A phase 2 randomized trial of paclitaxel and carboplatin with or without panitumumab for first-line treatment of advanced non-small-cell lung cancer

Jeffrey Crawford, Paul Swanson, Paul Schwarzenberger, Alan Sandler, Diane Prager, Kathy Zhang, Daniel J. Freeman, Carol W. Johnson, Kartik Krishnan, David Johnson

Research output: Contribution to journalArticle

21 Scopus citations

Abstract

Introduction: This two-part phase 2 study evaluated the efficacy and safety of panitumumab, a fully human anti-epidermal growth factor receptor monoclonal antibody, combined with carboplatin/paclitaxel in patients with previously untreated advanced non-small-cell lung cancer. Methods: In part 1, patients were sequentially enrolled to receive paclitaxel 200 mg/m2 and carboplatin (area under the concentration-versus-time curve, 6 mg/min/ml) plus panitumumab (1.0, 2.0, or 2.5 mg/kg). In part 2, patients were randomized 2:1 to receive paclitaxel/carboplatin with (arm A) or without (arm B) the maximum tolerated dose of panitumumab identifed in part 1. Primary endpoints in parts 1 and 2 were the incidence of dose-limiting toxicities and time to progression (TTP), respectively. Results: In part 1, four of 19 patients had dose-limiting toxicities: three at 2.0 mg/kg (fatigue, pain in extremity, dyspepsia) and one at 2.5 mg/kg (rash). The maximum tolerated dose was not reached; panitumumab 2.5 mg/kg was selected for part 2. In part 2, TTP was 18.1 weeks (95% confidence interval [CI], 13.6-23.3) in arm A and 23.0 weeks (95% CI, 15.9-24.1) in arm B (hazard ratio, 0.9; 90% CI, 0.66-1.21; p = 0.555). Progression-free survival in arms A and B was 17.6 weeks and 18.3 weeks, respectively, and the objective response rate was 15.2% and 11.1%. Adverse events occurring more frequently in arm A than in arm B included skin toxicity, diarrhea, stomatitis, vomiting, and dizziness. Exploratory analyses did not demonstrate associations between potential biomarkers and outcomes. Conclusion: Although toxicity was predictable and manageable, the addition of panitumumab to paclitaxel/carboplatin did not improve TTP in patients with previously untreated advanced non-small-cell lung cancer.

Original languageEnglish (US)
Pages (from-to)1510-1518
Number of pages9
JournalJournal of Thoracic Oncology
Volume8
Issue number12
DOIs
StatePublished - Jan 1 2013

Keywords

  • Epidermal growth factor receptor
  • KRAS
  • Non-small-cell lung cancer
  • Paclitaxel/carboplatin
  • Panitumumab

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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    Crawford, J., Swanson, P., Schwarzenberger, P., Sandler, A., Prager, D., Zhang, K., Freeman, D. J., Johnson, C. W., Krishnan, K., & Johnson, D. (2013). A phase 2 randomized trial of paclitaxel and carboplatin with or without panitumumab for first-line treatment of advanced non-small-cell lung cancer. Journal of Thoracic Oncology, 8(12), 1510-1518. https://doi.org/10.1097/JTO.0b013e3182a7d1da