Cargando…
A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup
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:...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4777611/ https://www.ncbi.nlm.nih.gov/pubmed/26864131 http://dx.doi.org/10.1093/jjco/hyv184 |
_version_ | 1782419331624206336 |
---|---|
author | Kawai, Akira Araki, Nobuhito Hiraga, Hiroaki Sugiura, Hideshi Matsumine, Akihiko Ozaki, Toshifumi Ueda, Takafumi Ishii, Takeshi Esaki, Taito Machida, Michiko Fukasawa, Nobuaki |
author_facet | Kawai, Akira Araki, Nobuhito Hiraga, Hiroaki Sugiura, Hideshi Matsumine, Akihiko Ozaki, Toshifumi Ueda, Takafumi Ishii, Takeshi Esaki, Taito Machida, Michiko Fukasawa, Nobuaki |
author_sort | Kawai, Akira |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4777611 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-47776112016-03-04 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, Toshifumi Ueda, Takafumi Ishii, Takeshi Esaki, Taito Machida, Michiko Fukasawa, Nobuaki Jpn J Clin Oncol Original Articles 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. Oxford University Press 2016-03 2016-02-10 /pmc/articles/PMC4777611/ /pubmed/26864131 http://dx.doi.org/10.1093/jjco/hyv184 Text en © The Author 2016. Published by Oxford University Press http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Original Articles Kawai, Akira Araki, Nobuhito Hiraga, Hiroaki Sugiura, Hideshi Matsumine, Akihiko Ozaki, Toshifumi 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 |
title | A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup |
title_full | A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup |
title_fullStr | A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup |
title_full_unstemmed | A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup |
title_short | A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup |
title_sort | randomized, double-blind, placebo-controlled, phase iii study of pazopanib in patients with soft tissue sarcoma: results from the japanese subgroup |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4777611/ https://www.ncbi.nlm.nih.gov/pubmed/26864131 http://dx.doi.org/10.1093/jjco/hyv184 |
work_keys_str_mv | AT kawaiakira arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT arakinobuhito arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT hiragahiroaki arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT sugiurahideshi arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT matsumineakihiko arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT ozakitoshifumi arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT uedatakafumi arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT ishiitakeshi arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT esakitaito arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT machidamichiko arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT fukasawanobuaki arandomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT kawaiakira randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT arakinobuhito randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT hiragahiroaki randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT sugiurahideshi randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT matsumineakihiko randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT ozakitoshifumi randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT uedatakafumi randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT ishiitakeshi randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT esakitaito randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT machidamichiko randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup AT fukasawanobuaki randomizeddoubleblindplacebocontrolledphaseiiistudyofpazopanibinpatientswithsofttissuesarcomaresultsfromthejapanesesubgroup |