术前化疗与术后辅助化疗治疗可检测循环肿瘤细胞的胸段食管鳞癌的随机对照试验。

Preoperative chemotherapy compared with postoperative adjuvant chemotherapy for squamous cell carcinoma of the thoracic oesophagus with the detection of circulating tumour cells randomized controlled trial.

机构信息

Department of Thoracic Surgery, The Second Hospital of Shandong University, Jinan, Shandong, China.

Department of Thoracic Surgery, Shandong Cancer Hospital and Institute (HL), Jinan, Shandong, China.

出版信息

Int J Surg. 2020 Jan;73:1-8. doi: 10.1016/j.ijsu.2019.11.005. Epub 2019 Nov 20.

DOI:10.1016/j.ijsu.2019.11.005

PMID:31756547

Abstract

BACKGROUND

The role of preoperative chemotherapy in the treatment of patients with oesophageal squamous cell carcinoma (ESCC) remains controversial. Chemotherapy followed by surgery was compared with surgery ± chemotherapy, and the detection of circulating tumour cells (CTCs) was performed on all enrolled patients.

METHODS

We randomly assigned patients with resectable tumours to the preoperative chemotherapy group (Pre group) or surgery group (patients who were either given or not given adjuvant chemotherapy according to their postoperative lymph node status, Post group). Blood samples were collected 1-3 days before treatment (including preoperative chemotherapy and surgery) and 7 days after surgery for CTC detection.

RESULTS

From July 2016 to October 2018, 115 patients were enrolled in the study, of whom 57 were assigned to the Pre group and 58 to the Post group. The proportion of patients with stage III ESCC was 63.16% in the Pre group and 48.28% in the Post group. No patients died during chemotherapy. One patient exhibited a complete response to preoperative chemotherapy, and 13 patients exhibited partial responses. The 2-year progression-free survival (PFS) and overall survival (OS) rates were not significantly different between the Pre and Post groups. In the subgroup analysis, patients with CTC (+) prior to treatments receiving preoperative chemotherapy had a better 2-year PFS (71.90% vs. 38.73%, P = 0.0379). In the Cox proportional hazards regression analysis, platelet count was proven to correlate significantly with disease progression (P = 0.016), and no factors were proven to correlate significantly with mortality after the factors were balanced in the present analysis.

CONCLUSIONS

Preoperative chemotherapy improved the short-term PFS when CTC detection was positive prior to any treatment for patients with stage II or III ESCC. CTC detection may be used as an index to guide individualized strategic decisions regarding preoperative chemotherapy, but more evidence is needed.

摘要

背景

术前化疗在治疗食管鳞状细胞癌（ESCC）患者中的作用仍存在争议。本研究比较了化疗后手术与手术±化疗，并对所有入组患者进行了循环肿瘤细胞（CTC）检测。

方法

我们将可切除肿瘤患者随机分配至术前化疗组（Pre 组）或手术组（术后根据淋巴结状态给予或不给予辅助化疗，Post 组）。治疗前（包括术前化疗和手术）及术后 7 天行血样采集，以检测 CTC。

结果

2016 年 7 月至 2018 年 10 月，共纳入 115 例患者，其中 57 例患者入组 Pre 组，58 例患者入组 Post 组。Pre 组中 III 期 ESCC 患者比例为 63.16%，Post 组中 III 期 ESCC 患者比例为 48.28%。化疗期间无患者死亡。1 例患者对术前化疗完全缓解，13 例患者部分缓解。Pre 组和 Post 组患者的 2 年无进展生存率（PFS）和总生存率（OS）无显著差异。亚组分析显示，治疗前 CTC（+）患者行术前化疗时，2 年 PFS 更好（71.90% vs. 38.73%，P=0.0379）。Cox 比例风险回归分析表明，血小板计数与疾病进展显著相关（P=0.016），本分析中平衡了各因素后，未发现与死亡率相关的因素。