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Randomized Phase II Study of Gemcitabine Plus Cisplatin or Carboplatin, With or Without Cetuximab, As First-Line Therapy for Patients With Advanced or Metastatic Non–Small-Cell Lung Cancer

Charles A. Butts, David Bodkin, Edward L. Middleman, Craig W. Englund, David Ellison, Yasmin Alam, Harvey Kreisman, Peter Graze, James Maher, Helen J. Ross, Peter M. Ellis, William McNulty, Edward Kaplan, Virginie Pautret, Martin R. Weber, Frances A. Shepherd

From the Cross Cancer Institute, Edmonton, Alberta; Windsor Regional Cancer Center, Windsor; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Canada University Health Network, Princess Margaret Hospital, Toronto, Ontario; Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quèbec, Canada; Sharp Health Care, San Diego, CA; Dallas Oncology Consultants, Dallas, TX; The Florida Wellcare Alliance, Inverness, FL; Charleston Hematology/Oncology, Charleston, SC; Annapolis Oncology Center, Annapolis, MD; Oncology Partners Network, Cincinnati, OH; Earle A. Chiles Research Institute, Portland, OR; Hanover Medical Specialists, Wilmington, NC; North Shore Cancer Research Association, Skokie, IL; Bristol-Myers Squibb Company, Braine l'Allued, Belgium; and Bristol-Myers Squibb Company, Wallingford, CT

Address reprint requests to Charles A. Butts, MD, Cross Cancer Institute, 11560 University Ave, Edmonton, Alberta, Canada; e-mail: charlesb{at}cancerboard.ab.ca

Purpose: To evaluate the efficacy of cetuximab added to first-line gemcitabine/platinum in chemotherapy-naïve patients with advanced non–small-cell lung cancer (NSCLC).

Patients and Methods: In this noncomparative, randomized trial, chemotherapy-naïve patients with recurrent/metastatic NSCLC (stage IV or stage IIIB with malignant pleural effusion) were eligible. Patients received cisplatin (75 mg/m² IV, every 3 weeks) or carboplatin (area under the concentration-versus-time curve of 5 intravenously [IV], every 3 weeks), and gemcitabine (1,250 or 1,000 mg/m² IV, days 1 and 8) plus cetuximab (400 mg/m² IV day 1, followed by 250 mg/m² weekly), in arm A, or chemotherapy alone, in arm B. Response rate was the primary end point; safety, progression-free survival, and overall survival were secondary end points.

Results: Sixty-five patients were randomly assigned to arm A and 66 to arm B. Partial responses were observed in 18 patients (27.7%; 95% CI, 17.3 to 40.2) in arm A and 12 (18.2%; 95% CI, 9.8 to 29.6) in arm B. Median progression-free survival was 5.09 months for arm A (95% CI, 4.17 to 5.98) and 4.21 months (95% CI, 3.81 to 5.49) in arm B. Median overall survival was 11.99 months (95% CI, 8.80 to 15.18) and 9.26 months (95% CI, 7.43 to 11.79) in arms A and B, respectively. Overall toxicity was acceptable and consistent with the profiles of the individual agents.

Conclusion: First-line treatment with cetuximab plus gemcitabine/platinum is well tolerated and can be administered safely in patients with advanced NSCLC. Differences in response rate, progression-free survival, and overall survival suggest that the addition of cetuximab to platinum/gemcitabine may improve clinical outcomes. Larger studies are in progress to address this hypothesis.

Supported by Bristol-Myers Squibb and ImClone Systems Incorporated.

Presented at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

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