Phase III trial of everolimus in metastatic renal cell carcinoma: Subgroup analysis of Japanese patients from RECORD-1

Taiji Tsukamoto, Nobuo Shinohara, Norihiko Tsuchiya, Yasuo Hamamoto, Masayuki Maruoka, Hiroyuki Fujimoto, Masashi Niwakawa, Hirotsugu Uemura, Michiyuki Usami, Akito Terai, Hiro Omi Kanayama, Yoshiteru Sumiyoshi, Masatoshi Eto, Hideyuki Akaza

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

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, placebocontrolled 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.

Original languageEnglish
Article numberhyq166
Pages (from-to)17-24
Number of pages8
JournalJapanese Journal of Clinical Oncology
Volume41
Issue number1
DOIs
Publication statusPublished - 2011 Jan 1
Externally publishedYes

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Renal Cell Carcinoma
Confidence Intervals
Placebos
Population
Pneumonia
Safety
Stomatitis
Incidence
Everolimus
Exanthema
Disease-Free Survival
Disease Progression
Steroids
Survival
Therapeutics
Infection

Keywords

  • Everolimus
  • mTOR
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

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.

In: Japanese Journal of Clinical Oncology, Vol. 41, No. 1, hyq166, 01.01.2011, p. 17-24.

Research output: Contribution to journalArticle

Tsukamoto, T, Shinohara, N, Tsuchiya, N, Hamamoto, Y, Maruoka, M, Fujimoto, H, Niwakawa, M, Uemura, H, Usami, M, Terai, A, Kanayama, HO, Sumiyoshi, Y, Eto, M & Akaza, H 2011, 'Phase III trial of everolimus in metastatic renal cell carcinoma: Subgroup analysis of Japanese patients from RECORD-1', Japanese Journal of Clinical Oncology, vol. 41, no. 1, hyq166, pp. 17-24. https://doi.org/10.1093/jjco/hyq166
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. In: Japanese Journal of Clinical Oncology. 2011 ; Vol. 41, No. 1. pp. 17-24.
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abstract = "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, placebocontrolled 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.",
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AU - Tsukamoto, Taiji

AU - Shinohara, Nobuo

AU - Tsuchiya, Norihiko

AU - Hamamoto, Yasuo

AU - Maruoka, Masayuki

AU - Fujimoto, Hiroyuki

AU - Niwakawa, Masashi

AU - Uemura, Hirotsugu

AU - Usami, Michiyuki

AU - Terai, Akito

AU - Kanayama, Hiro Omi

AU - Sumiyoshi, Yoshiteru

AU - Eto, Masatoshi

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