Real-world use of temsirolimus in Japanese patients with unresectable or metastatic renal cell carcinoma: Recent consideration based on the results of a post-marketing, all-case surveillance study

Shigeru Sugiyama, Kazuo Sato, Yoshiyuki Shibasaki, Yutaka Endo, Taku Uryu, Yasuharu Toyoshima, Mototsugu Oya, Naoto Miyanaga, Nagahiro Saijo, Akihiko Gemma, Hideyuki Akaza

研究成果: Article査読

2 被引用数 (Scopus)

抄録

Objective: A prospective, observational, post-marketing surveillance was conducted to assess the safety and effectiveness of temsirolimus in patients with renal cell carcinoma in Japan. Methods: Patients prescribed temsirolimus for advanced renal cell carcinoma were registered and received temsirolimus (25 mg weekly, intravenous infusion for 30-60 minutes) in routine clinical settings (observation period: 96 weeks). Results: Among 1001 patients included in the safety analysis data set (median age, 65.0 years; men, 74.8%; Eastern Cooperative Oncology Group performance status 0 or 1, 69.6%), 778 (77.7%) reported adverse drug reactions. The most common (≥10%) all-grade adverse drug reactions were stomatitis (26.7%), interstitial lung disease (17.3%) and platelet count decreased (11.1%). The incidence rate of grade ≥3 interstitial lung disease was 4.5%. The onset of interstitial lung disease was more frequent after 4-8 weeks of treatment or in patients with lower Eastern Cooperative Oncology Group performance status (21.6% for score 0 vs 8.3% for score 4, P < 0.001). Among 654 patients in the effectiveness analysis data set, the response and clinical benefit rates were 6.7% (95% confidence interval 4.9-8.9) and 53.2% (95% confidence interval 49.3-57.1), respectively. The median progression-free survival was 18.3 weeks (95% confidence interval 16.9-21.1). Conclusions: The safety and effectiveness profile of temsirolimus observed in this study was similar to that observed in the multinational phase 3 study. The results are generalizable to the real-world scenario at the time of this research, and safety and effectiveness of temsirolimus as a subsequent anticancer therapy for renal cell carcinoma warrants further investigation.

本文言語English
ページ(範囲)940-947
ページ数8
ジャーナルJapanese journal of clinical oncology
50
8
DOI
出版ステータスPublished - 2020 8 1

ASJC Scopus subject areas

  • 腫瘍学
  • 放射線学、核医学およびイメージング
  • 癌研究

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