Tian Yuan, Wang Jun, Qiao Xueying, Zhang Jun, Li Yong, Fan Liqiao, Zhang Zhidong, Zhao Xuefeng, Tan Bibo, Wang Dong, Yang Peigang, Zhao Qun
Third Surgery Department, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Department of Radiation, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Front Oncol. 2021 Nov 11;11:756440. doi: 10.3389/fonc.2021.756440. eCollection 2021.
Reports have shown that neoadjuvant concurrent chemoradiotherapy (nCRT) increases the R0 resection rate for patients with Siewert type II or III adenocarcinoma of the gastroesophageal junction (AEG). However, the long-term efficacy of nCRT for AEG patients remains unclear. In this multicenter study, we investigated the long-term results of AEG patients treated with nCRT.
A total of 149 patients with potentially resectable advanced AEG (T3/4, Nany, M0) were randomly divided into two groups: the nCRT-treated group (treated group) ( = 76) and the surgery group (control group) ( = 73). The primary endpoint was disease-free survival (DFS), and the secondary outcome indexes included the R0 resection rate, HER-2 expression, tumor regression grade (TRG), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and adverse events.
In the treated group, the overall therapeutic efficacy rate was 40.8%, and the pathological complete response (pCR) rate was 16.9%. The rates of patients who underwent R0 resection in the treated and control groups were 97.0% and 87.7%, respectively ( < 0.05). The toxic effects were mainly graded 1-2 in the treated group. The median DFS times in the treated and control groups were 33 and 27 months, respectively ( = 0.08), whereas the median OS times were 39 and 30 months, respectively ( = 0.01). The median DFS times of patients with positive and negative HER-2 expression in the treated group were 13 and 43 months, respectively ( = 0.01), and the median OS times were 27 and 41 months, respectively ( = 0.01).
Surgery after nCRT improved the efficacy of treatment for AEG patients and thus provided a better prognosis.
The trial is registered with ClinicalTrials.gov (number NCT01962246).
报告显示，新辅助同步放化疗（nCRT）可提高胃食管交界部（AEG）Siewert II型或III型腺癌患者的R0切除率。然而，nCRT对AEG患者的长期疗效仍不明确。在这项多中心研究中，我们调查了接受nCRT治疗的AEG患者的长期结果。
总共149例具有潜在可切除的晚期AEG（T3/4，Nany，M0）患者被随机分为两组：nCRT治疗组（治疗组）（n = 76）和手术组（对照组）（n = 73）。主要终点是无病生存期（DFS），次要结局指标包括R0切除率、HER-2表达、肿瘤退缩分级（TRG）、客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和不良事件。
在治疗组中，总体治疗有效率为40.8%，病理完全缓解（pCR）率为16.9%。治疗组和对照组中接受R0切除的患者比例分别为97.0%和87.7%（P<0.05）。治疗组的毒性作用主要为1-2级。治疗组和对照组的中位DFS时间分别为33个月和27个月（P = 0.08），而中位OS时间分别为39个月和30个月（P = 0.01）。治疗组中HER-2表达阳性和阴性患者的中位DFS时间分别为13个月和43个月（P = 0.01），中位OS时间分别为27个月和41个月（P = 0.01）。
nCRT后手术提高了AEG患者的治疗效果，从而提供了更好的预后。
该试验已在ClinicalTrials.gov注册（编号NCT01962246）。
