2016年6月3-7日，一年一度的美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）年会在芝加哥举办。6月4日上午的消化系统（非结直肠）肿瘤壁报专场上，四川省肿瘤医院研究所的李涛教授呈现了一项摘要号为4050的中国研究，该研究是在IV期食管鳞状细胞癌患者中开展的一项随机II期研究，将同步放化疗与单纯化疗进行比较，整理如下：

IV期食管鳞状细胞癌（ESCC）的预后较差，中位生存期为6-9个月。标准治疗策略传统上一直是化疗。姑息性放疗主要用于缓解症状。IV期ESCC的最佳治疗尚未确定。这项研究的目标是比较CCRT与单纯化疗在IV期ESCC患者中的疗效和安全性。

IV期ESCC，体力状态为0-1的患者被随机分配到CCRT组和化疗组。两组患者均接受至少2个周期的顺铂+多西他赛每3周的化疗。CCRT组患者对食管原发肿瘤进行50-60Gy/25-30次的同步放疗。主要终点是总生存期（OS）。次要终点是无进展生存期（PFS），原发肿瘤客观缓解率（ORR）和毒性。

在2013年8月到2015年10月之间，60例患者被招募，分为CCRT组（n=30）和化疗组（n=30）。两组的基线临床特征相似。CCRT组患者接受平均54.7Gy的放疗和平均3.6个周期的化疗，而化疗组患者接受平均3.8个周期的化疗。原发肿瘤ORR在CCRT组较高于化疗组（83.3% vs 46.7%，P=0.001）。在中位16个月的随访时，CCRT组的中位PFS（9.3个月 vs 4.7个月，P=0.021）和中位OS（18.3个月 vs 10.2个月，P=0.001）显著长于化疗组。CCRT组的1，2年-总存活率为73.3%，43.3%，化疗组的1，2年-总存活率为46.6%，26.7%（P=0.020）。虽然≥3级的中性粒细胞减少在CCRT组显著高于化疗组（33.3% vs 20.0%，P＜0.05），而其他毒性发生率没有差异。

在IV期食管鳞状细胞癌患者中，同步放化疗耐受性良好，相比于单纯化疗，同步放化疗会带来较长的PFS和OS。为了确定同步放化疗是否是IV期ESCC患者的一种主要治疗选择，还需要开展对照随机多中心试验。

原文摘要：

Prospective randomized phase II study of concurrent chemoradiotherapy versus chemotherapy alone in stage IV esophageal squamous cell carcinoma.（Abstract4050）

Authors：Tao Li, Jiahua Lv, Fang Li,et al

Session Type：Poster Session

Background: Stage IV ESCC carries a poor prognosis with a median survivals of 6-9 months. The standard treatment has traditionally been chemotherapy. Palliative radiotherapy was used for symptom relief. The optimal treatment for stage IV ESCC has not yet been established. The aim of this study was to compare the efficacy and safety of CCRT versus chemotherapy alone in patients with stage IV ESCC. 

Methods: Stage IV ESCC with a performance status of 0-1 were randomly assigned to the CCRT group and the chemotherapy group. Both groups of patients received at least 2 cycles of chemotherapy with cisplatin and docetaxel every 3 weeks. Patients in CCRT group received 50-60 Gy/25-30 fractions of concurrent radiotherapy to the esophageal primary tumor. The primary end point was overall survival (OS). The secondary end points were progression-free survival (PFS), object response rate (ORR) of primary tumor and toxicity. 

Results: Between Aug. 2013 and Oct. 2015, 60 patients were enrolled and divided into the CCRT group (n = 30) and the chemotherapy group (n = 30). The baseline clinical characteristics of the 2 groups were similar. Patients in the CCRT group received a mean 54.7 Gy of radiotherapy and a mean 3.6 cycles of chemotherapy, whereas patients in the chemotherapy group received a mean 3.8 cycles. The ORR of the primary tumor was higher in the CCRT group than in the chemotherapy group (83.3% vs. 46.7%, p = 0.001). At a median follow-up of 16 months, median PFS (9.3 vs. 4.7 months, p = 0.021) and median OS (18.3 vs. 10.2 months, p = 0.001) were significantly longer in the CCRT than that in the chemotherapy group. Overall survival rates at 1, 2 years were 73.3%, 43.3% in the CCRT group and 46.6%, 26.7% in chemotherapy group (p = 0.030) Although ≥ grade 3 neutropenia was significantly more frequent in the CCRT group than that in the chemotherapy group (33.3% vs. 20.0 %, p < 0.05), the rates of other toxicities did not differ. 

Conclusions: CCRT was well tolerated and was associated with longer PFS and OS than chemotherapy alone in patients with stage IV ESCC. Controlled randomized, multi-center trials are required to determine whether CCRT is a primary treatment option for patients with stage IV ESCC.