| General information |
| Database: | DB00859 |
| Objective: | To compare the efficacy of aflibercept (zivaflibercept), a recombinant human fusion protein targeting the vascular endothelial growth factor (VEGF) pathway, with or without docetaxel in platinumpretreated patients with advanced or metastatic nonsquamous non small cell lung cancer |
| Authors: | Ramlau R, et al |
| Title: | Aflibercept and Docetaxel versus Docetaxel alone after platinum failure in patients with advanced or metastatic non small cell lung cancer: a randomized, controlledphase III trial. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22965962 |
| Trial Design |
| Clinical Trial Id: | NCT00532155 |
| Agent: | aflibercept
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non smallcell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Aflibercept + Docetaxel |
| Study Type: | a international, doubleblind, placebocontrolledphase III trial |
| Key Patients Feature: | Patients with histologically or cytologically proven locally advanced or metastatic non small cell lung cancer, excluding squamous histology, who experienced disease progression during or after firstline treatment for advanced disease consisting of platinumbased therapy or within 6 months of platinumbased adjuvant therapy were considered for enrollment onto the study. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Aflibercept and Docetaxel versus Docetaxel alone |
| Treatment Info: | 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). |
| Primary End Point: | overall survival (OS). |
| Secondary End Point: | Other efficacy outcomes, safety, and immunogenicity |
| Patients Number: | 913 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 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. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 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) |
| Median OS A vs. C: | 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. |
| Adverse Event(agent arm): | NA |
| Conclusions: | The addition of (ziv)aflibercept to standard docetaxel therapy did not improve OS. In exploratory analyses, secondary efficacy end points did seem to be improved in the (ziv)aflibercept arm. The study regimen was associated with increased toxicities, consistent with known antiVEGF and chemotherapyinduced events. |