Zhang Bin, Li Rui, Chang Chun-Xiao, Han Yong, Shi Sheng-Bin, Tian Jing
Department of Medical Oncology, Shandong Ji Ning First People's Hospital.
Department of Medical Oncology, Shandong Cancer Hospital, Shandong University, Shandong; Department of Medical Oncology, Shandong Cancer Hospital and Institute, Shandong Academy of Medical Sciences, Jinan, People's Republic of China.
Onco Targets Ther. 2016 Jun 29;9:3901-6. doi: 10.2147/OTT.S107319. eCollection 2016.
This study was conducted to evaluate the toxicity and efficacy of pemetrexed plus dendritic cells (DCs) when administered as third-line treatment for metastatic esophageal squamous cell carcinoma (ESCC). All patients in the study group had previously failed first-line treatment with 5-fluorouracil and cisplatin-based regimens, as well as second-line treatment with taxane-based regimens. A total of 31 patients were treated with pemetrexed (500 mg/m(2)) plus DCs on day 1, every 3 weeks. DCs were given for one cycle of 21 days. Thirty patients were evaluated for their response. No patient had a complete response, three patients (10.0%) had a partial response, ten patients (33.3%) had stable disease, and 17 patients (56.7%) had progressive disease. The overall response rate was 10.0%. The median progression-free survival (PFS) time was 2.9 months (95% CI, 2.7-3.2), and the median overall survival (OS) time was 7.1 months (95% CI, 6.4-7.9). The median PFS and OS times among patients with high and low levels of miR-143 expression in their blood serum were significantly different: median PFS times =3.2 months (95% CI, 2.9-3.4) and 2.7 months (95% CI, 2.4-3.0), respectively (P=0.017), and median OS times =7.8 months (95% CI, 6.8-8.9) and 6.3 months (95% CI, 5.3-7.3), respectively (P=0.036). No patient experienced Grade 4 toxicity. Combined third-line treatment with pemetrexed and DCs was marginally effective and well tolerated in patients with advanced ESCC. Serum miR-143 levels are a potential biomarker for predicting the efficacy of pemetrexed plus DCs in the treatment of ESCC.
本研究旨在评估培美曲塞联合树突状细胞（DCs）作为转移性食管鳞状细胞癌（ESCC）三线治疗的毒性和疗效。研究组所有患者一线接受基于5-氟尿嘧啶和顺铂的方案治疗失败，二线接受基于紫杉烷的方案治疗也失败。总共31例患者在第1天接受培美曲塞（500 mg/m²）联合DCs治疗，每3周一次。DCs给予21天的一个周期。30例患者接受疗效评估。无患者达到完全缓解，3例患者（10.0%）达到部分缓解，10例患者（33.3%）疾病稳定，17例患者（56.7%）疾病进展。总缓解率为10.0%。中位无进展生存期（PFS）为2.9个月（95%CI，2.7 - 3.2），中位总生存期（OS）为7.1个月（95%CI，6.4 - 7.9）。血清中miR-143表达水平高和低的患者之间的中位PFS和OS时间有显著差异：中位PFS时间分别为3.2个月（95%CI，2.9 - 3.4）和2.7个月（95%CI，2.4 - 3.0）（P = 0.017），中位OS时间分别为7.8个月（95%CI，6.8 - 8.9）和6.3个月（95%CI，5.3 - 7.3）（P = 0.036）。无患者发生4级毒性。培美曲塞和DCs联合三线治疗对晚期ESCC患者疗效欠佳但耐受性良好。血清miR-143水平是预测培美曲塞联合DCs治疗ESCC疗效的潜在生物标志物。
