Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer.
Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer.
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新辅助FLOT与SOX治疗局部晚期胃癌患者的II期随机临床试验
DOI：
10.1038/s41467-020-19965-6
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发表时间：
2020-11-30
影响因子：
16.6
通讯作者：
Zhu Z
中科院分区：
文献类型：
--
作者：
Sah BK;Zhang B;Zhang H;Li J;Yuan F;Ma T;Shi M;Xu W;Zhu Z;Liu W;Yan C;Li C;Liu B;Yan M;Zhu Z
在局部晚期可切除胃癌（LAGC）患者中，多西他赛、奥沙利铂、氟尿嘧啶和亚叶酸（FLOT方案）新辅助化疗在病理学缓解和生存率方面显示出有希望的结果。然而，替加氟吉美拉西钾胶囊（S-1）联合奥沙利铂（SOX方案）是东方国家的首选化疗方案。在这里，我们进行了一项开放标签、两组、II期随机干预性临床试验（Dragon III; ClinicalTrials.gov：NCT 03636893），以评估两种方案的安全性和有效性。LAGC患者在胃切除术前随机分配接受4个周期的新辅助FLOT方案（40例患者）或3个周期的SOX方案（34例患者）。主要终点是比较原发性肿瘤的完全（TRG 1a）或次全（TRG 1b）肿瘤消退分级。两组之间的不良反应或术后发病率和死亡率无显著差异。两组间肿瘤消退比例无显著性差异，完全或次全TRG在FLOT组为20.0%，SOX组为32.4%。因此，我们的研究没有发现新辅助FLOT和SOX方案在局部晚期胃癌的主要结局方面存在统计学显著差异。新辅助化疗FLOT方案治疗局部晚期胃癌已显示出良好的效果，但SOX方案仍是东方国家的首选化疗方案。在此，作者报告说，在一项II期随机临床试验中，这两种疗法产生了相似的结果，如临床分期下调和病理反应。
Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (FLOT regimen) has shown promising results in terms of pathological response and survival rate in patients with locally advanced resectable gastric cancer (LAGC). However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (SOX regimen) is the preferred chemotherapy regimen in Eastern countries. Here, we conduct an open label, two-arm, phase II randomized interventional clinical trial (Dragon III; ClinicalTrials.gov: NCT03636893) to evaluate the safety and efficacy of both regimens. Patients with LAGC are randomly assigned to receive either 4 cycles of the neoadjuvant FLOT regimen (40 patients) or 3 cycles of the SOX regimen (34 patients) before gastrectomy. The primary endpoint is the comparison of complete (TRG1a) or subtotal (TRG1b) tumor regression grading in the primary tumor. There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups. No significant differences in the proportion of tumor regression grading between the FLOT group and the SOX group are found. Complete or subtotal TRG is 20.0% in the FLOT group versus 32.4% in the SOX group. Therefore, our study does not find statistically significant differences between neoadjuvant FLOT and SOX regimens for the primary outcomes reported here in locally advanced gastric cancer. Neoadjuvant FLOT regimen has shown promising results for the treatment of locally advanced gastric cancer, however SOX regimen remains the preferred chemotherapy in Eastern countries. Here the authors report that the two therapies result in similar outcomes, measured as clinical downstaging and pathological response, in a phase II randomized clinical trial.
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影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
7.3
作者：
Satake H;Miki A;Kondo M;Kotake T;Okita Y;Hatachi Y;Yasui H;Imai Y;Ichikawa C;Murotani K;Hashida H;Kobayashi H;Kotaka M;Kato T;Kaihara S;Tsuji A
通讯作者：
Tsuji A
影响因子：
3.8
作者：
Zhao JH;Gao P;Song YX;Sun JX;Chen XW;Ma B;Yang YC;Wang ZN
通讯作者：
Wang ZN
影响因子：
7.4
作者：
Eto, Kojiro;Hiki, Naoki;Yamaguchi, Toshiharu
通讯作者：
Yamaguchi, Toshiharu
影响因子：
51.1
作者：
Al-Batran, Salah-Eddin;Hofheinz, Ralf D.;Tannapfel, Andrea
通讯作者：
Tannapfel, Andrea