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Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1
OBJECTIVE: To assess the efficacy and safety of everolimus in Japanese patients with metastatic renal cell carcinoma. METHODS: A subgroup analysis of the pivotal Phase III, randomized, double-blind, placebo-controlled trial of everolimus 10 mg/day in patients with disease progression after treatment...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3012894/ https://www.ncbi.nlm.nih.gov/pubmed/20965941 http://dx.doi.org/10.1093/jjco/hyq166 |
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author | Tsukamoto, Taiji Shinohara, Nobuo Tsuchiya, Norihiko Hamamoto, Yasuo Maruoka, Masayuki Fujimoto, Hiroyuki Niwakawa, Masashi Uemura, Hirotsugu Usami, Michiyuki Terai, Akito Kanayama, Hiro-omi Sumiyoshi, Yoshiteru Eto, Masatoshi Akaza, Hideyuki |
author_facet | Tsukamoto, Taiji Shinohara, Nobuo Tsuchiya, Norihiko Hamamoto, Yasuo Maruoka, Masayuki Fujimoto, Hiroyuki Niwakawa, Masashi Uemura, Hirotsugu Usami, Michiyuki Terai, Akito Kanayama, Hiro-omi Sumiyoshi, Yoshiteru Eto, Masatoshi Akaza, Hideyuki |
author_sort | Tsukamoto, Taiji |
collection | PubMed |
description | OBJECTIVE: To assess the efficacy and safety of everolimus in Japanese patients with metastatic renal cell carcinoma. METHODS: A subgroup analysis of the pivotal Phase III, randomized, double-blind, placebo-controlled trial of everolimus 10 mg/day in patients with disease progression after treatment with sorafenib, sunitinib or both assessed outcomes in Japanese participants. Results were compared with those for the overall study population. RESULTS: The final trial analysis included 24 Japanese patients (everolimus, n= 15; placebo, n = 9). Median progression-free survival in the Japanese subpopulation was 5.75 months (95% confidence interval, 4.90 months to not reached) with everolimus and 3.61 months (95% confidence interval, 1.91–9.03 months) with placebo (hazard ratio, 0.19; 95% confidence interval, 0.05–0.83). Median overall survival was not reached with everolimus and was 14.9 months (95% confidence interval, 11.0–16.8 months) with placebo (hazard ratio, 0.30; 95% confidence interval, 0.07–1.27). Overall, efficacy and safety were similar when comparing the Japanese and overall populations. In the Japanese subpopulation, the most common adverse events with everolimus were stomatitis, infections and rash. Four Japanese subjects (27%) developed Grade 1 (n = 2) or 2 (n = 2) pneumonitis (all reversible and allowing for continuation of therapy, after interruption, steroids and dose reduction for both Grade 2 cases), with a lower pneumonitis incidence of 14% in the overall population (albeit associated with a Grade 3 incidence of 4%). CONCLUSIONS: These findings suggest that the demonstrated benefits of everolimus in the overall trial population are similar in Japanese patients with metastatic renal cell carcinoma. |
format | Text |
id | pubmed-3012894 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-30128942011-01-03 Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1 Tsukamoto, Taiji Shinohara, Nobuo Tsuchiya, Norihiko Hamamoto, Yasuo Maruoka, Masayuki Fujimoto, Hiroyuki Niwakawa, Masashi Uemura, Hirotsugu Usami, Michiyuki Terai, Akito Kanayama, Hiro-omi Sumiyoshi, Yoshiteru Eto, Masatoshi Akaza, Hideyuki Jpn J Clin Oncol Original Articles OBJECTIVE: To assess the efficacy and safety of everolimus in Japanese patients with metastatic renal cell carcinoma. METHODS: A subgroup analysis of the pivotal Phase III, randomized, double-blind, placebo-controlled trial of everolimus 10 mg/day in patients with disease progression after treatment with sorafenib, sunitinib or both assessed outcomes in Japanese participants. Results were compared with those for the overall study population. RESULTS: The final trial analysis included 24 Japanese patients (everolimus, n= 15; placebo, n = 9). Median progression-free survival in the Japanese subpopulation was 5.75 months (95% confidence interval, 4.90 months to not reached) with everolimus and 3.61 months (95% confidence interval, 1.91–9.03 months) with placebo (hazard ratio, 0.19; 95% confidence interval, 0.05–0.83). Median overall survival was not reached with everolimus and was 14.9 months (95% confidence interval, 11.0–16.8 months) with placebo (hazard ratio, 0.30; 95% confidence interval, 0.07–1.27). Overall, efficacy and safety were similar when comparing the Japanese and overall populations. In the Japanese subpopulation, the most common adverse events with everolimus were stomatitis, infections and rash. Four Japanese subjects (27%) developed Grade 1 (n = 2) or 2 (n = 2) pneumonitis (all reversible and allowing for continuation of therapy, after interruption, steroids and dose reduction for both Grade 2 cases), with a lower pneumonitis incidence of 14% in the overall population (albeit associated with a Grade 3 incidence of 4%). CONCLUSIONS: These findings suggest that the demonstrated benefits of everolimus in the overall trial population are similar in Japanese patients with metastatic renal cell carcinoma. Oxford University Press 2011-01 2010-10-21 /pmc/articles/PMC3012894/ /pubmed/20965941 http://dx.doi.org/10.1093/jjco/hyq166 Text en © 2010 The Author(s) http://creativecommons.org/licenses/by-nc/2.5/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.5), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Articles Tsukamoto, Taiji Shinohara, Nobuo Tsuchiya, Norihiko Hamamoto, Yasuo Maruoka, Masayuki Fujimoto, Hiroyuki Niwakawa, Masashi Uemura, Hirotsugu Usami, Michiyuki Terai, Akito Kanayama, Hiro-omi Sumiyoshi, Yoshiteru Eto, Masatoshi Akaza, Hideyuki Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1 |
title | Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1 |
title_full | Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1 |
title_fullStr | Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1 |
title_full_unstemmed | Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1 |
title_short | Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1 |
title_sort | phase iii trial of everolimus in metastatic renal cell carcinoma: subgroup analysis of japanese patients from record-1 |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3012894/ https://www.ncbi.nlm.nih.gov/pubmed/20965941 http://dx.doi.org/10.1093/jjco/hyq166 |
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