A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup

Akira Kawai, Nobuhito Araki, Hiroaki Hiraga, Hideshi Sugiura, Akihiko Matsumine, Toshifumi Ozaki, Takafumi Ueda, Takeshi Ishii, Taito Esaki, Michiko Machida, Nobuaki Fukasawa, Akira Kawai, Nobuhito Araki, Hiroaki Hiraga, Hideshi Sugiura, Akihiko Matsumine, Toshifumi Ozaki, Takafumi Ueda, Takeshi Ishii, Taito Esaki, Michiko Machida, Nobuaki Fukasawa

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 2:1 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.

Keywords: pazopanib; randomized controlled trial; soft tissue sarcoma.

© The Author 2016. Published by Oxford University Press.

Figures

Figure 1.
Figure 1.
Patient disposition.
Figure 2.
Figure 2.
Progression-free survival (ITT population, assessed by independent radiologist). ITT, intent-to-treat.
Figure 3.
Figure 3.
Overall survival (ITT population). ITT, intent-to-treat.

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Source: PubMed

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