| Author/Editor | O'Brien, Mary E. R.; Gaafar, Rabab; Hasan, Baktiar; Menis, Jessica; Čufer, Tanja; Popat, Sanjay; Woll, Penella J.; Surmont, Veerle; Georgoulias, Vassilis; Montes, Ana; Blackhall, Fiona; Hennig, Ivo; Schmid-Bindert, Gerald; Baas, Paul | |
| Title | Maintenance pazopanib versus placebo in Non-Small Cell Lung Cancer patients non-progressive after first line chemotherapy | |
| Type | članek | |
| Vol. and No. | Letnik 51, št. 12 | |
| Publication year | 2015 | |
| Volume | str. 1511-1528 | |
| ISSN | 0959-8049 - European journal of cancer (Oxford, England : 1990) | |
| Language | eng | |
| Abstract | Switch maintenance is an effective strategy in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC). Pazopanib is an oral, multi-targeted tyrosine kinase inhibitor (TKI). EORTC 08092 evaluated pazopanib given as maintenance treatment following standard first line platinum-based chemotherapy in patients with advanced NSCLC. METHODS: Patients with non-progressive disease after 4-6 cycles of chemotherapy were randomised to receive either pazopanib 800mg/day or matched placebo until progression or unacceptable toxicity. The primary end-point was overall survival and secondary end-points were progression-free survival (PFS) and safety. RESULTS: A total of 600 patients were planned to be randomised. The trial was prematurely stopped following an early interim analysis, after 102 patients were randomised to pazopanib (n=50) or placebo (n=52). Median age was 64years in both arms. Median overall survival was 17.4months for pazopanib and 12.3months for placebo (adjusted hazard ratio (HR) 0.72 [95% confidence interval (CI) 0.40-1.28]; p=0.257). Median PFS was 4.3months versus 3.2months (HR 0.67, [95% CI 0.43-1.03], p=0.068). PFS rates at 4months were 56% and 45% respectively. The majority of treatment-related adverse events (AEs) were grade 1-2. Grade 3-4 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 treatment-related AE. CONCLUSIONS: Switch maintenance with pazopanib following platinum-based chemotherapy in advanced NSCLC patients had limited side-effects. This study was stopped due to lack of efficacy by stringent criteria for PFS at a futility interim analysis. | |
| Keywords | nedrobnocelični rak rak pljuč kemoterapija pazopanib non-small cell cancer lung cancer chemotherapy |