两种同期放化疗方案治疗局部晚期食管鳞癌的比较

A comparative study of the efficacy and safety between paclitaxel plus fluorouraci and cisplatin plus fluorouracil in the treatment of locally advanced esophageal squamous carcinoma

目的 比较紫杉醇联合氟尿嘧啶(TF)与顺铂联合氟尿嘧啶(PF)两种同期放化疗方案治疗局部晚期食管鳞癌的疗效与安全性.方法 共纳入江南大学附属医院自2014年7月至2016年6月所收治的103例食管癌患者,采用随机数表法将入组的患者按1:1比例随机分为研究组(TF)或对照组(PF),TF组52例,PF组51例.研究的主要终点为生存率(OS),次要终点为局部控制率(LPFS)、无进展生存率(PFS)和不良反应.结果 经过2年随访,TF组及PF组1年OS分别为76.9%及74.5%(P>0.05),2年OS分别为和59.6%及56.9%,差异无统计学意义(P>0.05).TF组及PF组1年LPFS分别为71.2%及66.7%(P>0.05);2年LPFS分别为61.5%及58.8%(P>0.05);1年PFS分别为63.5%及62.7%(P>0.05),2年PFS分别为51.9%及39.2%,差异无统计学意义(P>0.05).不良反应方面,TF组与PF组3~4级白细胞减低分别为36.5%及17.6%(χ^2=4.642,P<0.05),3~4级急性放射性肺炎发生率分别为15.4%及3.9%(χ^2=3.859,P<0.05),PF组3~4级恶心呕吐反应率17.6%,高于TF组的1.9%,差异有统计学意义(χ^2=7.262,P<0.05).结论 两组同期放化疗方案治疗局部晚期食管鳞癌的OS、PFS、LPFS无差异,但不良反应不同.TF组在血液学毒性、放射性肺炎等发生率上要高于PF组,而PF组更应关注消化系统不良反应的发生.

Objective To compare the efficacy and safety of two concurrent chemoradiotherapy regimens between paclitaxel plus fluorouracil(TF) and cisplatin plus fluorouracil (PF) in the treatment of locally advanced esophageal squamous carcinoma.Methods 103 patients with locally advanced esophagus carcinoma were treated in Affiliated Hospital of Jiangnan University from December 2014 to February 2016, and randomly assigned to either study group (TF) or control group (PF) according to random number table, of which 52 patients in the TF group while 51 patients in the PF group. The primary outcome was overall survival(OS), and secondary outcomes include progression-free survival(PFS), local progression-free survival(LPFS) and side effects.Results The 1-year OS for TF group was 76.9% versus 74.5% for PF group(P>0.05), and the 2-year OS for TF group was 59.6% versus 56.9% for PF group(P>0.05). The 1-year LPFS for TF group and PF group were 71.2% and 66.7% respectively(P>0.05), and the 2-year LPFS for TF group and PF group were 61.5% and 58.8% respectively(P>0.05). The 1-year PFS for TF group was 63.5% versus 62.7% for PF group(P>0.05), and the 2-year PFS for TF group was 51.9% versus 39.2% for PF group(P>0.05). The incidence rate of serious (grade 3-4) leukopenia for TF group was 36.5% versus 17.6% for PF group(χ^2=4.642, P<0.05). The incidence rate of serious (grade 3-4) acute radiation pneumonitis was 15.4% in the TF group, higher than that in the PF group with the rate of 3.9%(χ^2=3.859, P<0.05), while the incidence rate of severe nausea and vomiting for PF group was 17.6% versus 1.9% for TF group(χ^2=7.262, P<0.05). The difference between the two groups was statistically significant.Conclusions Patients who were treated with two concurrent chemoradiotherapy regimens showed no difference in OS, PFS and LPFS. The regimen on the basis of Paclitaxel has higher risk of adverse effects incidence rates of hematological toxicity and acute radiation pneumonitis, while digestive system toxicity must be concerned when concurrent chemoradiotherapy is performed on the basis of cisplatin plus fluorouracil.