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

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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

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Confidence Intervals
Therapeutics
Neutropenia
Disease-Free Survival
Area Under Curve
Fatigue
Odds Ratio
axitinib
Bevacizumab
Hypertension
Safety
Survival

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

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. / 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.

In: Annals of Oncology, Vol. 25, No. 1, mdt489, 2014, p. 132-138.

Research output: Contribution to journalArticle

Twelves, C, Chmielowska, E, Havel, L, Popat, S, Swieboda-Sadlej, A, Sawrycki, P, Bycott, P, Ingrosso, A, Kim, S, Williams, JA, Chen, C, Olszanski, AJ, de Besi, P & Schiller, JH 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, vol. 25, no. 1, mdt489, pp. 132-138. https://doi.org/10.1093/annonc/mdt489
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. / 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. In: Annals of Oncology. 2014 ; Vol. 25, No. 1. pp. 132-138.
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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.",
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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

Y1 - 2014

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.

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KW - Bevacizumab

KW - Chemotherapy

KW - Non-small-cell lung cancer

KW - Non-squamous

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