Wang Hai-Ying, Yao Zhi-Hua, Tang Hong, Zhao Yan, Zhang Xiao-San, Yao Shu-Na, Yang Shu-Jun, Liu Yan-Yan
Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan, People's Republic of China.
Onco Targets Ther. 2016 Sep 23;9:5663-5669. doi: 10.2147/OTT.S108580. eCollection 2016.
More effective regimens for advanced esophageal squamous cell carcinoma (ESCC) are urgently needed. Therefore, a retrospective study concerning the efficacy and safety of nanoparticle albumin-bound paclitaxel plus cisplatin (nab-TP) versus solvent-based paclitaxel plus cisplatin (sb-TP) as a first-line therapy was conducted in Chinese patients with advanced ESCC.
From June 2009 to June 2015, 32 patients were treated with nab-paclitaxel (125 mg/m) on the first and eighth days (30 minutes infusion) and cisplatin (75 mg/m) on the second day every 21 days (nab-TP arm). Also, 43 patients were treated with solvent-based paclitaxel (80 mg/m) intravenously on the first and eighth days and the same dose of cisplatin (sb-TP arm). The two groups were compared in terms of objective response rate (ORR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety profile. OS and PFS were estimated using Kaplan-Meier methods to determine associations between chemotherapy regimens and survival outcomes.
Nab-TP demonstrated a higher ORR (50% vs 30%; =0.082) and disease control rate (81% vs 65%; =0.124) than sb-TP. Median OS was similar for nab-TP and sb-TP (12.5 vs 10.7 months; =0.269). However, nab-TP resulted in a longer median PFS (6.1 months [95% confidence interval: 5.3-6.9]) than sb-TP (5.0 months [95% confidence interval: 4.4-5.6]) (=0.029). The most common adverse events included anemia, leukopenia, neutropenia, febrile neutropenia, and thrombocytopenia in both the groups and no statistically significant differences were observed between the groups. With statistically significant differences, significantly less grade ≥3 peripheral neuropathy, arthralgia, and myalgia occurred in the nab-TP arm (all <0.05). Dose reduction, treatment delays, and second-line therapy were similar between the two regimens. There were no treatment-related deaths in either group.
Nab-paclitaxel plus cisplatin is found to be an effective and tolerable option for advanced ESCC in the People's Republic of China.
迫切需要更有效的晚期食管鳞状细胞癌（ESCC）治疗方案。因此，针对纳米白蛋白结合型紫杉醇联合顺铂（nab-TP）与溶剂型紫杉醇联合顺铂（sb-TP）作为一线治疗方案在中国晚期ESCC患者中的疗效和安全性进行了一项回顾性研究。
2009年6月至2015年6月，32例患者接受纳米白蛋白结合型紫杉醇（125mg/m²）于第1天和第8天静脉输注（输注30分钟）和顺铂（75mg/m²）于第2天，每21天重复（nab-TP组）。另外，43例患者接受溶剂型紫杉醇（80mg/m²）于第1天和第8天静脉输注以及相同剂量的顺铂（sb-TP组）。比较两组的客观缓解率（ORR）、疾病控制率、无进展生存期（PFS）、总生存期（OS）和安全性。采用Kaplan-Meier方法估计OS和PFS，以确定化疗方案与生存结局之间的关联。
nab-TP组的ORR（50%对30%；P = 0.082）和疾病控制率（81%对65%；P = 0.124）均高于sb-TP组。nab-TP组和sb-TP组的中位OS相似（12.5个月对10.7个月；P = 0.269）。然而，nab-TP组的中位PFS更长（6.1个月[95%置信区间：5.3 - 6.9]），高于sb-TP组（5.0个月[95%置信区间：4.4 - 5.6]）（P = 0.029）。两组最常见的不良事件包括贫血、白细胞减少、中性粒细胞减少、发热性中性粒细胞减少和血小板减少，且两组间未观察到统计学显著差异。在有统计学显著差异方面，nab-TP组≥3级周围神经病变、关节痛和肌痛的发生率显著更低（均P < 0.05）。两组在剂量减少、治疗延迟和二线治疗方面相似。两组均无治疗相关死亡。
在中国，纳米白蛋白结合型紫杉醇联合顺铂被发现是晚期ESCC一种有效且可耐受的治疗选择。
