医学
肾细胞癌
临床终点
内科学
风险模型
一致性
肿瘤科
肾癌
随机对照试验
风险分析(工程)
作者
Emre Yekedüz,Serdar Karakaya,İsmail Ertürk,Deniz Tural,Gökhan Uçar,Nihan Şentürk Öztaş,Rukiye Arıkan,Mutlu Hızal,Ahmet Küçükarda,Özlem Nuray Sever,Çağatay Arslan,Orçun Can,Saadettin Kılıçkap,Satı Coşkun Yazgan,Nuri Karadurmuş,Mehmet Ali Nahit Şendur,İrfan Çiçin,Umut Demırcı,Mustafa Özgüroğlu,Berna Öksüzoğlu,Yüksel Ürün
标识
DOI:10.1016/j.clgc.2022.07.006
摘要
A novel prognostic model was recommended for patients with metastatic RCC (mRCC) by the International mRCC Database Consortium (IMDC). In this study, we aimed to externally validate a novel risk model for the IMDC-favorable risk group in patients with mRCC.The Turkish Oncology Group Kidney Cancer Consortium (TKCC) is a multicenter registry that includes 13 cancer centers in Turkey. As described by Schmidt et al., 3 parameters (ie, time from diagnosis to systemic therapy <3 vs. ≥3 years, Karnofsky Performance Status [KPS] 80 vs. >80, and the presence of brain, liver, or bone metastasis) were used to divide the IMDC favorable risk group into 2 new categories: very favorable and favorable risk groups. The primary endpoint was overall survival (OS). Time to treatment failure (TTF) and objective response rate (ORR) in the very favorable and favorable risk groups were the secondary endpoints.A total of 545 patients with mRCC from all IMDC risk groups and 112 patients from the favorable risk group were included in this study. According to the novel classification model, 44 (39.3%) and 68 (60.7%) patients with former favorable risk were categorized into very favorable and favorable risk groups, respectively. The median OS (55.8 months vs. 34.2 months, P = .025) and TTF (25.5 months vs. 15.5 months, P = .010) were longer in the very favorable risk group than in the favorable risk group. The concordance index of the new IMDC model in all patients was 0.65 for OS. Despite the higher ORR in the very favorable risk group than in the favorable risk group, the difference between the groups was not statistically significant (52.4% vs. 44.7, P = .573).This was the first study to externally validate the novel IMDC risk model presented in the American Society of Clinical Oncology Genitourinary Cancers Symposium 2021.
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