Abstract | PURPOSE: PATIENTS AND METHODS: In this international, double-blind, placebo-controlled phase III trial, 913 patients were randomly assigned to ( ziv-)aflibercept 6 mg/kg intravenous (IV; n = 456) or IV placebo (n = 457), both administered every 3 weeks and in combination with docetaxel 75 mg/m(2). The primary end point was overall survival (OS). Other efficacy outcomes, safety, and immunogenicity were also assessed. RESULTS: Patient characteristics were balanced between arms; 12.3% of patients had received prior bevacizumab. ( Ziv-)Aflibercept did not improve OS (hazard ratio [HR], 1.01; 95% CI, 0.87 to 1.17; stratified log-rank P = .90). The median OS was 10.1 months (95% CI, 9.2 to 11.6 months) for ( ziv-)aflibercept and 10.4 months (95% CI, 9.2 to 11.9 months) for placebo. In exploratory analyses, median progression-free survival was 5.2 months (95% CI, 4.4 to 5.6 months) for ( ziv-)aflibercept versus 4.1 months (95% CI, 3.5 to 4.3 months) for placebo (HR, 0.82; 95% CI, 0.72 to 0.94; P = .0035); overall response rate was 23.3% of evaluable patients (95% CI, 19.1% to 27.4%) in the ( ziv-)aflibercept arm versus 8.9% (95% CI, 6.1% to 11.6%; P < .001) in the placebo arm. Grade ≥ 3 adverse events occurring more frequently in the ( ziv-)aflibercept arm versus the placebo arm were neutropenia (28.0% v 21.1%, respectively), fatigue (11.1% v 4.2%, respectively), stomatitis (8.8% v 0.7%, respectively), and hypertension (7.3% v 0.9%, respectively). CONCLUSION:
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Authors | Rodryg Ramlau, Vera Gorbunova, Tudor Eliade Ciuleanu, Silvia Novello, Mustafa Ozguroglu, Tuncay Goksel, Clarissa Baldotto, Jaafar Bennouna, Frances A Shepherd, Solenn Le-Guennec, Augustin Rey, Vincent Miller, Nicholas Thatcher, Giorgio Scagliotti |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 30
Issue 29
Pg. 3640-7
(Oct 10 2012)
ISSN: 1527-7755 [Electronic] United States |
PMID | 22965962
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Recombinant Fusion Proteins
- Taxoids
- aflibercept
- Docetaxel
- Platinum
- Receptors, Vascular Endothelial Growth Factor
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Topics |
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality, pathology)
- Confidence Intervals
- Disease-Free Survival
- Docetaxel
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Kaplan-Meier Estimate
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Maximum Tolerated Dose
- Neoplasm Invasiveness
(pathology)
- Neoplasm Staging
- Platinum
(therapeutic use)
- Prognosis
- Proportional Hazards Models
- Prospective Studies
- Receptors, Vascular Endothelial Growth Factor
- Recombinant Fusion Proteins
(therapeutic use)
- Risk Assessment
- Survival Analysis
- Taxoids
(therapeutic use)
- Treatment Outcome
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