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紫杉醇、吉西他滨和顺铂二线化疗治疗晚期尿路上皮癌的 II 期研究。

Phase II Study of Second-line Chemotherapy With Paclitaxel, Gemcitabine, and Cisplatin for Advanced Urothelial Carcinoma.

机构信息

Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan

Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.

出版信息

Anticancer Res. 2020 Mar;40(3):1613-1618. doi: 10.21873/anticanres.14109.

DOI:10.21873/anticanres.14109
PMID:32132064
Abstract

BACKGROUND/AIM: To evaluate the efficacy and toxicity of paclitaxel, gemcitabine, and cisplatin (TGP) as second-line treatment for advanced urothelial carcinoma (UC).

PATIENTS AND METHODS

This study comprised advanced UC progressed after first-line cisplatin-based chemotherapy. Advanced UC was defined as a non-resectable (T4b, any N or any T, or N2-3) or metastatic disease. Twenty-one patients were included in this study. TGP was administered every 3 weeks. The primary endpoint was objective response rate (ORR); the secondary end points were progression-free survival (PFS), overall survival (OS), and toxicity.

RESULTS

The ORR with TGP was 23.8%; the median PFS and OS were 4 and 8.4 months, respectively. The primary side effect was myelosuppression. Grade 3-4 neutropenia and thrombocytopenia were observed in 71.4% and 42.9%, respectively. There were no toxic deaths.

CONCLUSION

TGP is moderately effective and tolerable as second-line chemotherapy for patients with UC.

摘要

背景/目的:评估紫杉醇、吉西他滨和顺铂(TGP)作为二线治疗晚期尿路上皮癌(UC)的疗效和毒性。

患者和方法

本研究纳入了一线顺铂为基础的化疗后进展的晚期 UC 患者。晚期 UC 定义为不可切除(T4b,任何 N 或任何 T,或 N2-3)或转移性疾病。本研究纳入了 21 例患者。TGP 每 3 周给药一次。主要终点是客观缓解率(ORR);次要终点是无进展生存期(PFS)、总生存期(OS)和毒性。

结果

TGP 的 ORR 为 23.8%;中位 PFS 和 OS 分别为 4 个月和 8.4 个月。主要的副作用是骨髓抑制。71.4%的患者出现 3-4 级中性粒细胞减少症,42.9%的患者出现 3-4 级血小板减少症。无治疗相关死亡。

结论

TGP 作为二线化疗药物,对 UC 患者具有一定的疗效和可耐受性。

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