Feasibility and Efficacy of Adjuvant Chemotherapy With Gemcitabine After Liver Transplantation for Perihilar Cholangiocarcinoma - A Multi-Center, Randomized, Controlled Trial (pro-duct001)
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Feasibility and Efficacy of Adjuvant Chemotherapy With Gemcitabine After Liver Transplantation for Perihilar Cholangiocarcinoma - A Multi-Center, Randomized, Controlled Trial (pro-duct001). / Schmelzle, Moritz; Benzing, Christian; Fischer, Lutz; Herden, Uta; Sterneck, Martina; Settmacher, Utz; Bauschke, Astrid; Neumann, Ulf; Pelzer, Uwe; Müller, Tobias; Strassburg, Christian; Lang, Hauke; Becker, Thomas; Königsrainer, Alfred; Nadalin, Silvio; Quante, Markus; Paul, Andreas; Friess, Helmut; Klempnauer, Jürgen; Richter, Nicolas; Vondran, Florian; Pascher, Andreas; Rösch, Thomas; Schöning, Wenzel; Krenzien, Felix; Öllinger, Robert; Seehofer, Daniel; Neuhaus, Peter; Pratschke, Johann.
in: FRONT ONCOL, Jahrgang 12, 910871, 2022.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Feasibility and Efficacy of Adjuvant Chemotherapy With Gemcitabine After Liver Transplantation for Perihilar Cholangiocarcinoma - A Multi-Center, Randomized, Controlled Trial (pro-duct001)
AU - Schmelzle, Moritz
AU - Benzing, Christian
AU - Fischer, Lutz
AU - Herden, Uta
AU - Sterneck, Martina
AU - Settmacher, Utz
AU - Bauschke, Astrid
AU - Neumann, Ulf
AU - Pelzer, Uwe
AU - Müller, Tobias
AU - Strassburg, Christian
AU - Lang, Hauke
AU - Becker, Thomas
AU - Königsrainer, Alfred
AU - Nadalin, Silvio
AU - Quante, Markus
AU - Paul, Andreas
AU - Friess, Helmut
AU - Klempnauer, Jürgen
AU - Richter, Nicolas
AU - Vondran, Florian
AU - Pascher, Andreas
AU - Rösch, Thomas
AU - Schöning, Wenzel
AU - Krenzien, Felix
AU - Öllinger, Robert
AU - Seehofer, Daniel
AU - Neuhaus, Peter
AU - Pratschke, Johann
N1 - Copyright © 2022 Schmelzle, Benzing, Fischer, Herden, Sterneck, Settmacher, Bauschke, Neumann, Pelzer, Müller, Strassburg, Lang, Becker, Königsrainer, Nadalin, Quante, Paul, Friess, Klempnauer, Richter, Vondran, Pascher, Rösch, Schöning, Krenzien, Öllinger, Seehofer, Neuhaus and Pratschke.
PY - 2022
Y1 - 2022
N2 - BACKGROUND: Liver transplantation (LT) is considered a therapeutic option for unresectable perihilar cholangiocarcinoma (PHC) within defined criteria. It remains uncertain whether patients can safely receive adjuvant chemotherapy after LT.METHODS: We performed a prospective, multi-center, randomized, non-blinded two-arm trial (pro-duct001). Patients after LT for unresectable PHC within defined criteria were randomized to adjuvant gemcitabine (LT-Gem group) and LT alone (LT alone group). The primary objective was to investigate if adjuvant chemotherapy is feasible in ≥ 85% of patients after LT. The primary endpoint was the percentage of patients completing the 24 weeks course of adjuvant chemotherapy. Secondary endpoints included overall survival (OS) and disease-free (DFS), and complication rates.RESULTS: Twelve patients underwent LT for PHC, of which six (50%) were eligible for randomization (LT-Gem: three patients, LT alone: three patients). Two out of three patients discontinued adjuvant chemotherapy after LT due to intolerance. The study was prematurely terminated due to slow enrollment. One patient with PHC had underlying primary sclerosing cholangitis (PSC). Tumor-free margins could be achieved in all patients. In both the LT-Gem and the LT alone group, the cumulative 1-, 3-, and 5-year OS and DFS rates were 100%, 100%, 67%, and 100%, 67% and 67%, respectively.CONCLUSIONS: This prospective, multi-center study was prematurely terminated due to slow enrollment and a statement on the defined endpoints cannot be made. Nevertheless, long-term survival data are consistent with available retrospective data and confirm defined criteria for LT. Since more evidence of LT per se in unresectable PHC is urgently needed, a prospective, non-randomized follow-up study (pro-duct002) has since been launched.
AB - BACKGROUND: Liver transplantation (LT) is considered a therapeutic option for unresectable perihilar cholangiocarcinoma (PHC) within defined criteria. It remains uncertain whether patients can safely receive adjuvant chemotherapy after LT.METHODS: We performed a prospective, multi-center, randomized, non-blinded two-arm trial (pro-duct001). Patients after LT for unresectable PHC within defined criteria were randomized to adjuvant gemcitabine (LT-Gem group) and LT alone (LT alone group). The primary objective was to investigate if adjuvant chemotherapy is feasible in ≥ 85% of patients after LT. The primary endpoint was the percentage of patients completing the 24 weeks course of adjuvant chemotherapy. Secondary endpoints included overall survival (OS) and disease-free (DFS), and complication rates.RESULTS: Twelve patients underwent LT for PHC, of which six (50%) were eligible for randomization (LT-Gem: three patients, LT alone: three patients). Two out of three patients discontinued adjuvant chemotherapy after LT due to intolerance. The study was prematurely terminated due to slow enrollment. One patient with PHC had underlying primary sclerosing cholangitis (PSC). Tumor-free margins could be achieved in all patients. In both the LT-Gem and the LT alone group, the cumulative 1-, 3-, and 5-year OS and DFS rates were 100%, 100%, 67%, and 100%, 67% and 67%, respectively.CONCLUSIONS: This prospective, multi-center study was prematurely terminated due to slow enrollment and a statement on the defined endpoints cannot be made. Nevertheless, long-term survival data are consistent with available retrospective data and confirm defined criteria for LT. Since more evidence of LT per se in unresectable PHC is urgently needed, a prospective, non-randomized follow-up study (pro-duct002) has since been launched.
U2 - 10.3389/fonc.2022.910871
DO - 10.3389/fonc.2022.910871
M3 - SCORING: Journal article
C2 - 36330499
VL - 12
JO - FRONT ONCOL
JF - FRONT ONCOL
SN - 2234-943X
M1 - 910871
ER -
