Goto Takayuki, Yoshimura Koji, Matsui Yoshiyuki, Shimizu Yosuke, Inoue Takahiro, Okubo Kazutoshi, Kamba Tomomi, Nishiyama Hiroyuki, Ogawa Osamu
The Department of Urology, Kyoto University Graduate School of Medicine.
Hinyokika Kiyo. 2011 Dec;57(12):671-6.
Assessment of renal function is important to determine the appropriate dose for cisplatin (CDDP)-based chemotherapy. Many previous CDDP-based chemotherapy trials for bladder cancer have required a creatinine-clearance (Ccr) ≧60 ml/min for entry. However, there is little evidence on renal function assessed by estimated glomerular filtration rate (eGFR) using the 4-variable Modification of Diet in Renal Disease Study Equation (MDRD), which has recently been introduced, to determine the eligibility for CDDP-based chemotherapy. To evaluate the proportion of patients with invasive urothelial carcinoma(UC) who would be ineligible ("unfit") to receive CDDP-based chemotherapy based on eGFR criteria (eGFR ＜60 ml/min/1.73 m2), and to determine the side effects of chemotherapy in these "unfit" patients, we conducted a retrospective clinical study. Our study population consisted of 61 consecutive patients who underwent 100% dose CDDP-based chemotherapy for invasive UC with 24 h-Ccr≧50 ml/min between June 2001 and July 2009. We assessed renal function using 3 equations (eGFR, Ccr according to Cockcroft-Gault formula (C-G Ccr), and Ccr examined by 24-hour urine collection (24 h-Ccr)) as well. Mean values of eGFR, C-G Ccr, and 24 h-Ccr were 58.6, 68.9, and 82.8 ml/min, respectively (P＜ 0.001). In total, 29/61(48%) patients were ineligible ("unfit") to receive chemotherapy based on eGFR criteria. However, there was no difference in the frequency of side effects between eGFR ≧60 ml/min/ 1.73 m2 and eGFR ＜60 ml/min/1.73 m2 groups. Our observations suggest that 24 h-Ccr≧50 ml/min would be a reasonable cutoff for CDDP-based chemotherapy even when eGFR ＜60 ml/min/1.73 m2.
评估肾功能对于确定基于顺铂（CDDP）的化疗的合适剂量很重要。以前许多针对膀胱癌的基于CDDP的化疗试验都要求肌酐清除率（Ccr）≧60 ml/分钟才能入组。然而，对于使用最近引入的4变量肾脏病饮食改良研究方程（MDRD）通过估算肾小球滤过率（eGFR）评估的肾功能，几乎没有证据表明其可用于确定基于CDDP的化疗的 eligibility。为了评估基于eGFR标准（eGFR＜60 ml/分钟/1.73 m²）不符合（“不适合”）接受基于CDDP的化疗的浸润性尿路上皮癌（UC）患者的比例，并确定这些“不适合”患者化疗的副作用，我们进行了一项回顾性临床研究。我们的研究人群包括2001年6月至2009年7月期间连续61例接受基于CDDP的100%剂量化疗的浸润性UC患者，其24小时Ccr≧50 ml/分钟。我们还使用3个方程（eGFR、根据Cockcroft-Gault公式计算的Ccr（C-G Ccr）以及通过24小时尿液收集检查的Ccr（24 h-Ccr））评估肾功能。eGFR、C-G Ccr和24 h-Ccr的平均值分别为58.6、68.9和82.8 ml/分钟（P＜0.001）。总体而言，29/61（48%）的患者基于eGFR标准不符合（“不适合”）接受化疗。然而，eGFR≧60 ml/分钟/1.73 m²组和eGFR＜60 ml/分钟/1.73 m²组之间的副作用发生率没有差异。我们的观察结果表明，即使eGFR＜60 ml/分钟/1.73 m²，24小时Ccr≧50 ml/分钟对于基于CDDP的化疗来说也是一个合理的临界值。
