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1. FOLFOX plus panitumumab or FOLFOX alone as additive therapy following R0/1 resection of RAS wild-type colorectal cancer liver metastases – The PARLIM trial (AIO KRK 0314)

Author

Modest, Dominik Paul, Karthaus, Meinolf, Kasper, Stefan, Moosmann, Nicolas, Keitel, Verena, Kiani, Alexander, Uhlig, Jens, Jacobasch, Lutz, Fischer v. Weikersthal, Ludwig, Fuchs, Martin, Kaiser, Florian, Lerchenmüller, Christian, Sent, Dagmar, Junghanß, Christian, Held, Swantje, Lorenzen, Sylvie, Kaczirek, Klaus, Jung, Andreas, Stintzing, Sebastian, and Heinemann, Volker

Published
2022
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2. 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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3. Impact of Primary Tumor Sidedness on Prognosis and Anti-EGFR Antibody Efficacy in BRAF-Mutant Metastatic Colorectal Cancer: A Pooled Analysis of AIO Studies FIRE-1, CIOX, FIRE-3, XELAVIRI, and VOLFI

Author

Alig, Annabel, primary, Modest, Dominik Paul, additional, Stintzing, Sebastian, additional, Heinrich, Kathrin, additional, Geissler, Michael, additional, Fischer von Weikersthal, Ludwig, additional, Decker, Thomas, additional, Vehling-Kaiser, Ursula, additional, Held, Swantje, additional, Moosmann, Nicolas, additional, Stahler, Arndt, additional, Tannapfel, Andrea, additional, Giessen-Jung, Clemens, additional, Jung, Andreas, additional, Weiss, Lena, additional, and Heinemann, Volker, additional

Published
2024
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4. Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I Trial

Author

Rau, Beate, primary, Lang, Hauke, additional, Koenigsrainer, Alfred, additional, Gockel, Ines, additional, Rau, Horst-Guenter, additional, Seeliger, Hendrik, additional, Lerchenmueller, Christian, additional, Reim, Daniel, additional, Wahba, Roger, additional, Angele, Martin, additional, Heeg, Steffen, additional, Keck, Tobias, additional, Weimann, Arved, additional, Topp, Stefan, additional, Piso, Pompiliu, additional, Brandl, Andreas, additional, Schuele, Silke, additional, Jo, Peter, additional, Pratschke, Johann, additional, Wegel, Sandra, additional, Rehders, Alexander, additional, Moosmann, Nicolas, additional, Gaedcke, Jochen, additional, Heinemann, Volker, additional, Trips, Evelyn, additional, Loeffler, Markus, additional, Schlag, Peter Michael, additional, and Thuss-Patience, Peter, additional

Published
2023
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5. Pembrolizumab and trastuzumab in combination with FLOT in the perioperative treatment of HER2-positive, localized esophagogastric adenocarcinoma—a phase II trial of the AIO study group (AIO STO 0321)

Author

Tintelnot, Joseph, primary, Stein, Alexander, additional, Al-Batran, Salah-Eddin, additional, Ettrich, Thomas, additional, Götze, Thorsten, additional, Grün, Barbara, additional, Haag, Georg Martin, additional, Heuer, Vera, additional, Hofheinz, Ralf-Dieter, additional, Homann, Nils, additional, Bröring, Tobias Sebastian, additional, Cruz, Mariana Santos, additional, Kurreck, Annika, additional, Lorenzen, Sylvie, additional, Moosmann, Nicolas, additional, Müller, Christian, additional, Schuler, Markus, additional, Siegler, Gabriele, additional, Binder, Mascha, additional, and Gökkurt, Eray, additional

Published
2023
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6. eTable 2 from Amphiregulin Expression Is a Predictive Biomarker for EGFR Inhibition in Metastatic Colorectal Cancer: Combined Analysis of Three Randomized Trials

Author

Stahler, Arndt, primary, Stintzing, Sebastian, primary, Modest, Dominik P., primary, Ricard, Ingrid, primary, Giessen-Jung, Clemens, primary, Kapaun, Christine, primary, Ivanova, Boryana, primary, Kaiser, Florian, primary, Fischer von Weikersthal, Ludwig, primary, Moosmann, Nicolas, primary, Schalhorn, Andreas, primary, Stauch, Martina, primary, Kiani, Alexander, primary, Held, Swantje, primary, Decker, Thomas, primary, Moehler, Markus, primary, Neumann, Jens, primary, Kirchner, Thomas, primary, Jung, Andreas, primary, and Heinemann, Volker, primary

Published
2023
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7. eFigure 3 from Amphiregulin Expression Is a Predictive Biomarker for EGFR Inhibition in Metastatic Colorectal Cancer: Combined Analysis of Three Randomized Trials

Author

Stahler, Arndt, primary, Stintzing, Sebastian, primary, Modest, Dominik P., primary, Ricard, Ingrid, primary, Giessen-Jung, Clemens, primary, Kapaun, Christine, primary, Ivanova, Boryana, primary, Kaiser, Florian, primary, Fischer von Weikersthal, Ludwig, primary, Moosmann, Nicolas, primary, Schalhorn, Andreas, primary, Stauch, Martina, primary, Kiani, Alexander, primary, Held, Swantje, primary, Decker, Thomas, primary, Moehler, Markus, primary, Neumann, Jens, primary, Kirchner, Thomas, primary, Jung, Andreas, primary, and Heinemann, Volker, primary

Published
2023
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8. eFigure 4 from Amphiregulin Expression Is a Predictive Biomarker for EGFR Inhibition in Metastatic Colorectal Cancer: Combined Analysis of Three Randomized Trials

Author

Stahler, Arndt, primary, Stintzing, Sebastian, primary, Modest, Dominik P., primary, Ricard, Ingrid, primary, Giessen-Jung, Clemens, primary, Kapaun, Christine, primary, Ivanova, Boryana, primary, Kaiser, Florian, primary, Fischer von Weikersthal, Ludwig, primary, Moosmann, Nicolas, primary, Schalhorn, Andreas, primary, Stauch, Martina, primary, Kiani, Alexander, primary, Held, Swantje, primary, Decker, Thomas, primary, Moehler, Markus, primary, Neumann, Jens, primary, Kirchner, Thomas, primary, Jung, Andreas, primary, and Heinemann, Volker, primary

Published
2023
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9. eFigure 1 from Amphiregulin Expression Is a Predictive Biomarker for EGFR Inhibition in Metastatic Colorectal Cancer: Combined Analysis of Three Randomized Trials

Author

Stahler, Arndt, primary, Stintzing, Sebastian, primary, Modest, Dominik P., primary, Ricard, Ingrid, primary, Giessen-Jung, Clemens, primary, Kapaun, Christine, primary, Ivanova, Boryana, primary, Kaiser, Florian, primary, Fischer von Weikersthal, Ludwig, primary, Moosmann, Nicolas, primary, Schalhorn, Andreas, primary, Stauch, Martina, primary, Kiani, Alexander, primary, Held, Swantje, primary, Decker, Thomas, primary, Moehler, Markus, primary, Neumann, Jens, primary, Kirchner, Thomas, primary, Jung, Andreas, primary, and Heinemann, Volker, primary

Published
2023
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10. Randomized phase III trial of induction chemotherapy followed by chemoradiotherapy or chemotherapy alone for nonresectable locally advanced pancreatic cancer: First results of the CONKO-007 trial.

Author

Fietkau, Rainer, primary, Ghadimi, Michael, additional, Grützmann, Robert, additional, Wittel, Uwe A, additional, Jacobasch, Lutz, additional, Uhl, Waldemar, additional, Croner, Roland S., additional, Bechstein, Wolf Otto, additional, Neumann, Ulf Peter, additional, Waldschmidt, Dirk, additional, Boeck, Stefan Hubert, additional, Moosmann, Nicolas, additional, Reinacher-Schick, Anke C., additional, Golcher, Henriette, additional, Adler, Werner, additional, Semrau, Sabine, additional, Kallies, Annett, additional, Hecht, Markus, additional, Tannapfel, Andrea, additional, and Oettle, Helmut, additional

Published
2022
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11. BRAF-mutant metastatic colorectal cancer: Prognostic and predictive value of primary tumor location—A pooled analysis of the AIO studies FIRE-1, CIOX, XELAVIRI, FIRE-3, and VOLFI.

