title: Neoadjuvant paclitaxel poliglumex, cisplatin, and radiation for esophageal cancer: a phase 2 trial.
abstract: OBJECTIVE
  To evaluate the pathologic complete response (CR) rate and safety of paclitaxel poliglumex (PPX), cisplatin, and concurrent radiation for patients with esophageal cancer.
  
  
  METHODS
  Patients with adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction with no evidence of distant metastasis received PPX (50 mg/m(2)/wk) and cisplatin (25 mg/m(2)/wk) for 6 weeks with 50.4 Gy concurrent radiation. Six to eight weeks after completion of chemoradiotherapy, patients underwent surgical resection.
  
  
  RESULTS
  Forty patients were enrolled, 37 patients with adenocarcinoma and 3 patients with squamous cell cancer. The treatment-related grade 3 nonhematologic toxicities included esophagitis (7%), nausea (7%), and fatigue (5%). Three patients with clinical endoscopic CR (2 with squamous cell cancer) refused surgery. Twelve of the remaining 37 patients (32%) had a pathologic CR. The 12 patients with pathologic CR all had adenocarcinoma.
  
  
  CONCLUSIONS
  PPX, cisplatin, and concurrent radiation are well tolerated, easily administered regimen for esophageal cancer with a low incidence of significant esophagitis and a high pathologic CR rate consistent with the preclinical data of PPX and radiation.
authors.affiliation: The Brown University Oncology Group, Providence, Rhode Island, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Dipetrillo
authors.forename: Mohan
authors.initials: M
authors.lastname: Suntharalingam
authors.forename: Thomas
authors.initials: T
authors.lastname: Ng
authors.forename: Jacques
authors.initials: J
authors.lastname: Fontaine
authors.forename: Naomi
authors.initials: N
authors.lastname: Horiba
authors.forename: Nicklas
authors.initials: N
authors.lastname: Oldenburg
authors.forename: Kimberly
authors.initials: K
authors.lastname: Perez
authors.forename: Ari
authors.initials: A
authors.lastname: Birnbaum
authors.forename: Richard
authors.initials: R
authors.lastname: Battafarano
authors.forename: Whitney
authors.initials: W
authors.lastname: Burrows
authors.forename: Howard
authors.initials: H
authors.lastname: Safran
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D059186:Chemoradiotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D016629:Esophagectomy; D004941:Esophagitis / Q000209:etiology; D004943:Esophagogastric Junction; D005221:Fatigue / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D020360:Neoadjuvant Therapy / Q000379:methods*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D011099:Polyglutamic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D011099:Polyglutamic Acid; D017239:Paclitaxel; D002945:Cisplatin; C509139:paclitaxel poliglumex