Clinical Research Division, Center of Molecular Immunology, Calle 216 esq 15, 11600, Atabey, Havana, Cuba.
Department of Radiation Oncology, Conrado Benitez University Hospital, Avenida Libertadores y P. Martí, CP 90100, Santiago de Cuba, Cuba.
Adv Ther. 2017 Dec;34(12):2638-2647. doi: 10.1007/s12325-017-0631-7. Epub 2017 Nov 13.
Despite improvements in surgical techniques and treatments introduced into clinical practice, the overall survival of patients with esophageal squamous cell carcinoma remains low. Several epidermal growth factor receptor inhibitors are being evaluated in the context of clinical trials, but there is little evidence of effectiveness in real-world conditions. This study aimed at assessing the effectiveness of nimotuzumab combined with onco-specific treatment in Cuban real-life patients with locally advanced or metastatic esophageal squamous cell carcinoma.
A comparative and retrospective effectiveness study was performed. The 93 patients treated with nimotuzumab were matched, with use of propensity score matching, with patients who received a diagnosis of locally advanced or metastatic squamous cell carcinoma of the esophagus in three Cuban provinces reported between 2011 and 2015 to the National Cancer Registry. The Kaplan-Meier method was used to estimate event-time distributions. Log-rank statistics were used for comparisons of overall survival between groups. A two-component mixture model assuming a Weibull distribution was fitted to assess the effect of nimotuzumab on short-term and long-term survival populations.
There was an increase in median overall survival in patients treated with nimotuzumab (11.9 months versus 6.5 months without treatment) and an increase in the 1-year survival rate (54.0% versus 21.9% without treatment). The 2-year survival rates were 21.1% for patients treated with nimotuzumab and 0% in the untreated cohort. There were statistically significant differences in survival between groups treated and not treated with nimotuzumab, both in the short-term survival population (6.0 months vs 4.0 months, p = 0.009) and in the long-term survival population (18.0 months vs 11.0 months, p = 0.001).
Our study shows that nimotuzumab treatment concurrent with chemoradiotherapy increases the survival of real-world patients with locally advanced or metastatic esophageal squamous cell carcinoma. Further prospective studies are required to confirm the therapeutic effectiveness of nimotuzumab in esophageal cancer.
尽管手术技术和治疗方法有所改进，但食管鳞状细胞癌患者的总体生存率仍然较低。几种表皮生长因子受体抑制剂正在临床试验中进行评估，但在实际情况下，其有效性证据有限。本研究旨在评估尼妥珠单抗联合肿瘤特异性治疗在古巴局部晚期或转移性食管鳞状细胞癌患者中的疗效。
进行了一项比较性回顾性疗效研究。使用倾向评分匹配，将在 2011 年至 2015 年期间向国家癌症登记处报告的在古巴三个省份被诊断为局部晚期或转移性食管鳞状细胞癌的 93 例接受尼妥珠单抗治疗的患者与未接受治疗的患者进行匹配。使用 Kaplan-Meier 方法估计事件时间分布。对数秩统计用于比较两组的总生存率。拟合了一个假设威布尔分布的两成分混合模型，以评估尼妥珠单抗对短期和长期生存人群的影响。
接受尼妥珠单抗治疗的患者的中位总生存率有所提高（11.9 个月 vs 未治疗的 6.5 个月），1 年生存率也有所提高（54.0% vs 未治疗的 21.9%）。接受尼妥珠单抗治疗的患者 2 年生存率为 21.1%，而未治疗的患者为 0%。接受和未接受尼妥珠单抗治疗的两组患者的生存存在统计学显著差异，无论是在短期生存人群（6.0 个月 vs 4.0 个月，p=0.009）还是在长期生存人群（18.0 个月 vs 11.0 个月，p=0.001）。
我们的研究表明，尼妥珠单抗联合放化疗治疗可提高局部晚期或转移性食管鳞状细胞癌患者的生存率。需要进一步的前瞻性研究来证实尼妥珠单抗在食管癌中的治疗效果。
