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真实世界中晚期尿路上皮癌患者中吉西他滨/顺铂全剂量、低剂量与吉西他滨/卡铂的比较。

Comparison of full-dose gemcitabine/cisplatin, dose-reduced gemcitabine/cisplatin, and gemcitabine/carboplatin in real-world patients with advanced urothelial carcinoma.

机构信息

Department of Urology, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan.

Department of Urology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.

出版信息

BMC Urol. 2022 Nov 9;22(1):177. doi: 10.1186/s12894-022-01139-9.

Abstract

BACKGROUND

While gemcitabine/cisplatin (GC) is the gold standard regimen for patients with advanced urothelial carcinoma (aUC), either dose-reduced GC or gemcitabine/carboplatin (GCa) is an alternative option for "cisplatin-unfit" patients. However, few studies have compared outcomes with these commonly used regimens in the real-world setting.

METHODS

We retrospectively reviewed patients with aUC who received full-dose GC, dose-reduced GC, or GCa as first-line salvage chemotherapy at two university hospitals between 2016 and 2020. Progression-free survival, cancer-specific survival, and overall survival, as well as best overall response and adverse event profiles, were compared among these three regimens.

RESULTS

Of 105 patients, 41, 27, and 37 patients received full-dose GC, dose-reduced GC, and GCa, respectively. Significant differences were noted in the patients' baseline age, primary site, and renal function among the three regimens. Sixty-nine (65.7%) patients died during a median follow-up period of 14 months. There was no significant difference among the three regimens for all survival outcomes and best overall response. However, the complete response rate of dose-reduced GC (2/27, 7.4%) appeared inferior to that of full-dose GC (9/41, 22.0%) or GCa (6/37, 16.2%). Regarding adverse event profiles, no significant difference was observed among the three regimens, except for significantly fewer cases with elevated alanine aminotransferase in the GCa group compared with the other groups.

CONCLUSIONS

This study compared the oncological and toxicological outcomes of full-dose GC, dose-reduced GC, and GCa in real-world patients with aUC. Unlike in the clinical trial setting, there were almost no significant differences among the three regimens.

摘要

背景

吉西他滨/顺铂(GC)是晚期尿路上皮癌(aUC)患者的金标准治疗方案,但对于“顺铂不耐受”患者,剂量降低的 GC 或吉西他滨/卡铂(GCa)也是一种替代方案。然而,在真实世界环境中,很少有研究比较这些常用方案的疗效。

方法

我们回顾性分析了 2016 年至 2020 年在两家大学医院接受全剂量 GC、剂量降低的 GC 或 GCa 作为一线挽救化疗的 aUC 患者。比较了这三种方案的无进展生存期、癌症特异性生存期和总生存期,以及最佳总缓解和不良事件谱。

结果

105 例患者中,41 例、27 例和 37 例分别接受全剂量 GC、剂量降低的 GC 和 GCa。三种方案的患者基线年龄、原发部位和肾功能存在显著差异。69 例(65.7%)患者在中位随访 14 个月期间死亡。三种方案的所有生存结果和最佳总缓解均无显著差异。然而,剂量降低的 GC(2/27,7.4%)的完全缓解率似乎低于全剂量 GC(9/41,22.0%)或 GCa(6/37,16.2%)。关于不良事件谱,三种方案之间除了 GCa 组的丙氨酸氨基转移酶升高病例明显少于其他组外,没有显著差异。

结论

本研究比较了全剂量 GC、剂量降低的 GC 和 GCa 在真实世界的 aUC 患者中的肿瘤学和毒理学结果。与临床试验环境不同,三种方案之间几乎没有显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe25/9647899/1b1746b62477/12894_2022_1139_Fig1_HTML.jpg

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