Annals of Oncology Advance Access originally published online on February 2, 2009
Annals of Oncology 2009 20(6):1068-1073; doi:10.1093/annonc/mdn745
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lung cancer |
A randomized, phase II trial of two dose schedules of carboplatin/paclitaxel/cetuximab in stage IIIB/IV non-small-cell lung cancer (NSCLC)
1 Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill
2 Georgia Cancer Specialists, Marietta
3 Virginia Cancer Institute, Richmond
4 Tennessee Cancer Specialists, Knoxville
5 Department of Hematology/Oncology, Florida Hospital Cancer Institute, Orlando
6 Greater Baltimore Medical Center, Baltimore
7 Ann Arbor Hematology Oncology, Ann Arbor; 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: This trial investigated the efficacy and safety of weekly cetuximab combined with two different schedules of paclitaxel/carboplatin for stage IIIB/IV non-small-cell lung cancer (NSCLC).
Methods: A total of 168 patients with previously untreated stage IIIB/IV NSCLC were randomized to arm A, cetuximab (400 mg/m2 day 1 followed by weekly 250 mg/m2) + paclitaxel (Taxol) (225 mg/m2)/carboplatin (AUC6) day 1 every 3 weeks or arm B, same cetuximab regimen plus paclitaxel (100 mg/m2) days 1, 8, and 15 every 3 weeks and carboplatin (AUC6) day 1 every 4 weeks. Treatment continued for a four-cycle maximum. Patients with a complete response, partial response, or stable disease after four cycles could receive cetuximab 250 mg/m2/week until disease progression or unacceptable toxicity. The primary end point was to evaluate progression-free survival (PFS).
Results: Median PFS was 4.7 and 4.3 months for arms A and B, respectively (6-month PFS, 27.3% versus 30.9%). Median overall survival was 11.4 versus 9.8 months for arms A and B, respectively; estimated 1-year survival, 47.7% versus 39.3%; and objective response rate, 29.6% versus 25%. The regimen was well tolerated with rash and hematologic toxicity being most common.
Conclusions: This study did not meet the prespecified benchmark of 35% 6-month PFS rate; both combination schedules of cetuximab plus paclitaxel/carboplatin were feasible and equivalent for treating advanced NSCLC.
Key words: biomarkers, cetuximab, combination therapy, EGFR, NSCLC
Received for publication September 3, 2008. Revision received November 5, 2008. Accepted for publication November 6, 2008.
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