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Phase I/II Trial of Weekly Intravenous 130-nm Albumin-Bound Paclitaxel As Initial Chemotherapy in Patients With Stage IV Non–Small-Cell Lung Cancer

Naiyer A. Rizvi, Gregory J. Riely, Christopher G. Azzoli, Vincent A. Miller, Kenneth K. Ng, John Fiore, Gloria Chia, Martin Brower, Robert Heelan, Michael J. Hawkins, Mark G. Kris

From the Thoracic Oncology Service, Departments of Medicine and Radiology, Memorial Sloan-Kettering Cancer Center; Weill Medical College of Cornell University, New York, NY; and Abraxis BioScience, San Diego, CA

Corresponding author: Naiyer A. Rizvi, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: rizvin{at}mskcc.org

Purpose Nanoparticle albumin-bound paclitaxel (NAB-paclitaxel) is an albumin-bound formulation of paclitaxel that has demonstrated improved efficacy compared with paclitaxel in the treatment of metastatic breast cancer. We undertook this trial to determine the maximum-tolerated dose (MTD) and single-agent activity of NAB-paclitaxel administered on a weekly basis to patients with stage IV non–small-cell lung cancer (NSCLC).

Patients and Methods This was an open-label, single-arm, phase I/II study. Patients were treated with NAB-paclitaxel intravenously during 30 minutes without corticosteroid or antihistamine premedications on days 1, 8, and 15 of a 28-day cycle. Radiologic tumor assessment was performed every 8 weeks.

Results Dose levels of 100 and 125 mg/m² were tolerated without dose-limiting toxicities (DLTs). At 150 mg/m² the MTD was exceeded; two of three patients experienced a DLT (grade 3 sensory neuropathy and febrile neutropenia). The 125 mg/m² dose level was expanded and determined to be the MTD. A total of 40 patients were treated at 125 mg/m². The objective response rate was 30% (12 of 40 patients; 95% CI, 16% to 44%), median time to progression was 5 months (95% CI, 3 to 8 months), and median overall survival was 11 months (95% CI, 7 months to not reached). The 1-year survival was 41%.

Conclusion NAB-paclitaxel 125 mg/m² administered on days 1, 8, and 15 of a 28-day cycle was well tolerated and demonstrated encouraging single-agent activity. No corticosteroid premedication was administered and no hypersensitivity reactions were seen. Additional studies of single-agent NAB-paclitaxel as well as platinum-based combinations are warranted.

Supported by Abraxis BioScience.

Presented in part at the 42nd Annual Meeting of the American Society of Oncology, June 2-6, 2007, Atlanta, GA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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