Department of Oncology, Mian Yang Central Hospital, Mianyang, 621000, People's Republic of China.
Department of Oncology, West China Hospital of Sichuan University, Chengdu, China.
Radiat Oncol. 2018 Jan 22;13(1):12. doi: 10.1186/s13014-018-0958-5.
Some Chinese patients with esophageal squamous cell carcinomaare often treated with single-agent concurrent chemoradiotherapy. However, no results have been reported from randomized controlled clinical trials comparing single-agent with double-agent concurrent chemoradiotherapy. It therefore remains unclear whether these regimens are equally clinically effective. In this study, we retrospectively analyzed and compared the therapeutic effects of single-agent and double-agent concurrent chemoradiotherapy in patients with unresectable esophageal squamous cell carcinoma.
This study enrolled 168 patients who received definitive concurrent chemoradiotherapy for locally advanced unresectable esophageal squamous carcinoma at 10 hospitals between 2010 and 2015. We evaluated survival time and toxicity. The Kaplan-Meier method was used to estimate survival data. The log-rank test was used in univariate analysis A Cox proportional hazards regression model was used to conduct a multivariate analysis of the effects of prognostic factors on survival.
In this study, 100 (59.5%) and 68 patients (40.5%) received single-agent and dual-agent combination chemoradiotherapy, respectively. The estimate 5-year progression-free survival (PFS) rate and overall survival (OS) rate of dual-agent therapy was higher than that of single-agent therapy (52.5% and 40.9%, 78.2% and 60.7%, respectively), but there were no significant differences (P = 0.367 and 0.161, respectively). Multivariate analysis showed that sex, age,and radiotherapy dose had no significant effects on OS or PFS. Only disease stage was associated with OS and PFS in the multivariable analysis (P = 0.006 and 0.003, respectively). In dual-agent group, the incidence of acute toxicity and the incidence of 3 and4 grade toxicity were higher than single-agent group.
The 5-year PFS and OS rates of dual-agent therapy were higher than those of single-agent concurrent chemoradiotherapy for patients with unresectable esophageal squamous cell carcinoma; however, there were no significant differences in univariate analysis and multivariable analysis. Single-agent concurrent chemotherapy had less toxicity than a double-drug regimen. Therefore, we suggest that single therapis not inferior to dual therapy y. In the future, we aim to confirm our hypothesis through a prospective randomized study.
中国部分食管鳞癌患者常接受单药同步放化疗,但目前尚无随机对照临床试验比较单药与双药同步放化疗的结果,故这两种方案的临床疗效是否相当尚不清楚。本研究回顾性分析比较了不可切除食管鳞癌患者接受单药与双药同步放化疗的疗效。
本研究纳入 2010 年至 2015 年 10 家医院收治的 168 例局部晚期不可切除食管鳞癌患者,行根治性同步放化疗,评估生存时间和毒性。采用 Kaplan-Meier 法估计生存数据,采用对数秩检验进行单因素分析,采用 Cox 比例风险回归模型进行多因素分析。
本研究中单药组和双药组分别有 100 例(59.5%)和 68 例(40.5%)患者入组。双药组的 5 年无进展生存(PFS)率和总生存(OS)率均高于单药组(52.5%和 40.9%,78.2%和 60.7%),但差异无统计学意义(P=0.367 和 0.161)。多因素分析显示,性别、年龄和放疗剂量对 OS 和 PFS 无显著影响,仅疾病分期在多因素分析中与 OS 和 PFS 相关(P=0.006 和 0.003)。双药组急性毒性和 3-4 级毒性发生率均高于单药组。
与单药同步放化疗相比,双药同步放化疗可提高不可切除食管鳞癌患者的 5 年 PFS 和 OS 率,但单因素和多因素分析均无统计学差异。单药同步化疗毒性较双药方案小。因此,我们建议单药治疗不劣于双药治疗。未来我们希望通过前瞻性随机研究验证这一假设。