Overall survival of first-line axitinib in metastatic renal cell carcinoma: Japanese subgroup analysis from phase II study

Mototsugu Oya, Yoshihiko Tomita, Satoshi Fukasawa, Nobuo Shinohara, Tomonori Habuchi, Brian I. Rini, Yosuke Fujii, Yoichi Kamei, Yoshiko Umeyama, Angel H. Bair, Hirotsugu Uemura

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66% and median progression-free survival of 27.6 months in treatment-naïve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and safety in 44 Japanese patients and compared the results with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored in all patients using a Cox proportional hazard model. With median follow-up of 33 months, fewer than half (16 of 44) of the Japanese patients had died and median OS was not reached (95% confidence interval [CI], 38.8 months-not estimable), whereas 107 of 169 (63%) non-Japanese patients had died and median OS was 33.9 months (95% CI, 28.9-42.7). Estimated 1-year, 2-year and 3-year survival probability (95% CI) was 86.4% (76.2-96.5), 75.0% (62.2-87.8) and 68.2% (54.4-81.9), respectively, in Japanese patients, and was higher than that in non-Japanese patients (75.1% [68.4-81.8], 62.1% [54.5-69.7] and 47.2% [39.3-55.1], respectively). The updated safety analysis did not reveal any new adverse events of concern among Japanese or non-Japanese patients. The multivariate analysis identified that lower baseline Eastern Cooperative Oncology Group performance status, lower baseline tumor burden, and longer time from histopathological diagnosis to treatment were significant positive predictors of OS. The current analysis confirmed the clinical activity of axitinib in treatment-naïve Japanese patients with metastatic RCC, with an acceptable toxicity profile.

Original languageEnglish
JournalCancer Science
DOIs
Publication statusAccepted/In press - 2017

Fingerprint

Renal Cell Carcinoma
Survival
Confidence Intervals
axitinib
Safety
Tumor Burden
Proportional Hazards Models
Disease-Free Survival
Therapeutics
Multivariate Analysis

Keywords

  • Antiangiogenic agent
  • Axitinib
  • Clinical trial phase II
  • Japanese
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Overall survival of first-line axitinib in metastatic renal cell carcinoma : Japanese subgroup analysis from phase II study. / Oya, Mototsugu; Tomita, Yoshihiko; Fukasawa, Satoshi; Shinohara, Nobuo; Habuchi, Tomonori; Rini, Brian I.; Fujii, Yosuke; Kamei, Yoichi; Umeyama, Yoshiko; Bair, Angel H.; Uemura, Hirotsugu.

In: Cancer Science, 2017.

Research output: Contribution to journalArticle

Oya, M, Tomita, Y, Fukasawa, S, Shinohara, N, Habuchi, T, Rini, BI, Fujii, Y, Kamei, Y, Umeyama, Y, Bair, AH & Uemura, H 2017, 'Overall survival of first-line axitinib in metastatic renal cell carcinoma: Japanese subgroup analysis from phase II study', Cancer Science. https://doi.org/10.1111/cas.13232
Oya, Mototsugu ; Tomita, Yoshihiko ; Fukasawa, Satoshi ; Shinohara, Nobuo ; Habuchi, Tomonori ; Rini, Brian I. ; Fujii, Yosuke ; Kamei, Yoichi ; Umeyama, Yoshiko ; Bair, Angel H. ; Uemura, Hirotsugu. / Overall survival of first-line axitinib in metastatic renal cell carcinoma : Japanese subgroup analysis from phase II study. In: Cancer Science. 2017.
@article{162fcfc41fd64451bdeb30ac4d5896d6,
title = "Overall survival of first-line axitinib in metastatic renal cell carcinoma: Japanese subgroup analysis from phase II study",
abstract = "Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66{\%} and median progression-free survival of 27.6 months in treatment-na{\"i}ve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and safety in 44 Japanese patients and compared the results with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored in all patients using a Cox proportional hazard model. With median follow-up of 33 months, fewer than half (16 of 44) of the Japanese patients had died and median OS was not reached (95{\%} confidence interval [CI], 38.8 months-not estimable), whereas 107 of 169 (63{\%}) non-Japanese patients had died and median OS was 33.9 months (95{\%} CI, 28.9-42.7). Estimated 1-year, 2-year and 3-year survival probability (95{\%} CI) was 86.4{\%} (76.2-96.5), 75.0{\%} (62.2-87.8) and 68.2{\%} (54.4-81.9), respectively, in Japanese patients, and was higher than that in non-Japanese patients (75.1{\%} [68.4-81.8], 62.1{\%} [54.5-69.7] and 47.2{\%} [39.3-55.1], respectively). The updated safety analysis did not reveal any new adverse events of concern among Japanese or non-Japanese patients. The multivariate analysis identified that lower baseline Eastern Cooperative Oncology Group performance status, lower baseline tumor burden, and longer time from histopathological diagnosis to treatment were significant positive predictors of OS. The current analysis confirmed the clinical activity of axitinib in treatment-na{\"i}ve Japanese patients with metastatic RCC, with an acceptable toxicity profile.",
keywords = "Antiangiogenic agent, Axitinib, Clinical trial phase II, Japanese, Renal cell carcinoma",
author = "Mototsugu Oya and Yoshihiko Tomita and Satoshi Fukasawa and Nobuo Shinohara and Tomonori Habuchi and Rini, {Brian I.} and Yosuke Fujii and Yoichi Kamei and Yoshiko Umeyama and Bair, {Angel H.} and Hirotsugu Uemura",
year = "2017",
doi = "10.1111/cas.13232",
language = "English",
journal = "Cancer Science",
issn = "1347-9032",
publisher = "Wiley-Blackwell",

