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Phase II Trial of Cetuximab in Patients With Previously Treated Non–Small-Cell Lung Cancer

Nasser Hanna, Rogerio Lilenbaum, Rafat Ansari, Thomas Lynch, Ramaswamy Govindan, Pasi A. Jänne, Philip Bonomi

From the Indiana University, Indianapolis; Michiana Oncology/Hematology, South Bend, IN; Mt Sinai Cancer Center, Miami Beach, FL; Massachusetts General Hospital; Dana-Farber Cancer Institute, Boston, MA; Washington University, St Louis, MO; and Rush Medical College, Chicago, IL

Address reprint requests to Nasser Hanna, MD, 535 Barnhill Dr, RT 473, Indianapolis, IN 46202; e-mail: nhanna{at}iupui.edu

Purpose: To determine the efficacy of cetuximab in patients with recurrent or progressive non–small-cell lung cancer (NSCLC) after receiving at least one prior chemotherapy regimen.

Patients and Methods: This was an open-label, phase II study of patients with epidermal growth factor receptor (EGFR) –positive and EGFR-negative advanced NSCLC with Eastern Cooperative Oncology Group performance status 0 to 1. Patients received cetuximab 400 mg/m² intravenously (IV) during 120 minutes on week 1 followed by weekly doses of cetuximab 250 mg/m² IV during 60 minutes. A cycle was considered as 4 weeks of treatment and therapy was continued until disease progression or intolerable toxicities. The primary end point was to assess response rate. Secondary end points included an estimation of time to progression and survival.

Results: Patient and disease characteristics (n = 66) included EGFR-positive status (n = 60); EGFR-negative status (n = 6); number of prior regimens (one, n = 28; two, n = 27; three, n = 11); male (n = 41); female (n = 25); adenocarcinoma (n = 36); and smoking status (never, n = 13; former, n = 45; current, n = 8). Grade 3/4 toxicities included acne-like rash (6.1%), anaphylactic reactions (1.5%), and diarrhea (1.5%). The response rate for all patients (n = 66) was 4.5% (95% CI, 0.9% to 12.7%) and the stable disease rate was 30.3% (95% CI, 19.6% to 42.9%). The response rate for patients with EGFR-positive tumors (n = 60) was 5% (95% CI, 1.0% to 13.9%). The median time to progression for all patients was 2.3 months (95% CI, 2.1 to 2.6 months) and median survival time was 8.9 months (95% CI, 6.2 to 12.6 months).

Conclusion: Although the response rate with single-agent cetuximab in this heavily pretreated patient population with advanced NSCLC was only 4.5%, the disease control rates and overall survival seem comparable to that of pemetrexed, docetaxel, and erlotinib in similar groups of patients.

Supported by a grant from Bristol-Myers Squibb Co.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, June 4-8, 2004, New Orleans, LA; the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL; and the International Association for the Study of Lung Cancer, July 3-6, 2005, Barcelona, Spain.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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