Carles Joan, Suárez Cristina, Mesía Carlos, Nogué Miquel, Font Albert, Doménech Montserrat, Suárez Marta, Tusquets Ignasi, Gallén M, Albanell Joan, Fabregat Xavier
Oncology Department. Hospital del Mar, URTEC, Universitat Autónoma de Barcelona, Spain.
Clin Transl Oncol. 2006 Oct;8(10):755-7. doi: 10.1007/s12094-006-0123-8.
Cisplatin-based combination chemotherapy is the mainstay of treatment for advanced bladder cancer. However, full doses of cisplatin cannot be delivered in patients with impaired renal function. Our aim was to prove the feasibility of a gemcitabine and low-dose cisplatin regimen, delivered every two weeks in patients with impaired renal function.
Patients with locally advanced or metastatic bladder cancer with creatinine clearance between 35-60 ml/min received gemcitabine 2500 mg/m2 and cisplatin 35 mg/m2 on day 1, every 14 days.
Between January 2004 and March 2005, 17 patients were treated. Mean creatinine clearance was 47.8 ml/min (range: 37-59 ml/min). Four patients had previously received chemotherapy with gemcitabine and/ or platinum. Median number of cycles per patient was 5 (1-13). No patient developed renal toxicity or worsening of renal function. Main toxicities were (grade 3/4): Anemia 2/1; leucopenia: 1/2; trombopenia 1/1. There was one toxic death related to metabolic acidosis, secondary to vomiting. Among 16 patients evaluable for response, we observed one complete response, 7 partial responses (ORR: 53.3%; IC 95%: 28.1-78.5%), 6 stabilizations (37.5%) and 2 progressions (12.5%).
Gemcitabine and low-dose cisplatin is a safe and feasible combination in patients with poor renal function. Response rates seem similar to those previously described with standard schedules of this combination.
基于顺铂的联合化疗是晚期膀胱癌治疗的主要手段。然而，肾功能受损的患者无法接受全剂量顺铂治疗。我们的目的是证明吉西他滨与低剂量顺铂方案每两周给药一次在肾功能受损患者中的可行性。
肌酐清除率在35 - 60 ml/分钟之间的局部晚期或转移性膀胱癌患者在第1天接受吉西他滨2500 mg/m²和顺铂35 mg/m²治疗，每14天一次。
2004年1月至2005年3月期间，17例患者接受了治疗。平均肌酐清除率为47.8 ml/分钟（范围：37 - 59 ml/分钟）。4例患者之前接受过吉西他滨和/或铂类化疗。每位患者的中位周期数为5（1 - 13）。没有患者出现肾毒性或肾功能恶化。主要毒性反应（3/4级）为：贫血2/1；白细胞减少：1/2；血小板减少1/1。有1例与呕吐继发的代谢性酸中毒相关的毒性死亡。在16例可评估疗效的患者中，我们观察到1例完全缓解，7例部分缓解（客观缓解率：53.3%；95%置信区间：28.1 - 78.5%），6例病情稳定（37.5%）和2例进展（12.5%）。
吉西他滨与低剂量顺铂联合方案在肾功能较差的患者中是安全可行的。缓解率似乎与该联合方案之前标准给药方案所描述的相似。
