A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup.
Jpn J Clin Oncol
; 46(3): 248-53, 2016 Mar.
Article
en En
| MEDLINE
| ID: mdl-26864131
ABSTRACT
OBJECTIVE:
This analysis of the Japanese subpopulation of the PALETTE Phase III, randomized, placebo-controlled study investigated efficacy and safety of pazopanib in patients with metastatic soft tissue sarcoma after failure of standard chemotherapy.METHODS:
Patients were randomly assigned in a 21 ratio to receive either pazopanib 800 mg once daily or placebo, with no subsequent cross-over. Primary endpoint was progression-free survival. Secondary endpoints included overall survival and overall response rate. Efficacy analysis was by intent-to-treat. Safety was also investigated.RESULTS:
Forty-seven patients received either pazopanib (n = 31) or placebo (n = 16). Median progression-free survival was 7.0 weeks (95% confidence interval 4.0-11.7) for placebo and 24.7 weeks (95% confidence interval 8.6-28.1) for pazopanib (hazard ratio = 0.41 [95% confidence interval 0.19-0.90]; P = 0.002). Median overall survival was 14.9 months (95% confidence interval 6.8-not calculable) for placebo and 15.4 months (95% confidence interval 7.9-28.8) for pazopanib (hazard ratio = 0.87 [95% confidence interval 0.41-1.83]; P = 0.687). More patients receiving pazopanib experienced best response of stable disease versus placebo. Adverse events were similar to the global population; those leading to dose reduction were more common and mean daily dose was lower in the Japanese population versus the global population (45 vs. 32% and 624.4 vs. 700.4 mg, respectively).CONCLUSIONS:
The efficacy and safety of pazopanib observed in the Japanese subpopulation of PALETTE were similar to those in the global population. Pazopanib is a new treatment option for Japanese patients with metastatic non-adipocytic soft tissue sarcoma after chemotherapy. CLINICAL TRIAL REGISTRATION NUMBER NCT00753688; GSK study ID VEG110727; http//www.gsk-clinicalstudyregister.com/study/VEG110727#ps.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pirimidinas
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Sarcoma
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Sulfonamidas
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Inhibidores de la Angiogénesis
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Factor A de Crecimiento Endotelial Vascular
Tipo de estudio:
Clinical_trials
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Etiology_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Asia
Idioma:
En
Revista:
Jpn J Clin Oncol
Año:
2016
Tipo del documento:
Article