Joly Florence, Eymard Jean-Christophe, Albiges Laurence, Nguyen Thierry, Guillot Aline, Rolland Frederic, Spaeth Dominique, Laguerre Brigitte, Lebret Thierry, Kelkouli Nadia, Slimane Khemaies, Ravaud Alain
Centre François Baclesse-CHU, Caen, France.
Institut Jean Godinot, Reims, France.
Support Care Cancer. 2017 Jul;25(7):2055-2062. doi: 10.1007/s00520-017-3594-y. Epub 2017 Feb 10.
The objective of the study was to describe the occurrence of stomatitis and noninfectious lung disease in patients with metastatic renal cell carcinoma (mRCC) treated with second-line everolimus in a real-world setting.
This multicenter, prospective, observational study was conducted in France by physicians with experience of treatment of patients with mRCC. Patients aged ≥18 years who received everolimus after first-line antivascular endothelial growth factor (VEGF) therapy were included in the study. The primary safety assessments were occurrence of stomatitis (in terms of severity, event dates, and therapeutic management) and noninfectious pneumonitis (in terms of detection methodology, severity, event dates, and therapeutic management).
Between September 2010 and August 2012, 284 patients were enrolled at 77 centers, of whom, 274 received everolimus therapy. Most patients had mRCC of clear cell histology (88%), and most of them (84%) received first-line sunitinib. In total, 40% of patients experienced treatment-related stomatitis, and 15% of patients experienced noninfectious lung disease. Most of them had a single episode. The incidence of grade 3 stomatitis and noninfectious lung disease were 8 and 3%, respectively. Mean time to the first episode was 27 days for stomatitis and 72 days for noninfectious lung disease from treatment initiation. Stomatitis and noninfectious lung disease resulted in treatment discontinuations in 2 and 7% of patients, respectively. The primary first-episode treatment was mouthwash (86%) for stomatitis and corticosteroids (65%) for noninfectious lung disease.
This study confirms that stomatitis and noninfectious lung disease are commonly associated with everolimus use. Both adverse events were rarely severe and were managed easily and efficiently.
本研究的目的是描述在真实世界中接受二线依维莫司治疗的转移性肾细胞癌（mRCC）患者口腔炎和非感染性肺部疾病的发生情况。
这项多中心、前瞻性、观察性研究由法国具有mRCC患者治疗经验的医生进行。年龄≥18岁且在一线抗血管内皮生长因子（VEGF）治疗后接受依维莫司治疗的患者纳入本研究。主要安全性评估包括口腔炎的发生情况（根据严重程度、事件日期和治疗管理）和非感染性肺炎（根据检测方法、严重程度、事件日期和治疗管理）。
2010年9月至2012年8月期间，77个中心共纳入284例患者，其中274例接受了依维莫司治疗。大多数患者为透明细胞组织学类型的mRCC（88%），且大多数患者（84%）接受了一线舒尼替尼治疗。总体而言，40%的患者发生了与治疗相关的口腔炎，15%的患者发生了非感染性肺部疾病。大多数患者为单次发作。3级口腔炎和非感染性肺部疾病的发生率分别为8%和3%。从治疗开始到首次发作的平均时间，口腔炎为27天，非感染性肺部疾病为72天。口腔炎和非感染性肺部疾病分别导致2%和7%的患者停药。口腔炎首次发作的主要治疗方法是漱口（86%），非感染性肺部疾病是使用皮质类固醇（65%）治疗。
本研究证实口腔炎和非感染性肺部疾病与依维莫司的使用密切相关。这两种不良事件很少严重，且易于有效处理。
