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.
abstract: 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.
  
  
  CONCLUSIONS
  Neoadjuvant RCT with docetaxel 20 mg/m2 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.
  
  
  BACKGROUND
  NCT00374985.
authors: I, Medical Department, Johannes-Gutenberg University Mainz, Langenbeckstr,1, Mainz 55101, Germany. moehler@mail.uni-mainz.de
authors: Markus
authors: M
authors: Moehler
authors: Ines
authors: I
authors: Gockel
authors: Hans-Peter
authors: HP
authors: Roessler
authors: Dirk
authors: D
authors: Arnold
authors: Tanja
authors: T
authors: Trarbach
authors: Thomas
authors: T
authors: Thomaidis
authors: Gunther
authors: G
authors: Klautke
authors: Claus
authors: C
authors: Rödel
authors: Baruch
authors: B
authors: Brenner
authors: Hauke
authors: H
authors: Lang
authors: Peter R
authors: PR
authors: Galle
authors: Carl C
authors: CC
authors: Schimanski
authors: Heinz
authors: H
authors: Schmidberger
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D004943:Esophagogastric Junction / Q000187:drug effects* / Q000473:pathology / Q000528:radiation effects* / Q000601:surgery; D005260:Female; D005858:Germany; D006801:Humans; D007557:Israel; D053208:Kaplan-Meier Estimate; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077150:Oxaliplatin; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel
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