title: Paclitaxel in the neoadjuvant treatment for adeno carcinoma of the distal esophagus (AEG I). A comparison of two phase II trials with long-term follow-up.
abstract: BACKGROUND
  We report a comparative analysis of 2 sequential, prospective phase II trials on the efficacy of platinum/leucovorin/5-fluorouracil (PLF) +/- paclitaxel (T-PLF) in the neoadjuvant treatment of adenocarcinoma of the esophagus (AEG I).
  
  
  METHODS
  Inclusion criteria were histologically proven, locally advanced AEG I stage uT3/4 anyN cM0/M1a. 67 patients were treated with either PLF (n = 32) or T-PLF (n = 35). Paclitaxel (80 mg/m(2)) was added to PLF on days 1, 15, and 29. Primary endpoint was the response. Additionally, 5-year survival was analyzed.
  
  
  RESULTS
  The study population was well balanced, apart from an imbalance in clinical cM1a (33.3% PLF vs. 8.6% T-PLF; p = 0.01). Histopathological response rates (23.3% PLF vs. 25.0% T-PLF) showed no significant difference. Clinical response rates were improved for T-PLF (21.9 vs. 45.7%; p = 0.04). Median overall survival for clinical and histopathological responders was significantly improved for T-PLF (p = 0.005, p = 0.01), but not for PLF (p = 0.08, p = 0.25). Median overall survival was better with T-PLF without reaching statistical significance (18.9 months PLF vs. 43.1 months T-PLF; p = 0.27). Toxicity was slightly increased by paclitaxel. No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  Our data failed to demonstrate statistically significant superiority of the T-PLF regimen except for clinical response. However, there was a trend towards improved survival.
authors.affiliation: Department of Surgery, University of Schleswig-Holstein, Campus Lubeck, Germany.
authors.forename: Franz G
authors.initials: FG
authors.lastname: Bader
authors.forename: Florian
authors.initials: F
authors.lastname: Lordick
authors.forename: Ulrich
authors.initials: U
authors.lastname: Fink
authors.forename: Karen
authors.initials: K
authors.lastname: Becker
authors.forename: Heinz
authors.initials: H
authors.lastname: Hofler
authors.forename: Raymonde
authors.initials: R
authors.lastname: Busch
authors.forename: Jorg R
authors.initials: JR
authors.lastname: Siewert
authors.forename: Katja
authors.initials: K
authors.lastname: Ott
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant / Q000379:methods; D017322:Clinical Trials, Phase II as Topic; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel