Safety and efficacy of combination therapy with low-dose gemcitabine, paclitaxel, and sorafenib in patients with cisplatin-resistant urothelial cancer.
Safety and efficacy of combination therapy with low-dose gemcitabine, paclitaxel, and sorafenib in patients with cisplatin-resistant urothelial cancer.
复制标题
DOI：
10.1007/s12032-015-0683-y
复制
发表时间：
2015-10
期刊：
影响因子：
--
通讯作者：
Sakai H
中科院分区：
文献类型：
--
作者：
Miyata Y;Asai A;Mitsunari K;Matsuo T;Ohba K;Sakai H
包括分子靶向药物在内的各种治疗方案已在顺铂 (CDDP) 耐药的尿路上皮癌 (UC) 患者中进行了检查。然而，由于严重不良事件的发生，一些研究已停止。本研究的主要目的是检查低剂量吉西他滨、紫杉醇和索拉非尼 (LD-GPS) 联合治疗 CDDP 耐药 UC 患者的抗癌效果、生活质量 (QoL) 变化和安全性。 20 名患者接受了吉西他滨（第 1 天 700 mg/m2）、紫杉醇（第 1 天 70 mg/m2）和索拉非尼（第 8-22 天 400 mg/天）治疗。使用身体疼痛简短调查 (SF)-36 和视觉模拟量表 (VAS) 评估生活质量和疼痛缓解。二线和三线治疗的 VAS 评分均显着降低（P 分别 = 0.012 和 0.028）。 SF-36 调查的身体疼痛评分也显着下降 (P = 0.012)。完全缓解、部分缓解和疾病稳定的患者分别为 0 例 (0.0%)、1 例 (5.0%) 和 13 例 (65%)。开始该治疗后的中位总生存期（四分位距）为 7 (5-11) 个月。三名患者 (15.0%) 由于 3 级疲劳和手足反应而停止治疗。 CDDP 耐药 UC 患者对 LD-GPS 治疗的耐受性良好。治疗后，生活质量得以维持，疼痛水平有所改善；三线治疗后检测到疼痛缓解。我们建议该治疗方案值得考虑作为 CDDP 耐药 UC 患者的二线和三线治疗。
Various regimens including molecular targeted agents have been examined in patients with cisplatin (CDDP)-resistant urothelial cancer (UC). However, some studies have been stopped owing to the development of severe adverse events. The main aim of this study was to examine the anticancer effects, changes in the quality of life (QoL), and safety of combined therapy of low-dose gemcitabine, paclitaxel, and sorafenib (LD-GPS) in patients with CDDP-resistant UC. Twenty patients were treated with gemcitabine (700 mg/m2 on day 1), paclitaxel (70 mg/m2 on day 1), and sorafenib (400 mg/day on days 8–22). QoL and pain relief were evaluated using the short-form survey (SF)-36 for bodily pain and the visual analog scale (VAS). VAS scores were significantly decreased by both the second- and third-line therapies (P = 0.012 and 0.028, respectively). The bodily pain score from the SF-36 survey was also significantly (P = 0.012) decreased. Complete responses, partial responses, and stable disease were found in 0 (0.0 %), 1 (5.0 %), and 13 patients (65 %), respectively. The median (interquartile range) period of overall survival after starting of this therapy was 7 (5–11) months. Three patients (15.0 %) stopped therapy because of grade 3 fatigue and hand–foot reactions. LD-GPS therapy was well tolerated by patients with CDDP-resistant UC. QoL was maintained, and improvements in their pain levels were found after treatment; pain relief was detected after third-line therapy. We suggest that this treatment regimen is worthy of consideration as second- and third-line therapy for patients with CDDP-resistant UC.