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.

INTRODUCTION: 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. PATIENTS AND 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%. CONCLUSION: 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.