Author

Alig, Annabel Helga Sophie, primary, Heinemann, Volker, additional, Stintzing, Sebastian, additional, Geissler, Michael, additional, von Weikersthal, Ludwig, additional, Decker, Thomas, additional, Kaiser, Florian, additional, Moosmann, Nicolas, additional, Heinrich, Kathrin, additional, Held, Swantje, additional, Holch, Julian Walter, additional, Stahler, Arndt, additional, Kurreck, Annika, additional, Reinacher-Schick, Anke C., additional, Tannapfel, Andrea, additional, Klauschen, Frederick, additional, Jung, Andreas, additional, Giessen-Jung, Clemens, additional, and Modest, Dominik Paul, additional

Published
2022
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13. Exact Primary Tumor Location in mCRC: Prognostic Value and Predictive Impact on Anti-EGFR mAb Efficacy

Author

Alig, Annabel H. S., primary, Heinemann, Volker, additional, Geissler, Michael, additional, Fischer von Weikersthal, Ludwig, additional, Decker, Thomas, additional, Heinrich, Kathrin, additional, Held, Swantje, additional, Weiss, Lena, additional, Fischer, Laura E., additional, Moosmann, Nicolas, additional, Stahler, Arndt, additional, Jelas, Ivan, additional, Kurreck, Annika, additional, von Einem, Jobst C., additional, Reinacher-Schick, Anke C., additional, Tannapfel, Andrea, additional, Giessen-Jung, Clemens, additional, Stintzing, Sebastian, additional, and Modest, Dominik P., additional

Published
2022
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15. FOLFOX plus panitumumab or FOLFOX alone as additive therapy following R0/1 resection of RAS wild-type colorectal cancer liver metastases: The PARLIM trial (AIO KRK 0314).

Author

Modest, Dominik Paul, primary, Karthaus, Meinolf, additional, Kasper, Stefan, additional, Moosmann, Nicolas, additional, Keitel, Verena, additional, Kiani, Alexander, additional, Fischer von Weikersthal, Ludwig, additional, Uhlig, Jens, additional, Jacobasch, Lutz, additional, Fuchs, Martin, additional, Kaiser, Florian, additional, Lerchenmuller, Christian A., additional, Junghanss, Christian, additional, Held, Swantje, additional, Heinrich, Kathrin, additional, Jung, Andreas, additional, Stahler, Arndt, additional, Stintzing, Sebastian, additional, and Heinemann, Volker, additional

Published
2021
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17. Impact of exact segment by segment primary tumor location status on anti-EGFR antibody first-line treatment efficacy in RAS/BRAF wild-type and BRAF mutant metastatic colorectal cancer. A pooled analysis of AIO studies FIRE-1, CIOX, FIRE-3, XELAVIRI, and VOLFI.

Author

Alig, Annabel Helga Sophie, primary, Heinemann, Volker, additional, Geissler, Michael, additional, Weikersthal, Ludwig Fischer von, additional, Decker, Thomas, additional, Heinrich, Kathrin, additional, Held, Swantje, additional, Weiss, Lena, additional, Fischer, Laura Elisabeth, additional, Moosmann, Nicolas, additional, Stahler, Arndt, additional, Jelas, Ivan, additional, Kurreck, Annika, additional, Striefler, Jana Kaethe, additional, Einem, Jobst Christian von, additional, Reinacher-Schick, Anke Claudia, additional, Tannapfel, Andrea, additional, Giessen-Jung, Clemens, additional, Stintzing, Sebastian, additional, and Modest, Dominik Paul, additional

Published
2021
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18. Prognostic value of cetuximab-related skin toxicity in metastatic colorectal cancer patients and its correlation with parameters of the epidermal growth factor receptor signal transduction pathway: Results from a randomized trial of the GERMAN AIO CRC Study Group

Author

Stintzing, Sebastian, Kapaun, Christine, Laubender, Rüdiger Paul, Jung, Andreas, Neumann, Jens, Modest, Dominik Paul, Giessen, Clemens, Moosmann, Nicolas, Wollenberg, Andreas, Kirchner, Thomas, and Heinemann, Volker

Published
2013
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19. Amphiregulin Expression Is a Predictive Biomarker for EGFR Inhibition in Metastatic Colorectal Cancer: Combined Analysis of Three Randomized Trials

Author

Stahler, Arndt, primary, Stintzing, Sebastian, additional, Modest, Dominik P., additional, Ricard, Ingrid, additional, Giessen-Jung, Clemens, additional, Kapaun, Christine, additional, Ivanova, Boryana, additional, Kaiser, Florian, additional, Fischer von Weikersthal, Ludwig, additional, Moosmann, Nicolas, additional, Schalhorn, Andreas, additional, Stauch, Martina, additional, Kiani, Alexander, additional, Held, Swantje, additional, Decker, Thomas, additional, Moehler, Markus, additional, Neumann, Jens, additional, Kirchner, Thomas, additional, Jung, Andreas, additional, and Heinemann, Volker, additional

