Annals of Oncology Advance Access published online on February 2, 2009
Annals of Oncology, doi:10.1093/annonc/mdn745
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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.
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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