1. 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
- Author
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Nagahiro Saijo, Yoshiyuki Shibasaki, Yutaka Endo, Mototsugu Oya, Akihiko Gemma, Yasuharu Toyoshima, Hideyuki Akaza, Kazuo Sato, Shigeru Sugiyama, Naoto Miyanaga, and Taku Uryu
- Subjects
Adult ,Male ,safety ,Cancer Research ,medicine.medical_specialty ,Surveillance study ,Phases of clinical research ,Antineoplastic Agents ,Disease-Free Survival ,03 medical and health sciences ,0302 clinical medicine ,Asian People ,Japan ,Renal cell carcinoma ,Internal medicine ,temsirolimus ,Product Surveillance, Postmarketing ,medicine ,Humans ,AcademicSubjects/MED00300 ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,030212 general & internal medicine ,Carcinoma, Renal Cell ,Stomatitis ,Aged ,Aged, 80 and over ,Sirolimus ,business.industry ,Interstitial lung disease ,General Medicine ,Middle Aged ,medicine.disease ,Kidney Neoplasms ,Temsirolimus ,Confidence interval ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Female ,Original Article ,Observational study ,product surveillance postmarketing ,carcinoma renal cell ,Lung Diseases, Interstitial ,business ,medicine.drug - Abstract
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, In this Japanese post-marketing surveillance study, the safety and effectiveness profile of temsirolimus was similar to that in the multinational phase 3 study. No new safety signals were identified.
- Published
- 2020
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