title: Neoadjuvant, surgery and adjuvant chemotherapy without radiation for esophageal cancer.
abstract: BACKGROUND
  A phase II trial to evaluate neoadjuvant (NAD), surgery and adjuvant (AD) combination chemotherapy without radiation therapy (RT) for patients with esophageal adenocarcinoma staged with endoscopic ultrasound and CT as T3N1 was carried out.
  
  
  METHODS
  Thirty-three eligible patients were enrolled. NAD therapy was administered in two 49-day cycles and included cisplatin, floxuridine, paclitaxel and leucovorin. Esophageal resection was performed followed by AD therapy.
  
  
  RESULTS
  Thirty-three patients initiated NAD therapy; 10 experienced grade 3 and 4 toxicities, which included leucopenia, fatigue, nausea, diarrhea and stomatitis. Additionally, 16 patients experienced grade 1 and 2 hematologic and non-hematologic toxicities. Fifteen patients were down-staged, of whom five were T2, seven were T1, and three had nodal disease with no evidence of residual cancer in the esophageal bed. Fifteen patients remained T3, and two showed progressive disease. Thirty-two patients proceeded to surgery and 30 were resected. Although all resected patients were eligible for AD therapy, 15 did not receive it either because of patient refusal or surgeon recommendation. Fifteen patients received AD therapy: nine who had remained T3 and six who had down-staged. Three patients experienced grade 3 and 4 toxicities similar to those in NAD therapy. Six patients had grade 1 and 2 toxicities. Kaplan-Meier estimates of overall survival at 1, 3 and 5 years were 73% (95% CI: 58-88%), 52% (95% CI: 34-69%) and 29% (95% CI: 13-45%), respectively. Median survival was 42 months.
  
  
  CONCLUSIONS
  Deletion of RT may safely allow for more aggressive chemotherapy and increase chances of survival. The results need to be confirmed in a randomized phase II or larger phase III trial.
authors: Sylvester Comprehensive Cancer Center, Division of Hematology and Oncology, Miami, Florida 33136, USA. bardalan@med.miami.edu
authors: Bach
authors: B
authors: Ardalan
authors: Seth A
authors: SA
authors: Spector
authors: Alan S
authors: AS
authors: Livingstone
authors: Dido
authors: D
authors: Franceschi
authors: Dmitry
authors: D
authors: Mezentsev
authors: Mayra
authors: M
authors: Lima
authors: Carol P
authors: CP
authors: Bowen-Wells
authors: Lynne
authors: L
authors: Sparling
authors: Eli
authors: E
authors: Avisar
authors: Michelle
authors: M
authors: Sapp
authors: Joyce
authors: J
authors: Rios
authors: Gail
authors: G
authors: Walker
authors: Parvin
authors: P
authors: Ganjei-Azar
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000628:therapy*; D016629:Esophagectomy; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods*; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D005467:Floxuridine; D017239:Paclitaxel; D002945:Cisplatin; D002955:Leucovorin