Published
2020
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23. A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: The AIO KRK 0110 Trial/ML22011 Trial

Author

Teschendorf Christian, Sieber Markus, Denzlinger Claudio, Bangerter Markus, Mayerle Julia, Vehling-Kaiser Ursula, Kullmann Frank, Stintzing Sebastian, Hinke Axel, von Weikersthal Ludwig, Giessen Clemens, Freiberg-Richter Jens, Schulz Christoph, Modest Dominik, Moosmann Nicolas, Aubele Philipp, and Heinemann Volker

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Several randomized trials have indicated that combination chemotherapy applied in metastatic colorectal cancer (mCRC) does not significantly improve overall survival when compared to the sequential use of cytotoxic agents (CAIRO, MRC Focus, FFCD 2000-05). The present study investigates the question whether this statement holds true also for bevacizumab-based first-line treatment including escalation- and de-escalation strategies. Methods/Design The AIO KRK 0110/ML22011 trial is a two-arm, multicenter, open-label randomized phase III trial comparing the efficacy and safety of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in the first-line treatment of metastatic colorectal cancer. Patients with unresectable metastatic colorectal cancer, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, will be assigned in a 1:1 ratio to receive either capecitabine 1250 mg/m2 bid for 14d (d1-14) plus bevacizumab 7.5 mg/kg (d1) q3w (Arm A) or capecitabine 800 mg/m2 BID for 14d (d1-14), irinotecan 200 mg/m2 (d1) and bevacizumab 7.5 mg/kg (d1) q3w (Arm B). Patients included into this trial are required to consent to the analysis of tumour tissue and blood for translational investigations. In Arm A, treatment escalation from Cape-Bev to CAPIRI-Bev is recommended in case of progressive disease (PD). In Arm B, de-escalation from CAPIRI-Bev to Cape-Bev is possible after 6 months of treatment or in case of irinotecan-associated toxicity. Re-escalation to CAPIRI-Bev after PD is possible. The primary endpoint is time to failure of strategy (TFS). Secondary endpoints are overall response rate (ORR), overall survival, progression-free survival, safety and quality of life. Conclusion The AIO KRK 0110 trial is designed for patients with disseminated, but asymptomatic mCRC who are not potential candidates for surgical resection of metastasis. Two bevacizumab-based strategies are compared: one starting as single-agent chemotherapy (Cape-Bev) allowing escalation to CAPIRI-Bev and another starting with combination chemotherapy (CAPIRI-Bev) and allowing de-escalation to Cape-Bev and subsequent re-escalation if necessary. Trial Registration ClinicalTrials.gov Identifier NCT01249638 EudraCT-No.: 2009-013099-38

Published
2011
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27. Prognostic value of cetuximab-related skin toxicity in metastatic colorectal cancer patients and its correlation with parameters of the epidermal growth factor receptor signal transduction pathway: Results from a randomized trial of the GERMAN AIO CRC Stu

Author

Stintzing, Sebastian, primary, Kapaun, Christine, additional, Laubender, Rüdiger Paul, additional, Jung, Andreas, additional, Neumann, Jens, additional, Modest, Dominik Paul, additional, Giessen, Clemens, additional, Moosmann, Nicolas, additional, Wollenberg, Andreas, additional, Kirchner, Thomas, additional, and Heinemann, Volker, additional

Published
2012
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29. Cetuximab-related skin toxicity in metastatic colorectal cancer (mCRC) patients and its correlation with molecular markers: Results from the German AIO CRC 0104 trial.

Author

Stintzing, Sebastian, primary, Kapaun, Christine, additional, Laubender, Ruediger P., additional, Jung, Andreas, additional, Neumann, Jens, additional, Modest, Dominik Paul, additional, Giessen, Clemens Albrecht, additional, Moosmann, Nicolas, additional, Wollenberg, Andreas, additional, Kirchner, Thomas, additional, and Heinemann, Volker, additional

Published
2012
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30. A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: The AIO KRK 0110 Trial/ML22011 Trial

Author

Giessen, Clemens, primary, von Weikersthal, Ludwig Fischer, additional, Hinke, Axel, additional, Stintzing, Sebastian, additional, Kullmann, Frank, additional, Vehling-Kaiser, Ursula, additional, Mayerle, Julia, additional, Bangerter, Markus, additional, Denzlinger, Claudio, additional, Sieber, Markus, additional, Teschendorf, Christian, additional, Freiberg-Richter, Jens, additional, Schulz, Christoph, additional, Modest, Dominik Paul, additional, Moosmann, Nicolas, additional, Aubele, Philipp, additional, and Heinemann, Volker, additional

Published
2011
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31. Cetuximab Plus Capecitabine and Irinotecan Compared With Cetuximab Plus Capecitabine and Oxaliplatin As First-Line Treatment for Patients With Metastatic Colorectal Cancer: AIO KRK-0104—A Randomized Trial of the German AIO CRC Study Group

Author

Moosmann, Nicolas, primary, von Weikersthal, Ludwig Fischer, additional, Vehling-Kaiser, Ursula, additional, Stauch, Martina, additional, Hass, Holger G., additional, Dietzfelbinger, Herrmann, additional, Oruzio, Daniel, additional, Klein, Stefan, additional, Zellmann, Klaus, additional, Decker, Thomas, additional, Schulze, Mathias, additional, Abenhardt, Wolfgang, additional, Puchtler, Gerhard, additional, Kappauf, Herbert, additional, Mittermüller, Johann, additional, Haberl, Christopher, additional, Schalhorn, Andreas, additional, Jung, Andreas, additional, Stintzing, Sebastian, additional, and Heinemann, Volker, additional

Published
2011
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36. A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: The AIO KRK 0110 Trial/ML22011 Trial

Author

Teschendorf Christian, Sieber Markus, Denzlinger Claudio, Bangerter Markus, Mayerle Julia, Vehling-Kaiser Ursula, Kullmann Frank, Stintzing Sebastian, Hinke Axel, von Weikersthal Ludwig, Giessen Clemens, Freiberg-Richter Jens, Schulz Christoph, Modest Dominik, Moosmann Nicolas, Aubele Philipp, and Heinemann Volker

Subjects
Male, Cancer Research, Dose-Response Relationship, Drug, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Antibodies, Monoclonal, Humanized, Irinotecan, lcsh:RC254-282, Deoxycytidine, Bevacizumab, Study Protocol, Oncology, Antineoplastic Combined Chemotherapy Protocols, Quality of Life, Genetics, Humans, Camptothecin, Female, Fluorouracil, Neoplasm Metastasis, Colorectal Neoplasms, Capecitabine
Abstract

Background Several randomized trials have indicated that combination chemotherapy applied in metastatic colorectal cancer (mCRC) does not significantly improve overall survival when compared to the sequential use of cytotoxic agents (CAIRO, MRC Focus, FFCD 2000-05). The present study investigates the question whether this statement holds true also for bevacizumab-based first-line treatment including escalation- and de-escalation strategies. Methods/Design The AIO KRK 0110/ML22011 trial is a two-arm, multicenter, open-label randomized phase III trial comparing the efficacy and safety of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in the first-line treatment of metastatic colorectal cancer. Patients with unresectable metastatic colorectal cancer, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, will be assigned in a 1:1 ratio to receive either capecitabine 1250 mg/m2 bid for 14d (d1-14) plus bevacizumab 7.5 mg/kg (d1) q3w (Arm A) or capecitabine 800 mg/m2 BID for 14d (d1-14), irinotecan 200 mg/m2 (d1) and bevacizumab 7.5 mg/kg (d1) q3w (Arm B). Patients included into this trial are required to consent to the analysis of tumour tissue and blood for translational investigations. In Arm A, treatment escalation from Cape-Bev to CAPIRI-Bev is recommended in case of progressive disease (PD). In Arm B, de-escalation from CAPIRI-Bev to Cape-Bev is possible after 6 months of treatment or in case of irinotecan-associated toxicity. Re-escalation to CAPIRI-Bev after PD is possible. The primary endpoint is time to failure of strategy (TFS). Secondary endpoints are overall response rate (ORR), overall survival, progression-free survival, safety and quality of life. Conclusion The AIO KRK 0110 trial is designed for patients with disseminated, but asymptomatic mCRC who are not potential candidates for surgical resection of metastasis. Two bevacizumab-based strategies are compared: one starting as single-agent chemotherapy (Cape-Bev) allowing escalation to CAPIRI-Bev and another starting with combination chemotherapy (CAPIRI-Bev) and allowing de-escalation to Cape-Bev and subsequent re-escalation if necessary. Trial Registration ClinicalTrials.gov Identifier NCT01249638 EudraCT-No.: 2009-013099-38

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37. Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I Trial.

