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

Winette T A Van Der Graaf, Jean Yves Blay, Sant P. Chawla, Dong Wan Kim, Binh Bui-Nguyen, Paolo G. Casali, Patrick Schöffski, Massimo Aglietta, Arthur P. Staddon, Yasuo Beppu, Axel Le Cesne, Hans Gelderblom, Ian R. Judson, Nobuhito Araki, Monia Ouali, Sandrine Marreaud, Rachel Hodge, Mohammed R. Dewji, Corneel Coens, George D. DemetriChristopher D. Fletcher, Angelo Paolo Dei Tos, Peter Hohenberger

Research output: Contribution to journalArticlepeer-review

Abstract

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 inhibitornaive,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

Original languageEnglish
Pages (from-to)1879-1886
Number of pages8
JournalLancet
Volume379
Issue number9829
DOIs
Publication statusPublished - May 2012

ASJC Scopus subject areas

  • Medicine(all)

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