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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Chawla, Sant P. Van Der Graaf, Winette T. A. Blay, Jean-yves Judson, Ian R. Le Cesne, Axel Casali, Paolo G. Gelderblom, Hans Marreaud, Sandrine Demetri, George D. Coens, Corneel Bui-nguyen, Binh Hohenberger, Peter Staddon, Arthur P. Araki, Nobuhito Dei Tos, Angelo Paolo Kim, Dong-wan Hodge, Rachel Dewji, Mohammed R. Schöffski, Patrick Aglietta, Massimo Beppu, Yasuo Ouali, Monia Fletcher, Christopher D. |
| Description | Author Affiliation: van der Graaf WT ( Radboud University Medical Centre, Department of Medical Oncology, Nijmegen, Netherlands. w.vandergraaf@onco.umcn.nl) |
| 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. FUNDING: GlaxoSmithKline. |
| ISSN | 01406736 |
| e-ISSN | 1474547X |
| Journal | The Lancet |
| Issue Number | 9829 |
| Volume Number | 379 |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2012-05-19 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Antineoplastic Agents Therapeutic Use Pyrimidines Sarcoma Drug Therapy Soft Tissue Neoplasms Sulfonamides Adolescent Cross-Over Studies Disease-Free Survival Double-Blind Method Kaplan-Meier Estimate Mortality Clinical Trial, Phase III Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
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