Author

Rau B, Lang H, Koenigsrainer A, Gockel I, Rau HG, Seeliger H, Lerchenmueller C, Reim D, Wahba R, Angele M, Heeg S, Keck T, Weimann A, Topp S, Piso P, Brandl A, Schuele S, Jo P, Pratschke J, Wegel S, Rehders A, Moosmann N, Gaedcke J, Heinemann V, Trips E, Loeffler M, Schlag PM, and Thuss-Patience P

Subjects
Adult, Humans, Hyperthermic Intraperitoneal Chemotherapy, Combined Modality Therapy, Cytoreduction Surgical Procedures adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Survival Rate, Retrospective Studies, Stomach Neoplasms drug therapy, Stomach Neoplasms surgery, Peritoneal Neoplasms drug therapy, Peritoneal Neoplasms secondary, Hyperthermia, Induced
Abstract

Purpose: In patients with peritoneal metastasis (PM) from gastric cancer (GC), chemotherapy is the treatment of choice. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are still being debated. This randomized, controlled, open-label, multicenter phase III trial (EudraCT 2006-006088-22; ClinicalTrials.gov identifier: NCT02158988) explored the impact on overall survival (OS) of HIPEC after CRS., Patients and Methods: Adult patients with GC and histologically proven PM were randomly assigned (1:1) to perioperative chemotherapy and CRS alone (CRS-A) or CRS plus HIPEC (CRS + H). HIPEC comprised mitomycin C 15 mg/m 2 and cisplatin 75 mg/m 2 in 5 L of saline perfused for 60 minutes at 42°C. The primary end point was OS; secondary endpoints included progression-free survival (PFS), other distant metastasis-free survival (MFS), and safety. Analyses followed the intention-to-treat principle., Results: Between March 2014 and June 2018, 105 patients were randomly assigned (53 patients to CRS-A and 52 patients to CRS + H). The trial stopped prematurely because of slow recruitment. In 55 patients, treatment stopped before CRS mainly due to disease progression/death. Median OS was the same for both groups (CRS + H, 14.9 [97.2% CI, 8.7 to 17.7] months v CRS-A, 14.9 [97.2% CI, 7.0 to 19.4] months; P = .1647). The PFS was 3.5 months (95% CI, 3.0 to 7.0) in the CRS-A group and 7.1 months (95% CI, 3.7 to 10.5; P = .047) in the CRS + H group. The CRS + H group showed better MFS (10.2 months [95% CI, 7.7 to 14.7] v CRS-A, 9.2 months [95% CI, 6.8 to 11.5]; P = .0286). The incidence of grade ≥3 adverse events (AEs) was similar between groups (CRS-A, 38.1% v CRS + H, 43.6%; P = .79)., Conclusion: This study showed no OS difference between CRS + H and CRS-A. PFS and MFS were significantly better in the CRS + H group, which needs further exploration. HIPEC did not increase AEs.

Published
2024
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38. [Colon cancer: adjuvant chemotherapy and aftercare].

Author

Heinemann V, Giessen C, Modest D, Moosmann N, and Stintzing S

Subjects
Aftercare, Antineoplastic Combined Chemotherapy Protocols adverse effects, Chemotherapy, Adjuvant, Colonic Neoplasms mortality, Colonic Neoplasms pathology, Combined Modality Therapy, Germany, Guideline Adherence, Humans, Neoplasm Recurrence, Local diagnosis, Neoplasm Recurrence, Local prevention & control, Neoplasm Staging, Survival Rate, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Colonic Neoplasms drug therapy, Colonic Neoplasms surgery
Published
2011

39. [Neoadjuvant and adjuvant therapies for solid tumours].

