A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: Results of over 3200 consecutive cases in post-marketing all-patient surveillance

Hideyuki Akaza, Mototsugu Oya, Masafumi Iijima, Ichinosuke Hyodo, Akihiko Gemma, Hiroshi Itoh, Masatoshi Adachi, Yutaka Okayama, Toshiyuki Sunaya, Lyo Inuyama

研究成果: Article査読

15 被引用数 (Scopus)

抄録

Objective: Real-life safety and efficacy of sorafenib in advanced renal cell carcinoma in a nationwide patient population were evaluated by post-marketing all-patient surveillance. Methods: All patients with unresectable or metastatic renal cell carcinoma in Japan who started sorafenib therapy from February 2008 to September 2009 were registered and followed for up to 12 months. Baseline characteristics, treatment status, tumor response, survival and safety data were recorded by the prescribing physicians. Results: Safety and efficacy were evaluated in 3255 and 3171 patients, respectively. The initial daily dose was 800 mg in 78.2% of patients. Median duration of treatment was 6.7 months and the mean relative dose intensity was 68.4%. Overall, 2227 patients (68.4%) discontinued the treatment by 12 months, half of which (52.0% of discontinued patients) were due to adverse events. The most common adverse drug reactions were hand-foot skin reaction (59%), hypertension (36%), rash (25%) and increase in lipase/amylase (23%). The median progression-free survival was 7.3 months (95% confidence intervals: 6.7-8.1), and the overall survival rate at 1 year was 75.4% (73.5-77.1). Prognostic factors for overall survival were mostly consistent with those in previous clinical trials in the univariate analysis and largely similar to those for progression-free survival and duration of treatment in the multivariate analysis.

本文言語English
論文番号hyv099
ページ(範囲)953-962
ページ数10
ジャーナルJapanese journal of clinical oncology
45
10
DOI
出版ステータスPublished - 2015 10

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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