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 Journal Article
| Authors: | Rizvi, N. A.; Riely, G. J.; Azzoli, C. G.; Miller, V. A.; Ng, K. K.; Fiore, J.; Chia, G.; Brower, M.; Heelan, R.; Hawkins, M. J.; Kris, M. G. |
| Article Title: | 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 |
| Abstract: | 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/m 2 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. © 2008 by American Society of Clinical Oncology. |
| Keywords: | cancer chemotherapy; cancer survival; clinical article; controlled study; treatment response; survival rate; unclassified drug; overall survival; clinical trial; constipation; drug tolerability; fatigue; mortality; neutropenia; cancer growth; diarrhea; drug withdrawal; monotherapy; paclitaxel; cancer staging; neoplasm staging; anorexia; edema; multiple cycle treatment; phase 2 clinical trial; sensory neuropathy; anemia; leukopenia; lung non small cell cancer; nausea; carcinoma, non-small-cell lung; lung neoplasms; myalgia; peripheral neuropathy; drug administration schedule; pathology; drug dose escalation; febrile neutropenia; rash; confidence interval; lung tumor; albumin; albumins; chemically induced disorder; maximum tolerated dose; phase 1 clinical trial; drug administration; corticosteroid; alopecia; infusions, intravenous; radiodiagnosis; peripheral nervous system diseases; intravenous drug administration; antihistaminic agent; albumin bound paclitaxel; albuminoid; drug formulation; paclitaxel derivative; hypersensitivity; 130 nm albumin bound paclitaxel; 130-nm albumin-bound paclitaxel |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 26 |
| Issue: | 4 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2008-02-01 |
| Start Page: | 639 |
| End Page: | 643 |
| Language: | English |
| DOI: | 10.1200/jco.2007.10.8605 |
| PUBMED: | 18235124 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 25" - "Export Date: 17 November 2011" - "CODEN: JCOND" - "Source: Scopus" |
