A randomized, phase II trial of two dose schedules of carboplatin/paclitaxel/cetuximab in stage IIIB/IV non-small-cell lung cancer (NSCLC)

• Published in: Annals of oncology Vol. 20; no. 6; pp. 1068 - 1073
• Main Authors: Socinski, M. A., Saleh, M. N., Trent, D. F., Dobbs, T. W., Zehngebot, L. M., Levine, M. A., Bordoni, R., Stella, P. J.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01-06-2009; Oxford Publishing Limited (England)
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal, Humanized; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; biomarkers; Carboplatin - administration & dosage; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Cetuximab; combination therapy; Dose-Response Relationship, Drug; EGFR; Female; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; NSCLC; Paclitaxel - administration & dosage; Pharmacology. Drug treatments; Pneumology; Tumors of the respiratory system and mediastinum; cetuximab; combination therapy; NSCLC; biomarkers; EGFR; Antineoplastic agent; Lung cancer; Biological marker; Monoclonal antibody; non-small cell lung carcinoma; Epidermal growth factor receptor; Randomization; Taxane derivatives; Phase II trial; Paclitaxel; Bronchus disease; Clinical trial; Advanced stage; Cetuximab; Antimitotic; Dose; Platinum II Complexes; Human; Lung disease; Respiratory disease; Malignant tumor; Carboplatin; Combined treatment; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdn745

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.