Wang Z P, Wang W Y, Zhu Y C, Xiao J, Lin J, Guo Y W, Tian Y
Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Transplant Proc. 2016 Jul-Aug;48(6):2076-9. doi: 10.1016/j.transproceed.2016.02.075.
The purpose of the present study was to evaluate the effects and safety of adjuvant chemotherapy with gemcitabine plus cisplatin in kidney transplant patients with locally advanced transitional cell carcinoma.
A total of 22 kidney transplant patients with locally advanced transitional cell carcinoma were assessed. Eleven patients who underwent surgery and received adjuvant chemotherapy were enrolled in the study. They were compared with 11 matched patients who were treated with surgery alone. The chemotherapy regimen was gemcitabine 800 mg/m(2) on days 1, 8, and 15 and cisplatin 70 mg/m(2) on day 2. A single treatment cycle lasted 28 days. Because of the potential concerted reaction between the immunosuppressant regimen and the chemotherapeutic agents, drug toxicities were closely observed, and a dose reduction of the chemotherapeutic agents was planned according to the toxicity grade. There was a 75% drug dose reduction for grade 2 hematologic toxicities and grade 1 nephrotoxicity, and there was a 50% drug dose reduction for grade 3 hematologic toxicity and grade 2 nephrotoxicity. Patients who developed grade 4 hematologic toxicity or grade 3 to 4 nephrotoxicities were withdrawn.
Eleven patients completed a total of 29 cycles. At a median follow-up time of 21 months, the mean overall survival time was longer than that of the observation group (P = .043). The incidence of hematologic toxicities was higher, resulting in a dose reduction of the chemotherapeutic agents in 45.5% of patients. Gastrointestinal reactions were most common in patients with nonhematologic toxicities. Grade 1 nephrotoxicity was reported in 3 patients; no other grade of nephrotoxicity was observed. Levels of serum creatinine and blood urea nitrogen were not obviously reduced during chemotherapy.
Our study data suggest that kidney transplant patients with locally advanced transitional cell carcinoma may derive an overall survival benefit from the administration of adjuvant chemotherapy with gemcitabine plus cisplatin after surgery. The drug toxicities were acceptable, and nephrotoxicity was mild.
本研究旨在评估吉西他滨联合顺铂辅助化疗对局部晚期移行细胞癌肾移植患者的疗效及安全性。
共评估了22例局部晚期移行细胞癌肾移植患者。11例接受手术并接受辅助化疗的患者纳入本研究。将他们与11例仅接受手术治疗的匹配患者进行比较。化疗方案为第1、8和15天给予吉西他滨800mg/m²,第2天给予顺铂70mg/m²。一个治疗周期持续28天。由于免疫抑制剂方案与化疗药物之间可能存在协同反应,因此密切观察药物毒性,并根据毒性分级计划减少化疗药物剂量。2级血液学毒性和1级肾毒性时化疗药物剂量减少75%,3级血液学毒性和2级肾毒性时化疗药物剂量减少50%。发生4级血液学毒性或3至4级肾毒性的患者退出研究。
11例患者共完成29个周期。中位随访时间为21个月时,平均总生存时间长于观察组(P = 0.043)。血液学毒性发生率较高,45.5%的患者因此减少了化疗药物剂量。非血液学毒性患者中胃肠道反应最为常见。3例患者报告有1级肾毒性;未观察到其他级别的肾毒性。化疗期间血清肌酐和血尿素氮水平未明显降低。
我们的研究数据表明,局部晚期移行细胞癌肾移植患者术后接受吉西他滨联合顺铂辅助化疗可能在总生存方面获益。药物毒性可接受,且肾毒性较轻。