Entry Detail
| General information | |
| Database: | DB00089 |
| Objective: | to evaluate pazopanib given as maintenance treatment following standard first line platinumbased chemotherapy in patients with advanced non small cell lung cancer. |
| Authors: | O'Brien ME, et al |
| Title: | Maintenance pazopanib versus placebo in non small cell lung cancer patients nonprogressive after first line chemotherapy: A double blind randomisedphase III study of the lung cancer group, EORTC 08092 (EudraCT: 201001856623, NCT01208064). |
| Journal: | Eur J Cancer |
| Year: | 2015 |
| PMID: | 26074395 |
| Trial Design | |
| Clinical Trial Id: | NCT01208064 |
| Agent: | pazopanib |
| Target: | Plateletderived growth factor receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A double blind randomisedphase III study |
| Key Patients Feature: | non small cell lung cancer patients nonprogressive after first line chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | placebo |
| Treatment Info: | pts were randomised to receive either pazopanib 800mg/day or matched placebo until progression or unacceptable toxicity. |
| Primary End Point: | overall survival |
| Secondary End Point: | progression free survival (PFS) and safety. |
| Patients Number: | 102 |
| Trial Results | |
| DLT_MTD: | Patients with nonprogressive disease after 46 cycles of chemotherapy were randomised to receive either pazopanib 800mg/day or matched placebo until progression or unacceptable toxicity. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.3 vs 3.2(HR 0.67, [95% CI 0.431.03], p=0.068). PFS rates at 4 months were 56% and 45% respectively |
| Median OS A vs. C: | 17.4 vs 12.3 (HR) 0.72 [95% confidence interval (CI) 0.401.28]; p=0.257 |
| Adverse Event(agent arm): | The majority of treatmentrelated adverse events (AEs) were grade 12. Grade 34 AEs (pazopanib versus placebo) were hypertension (38% versus 8%), neutropenia (8% versus 0%), and elevated SGPT (6% versus 0%). Of the patients randomised to pazopanib, 22% withdrew due to a treatmentrelated AE. |
| Conclusions: | Switch maintenance with pazopanib following platinumbased chemotherapy in advanced non small cell lung cancer patients had limited sideeffects. This study was stopped due to lack of efficacy by stringent criteria for PFS at a futility interim analysis. |