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Annals of Oncology Advance Access originally published online on October 25, 2005
Annals of Oncology 2006 17(1):104-109; doi:10.1093/annonc/mdj016
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Published by Oxford University Press 2005

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. Socinski1,*, A. Ivanova1, K. Bakri1, J. Wall1, M. Q. Baggstrom1, T. A. Hensing2, A. Mears1, M. Tynan1, J. Beaumont2, A. H. Peterman2 and H. B. Niell1

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

* Correspondence to: Dr M. A. Socinski, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, CB# 7305, University of North Carolina, Chapel Hill, NC 27599, USA. Tel: +1-919-966-4431; Fax: +1-919-966-6735; E-mail: socinski{at}med.unc.edu

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.

Key words: carboplatin, non-small cell lung cancer, paclitaxel


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