Department of Medical Oncology, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain.
Eur J Cancer. 2012 Aug;48(12):1816-21. doi: 10.1016/j.ejca.2012.04.002. Epub 2012 May 16.
Cisplatin-based combination chemotherapy is the mainstay of treatment for locally advanced or metastatic urothelial carcinoma. However, standard dose schedule of cisplatin cannot be used in patients with impaired renal function. We evaluated the safety and efficacy of gemcitabine and a split dose administration of cisplatin in patients with renal dysfunction.
Patients with locally advanced or metastatic urothelial carcinoma with creatinine clearance between 35 and 59 ml/min received gemcitabine 2500 mg/m(2) and cisplatin 35 mg/m(2) on day 1 and day 15 for an every 28 day schedule.
Between March 2004 and November 2009, 38 patients were treated. Median creatinine clearance was 49 ml/min. Median number of cycles per patient was 3 (1-7). There were 15 partial responses (39%) and 12 patients had stable disease (31%). Median progression free survival and overall survival were 3.5 and 8.5 months (mo), respectively. Grade 3-4 haematological toxicities were: neutropenia 9%, anaemia 6% and thrombocytopenia 16%. No patient developed renal toxicity.
Biweekly gemcitabine and cisplatin is an active and feasible regimen in this subset of patients and could be an option for unfit patients. However, results seem not to be superior to those obtained with carboplatin based regimens in this population of patients.
顺铂为基础的联合化疗是治疗局部晚期或转移性尿路上皮癌的主要方法。然而，对于肾功能受损的患者，不能使用标准剂量的顺铂。我们评估了吉西他滨联合顺铂分割剂量方案在肾功能不全患者中的安全性和疗效。
肌酐清除率在 35 至 59 ml/min 之间的局部晚期或转移性尿路上皮癌患者接受吉西他滨 2500 mg/m2 和顺铂 35 mg/m2，于第 1 天和第 15 天给药，每 28 天一个周期。
2004 年 3 月至 2009 年 11 月，共治疗 38 例患者。中位肌酐清除率为 49 ml/min。中位每个患者的周期数为 3（1-7）。15 例患者有部分缓解（39%），12 例患者疾病稳定（31%）。中位无进展生存期和总生存期分别为 3.5 和 8.5 个月。3-4 级血液学毒性为：中性粒细胞减少 9%、贫血 6%和血小板减少 16%。无患者发生肾毒性。
吉西他滨和顺铂每两周给药是肾功能不全患者的一种有效且可行的方案，可能是不适合患者的选择。然而，与该人群中基于卡铂的方案相比，结果似乎并不占优势。
