Dipartimento di Scienze Radiologiche, Oncologiche e Anatomo-Patologiche, Sapienza Università di Roma, Rome, Italy.
Acta Oncol. 2012 Sep;51(7):873-9. doi: 10.3109/0284186X.2012.705019. Epub 2012 Aug 22.
mTOR inhibitors are currently used in the treatment of solid malignancies. Since their approval, several cases of pulmonary toxicity (PT) have been described. This analysis aims to report the incidence and the risk of PT in published randomized controlled trials.
PubMed and Scopus were reviewed for phase II-III randomized controlled trials with temsirolimus and everolimus. The characteristic of each study and incidence of all- and high-grades PT were collected.
A total of 2233 patients were available for meta-analysis: 989 had breast cancer, 833 had neuroendocrine tumor and 411 had metastatic renal cell carcinoma. In patients taking mTOR inhibitors, the incidence of all- and high-grades PT was 10.4% and 2.4%, respectively. Compared to controls, the relative risk for all- and high-grades PT was 31- and 8.8-folds, respectively. No significant heterogeneity was observed between the studies. Not any relationship was found between the incidence of lung metastases, treatment exposure and the incidence of PT.
The high grade PT is a rare event and 10% of patients may experience mild grade toxicity with a worsening of quality of life and interruption of therapy in some cases. We recommend monitoring of PT in patients treated with mTOR inhibitors.
mTOR 抑制剂目前用于治疗实体恶性肿瘤。自批准以来，已经描述了几例肺毒性（PT）病例。本分析旨在报告已发表的随机对照试验中 PT 的发生率和风险。
在 PubMed 和 Scopus 上检索了接受替西罗莫司和依维莫司治疗的 II 期-III 期随机对照试验。收集了每个研究的特征和所有级别和高级别 PT 的发生率。
共有 2233 名患者可用于荟萃分析：989 名患有乳腺癌，833 名患有神经内分泌肿瘤，411 名患有转移性肾细胞癌。服用 mTOR 抑制剂的患者中，所有级别和高级别 PT 的发生率分别为 10.4%和 2.4%。与对照组相比，所有级别和高级别 PT 的相对风险分别为 31 倍和 8.8 倍。研究之间没有观察到显著的异质性。未发现肺转移的发生率、治疗暴露与 PT 发生率之间存在任何关系。
高级别 PT 是一种罕见的事件，10%的患者可能会经历轻度毒性，在某些情况下会导致生活质量下降和治疗中断。我们建议在接受 mTOR 抑制剂治疗的患者中监测 PT。
