title: 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.
abstract: 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 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/m(2) Q3W)/carboplatin (AUC 6 mg min/ml Q3W).
  
  
  
  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.
  
  
  
  In patients with advanced non-squamous NSCLC, axitinib/paclitaxel/carboplatin did not improve efficacy versus bevacizumab/paclitaxel/carboplatin, and was less well tolerated.
authors.affiliation: Cancer Research UK Clinical Centre, St James's University Hospital, Leeds, UK.
authors.forename: C
authors.initials: C
authors.lastname: Twelves
authors.forename: E
authors.initials: E
authors.lastname: Chmielowska
authors.forename: L
authors.initials: L
authors.lastname: Havel
authors.forename: S
authors.initials: S
authors.lastname: Popat
authors.forename: A
authors.initials: A
authors.lastname: Swieboda-Sadlej
authors.forename: P
authors.initials: P
authors.lastname: Sawrycki
authors.forename: P
authors.initials: P
authors.lastname: Bycott
authors.forename: A
authors.initials: A
authors.lastname: Ingrosso
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.forename: J A
authors.initials: JA
authors.lastname: Williams
authors.forename: C
authors.initials: C
authors.lastname: Chen
authors.forename: A J
authors.initials: AJ
authors.lastname: Olszanski
authors.forename: P
authors.initials: P
authors.lastname: de Besi
authors.forename: J H
authors.initials: JH
authors.lastname: Schiller
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077784:Axitinib; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage; D007191:Indazoles / Q000008:administration & dosage; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage; D016016:Proportional Hazards Models; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007093:Imidazoles; D007191:Indazoles; D000068258:Bevacizumab; D016190:Carboplatin; D000077784:Axitinib; D017239:Paclitaxel
keywords: axitinib; bevacizumab; chemotherapy; non-squamous; non-small-cell lung cancer