Xue Cong, An Xin, Cao Ye, Chen Tanhuan, Yang Wei, Deng Yingfei, Han Hui, Teng Xiaoyu, Zhou Fangjian, Shi Yanxia
Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China.
Department of GCP, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China.
Oncotarget. 2016 Sep 27;7(39):63722-63729. doi: 10.18632/oncotarget.11641.
The purpose of this study was to evaluate the effectiveness and toxicity of capecitabine (C) chemotherapy regimen with or without (w/o) docetaxel (D) in patients with advanced urothelial carcinoma (UC).
Clinical benefit rate were similar in two arms (C arm vs DC arm: 38.9% vs 45.5%, p = 0.411). There were two cases achieved partial response in DC arm. In C arm, the median PFS was 3.0 months (95% CI 2.5-3.5 months) and median OS was 11.3 months (95% CI 8.6-14.1 months). In DC arm, the median PFS was 2.2 months (95% CI 1.7-2.7 months) and median OS was 18 months (95% CI 6.8-29.9 months). Adverse events were mostly acceptable, including myelosuppession, hand-foot syndrome and mucositis. Anemia and leukopenia was found more in the DC arm than in the C arm.
This is a one-center, observational, retrospective study. From April 2009 to March 2015, a total of 29 patients with metastatic UC were included in the study. Survivals, response rates and toxicities were collected retrospectively.
The result showed the activity and toxicity of C w/o D. As DC treatment did not reveal better outcome, C or D single-agent might be an option in platinum-failed patients with advanced urothelial carcinoma. Further clinical trials are warranted.
本研究旨在评估卡培他滨(C)化疗方案联合或不联合多西他赛(D)治疗晚期尿路上皮癌(UC)患者的有效性和毒性。
两组的临床获益率相似(C组 vs DC组:38.9% vs 45.5%,p = 0.411)。DC组有2例达到部分缓解。在C组中,中位无进展生存期(PFS)为3.0个月(95%置信区间2.5 - 3.5个月),中位总生存期(OS)为11.3个月(95%置信区间8.6 - 14.1个月)。在DC组中,中位PFS为2.2个月(95%置信区间1.7 - 2.7个月),中位OS为18个月(95%置信区间6.8 - 29.9个月)。不良事件大多可接受,包括骨髓抑制、手足综合征和黏膜炎。DC组的贫血和白细胞减少症比C组更常见。
这是一项单中心、观察性、回顾性研究。2009年4月至2015年3月,共有29例转移性UC患者纳入本研究。对生存情况、缓解率和毒性进行回顾性收集。
结果显示了不联合D的C方案的活性和毒性。由于DC方案未显示出更好的疗效,对于铂类治疗失败的晚期尿路上皮癌患者,C或D单药治疗可能是一种选择。有必要进行进一步的临床试验。