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吉西他滨-顺铂对比培美曲塞顺铂用于晚期或转移性膀胱癌患者的I期研究

Phase I study of gemcitabine-cisplatin versus pemetrexed cisplatin for patients with advanced or metastatic bladder cancer.

作者信息

Cao Yifang, He Yi, Chen Hao, He Shunliang, Gu Yanqin, Wang Xueping, Chen Bin

机构信息

Department of Urology, Jiaxing First Hospital, the First Affiliated Hospital of Jiaxing College, Jiaxing, China.

出版信息

J BUON. 2018 Mar-Apr;23(2):475-481.

PMID:29745095
Abstract

PURPOSE

The present study aimed to compare the chemotherapeutic regimens of gemcitabine plus cisplatin (GC) vs pemetrexed plus cisplatin (PC) in bladder cancer (BC) with vascular invasion and/or distant metastasis.

METHODS

From January 2010 to January 2017, 53 patients with advanced or metastatic BC were included and randomly divided into two groups. Patients in the GC group were administered 1,000 mg/m gemcitabine on day 1 and 15 and 70 mg/m cisplatin on day 1 as an IV infusion. Patients in the PC group were administered 500 mg/m pemetrexed on day 1 and 15 and 70 mg/m2 cisplatin on day 1 as an IV infusion. The two regimens were repeated every 28 days. Patients were treated for about 4-6 cycles until the occurrence of severe toxicity or patient refusal.

RESULTS

The median overall survival (OS) and the median progression-free survival (PFS) in the GC group were significantly higher than that in the PC group (OS: p=0.033 and PFS: p=0.039, respectively). Besides, the response rates and disease control were obviously higher in the GC group (68% and 86%, respectively) compared to the PC group (44% and 56%, respectively), although without statistical significance. Regarding toxicity, higher rates of neutropenia and nausea in the PC group were noted, while thrombocytopenia was more frequent in the GC group.

CONCLUSIONS

The gemcitabine plus cisplatin combination was more effective and well tolerated in patients with advanced or metastatic BC compared to the pemetrexed plus cisplatin regimen.

摘要

目的

本研究旨在比较吉西他滨联合顺铂(GC)与培美曲塞联合顺铂(PC)两种化疗方案用于治疗伴有血管侵犯和/或远处转移的膀胱癌(BC)的疗效。

方法

选取2010年1月至2017年1月期间53例晚期或转移性BC患者,随机分为两组。GC组患者在第1天和第15天静脉输注1000mg/m²吉西他滨,第1天静脉输注70mg/m²顺铂。PC组患者在第1天和第15天静脉输注500mg/m²培美曲塞,第1天静脉输注70mg/m²顺铂。两种方案每28天重复一次。患者接受约4 - 6个周期的治疗,直至出现严重毒性反应或患者拒绝治疗。

结果

GC组的中位总生存期(OS)和中位无进展生存期(PFS)显著高于PC组(OS:p = 0.033,PFS:p = 0.039)。此外,GC组的缓解率和疾病控制率明显高于PC组(分别为68%和86%),而PC组分别为44%和56%,尽管无统计学意义。在毒性方面,PC组中性粒细胞减少和恶心的发生率较高,而GC组血小板减少更为常见。

结论

与培美曲塞联合顺铂方案相比,吉西他滨联合顺铂方案在晚期或转移性BC患者中更有效且耐受性良好。

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