dieter, Reichart, Alexander, Pauligk, Claudia, Schönherr, Caroline, Schlag, Rudolf, Siegler, Gabriele, Dörfel, Steffen, Koenigsmann, Michael, Zahn, Mark‐Oliver, Schubert, Jörg, Aldaoud, Ali, Höffkes, Heinz‐Gert, Schulz, Holger, Hahn, Lars, Uhlig, Jens, Blau, Wolfgang, Stauch, Martina, Weniger, Jörg, Wolf, Martin, Jacobasch, Lutz, Bildat, Stephan, Wehmeyer, Jürgen, Homann, Nils, Trojan, Jörg, Waidmann, Oliver, Fietz, Thomas, Feustel, Hans‐Peter, Groschek, Matthias, Wierecky, Jan, Waibel, Karin, Mahlmann, Stefan, Schwindel, Uwe, Peters, Uwe, Schuch, Gunter, Pink, Daniel, Eschenburg, Henning, Wörns, Marcus‐A., Harich, Hans‐Detlev, Weikersthal, Ludwig Fischer, Däßler, Klaus‐Ulrich, Behringer, Dirk M., Messmann, Helmut, Kretzschmar, Albrecht, Gallmeier, Eike, Forstbauer, Helmut, Kunzmann, Volker, Papke, Jens, Büchner‐Steudel, Petra, Vehling‐Kaiser, Ursula, Springfeld, Christoph, Vogel, Arndt, Ettrich, Thomas J., Schaaf, Marina, Hausen, Gerrit zur, and Götze, Thorsten Oliver

Published
2021

49. Cabozantinib in Advanced Hepatocellular Carcinoma: Efficacy and Safety Data from an International Multicenter Real-Life Cohort

Author

Finkelmeier, Fabian, Scheiner, Bernhard, Leyh, Catherine, Best, Jan, Fruendt, Thorben Wilhelm, Czauderna, Carolin, Beutel, Alica, Bettinger, Dominik, WeiSS, Johannes, Meischl, Tobias, Kuetting, Fabian, Waldschmidt, Dirk-Thomas, Radu, Pompilia, Schultheiss, Michael, Peiffer, Kai-Henrik, Ettrich, Thomas J., Weinmann, Arndt, Wege, Henning, Venerito, Marino, Dufour, Jean-Francois, Lange, Christian M., Pinter, Matthias, Waidmann, Oliver, Finkelmeier, Fabian, Scheiner, Bernhard, Leyh, Catherine, Best, Jan, Fruendt, Thorben Wilhelm, Czauderna, Carolin, Beutel, Alica, Bettinger, Dominik, WeiSS, Johannes, Meischl, Tobias, Kuetting, Fabian, Waldschmidt, Dirk-Thomas, Radu, Pompilia, Schultheiss, Michael, Peiffer, Kai-Henrik, Ettrich, Thomas J., Weinmann, Arndt, Wege, Henning, Venerito, Marino, Dufour, Jean-Francois, Lange, Christian M., Pinter, Matthias, and Waidmann, Oliver

Abstract

Background and Aims: The multikinase inhibitor cabozantinib has been approved for hepatocellular carcinoma (HCC) previously treated with sorafenib. We report safety and efficacy data of an international, multicenter, real-life cohort of patients with advanced HCC treated with cabozantinib. Methods: Patients with HCC who were treated with cabozantinib were retrospectively identified across 11 centers in Austria, Switzerland, and Germany. Patients' characteristics, adverse events, duration of treatment and overall survival (OS) data were analyzed until April 1, 2020. Results: Eighty-eight patients from 11 centers were included. The predominant underlying liver diseases were NAFLD/NASH in 26 (30%) and hepatitis C infection in 21 (24%) patients. Seventy-eight patients (89%) were classified as Barcelona clinic liver cancer (BCLC) stage C. Sixty patients (68%) were Child-Pugh A, whereas 22 (25%) were Child-Pugh B, respectively. Cabozantinib was used as systemic second- and third-line or later treatment in 41 (47%) and 46 (52%) patients, respectively. The following best responses under cabozantinib were documented: partial response in 6 (7%), stable disease in 28 (32%), and progressive disease in 28 (32%) patients, respectively. Fifty-two patients (59%) died during follow-up. The median OS from start of cabozantinib treatment was 7.0 months in the entire cohort and 9.7 months in Child-Pugh A patients, while Child-Pugh B patients had a median OS of 3.4 months, respectively. Thirty-seven (42%) patients fulfilled the CELESTIAL inclusion and exclusion criteria, showing a median OS of 11.1 months. Most common adverse events were fatigue (15.6%) and diarrhea (15.6%). Conclusion: Cabozantinib treatment was effective, safe, and feasible in patients with advanced HCC in patients with compensated cirrhosis. Patients in the real-life setting had more advanced liver disease - in which 25% of patients were Child-Pugh B. However, OS in patients with Child-Pugh A cirrhosis was similar to

