A randomized clinical trial of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the oesophagus or gastro-oesophageal junction
A randomized clinical trial of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the oesophagus or gastro-oesophageal junction
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DOI：
10.1093/annonc/mdw010
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发表时间：
2016-04-01
影响因子：
50.5
通讯作者：
Nilsson, M.
中科院分区：
文献类型：
--
作者：
Klevebro, F.;von Dobeln, G. Alexandersson;Nilsson, M.
与新辅助化疗相比，新辅助放化疗可提高局部肿瘤控制率，但对食管癌患者的生存率无显著影响。新辅助治疗可提高食管癌切除术后的长期生存率，但迄今为止的证据不足以确定化疗（nCT）或放化疗（nCRT）这两种主要的新辅助治疗类型中哪一种更有益。我们的目的是比较nCT与nCRT的效果。这项在瑞典和挪威进行的多中心试验招募了181例食管癌或胃食管交界处癌患者，这些患者都是治愈性治疗的候选人。主要终点是新辅助治疗后的组织学完全缓解，这已被证明与长期生存率增加相关。研究参与者随机接受nCT或nCRT，随后接受双视野淋巴结切除术。两组均接受3个周期的铂/5-氟尿嘧啶治疗，而nCRT组同时接受40戈伊的放疗。试验达到了主要终点，nCRT组的组织学完全缓解率为28%，nCT组为9%（P = 0.002）。在nCT组中观察到62%的淋巴结转移，而在nCRT组中观察到35%的淋巴结转移（P = 0.001）。nCRT后R 0切除率为87%，nCT后为74%（P = 0.04）。两治疗组的总生存率无差异。在新辅助化疗基础上加用放疗可提高组织学完全缓解率、R 0切除率和淋巴结转移率，但对生存率无显著影响。NCT 01362127（;完整的研究方案已在临床试验数据库中注册）。
Neoadjuvant chemoradiotherapy gives increased local tumour control compared with neoadjuvant chemotherapy, without significantly affecting survival in oesophageal cancer.Neoadjuvant therapy improves long-term survival after oesophagectomy, treating oesophageal cancer, but the evidence to date is insufficient to determine which of the two main neoadjuvant therapy types, chemotherapy (nCT) or chemoradiotherapy (nCRT), is more beneficial. We aimed to compare the effects of nCT with those of nCRT.This multicentre trial, which was conducted in Sweden and Norway, recruited 181 patients with carcinoma of the oesophagus or the gastro-oesophageal junction who were candidates for curative-intended treatment. The primary end point was histological complete response after neoadjuvant treatment, which has been shown to be correlated with increased long-term survival. Study participants were randomized to nCT or nCRT, followed by surgery with two-field lymphadenectomy. Three cycles of platin/5-fluorouracil were administered in both arms, whereas 40 Gy of concomitant radiotherapy was added in the nCRT arm.The trial met the primary end point, histological complete response being achieved in 28% after nCRT versus 9% after nCT (P = 0.002). Lymph-node metastases were observed in 62% in the nCT group versus 35% in the nCRT group (P = 0.001). The R0 resection rate was 87% after nCRT and 74% after nCT (P = 0.04). There was no difference in overall survival between the treatment arms.The addition of radiotherapy to neoadjuvant chemotherapy results in higher histological complete response rate, higher R0 resection rate, and a lower frequency of lymph-node metastases, without significantly affecting survival.NCT01362127 (; The full study protocol was registered in the Clinical Trials Database).