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"
Altmetric Score
MSK Authors
  1. Kenneth K Ng
    36 Ng
  2. Christopher G Azzoli
    105 Azzoli
  3. Gloria A Chia
    2 Chia
  4. Martin Brower
    2 Brower
  5. John J Fiore
    7 Fiore
  6. Naiyer A Rizvi
    156 Rizvi
  7. Vincent Miller
    259 Miller
  8. Gregory J Riely
    344 Riely
  9. Mark Kris
    597 Kris
  10. Robert T Heelan
    79 Heelan