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document
Pazopanib in locally advanced or metastatic renal cell carcinoma : results of a randomized phase III trial . PURPOSE Pazopanib is an oral angiogenesis inhibitor targeting vascular endothelial growth factor receptor , platelet-derived growth factor receptor , and c-Kit . This randomized , double-blind , placebo-controlled phase III study evaluated efficacy and safety of pazopanib monotherapy in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma ( RCC ) . PATIENTS AND METHODS Adult patients with measurable , locally advanced , and/or metastatic RCC were randomly assigned 2:1 to receive oral pazopanib or placebo . The primary end point was progression-free survival ( PFS ) . Secondary end points included overall survival , tumor response rate ( Response Evaluation Criteria in Solid Tumors ) , and safety . Radiographic assessments of tumors were independently reviewed . Results Of 435 patients enrolled , 233 were treatment naive ( 54 % ) and 202 were cytokine pretreated ( 46 % ) . PFS was significantly prolonged with pazopanib compared with placebo in the overall study population ( median , PFS 9.2 v 4.2 months ; hazard ratio [ HR ] , 0.46 ; 95 % CI , 0.34 to 0.62 ; P < .0001 ) , the treatment-naive subpopulation ( median PFS 11.1 v 2.8 months ; HR , 0.40 ; 95 % CI , 0.27 to 0.60 ; P < .0001 ) , and the cytokine-pretreated subpopulation ( median PFS , 7.4 v 4.2 months ; HR , 0.54 ; 95 % CI , 0.35 to 0.84 ; P < .001 ) . The objective response rate was 30 % with pazopanib compared with 3 % with placebo ( P < .001 ) . The median duration of response was longer than 1 year . The most common adverse events were diarrhea , hypertension , hair color changes , nausea , anorexia , and vomiting . There was no evidence of clinically important differences in quality of life for pazopanib versus placebo . CONCLUSION Pazopanib demonstrated significant improvement in PFS and tumor response compared with placebo in treatment-naive and cytokine-pretreated patients with advanced and/or metastatic RCC .
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Intervention_Pharmacological
Pazopanib
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Intervention_Pharmacological
Pazopanib
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Intervention_Pharmacological
oral angiogenesis inhibitor
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
pazopanib monotherapy
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Intervention_Pharmacological
cytokine-pretreated
44039
Intervention_Pharmacological
oral pazopanib
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Intervention_Control
placebo
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Intervention_Pharmacological
pazopanib
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Intervention_Control
placebo
44043
Intervention_Pharmacological
pazopanib
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Intervention_Control
placebo
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Intervention_Pharmacological
pazopanib
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Intervention_Control
placebo
44047
Intervention_Pharmacological
Pazopanib
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Intervention_Control
placebo
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Intervention_Pharmacological
cytokine-pretreated
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Outcome_Mortality
progression-free survival ( PFS )
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Outcome_Mortality
overall survival
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Outcome_Physical
tumor response rate
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Outcome_Physical
Response Evaluation Criteria in Solid Tumors
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Outcome_Other
safety
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Outcome_Mortality
PFS
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Outcome_Other
objective response rate
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Outcome_Physical
median duration of response
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Outcome_Adverse-effects
diarrhea
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Outcome_Adverse-effects
hypertension
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Outcome_Adverse-effects
hair color changes
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Outcome_Physical
nausea
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Outcome_Adverse-effects
anorexia
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Outcome_Adverse-effects
vomiting
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Participant_Condition
renal cell carcinoma
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Participant_Condition
RCC
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Participant_Sample-size
435
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Participant_Sample-size
233
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Participant_Sample-size
202