Author

Heinemann V and Moosmann N

Subjects
Breast Neoplasms drug therapy, Breast Neoplasms surgery, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Non-Small-Cell Lung radiotherapy, Carcinoma, Non-Small-Cell Lung surgery, Colonic Neoplasms drug therapy, Colonic Neoplasms pathology, Colonic Neoplasms surgery, Endometrial Neoplasms drug therapy, Endometrial Neoplasms pathology, Endometrial Neoplasms radiotherapy, Endometrial Neoplasms surgery, Esophageal Neoplasms drug therapy, Esophageal Neoplasms radiotherapy, Esophageal Neoplasms surgery, Female, Humans, Informed Consent, Lung Neoplasms drug therapy, Lung Neoplasms pathology, Lung Neoplasms radiotherapy, Lung Neoplasms surgery, Male, Neoplasm Recurrence, Local prevention & control, Neoplasm Staging, Neoplasms drug therapy, Neoplasms radiotherapy, Neoplasms surgery, Ovarian Neoplasms drug therapy, Ovarian Neoplasms pathology, Ovarian Neoplasms surgery, Pancreatic Neoplasms drug therapy, Pancreatic Neoplasms surgery, Prognosis, Prostatic Neoplasms drug therapy, Prostatic Neoplasms pathology, Prostatic Neoplasms surgery, Rectal Neoplasms drug therapy, Rectal Neoplasms pathology, Rectal Neoplasms radiotherapy, Rectal Neoplasms surgery, Risk Factors, Stomach Neoplasms drug therapy, Stomach Neoplasms pathology, Stomach Neoplasms surgery, Urinary Bladder Neoplasms drug therapy, Urinary Bladder Neoplasms pathology, Urinary Bladder Neoplasms surgery, Chemotherapy, Adjuvant, Neoadjuvant Therapy adverse effects, Neoplasms therapy, Radiotherapy, Adjuvant
Abstract

Today adjuvant or neoadjuvant therapies are standard treatment for many types of cancer. Chemotherapy, radiotherapy, hormone therapy or immunotherapy applied before, during or after an operation can lower the risk of relapse and hence, increase the chances of a cure. After neoadjuvant therapy, frequently the organ does not have to be removed in the subsequent operation. Depending on the risk of relapse, adjuvant therapies are employed after due consideration of benefit, risk and duration of treatment. In ongoing clinical studies, the possibilities of influencing the effect of epidermal growth factor (EGF) as well as vascular endothelial growth factor (VEGF) are being investigated.

Published
2007

40. [Importance of neoadjuvant chemotherapy in gastrointestinal tumors. A new standard?].

Author

Moosmann N, Boeck S, and Heinemann V

Subjects
Adenocarcinoma drug therapy, Adenocarcinoma pathology, Adenocarcinoma radiotherapy, Adenocarcinoma surgery, Combined Modality Therapy, Gastrointestinal Neoplasms pathology, Gastrointestinal Neoplasms radiotherapy, Gastrointestinal Neoplasms surgery, Humans, Lymphatic Metastasis pathology, Male, Middle Aged, Neoplasm Staging, Radiotherapy, Adjuvant, Rectal Neoplasms drug therapy, Rectal Neoplasms pathology, Rectal Neoplasms radiotherapy, Rectal Neoplasms surgery, Survival Rate, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Gastrointestinal Neoplasms drug therapy, Neoadjuvant Therapy
Published
2007
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41. Differential role of extra- and intracellular superoxide anions for nitric oxide-mediated apoptosis induction.

Author

Steinmann M, Moosmann N, Schimmel M, Gerhardus C, and Bauer G

Subjects
Animals, Anions, Cattle, Erythrocytes enzymology, Peroxynitrous Acid metabolism, Superoxide Dismutase blood, Apoptosis physiology, Nitric Oxide physiology, Superoxides metabolism
Abstract

Nitric oxide (NO) has recently been shown to mediate apoptosis induction selectively in transformed fibroblasts, in contrast to their nontransformed parental cells. Here we show that NO-mediated apoptosis induction in transformed fibroblasts can be divided into two major phases. During phase 1, peroxynitrite is generated by the interaction of extracellular superoxide anions with NO and the intracellular glutathione level is subsequently lowered. This defines the beginning of phase 2, in which NO-mediated signaling depends on intracellular superoxide anions exclusively. The resultant peroxynitrite seems to activate the mitochondrial permeability transition pore and thus triggers execution of apoptosis. Experimental depletion of intracellular glutathione causes a drastic decrease in the length of phase 1 in transformed cells and renders nontransformed cells sensitive to NO-mediated apoptosis induction. These findings allow the prediction that either induction of superoxide anion generation or glutathione depletion may render cells sensitive to NO-mediated apoptosis induction.

Published
2004

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