Efficacy and Safety of Paclitaxel Poliglumex as First-Line Chemotherapy in Patients at High Risk with Advanced-Stage Non-Small-Cell Lung Cancer: Results of a Phase II Study

BACKGROUND: The objectives of this open-labeled, multicenter, phase II trial were to evaluate response, survival, and tolerability in patients at high risk (Eastern Cooperative Oncology Group performance status [PS] of 2 or age ≤ 70 years) with advanced-stage non-small-cell lung cancer (NSCLC) receiving single-agent paclitaxel poliglumex as first-line monotherapy. PATIENTS AND METHODS: Paclitaxel poliglumex was administered as a 10-20-minute infusion on day 1 of each 3-week cycle. Thirty patients were enrolled: 28 received paclitaxel poliglumex 175 mg/m2, and 2 received 235 mg/m2. Patients exhibiting a partial response (PR; by Response Evaluation Criteria in Solid Tumors) or stable disease (SD) continued uninterrupted treatment with paclitaxel poliglumex for = 8 cycles. RESULTS: Neither patient treated at the 235 mg/m2 dose was evaluable for response. The overall response rate was 7% (PR in 2 patients), and 16 patients (57%) experienced SD. Of the 20 patients with stage IV disease, 2 exhibited a PR, and 13 exhibited SD. Median duration of response in patients with SD or better was 9 weeks. Overall median survival was 6 months. Median survival for patients with a PS of 0/1 or 2 was 7.8 months and 5.7 months, respectively; median survival for patients aged ≤ 70 years was 7.8 months. No grade 4 nonhematologic toxicities were reported. Three patients experienced grade 3 neuropathy. Weekly hematologic assessments showed grade 3 anemia in 2 patients, grade 3 neutropenia (not associated with neutropenic fever) in 3 patients, and grade 4 neutropenia in 2 patients. No patient required growth factor support. CONCLUSION: The results of this study indicate that paclitaxel poliglumex is generally well tolerated and has activity at a dose level of 175 mg/m2 as first-line monotherapy in patients at high risk with advanced NSCLC.