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, Toshihumi Ozaki, Takafumi Ueda, Takeshi Ishii, Taito Esaki, Michiko Machida, Nobuaki Fukasawa

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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.gskclinicalstudyregister. com/study/VEG110727#ps.

Original languageEnglish
Article numberhyv184
Pages (from-to)248-253
Number of pages6
JournalJapanese Journal of Clinical Oncology
Volume46
Issue number3
DOIs
Publication statusPublished - Mar 1 2016

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Sarcoma
Placebos
Confidence Intervals
Safety
Population
Disease-Free Survival
Drug Therapy
Survival
pazopanib
Clinical Trials

Keywords

  • Pazopanib
  • Randomized controlled trial
  • Soft tissue sarcoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging

Cite this

A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma : Results from the Japanese subgroup. / Kawai, Akira; Araki, Nobuhito; Hiraga, Hiroaki; Sugiura, Hideshi; Matsumine, Akihiko; Ozaki, Toshihumi; Ueda, Takafumi; Ishii, Takeshi; Esaki, Taito; Machida, Michiko; Fukasawa, Nobuaki.

In: Japanese Journal of Clinical Oncology, Vol. 46, No. 3, hyv184, 01.03.2016, p. 248-253.

Research output: Contribution to journalArticle

Kawai, A, Araki, N, Hiraga, H, Sugiura, H, Matsumine, A, Ozaki, T, Ueda, T, Ishii, T, Esaki, T, Machida, M & Fukasawa, N 2016, 'A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: Results from the Japanese subgroup', Japanese Journal of Clinical Oncology, vol. 46, no. 3, hyv184, pp. 248-253. https://doi.org/10.1093/jjco/hyv184
Kawai, Akira ; Araki, Nobuhito ; Hiraga, Hiroaki ; Sugiura, Hideshi ; Matsumine, Akihiko ; Ozaki, Toshihumi ; Ueda, Takafumi ; Ishii, Takeshi ; Esaki, Taito ; Machida, Michiko ; Fukasawa, Nobuaki. / A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma : Results from the Japanese subgroup. In: Japanese Journal of Clinical Oncology. 2016 ; Vol. 46, No. 3. pp. 248-253.
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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.gskclinicalstudyregister. com/study/VEG110727#ps.",
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AU - Sugiura, Hideshi

AU - Matsumine, Akihiko

AU - Ozaki, Toshihumi

AU - Ueda, Takafumi

AU - Ishii, Takeshi

AU - Esaki, Taito

AU - Machida, Michiko

AU - Fukasawa, Nobuaki

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N2 - 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.gskclinicalstudyregister. com/study/VEG110727#ps.

AB - 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.gskclinicalstudyregister. com/study/VEG110727#ps.

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