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
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
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替西罗莫司在日本不可切除或转移性肾细胞癌患者中的实际应用：基于上市后全病例监测研究结果的近期考虑
DOI：
10.1093/jjco/hyaa062
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发表时间：
2020
影响因子：
2.4
通讯作者：
Akaza Hideyuki
中科院分区：
文献类型：
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作者：
Sugiyama Shigeru;Sato Kazuo;Shibasaki Yoshiyuki;Endo Yutaka;Uryu Taku;Toyoshima Yasuharu;Oya Mototsugu;Miyanaga Naoto;Saijo Nagahiro;Gemma Akihiko;Akaza Hideyuki
在日本进行了一项前瞻性、观察性、上市后监测，以评估替西罗莫司在肾细胞癌患者中的安全性和有效性。（每周25 mg，静脉输注30-60分钟），在常规临床环境中结果在纳入安全性分析数据集的1001例患者中，（中位年龄65.0岁;男性74.8%;东部肿瘤协作组体能状态0或1，69.6%），778例（77.7%）报告了药物不良反应。最常见（≥10%）的所有级别药物不良反应为口腔炎（26.7%）、间质性肺病（17.3%）和血小板计数降低（11.1%）。≥3级间质性肺疾病的发生率为4.5%。治疗4-8周后或东部肿瘤协作组体力状态较低的患者中，间质性肺病的发病率更高（0分为21.6%，4分为8.3%，P< 0.001）。在有效性分析数据集中的654例患者中，缓解率和临床获益率分别为6.7%（95%置信区间4.9-8.9）和53.2%（95%置信区间49.3-57.1）。中位无进展生存期为18.3周（95%置信区间16.9-21.1）。结论本研究中观察到的替西罗莫司的安全性和有效性特征与多国3期研究中观察到的相似。结果可推广到本研究时的真实世界场景，替西罗莫司作为肾细胞癌后续抗癌治疗的安全性和有效性值得进一步研究。（ClinicalTrials.gov标识符NCT 01210482、NCT 01420601）。
ObjectiveA prospective, observational, post-marketing surveillance was conducted to assess the safety and effectiveness of temsirolimus in patients with renal cell carcinoma in Japan.MethodsPatients 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).ResultsAmong 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).ConclusionsThe 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. (ClinicalTrials.gov identifier NCT01210482, NCT01420601).