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Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction

BACKGROUND: This phase I/II-trial assessed the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of neoadjuvant radiochemotherapy (RCT) with docetaxel and oxaliplatin in patients with locally advanced adenocarcinoma of the oesophagogastric junction. METHODS: Patients received neoadjuva...

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Autores principales: Moehler, Markus, Gockel, Ines, Roessler, Hans-Peter, Arnold, Dirk, Trarbach, Tanja, Thomaidis, Thomas, Klautke, Gunther, Rödel, Claus, Brenner, Baruch, Lang, Hauke, Galle, Peter R, Schimanski, Carl C, Schmidberger, Heinz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3579685/
https://www.ncbi.nlm.nih.gov/pubmed/23394629
http://dx.doi.org/10.1186/1471-2407-13-75
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author Moehler, Markus
Gockel, Ines
Roessler, Hans-Peter
Arnold, Dirk
Trarbach, Tanja
Thomaidis, Thomas
Klautke, Gunther
Rödel, Claus
Brenner, Baruch
Lang, Hauke
Galle, Peter R
Schimanski, Carl C
Schmidberger, Heinz
author_facet Moehler, Markus
Gockel, Ines
Roessler, Hans-Peter
Arnold, Dirk
Trarbach, Tanja
Thomaidis, Thomas
Klautke, Gunther
Rödel, Claus
Brenner, Baruch
Lang, Hauke
Galle, Peter R
Schimanski, Carl C
Schmidberger, Heinz
author_sort Moehler, Markus
collection PubMed
description BACKGROUND: This phase I/II-trial assessed the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of neoadjuvant radiochemotherapy (RCT) with docetaxel and oxaliplatin in patients with locally advanced adenocarcinoma of the oesophagogastric junction. METHODS: Patients received neoadjuvant radiotherapy (50.4 Gy) together with weekly docetaxel (20 mg/m(2) at dose level (DL) 1 and 2, 25 mg/m(2) at DL 3) and oxaliplatin (40 mg/m(2) at DL 1, 50 mg/m(2) at DL 2 and 3) over 5 weeks. The primary endpoint was the DLT and the MTD of the RCT regimen. Secondary endpoints included overall response rate (ORR) and progression-free survival (PFS). RESULTS: A total of 24 patients were included. Four patients were treated at DL 1, 13 patients at DL 2 and 7 patients at DL 3. The MTD of the RCT was considered DL 2 with docetaxel 20 mg/m(2) and oxaliplatin 50 mg/m(2). Objective response (CR/PR) was observed in 32% (7/22) of patients. Eighteen patients (75%) underwent surgery after RCT. The median PFS for all patients (n = 24) was 6.5 months. The median overall survival for all patients (n = 24) was 16.3 months. Patients treated at DL 2 had a median overall survival of 29.5 months. CONCLUSION: Neoadjuvant RCT with docetaxel 20 mg/m(2) and oxaliplatin 50 mg/m(2) was effective and showed a good toxicity profile. Future studies should consider the addition of targeted therapies to current neoadjuvant therapy regimens to further improve the outcome of patients with advanced cancer of the oesophagogastric junction. TRIAL REGISTRATION: NCT00374985
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spelling pubmed-35796852013-02-23 Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction Moehler, Markus Gockel, Ines Roessler, Hans-Peter Arnold, Dirk Trarbach, Tanja Thomaidis, Thomas Klautke, Gunther Rödel, Claus Brenner, Baruch Lang, Hauke Galle, Peter R Schimanski, Carl C Schmidberger, Heinz BMC Cancer Research Article BACKGROUND: This phase I/II-trial assessed the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of neoadjuvant radiochemotherapy (RCT) with docetaxel and oxaliplatin in patients with locally advanced adenocarcinoma of the oesophagogastric junction. METHODS: Patients received neoadjuvant radiotherapy (50.4 Gy) together with weekly docetaxel (20 mg/m(2) at dose level (DL) 1 and 2, 25 mg/m(2) at DL 3) and oxaliplatin (40 mg/m(2) at DL 1, 50 mg/m(2) at DL 2 and 3) over 5 weeks. The primary endpoint was the DLT and the MTD of the RCT regimen. Secondary endpoints included overall response rate (ORR) and progression-free survival (PFS). RESULTS: A total of 24 patients were included. Four patients were treated at DL 1, 13 patients at DL 2 and 7 patients at DL 3. The MTD of the RCT was considered DL 2 with docetaxel 20 mg/m(2) and oxaliplatin 50 mg/m(2). Objective response (CR/PR) was observed in 32% (7/22) of patients. Eighteen patients (75%) underwent surgery after RCT. The median PFS for all patients (n = 24) was 6.5 months. The median overall survival for all patients (n = 24) was 16.3 months. Patients treated at DL 2 had a median overall survival of 29.5 months. CONCLUSION: Neoadjuvant RCT with docetaxel 20 mg/m(2) and oxaliplatin 50 mg/m(2) was effective and showed a good toxicity profile. Future studies should consider the addition of targeted therapies to current neoadjuvant therapy regimens to further improve the outcome of patients with advanced cancer of the oesophagogastric junction. TRIAL REGISTRATION: NCT00374985 BioMed Central 2013-02-11 /pmc/articles/PMC3579685/ /pubmed/23394629 http://dx.doi.org/10.1186/1471-2407-13-75 Text en Copyright ©2013 Moehler et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Moehler, Markus
Gockel, Ines
Roessler, Hans-Peter
Arnold, Dirk
Trarbach, Tanja
Thomaidis, Thomas
Klautke, Gunther
Rödel, Claus
Brenner, Baruch
Lang, Hauke
Galle, Peter R
Schimanski, Carl C
Schmidberger, Heinz
Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction
title Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction
title_full Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction
title_fullStr Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction
title_full_unstemmed Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction
title_short Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction
title_sort prospective, open, multi-centre phase i/ii trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3579685/
https://www.ncbi.nlm.nih.gov/pubmed/23394629
http://dx.doi.org/10.1186/1471-2407-13-75
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