Helke C, May M, Hoschke B
Urologische Klinik des Carl-Thiem-Klinikums Cottbus, Lehrkrankenhaus der Universitätsklinik Charité zu Berlin, Thiemstrasse 11, 03048 Cottbus.
Aktuelle Urol. 2006 Sep;37(5):363-8. doi: 10.1055/s-2006-932157.
The aim of this analysis is the evaluation of the activity and toxicity of gemcitabine and carboplatin in patients with advanced urothelial transitional carcinoma (TCC) with special regard to patients with impaired renal function.
30 consecutive patients with metastatic TCC [mean age: 68 (range: 47 - 82) years, median ECOG-PS:1] were treated with gemcitabine (1000 mg/m (2) on days 1 and 8 of a 21-day schedule) and carboplatin (AUC 4.5 day 1). In 15 patients (considered as renal unfit) a creatinine clearance of less than 60 mL/min (range: 31 - 59 mL/min) was seen.
Concerning the survival rate, no significant difference noticed between the two subgroups of renal impaired patients and patients with normal renal function was detected (median 13 vs. 14 months, p = 0.901). An overall response rate of 50 % was obtained. In 16.7 % and 33.3 % of all cases a complete or a partial response was noted. Median time to progression was 5.34 months. The 1-year-survival rate has been calculated as 51.8 %. There was no restriction of renal function under chemotherapy in any single patient.
The chemotherapy combination of gemcitabine and carboplatin is definitely powerful for a first-line-therapy in patients with advanced TCC. Toxicity is well manageable. Due to the dosage for carboplatin by AUC an adaptation to the glomerular filtration rate is possible. Decreases of effectiveness in cases of impaired renal function were not detected. Patients with metastatic TCC should be entered onto well designed, randomised clinical trials with the gemcitabine/carboplatin combination to afford a tailored chemotherapy.
本分析旨在评估吉西他滨和顺铂在晚期尿路上皮移行细胞癌（TCC）患者中的活性和毒性，尤其关注肾功能受损的患者。
30例连续的转移性TCC患者[平均年龄：68岁（范围：47 - 82岁），中位ECOG-PS：1]接受吉西他滨（在21天疗程的第1天和第8天给予1000 mg/m²）和顺铂（AUC 4.5，第1天）治疗。15例患者（被视为肾功能不佳）的肌酐清除率低于60 mL/分钟（范围：31 - 59 mL/分钟）。
关于生存率，未检测到肾功能受损患者和肾功能正常患者这两个亚组之间存在显著差异（中位生存期分别为13个月和14个月，p = 0.901）。总体缓解率为50%。在所有病例中，分别有16.7%和33.3%出现完全缓解或部分缓解。中位疾病进展时间为5.34个月。计算得出1年生存率为51.8%。在任何单个患者中，化疗期间肾功能均未受到限制。
吉西他滨和顺铂的化疗组合对于晚期TCC患者的一线治疗肯定有效。毒性易于控制。由于顺铂按AUC给药，有可能根据肾小球滤过率进行调整。未检测到肾功能受损情况下疗效降低。转移性TCC患者应参与设计良好的吉西他滨/顺铂联合随机临床试验，以提供个体化化疗。
