Randomized Phase II study of gemcitabine plus cisplatin, 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

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192 Scopus citations

Abstract

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/m 2 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.

Original languageEnglish (US)
Pages (from-to)5777-5784
Number of pages8
JournalJournal of Clinical Oncology
Volume25
Issue number36
DOIs
StatePublished - Dec 20 2007

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Butts, C. A., Bodkin, D., Middleman, E. L., Englund, C. W., Ellison, D., Alam, Y., Kreisman, H., Graze, P., Maher, J., Ross, H. J., Ellis, P. M., McNulty, W., Kaplan, E., Pautret, V., Weber, M. R., & Shepherd, F. A. (2007). Randomized Phase II study of gemcitabine plus cisplatin, with or without cetuximab, as first-line therapy for patients with advanced or metastatic non-small-cell lung cancer. Journal of Clinical Oncology, 25(36), 5777-5784. https://doi.org/10.1200/JCO.2007.13.0856