Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer

C. Twelves, E. Chmielowska, L. Havel, S. Popat, A. Swieboda-Sadlej, P. Sawrycki, P. Bycott, A. Ingrosso, S. Kim, J. A. Williams, C. Chen, A. J. Olszanski, P. de Besi, J. H. Schiller

Research output: Contribution to journalArticle

28 Scopus citations

Abstract

Background: Efficacy and safety of first-line axitinib/paclitaxel/carboplatin versus bevacizumab/paclitaxel/carboplatin in advanced non-squamous non-small-cell lung cancer (NSCLC) was evaluated. Patients and methods: Patients with stage IIIB/IV disease stratified by adjuvant therapy and gender were randomised 1: 1 to axitinib (5 mg twice daily) or bevacizumab [15 mg/kg every 3 weeks (Q3W)], both with paclitaxel (200 mg/m2 Q3W)/carboplatin (AUC 6 mg min/ml Q3W). Results: The trial was discontinued after preliminary analysis. Median progression-free survival (primary end point) for axitinib (N = 58) and bevacizumab (N = 60), respectively, was 5.7 and 6.1 months [hazard ratio (HR) 1.09, 95% confidence interval (CI) 0.68-1.76; one-sided stratified P = 0.64]; median overall survival was 10.6 and 13.3 months (HR 1.12, 95% CI 0.74-1.69; one-sided stratified P = 0.70). Objective response rates (95% CI) were 29.3% (18.1-42.7) and 43.3% (30.6-56.8), respectively; risk ratio 0.676 (95% CI 0.41-1.11; one-sided stratified P = 0.94). The most common grade 3/4 adverse events included neutropenia (28% versus 20%), fatigue (14% versus 7%), and hypertension (14% versus 5%). Patient-reported outcomes based on the EORTC QLQ-C30 were similar between arms. Conclusions: In patients with advanced non-squamous NSCLC, axitinib/paclitaxel/carboplatin did not improve efficacy versus bevacizumab/paclitaxel/carboplatin, and was less well tolerated.

Original languageEnglish (US)
Article numbermdt489
Pages (from-to)132-138
Number of pages7
JournalAnnals of Oncology
Volume25
Issue number1
DOIs
StatePublished - 2014

Keywords

  • Axitinib
  • Bevacizumab
  • Chemotherapy
  • Non-small-cell lung cancer
  • Non-squamous

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Twelves, C., Chmielowska, E., Havel, L., Popat, S., Swieboda-Sadlej, A., Sawrycki, P., Bycott, P., Ingrosso, A., Kim, S., Williams, J. A., Chen, C., Olszanski, A. J., de Besi, P., & Schiller, J. H. (2014). Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Annals of Oncology, 25(1), 132-138. [mdt489]. https://doi.org/10.1093/annonc/mdt489