}

TY - JOUR

T1 - Overall survival of first-line axitinib in metastatic renal cell carcinoma

T2 - Japanese subgroup analysis from phase II study

AU - Oya, Mototsugu

AU - Tomita, Yoshihiko

AU - Fukasawa, Satoshi

AU - Shinohara, Nobuo

AU - Habuchi, Tomonori

AU - Rini, Brian I.

AU - Fujii, Yosuke

AU - Kamei, Yoichi

AU - Umeyama, Yoshiko

AU - Bair, Angel H.

AU - Uemura, Hirotsugu

PY - 2017

Y1 - 2017

N2 - Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66% and median progression-free survival of 27.6 months in treatment-naïve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and safety in 44 Japanese patients and compared the results with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored in all patients using a Cox proportional hazard model. With median follow-up of 33 months, fewer than half (16 of 44) of the Japanese patients had died and median OS was not reached (95% confidence interval [CI], 38.8 months-not estimable), whereas 107 of 169 (63%) non-Japanese patients had died and median OS was 33.9 months (95% CI, 28.9-42.7). Estimated 1-year, 2-year and 3-year survival probability (95% CI) was 86.4% (76.2-96.5), 75.0% (62.2-87.8) and 68.2% (54.4-81.9), respectively, in Japanese patients, and was higher than that in non-Japanese patients (75.1% [68.4-81.8], 62.1% [54.5-69.7] and 47.2% [39.3-55.1], respectively). The updated safety analysis did not reveal any new adverse events of concern among Japanese or non-Japanese patients. The multivariate analysis identified that lower baseline Eastern Cooperative Oncology Group performance status, lower baseline tumor burden, and longer time from histopathological diagnosis to treatment were significant positive predictors of OS. The current analysis confirmed the clinical activity of axitinib in treatment-naïve Japanese patients with metastatic RCC, with an acceptable toxicity profile.

AB - Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66% and median progression-free survival of 27.6 months in treatment-naïve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and safety in 44 Japanese patients and compared the results with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored in all patients using a Cox proportional hazard model. With median follow-up of 33 months, fewer than half (16 of 44) of the Japanese patients had died and median OS was not reached (95% confidence interval [CI], 38.8 months-not estimable), whereas 107 of 169 (63%) non-Japanese patients had died and median OS was 33.9 months (95% CI, 28.9-42.7). Estimated 1-year, 2-year and 3-year survival probability (95% CI) was 86.4% (76.2-96.5), 75.0% (62.2-87.8) and 68.2% (54.4-81.9), respectively, in Japanese patients, and was higher than that in non-Japanese patients (75.1% [68.4-81.8], 62.1% [54.5-69.7] and 47.2% [39.3-55.1], respectively). The updated safety analysis did not reveal any new adverse events of concern among Japanese or non-Japanese patients. The multivariate analysis identified that lower baseline Eastern Cooperative Oncology Group performance status, lower baseline tumor burden, and longer time from histopathological diagnosis to treatment were significant positive predictors of OS. The current analysis confirmed the clinical activity of axitinib in treatment-naïve Japanese patients with metastatic RCC, with an acceptable toxicity profile.

KW - Antiangiogenic agent

KW - Axitinib

KW - Clinical trial phase II

KW - Japanese

KW - Renal cell carcinoma

UR - http://www.scopus.com/inward/record.url?scp=85019859003&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019859003&partnerID=8YFLogxK

U2 - 10.1111/cas.13232

DO - 10.1111/cas.13232

M3 - Article

C2 - 28267243

AN - SCOPUS:85019859003

JO - Cancer Science

JF - Cancer Science

SN - 1347-9032

ER -