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Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial

Cited 1,033 time in Web of Science Cited 1,111 time in Scopus
Authors
van der Graaf, Winette T. A.; Blay, Jean-Yves; Chawla, Sant P.; Kim, Dong-Wan; Binh Bui-Nguyen; Casali, Paolo G.; Schoffski, Patrick; Aglietta, Massimo; Staddon, Arthur P.; Beppu, Yasuo; Le Cesne, Axel; Gelderblom, Hans; Judson, Ian R.; Araki, Nobuhito; Ouali, Monia; Marreaud, Sandrine; Hodge, Rachel; Dewji, Mohammed R.; Coens, Corneel; Demetri, George D.; Fletcher, Christopher D.; Tos, Angelo Paolo Dei; Hohenberger, Peter
Issue Date
2012-05
Citation
The Lancet, Vol.379 No.9829, pp.1879-1886
Abstract
Background Pazopanib, a multitargeted tyrosine kinase inhibitor, has single-agent activity in patients with advanced non-adipocytic soft-tissue sarcoma. We investigated the effect of pazopanib on progression-free survival in patients with metastatic non-adipocytic soft-tissue sarcoma after failure of standard chemotherapy. Methods This phase 3 study was done in 72 institutions, across 13 countries. Patients with angiogenesis inhibitor-naive, metastatic soft-tissue sarcoma, progressing despite previous standard chemotherapy, were randomly assigned by an interactive voice randomisation system in a 2:1 ratio in permuted blocks (with block sizes of six) to receive either pazopanib 800 mg once daily or placebo, with no subsequent cross-over. Patients, investigators who gave the treatment, those assessing outcomes, and those who did the analysis were masked to the allocation. The primary endpoint was progression-free survival. Efficacy analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00753688. Findings 372 patients were registered and 369 were randomly assigned to receive pazopanib (n = 246) or placebo (n = 123). Median progression-free survival was 4.6 months (95% CI 3.7-4.8) for pazopanib compared with 1.6 months (0.9-1.8) for placebo (hazard ratio [HR] 0.31, 95% CI 0.24-0.40; p < 0.0001). Overall survival was 12.5 months (10.6-14.8) with pazopanib versus 10.7 months (8.7-12.8) with placebo (HR 0.86, 0.67-1.11; p = 0.25). The most common adverse events were fatigue (60 in the placebo group [49%] vs 155 in the pazopanib group [65%]), diarrhoea (20 [16%] vs 138 [58%]), nausea (34 [28%] vs 129 [54%]), weight loss (25 [20%] vs 115 [48%]), and hypertension (8 [7%] vs 99 [41%]). The median relative dose intensity was 100% for placebo and 96% for pazopanib. Interpretation Pazopanib is a new treatment option for patients with metastatic non-adipocytic soft-tissue sarcoma after previous chemotherapy.
ISSN
0140-6736
URI
http://hdl.handle.net/10371/165508
DOI
https://doi.org/10.1016/S0140-6736(12)60651-5
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College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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