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document
Randomized , placebo-controlled , phase III trial of sunitinib plus prednisone versus prednisone alone in progressive , metastatic , castration-resistant prostate cancer . PURPOSE We evaluated angiogenesis-targeted sunitinib therapy in a randomized , double-blind trial of metastatic castration-resistant prostate cancer ( mCRPC ) . PATIENTS AND METHODS Men with progressive mCRPC after docetaxel-based chemotherapy were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo . Patients also received oral prednisone 5 mg twice daily . The primary end point was overall survival ( OS ) ; secondary end points included progression-free survival ( PFS ) . Two interim analyses were planned . RESULTS Overall , 873 patients were randomly assigned to receive sunitinib ( n = 584 ) or placebo ( n = 289 ) . The independent data monitoring committee stopped the study for futility after the second interim analysis . After a median overall follow-up of 8.7 months , median OS was 13.1 months and 11.8 months for sunitinib and placebo , respectively ( hazard ratio [ HR ] , 0.914 ; 95 % CI , 0.762 to 1.097 ; stratified log-rank test , P = .168 ) . PFS was significantly improved in the sunitinib arm ( median 5.6 v 4.1 months ; HR , 0.725 ; 95 % CI , 0.591 to 0.890 ; stratified log-rank test , P < .001 ) . Toxicity and rates of discontinuations because of adverse events ( AEs ; 27 % v 7 % ) were greater with sunitinib than placebo . The most common treatment-related grade 3/4 AEs were fatigue ( 9 % v 1 % ) , asthenia ( 8 % v 2 % ) , and hand-foot syndrome ( 7 % v 0 % ) . Frequent treatment-emergent grade 3/4 hematologic abnormalities were lymphopenia ( 20 % v 11 % ) , anemia ( 9 % v 8 % ) , and neutropenia ( 6 % v < 1 % ) . CONCLUSION The addition of sunitinib to prednisone did not improve OS compared with placebo in docetaxel-refractory mCRPC . The role of antiangiogenic therapy in mCRPC remains investigational .
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Intervention_Pharmacological
sunitinib 37.5 mg/d
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Intervention_Control
placebo
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Intervention_Pharmacological
oral prednisone 5 mg twice daily
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Outcome_Physical
angiogenesis-targeted sunitinib therapy
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Outcome_Mortality
overall survival
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Outcome_Mortality
progression-free survival ( PFS )
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Outcome_Mortality
median OS
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Outcome_Mortality
PFS
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Outcome_Adverse-effects
Toxicity and rates of discontinuations because of adverse events
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Outcome_Adverse-effects
fatigue
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Outcome_Adverse-effects
asthenia
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Outcome_Adverse-effects
hand-foot syndrome
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Outcome_Adverse-effects
hematologic abnormalities
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Outcome_Adverse-effects
lymphopenia
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Outcome_Adverse-effects
anemia
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Outcome_Adverse-effects
neutropenia
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Outcome_Mortality
OS
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Participant_Condition
progressive , metastatic , castration-resistant prostate cancer .