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 journalArticlepeer-review

11 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
Pages (from-to)1231-1239
Number of pages9
JournalCancer science
Volume108
Issue number6
DOIs
Publication statusPublished - 2017 Jun

Keywords

  • Antiangiogenic agent
  • Japanese
  • axitinib
  • clinical trial phase II
  • renal cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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