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Annals of Oncology Advance Access published online on October 25, 2005

Annals of Oncology, doi:10.1093/annonc/mdj016
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© 2005 European Society for Medical Oncology
Received May 4, 2005
Revised July 11, 2005
Accepted August 8, 2005

original article

A randomized phase II trial comparing every 3-weeks carboplatin/paclitaxel with every 3-weeks carboplatin and weekly paclitaxel in advanced non-small cell lung cancer

M. A. Socinski 1*, A. Ivanova 1, K. Bakri 1, J. Wall 1, M. Q. Baggstrom 1, T. A. Hensing 2, A. Mears 1, M. Tynan 1, J. Beaumont 2, A. H. Peterman 2, and H. B. Niell 1

1 Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA
2 Evanston Northwestern Healthcare and Northwestern University, Chicago, IL, USA

* To whom correspondence should be addressed.
M. A. Socinski, E-mail: socinski{at}med.unc.edu


   Abstract

Background: The optimal schedule of taxane administration has been an area of active interest in several recent clinical trials.

Methods: To address a pure schedule question, we randomized 161 patients with advanced stage IIIB or IV non-small-cell lung cancer (NSCLC) to either paclitaxel 225 mg/m2 every 3 weeks x 4 cycles or 75 mg/m2/week x 12 (cumulative dose on each arm = 900 mg/m2). Both arms received concurrent carboplatin AUC 6 every 3 weeks x 4 cycles.

Results: The two arms were well-balanced in terms of known prognostic factors. The overall response rate and survival outcomes were similar on the two arms. There was significantly more grade 3/4 thrombocytopenia and grade 2-4 anemia on the weekly arm but less severe myalgias/arthralgias and alopecia. No difference in the rates of peripheral neuropathy was observed; however, patients on the every 3 weeks arm reported significantly more taxane therapy-related side-effects on the functional assessment of cancer therapy taxane subscale.

Conclusions: This randomized trial exploring schedule-related issues with carboplatin/paclitaxel confirms the versatility of this regimen.

Keywords: carboplatin; non-small cell lung cancer; paclitaxel.
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