title: DHA-paclitaxel (Taxoprexin) as first-line treatment in patients with stage IIIB or IV non-small cell lung cancer: report of a phase II open-label multicenter trial.
abstract: BACKGROUND
  This prospective, open-label, non-randomized, multi-institutional phase II study was undertaken to assess the antitumor activity and safety of docosahexaenoic acid-paclitaxel (Taxoprexin) as first-line treatment of patients with advanced non-small cell lung cancer.
  
  
  METHODS
  Chemotherapy-naive patients were eligible if they had measurable stage IIIB or IV non-small cell lung cancer. Forty-four patients received docosahexaenoic acid-paclitaxel by intravenous infusion every 21 days. Two doses were evaluated: 1100 mg/m and 900 mg/m. Patients were monitored for toxicity and tumor response.
  
  
  RESULTS
  Patients received between one and seven (median, two) cycles of treatment. Twenty-eight courses were administered in the cohort starting at 1100 mg/m and 109 courses at 900 mg/m. The starting dose was reduced to 900 mg/m because of toxicity in the first 13 patients. Subsequently, the most severe toxicity was neutropenia (grade III/IV in 68% of patients treated with 900 mg/m). Forty patients were eligible for assessment of tumor response. Two partial responses (4.5%) were documented, and a further 16 patients (36.4%) had stable disease based on an intent-to-treat analysis. The median duration of survival for all patients was 243 days (range, 154-359) and the 1-year survival rate was 35%.
  
  
  CONCLUSIONS
  As a single-agent, docosahexaenoic acid-paclitaxel has little activity in patients with advanced non-small cell lung cancer, with 18 patients (40.1%) achieving either stable disease or a partial response after treatment. Despite the low objective response rate, treatment was associated with survival comparable to that seen with standard platinum-based combination chemotherapy. The dose-limiting toxicity was myelosuppression.
authors.affiliation: Cancer Research UK Oxford Cancer Centre, Oxford, UK.
authors.forename: Miranda
authors.initials: M
authors.lastname: Payne
authors.forename: Paul
authors.initials: P
authors.lastname: Ellis
authors.forename: David
authors.initials: D
authors.lastname: Dunlop
authors.forename: Malcolm
authors.initials: M
authors.lastname: Ranson
authors.forename: Sarah
authors.initials: S
authors.lastname: Danson
authors.forename: Lee
authors.initials: L
authors.lastname: Schacter
authors.forename: Denis
authors.initials: D
authors.lastname: Talbot
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D018572:Disease-Free Survival; D004281:Docosahexaenoic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D018579:Patient Selection; D011336:Probability; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D016019:Survival Analysis
chemical_list: D004338:Drug Combinations; D004281:Docosahexaenoic Acids; D017239:Paclitaxel