Naiki Taku, Kawai Noriyasu, Hashimoto Yoshihiro, Okamura Takehiko, Ando Ryosuke, Yasui Takahiro, Okada Atsushi, Etani Toshiki, Tozawa Keiichi, Kohri Kenjiro
Department of Nephro-urology, Graduate School of Medical Sciences, Nagoya City University, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan,
Int J Clin Oncol. 2014;19(3):516-22. doi: 10.1007/s10147-013-0574-1. Epub 2013 Jun 11.
The objective of this study was to evaluate the efficacy of a gemcitabine and docetaxel (GD) combination as a second-line treatment for patients with metastatic urothelial carcinoma (UC) after failure of first-line treatment with platinum-based chemotherapy.
From June 2006 to January 2012, 38 patients with metastatic UC previously treated with platinum-based chemotherapy received GD therapy. This consisted of gemcitabine 800 mg/m(2) and docetaxel 40 mg/m(2) on days 1 and 8 of each 21-day cycle as second-line chemotherapy. All the patients were evaluated for toxicity and assessed every cycle by imaging. We analyzed the efficacy of GD as second-line chemotherapy in the follow-up study.
The median number of GD treatment cycles was 4 (range 2-9); the objective response rate was 47.4 %; and the median progression-free survival and median overall survival were 4.1 and 10.8 months, respectively. Univariate and multivariate analyses on the GD treated group showed that the existence of lung metastases was the only prognostic factor for tumor response. Grade 3 treatment-related toxicity included neutropenia (31.6 %) and thrombocytopenia (15.8 %), and only one patient with grade 4 toxicity had thrombocytopenia (2.6 %).
The GD regimen as second-line chemotherapy was especially effective for lung metastatic UC and yielded favorable results in patients whose first-line platinum-based chemotherapy had failed. Given the safety and benefit profile seen in this study, a large prospective study is warranted to consider the potential utility of GD chemotherapy as a second-line for UC.
本研究的目的是评估吉西他滨和多西他赛（GD）联合用药作为一线铂类化疗失败后的转移性尿路上皮癌（UC）患者二线治疗的疗效。
2006年6月至2012年1月，38例先前接受过铂类化疗的转移性UC患者接受了GD治疗。作为二线化疗，在每21天周期中的第1天和第8天给予吉西他滨800mg/m²和多西他赛40mg/m²。对所有患者进行毒性评估，并在每个周期通过影像学进行评估。在后续研究中，我们分析了GD作为二线化疗的疗效。
GD治疗周期的中位数为4（范围2 - 9）；客观缓解率为47.4%；无进展生存期和总生存期的中位数分别为4.1个月和10.8个月。对GD治疗组的单因素和多因素分析表明，肺转移的存在是肿瘤反应的唯一预后因素。3级治疗相关毒性包括中性粒细胞减少（31.6%）和血小板减少（15.8%），只有1例4级毒性患者出现血小板减少（2.6%）。
GD方案作为二线化疗对肺转移UC特别有效，且在一线铂类化疗失败的患者中取得了良好的结果。鉴于本研究中观察到的安全性和获益情况，有必要进行一项大型前瞻性研究，以考虑GD化疗作为UC二线治疗的潜在效用。
