依维莫司作为转移性肾细胞癌二线治疗的临床获益：法国回顾性SECTOR研究
Clinical Benefit of Everolimus as Second-Line Therapy in Metastatic Renal Cell Carcinoma: The French Retrospective SECTOR Study.
作者信息
Oudard Stéphane, Joly Florence, Geoffrois Lionnel, Laguerre Brigitte, Houede Nadine, Barthelemy Philippe, Gross-Goupil Marine, Vano Yann, Lucidarme Oliver, Bidault Francois, Kelkouli Nadia, Slimane Khemaies, Escudier Bernard
机构信息
Université René Descartes, Immunothérapie et traitement antiangiogénique en pathologie cancérologique, and Hôpital Européen Georges Pompidou, Service de Cancérologie Médicale, Paris, France.
Centre François Baclesse-CHU, INSERM, Cancer et Préventions, Caen, France.
出版信息
Clin Genitourin Cancer. 2016 Dec;14(6):e595-e607. doi: 10.1016/j.clgc.2016.04.019. Epub 2016 May 2.
BACKGROUND
Real-world data of everolimus after vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitor (TKI) therapy in metastatic renal cell carcinoma (mRCC) are limited.
PATIENTS AND METHODS
The retrospective, noninterventional SECTOR (SECond line with afiniTOR) study (N = 165) assessed outcomes of second-line everolimus after initial VEGFR-TKI (TKI-everolimus, n = 144) and of third-line VEGFR-TKI after everolimus (TKI-everolimus-TKI, n = 59) in patients with mRCC. The primary end point was duration of everolimus therapy for both populations.
RESULTS
Median duration was 4.0 months (range, 0.0-33.0 months) for second-line everolimus and 18.0 months (range, 2-78 months) for sequential VEGFR-TKI and everolimus. Median overall survival (OS) for this sequence was 36.0 months (95% confidence interval [CI], 27.0-56.0 months) and was longer for patients who received a first-line TKI for ≥ 9 months (not reached) than for < 9 months (28.0 months; P < .001). During second-line everolimus treatment, commonly reported adverse events (all grades) were fatigue (n = 66, 40.7%), anemia (n = 58, 35.8%), and stomatitis (n = 41, 25.3%). Median duration from initiation of first-line TKI to the end of the third-line TKI was 24.0 months (95% CI, 19.0-29.0 months). Median OS for this sequence was 41.0 months (95% CI, 25.0-57.0 months) and was significantly longer for patients who received the first-line TKI for ≥ 9 months (37.5 months) than for < 9 months (19.0 months; P < .0001).
CONCLUSION
These results reflect clinical use of sequential TKI-everolimus and TKI-everolimus-TKI and provide additional evidence that everolimus could be an option in second-line therapy in mRCC. Results of the CheckMate-025 (Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma) and METEOR (Metastatic RCC Phase 3 Study Evaluating Cabozantinib versus Everolimus) studies might change the treatment landscape.
背景
在转移性肾细胞癌（mRCC）中，血管内皮生长因子受体（VEGFR）-酪氨酸激酶抑制剂（TKI）治疗后使用依维莫司的真实世界数据有限。
患者与方法
回顾性、非干预性的SECTOR（afiniTOR二线治疗）研究（N = 165）评估了mRCC患者在初始VEGFR-TKI治疗后接受二线依维莫司治疗（TKI-依维莫司组，n = 144）以及依维莫司治疗后接受三线VEGFR-TKI治疗（TKI-依维莫司-TKI组，n = 59）的疗效。主要终点是这两组人群中依维莫司治疗的持续时间。
结果
二线依维莫司治疗的中位持续时间为4.0个月（范围：0.0 - 33.0个月），序贯VEGFR-TKI和依维莫司治疗的中位持续时间为18.0个月（范围：2 - 78个月）。该治疗序列的中位总生存期（OS）为36.0个月（95%置信区间[CI]，27.0 - 56.0个月），接受一线TKI治疗≥9个月的患者的总生存期未达到，长于接受一线TKI治疗<9个月的患者（28.0个月；P <.001）。在二线依维莫司治疗期间，常见的不良事件（所有级别）为疲劳（n = 66, 40.7%）、贫血（n = 58, 35.8%）和口腔炎（n = 41, 25.3%）。从一线TKI开始至三线TKI结束的中位持续时间为24.0个月（95% CI，19.0 - 29.0个月）。该治疗序列的中位OS为41.0个月（95% CI，25.0 - 57.0个月），接受一线TKI治疗≥9个月的患者的总生存期为37.5个月，长于接受一线TKI治疗<9个月的患者（19.0个月；P <.0001）。
结论
这些结果反映了序贯TKI-依维莫司和TKI-依维莫司-TKI的临床应用情况，并提供了更多证据表明依维莫司可作为mRCC二线治疗的一种选择。CheckMate-025（晚期肾细胞癌中纳武单抗与依维莫司对比）和METEOR（评估卡博替尼与依维莫司对比的转移性肾细胞癌3期研究）研究的结果可能会改变治疗格局。
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