Shirotake Suguru, Yasumizu Yota, Ito Keiichi, Masunaga Ayako, Ito Yujiro, Miyazaki Yasumasa, Hagiwara Masayuki, Kanao Kent, Mikami Shuji, Nakagawa Ken, Momma Tetsuo, Masuda Takeshi, Asano Tomohiko, Oyama Masafumi, Tanaka Nobuyuki, Mizuno Ryuichi, Oya Mototsugu
Department of Uro-Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.
Department of Urology, National Defense Medical College, Tokorozawa, Japan.
Clin Genitourin Cancer. 2016 Dec;14(6):e575-e583. doi: 10.1016/j.clgc.2016.03.014. Epub 2016 Mar 24.
Relative dose intensity (RDI) is a simple index for evaluation of the amount of drug administered per unit time. We retrospectively investigated the prognostic impact of RDI for patients with metastatic renal cell carcinoma (mRCC) treated with second-line targeted therapy.
We enrolled 168 patients with mRCC. We assessed RDI at 4 weeks after second-line targeted therapy induction.
The median follow-up after second-line targeted therapy was 18.1 months. The median time-to-treatment-failure (TTF) and overall survival (OS) were 4.9 and 25.4 months, respectively. In the Kaplan-Meier analysis, the median OS of patients with second-line RDI < 0.7 was significantly shorter than those with RDI ≥ 0.7 (12.1 vs. 31.3 months; P = .030). In the subgroup analysis, second-line RDI was definitely prognostic in the poor-risk group of the International Metastatic Renal Cell Carcinoma Database Consortium criteria, showing second-line RDI was an independent predictor for both TTF (hazard ratio [HR], 3.6; 95% confidence interval [CI], 1.6-8.0; P = .002) and OS (HR, 3.1; 95% CI, 1.1-8.4; P = .026). Also, assessing the type of second-line regimen, the multivariate analysis showed that second-line RDI was an independent prognostic indicator of TTF (HR, 1.7; 95% CI, 1.0-2.9; P = .040) and OS (HR, 2.7; 95% CI, 1.3-5.7; P = .009) in patients treated with everolimus. In this group, the median TTF and OS of patients with RDI < 0.7 were 2.4 and 11.1 months, and those with RDI ≥ 0.7 were 5.3 and 25.9 months, respectively.
The results suggest that second-line RDI may be a prognostic predictor for patients with mRCC treated with second-line targeted therapy, particularly in both the International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group and everolimus-treated group.
相对剂量强度（RDI）是评估单位时间内给药量的一个简单指标。我们回顾性研究了RDI对接受二线靶向治疗的转移性肾细胞癌（mRCC）患者预后的影响。
我们纳入了168例mRCC患者。在二线靶向治疗开始后4周评估RDI。
二线靶向治疗后的中位随访时间为18.1个月。中位治疗失败时间（TTF）和总生存期（OS）分别为4.9个月和25.4个月。在Kaplan-Meier分析中，二线RDI < 0.7的患者的中位OS显著短于RDI≥0.7的患者（12.1个月对31.3个月；P = 0.030）。在亚组分析中，根据国际转移性肾细胞癌数据库联盟标准，二线RDI在低危组中肯定具有预后意义，表明二线RDI是TTF（风险比[HR]，3.6；95%置信区间[CI]，1.6 - 8.0；P = 0.002）和OS（HR，3.1；95% CI，1.1 - 8.4；P = 0.026）的独立预测指标。此外，在评估二线治疗方案类型时，多因素分析显示，在接受依维莫司治疗的患者中，二线RDI是TTF（HR，1.7；95% CI，1.0 - 2.9；P = 0.040）和OS（HR，2.7；95% CI，1.3 - 5.7；P = 0.009）的独立预后指标。在该组中，RDI < 0.7的患者的中位TTF和OS分别为2.4个月和11.1个月，而RDI≥0.7的患者分别为5.3个月和25.9个月。
结果表明，二线RDI可能是接受二线靶向治疗的mRCC患者的预后预测指标，特别是在国际转移性肾细胞癌数据库联盟低危组和接受依维莫司治疗的组中。