Published
2021

50. Nab-paclitaxel plus gemcitabine versus nab-paclitaxel plus gemcitabine followed by FOLFIRINOX induction chemotherapy in locally advanced pancreatic cancer (NEOLAP-AIO-PAK-0113): a multicentre, randomised, phase 2 trial

Author

Kunzmann, Volker, Siveke, Jens T., Alguel, Hana, Goekkurt, Eray, Siegler, Gabriele, Martens, Uwe, Waldschmidt, Dirk, Pelzer, Uwe, Fuchs, Martin, Kullmann, Frank, Boeck, Stefan, Ettrich, Thomas J., Held, Swantje, Keller, Ralph, Klein, Ingo, Germer, Christoph-Thomas, Stein, Hubert, Friess, Helmut, Bahra, Marcus, Jakobs, Ralf, Hartlapp, Ingo, Heinemann, Volker, Kunzmann, Volker, Siveke, Jens T., Alguel, Hana, Goekkurt, Eray, Siegler, Gabriele, Martens, Uwe, Waldschmidt, Dirk, Pelzer, Uwe, Fuchs, Martin, Kullmann, Frank, Boeck, Stefan, Ettrich, Thomas J., Held, Swantje, Keller, Ralph, Klein, Ingo, Germer, Christoph-Thomas, Stein, Hubert, Friess, Helmut, Bahra, Marcus, Jakobs, Ralf, Hartlapp, Ingo, and Heinemann, Volker

Abstract

Background The optimal preoperative treatment for locally advanced pancreatic cancer is unknown. We aimed to compare the efficacy and safety of nab-paclitaxel plus gemcitabine with nab-paclitaxel plus gemcitabine followed by fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) as rnultidrug induction chemotherapy regimens in locally advanced pancreatic cancer. Methods In this open-label, multicentre, randomised phase 2 study, done at 28 centres in Germany, eligible patients were adults (aged 18-75 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and histologically or cytologically confirmed, treatment-naive locally advanced pancreatic adenocarcinoma, as determined by local multidisciplinary team review. After two cycles of nab-paclitaxe1125 mg/m(2) plus gemcitabine 1000 mg/m(2) (administered intravenously on days 1,8, and 15 of each 28-day cycle), patients without progressive disease or unacceptable adverse events were randomly assigned (1:1) to receive either two additional cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel plus gemcitabine group) or four cycles of sequential FOLFIRINOX (oxaliplatin 85 mg/m(2), leucovorin 400 mg/m(2), irinotecan 180 mg/m(2), fluorouracil 400 mg/m(2) by intravenous bolus followed by a continuous intravenous infusion of 2400 mg/m(2) for 46 h on day 1 of each 14-day cycle; sequential FOLFIRINOX group). Randomisation was done by the clinical research organisation on request of the trial centre using a permuted block design (block size 2 and 4). Patients, investigators, and study team members were not masked to treatment allocation. The primary endpoint was surgical conversion rate (complete macroscopic tumour resection) in the randomised population by intention-totreat analysis, which was assessed by surgical exploration in all patients with at least stable disease after completion of induction chemotherapy. This trial is registered with ClinicalTrials.gov, NCT02125136. Findings Betwee

Published
2021

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