TY - JOUR
T1 - 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
AU - Twelves, C.
AU - Chmielowska, E.
AU - Havel, L.
AU - Popat, S.
AU - Swieboda-Sadlej, A.
AU - Sawrycki, P.
AU - Bycott, P.
AU - Ingrosso, A.
AU - Kim, S.
AU - Williams, J. A.
AU - Chen, C.
AU - Olszanski, A. J.
AU - de Besi, P.
AU - Schiller, J. H.
PY - 2014/1
Y1 - 2014/1
N2 - 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.
AB - 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.
KW - Aged
KW - Antibodies, Monoclonal, Humanized/administration & dosage
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Axitinib
KW - Bevacizumab
KW - Carboplatin/administration & dosage
KW - Carcinoma, Non-Small-Cell Lung/drug therapy
KW - Disease-Free Survival
KW - Female
KW - Humans
KW - Imidazoles/administration & dosage
KW - Indazoles/administration & dosage
KW - Kaplan-Meier Estimate
KW - Lung Neoplasms/drug therapy
KW - Male
KW - Middle Aged
KW - Neoplasm Staging
KW - Neutropenia/chemically induced
KW - Paclitaxel/administration & dosage
KW - Proportional Hazards Models
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=84895480028&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000331268800020&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1093/annonc/mdt489
DO - 10.1093/annonc/mdt489
M3 - Article
C2 - 24356624
SN - 0923-7534
VL - 25
SP - 132
EP - 138
JO - Annals of Oncology
JF - Annals of Oncology
IS - 1
ER -