In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 26, No. 4 ( 2008-02-01), p. 639-643
Abstract:
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/m 2 were tolerated without dose-limiting toxicities (DLTs). At 150 mg/m 2 the MTD was exceeded; two of three patients experienced a DLT (grade 3 sensory neuropathy and febrile neutropenia). The 125 mg/m 2 dose level was expanded and determined to be the MTD. A total of 40 patients were treated at 125 mg/m 2 . 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/m 2 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.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2007.10.8605
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2008
detail.hit.zdb_id:
2005181-5
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