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An Open-Label Single-Arm Phase II Study of Treatment with Neoadjuvant S-1 Plus Cisplatin for Clinical Stage III Squamous Cell Carcinoma of the Esophagus.

一项新辅助 S-1 联合顺铂治疗临床 III 期食管鳞状细胞癌的开放标签单臂 II 期研究。

  • 影响因子:4.24
  • DOI:10.1634/theoncologist.2020-0546
  • 作者列表:"Kanda M","Koike M","Iwata N","Shimizu D","Tanaka C","Hattori N","Hayashi M","Yamada S","Omae K","Nakayama G","Kodera Y
  • 发表时间:2020-06-18
Abstract

LESSONS LEARNED:Two courses of neoadjuvant therapy using S-1 plus cisplatin for clinical stage III esophageal squamous cell carcinoma did not achieve expected response rate according to endoscopic evaluation of primary tumors. Subsequent esophagectomy was safely performed. BACKGROUND:In Japan, esophagectomy after two courses of 5-fluorouracil plus cisplatin is regarded a standard strategy for treating stage II or III esophageal squamous cell carcinoma (ESCC). However, 5-fluorouracil plus cisplatin does not benefit cohorts with clinical stage III ESCC, suggesting the need for a more effective regimen. METHODS:A single-arm, open-label phase II trial was conducted to evaluate the safety and efficacy of two courses of neoadjuvant chemotherapy using S-1 plus cisplatin (NAC-SP) for clinical stage III ESCC. The primary endpoint was overall response rate as defined by endoscopic evaluation of primary tumors. RESULTS:We enrolled 26 patients. The completion rate for the two courses of NAC-SP was 61.5%. Grade 3 or higher adverse events were experienced by 38.4% of patients. The treatment response rate according to endoscopic findings, acquired before the second course, was 34.6% and below the expected level (55.0%). The morbidity rate of patients who underwent radical subtotal esophagectomy (96.2%) was 32.0%. Repeat surgery was unnecessary, and surgery-associated deaths did not occur. The 5-year progression-free survival (PFS) and overall survival (OS) rates were 84.6% and 92.2%, respectively. CONCLUSION:We demonstrate safety of NAC-SP, but not its efficacy, for patients with clinical stage III ESCC. Subsequent esophagectomy was safely performed.

摘要

经验教训: 根据原发肿瘤的内镜评估,临床III期食管鳞状细胞癌使用S-1 加顺铂的两个疗程的新辅助治疗没有达到预期的反应率。随后的食管切除术是安全的。 背景: 在日本,5-氟尿嘧啶联合顺铂两个疗程后的食管切除术被认为是治疗II或III期食管鳞状细胞癌 (ESCC) 的标准策略。然而,5-氟尿嘧啶联合顺铂对临床III期ESCC的队列没有益处,提示需要更有效的方案。 方法: 一项单组、开放的II期临床试验旨在评价S-1 联合顺铂 (NAC-SP) 新辅助化疗两个疗程的安全性和有效性。对于临床III期ESCC。主要终点是通过内镜评估原发性肿瘤定义的总体缓解率。 结果: 我们入组了 26 例患者。NAC-SP两个疗程的完成率为 61.5%。38.4% 的患者经历了 3 级或更高的不良事件。根据内镜检查结果,第二疗程前获得的治疗应答率为 34.6%,低于预期水平 (55.0%)。根治性食管次全切除术的发病率 (96.2%) 为 32.0%。重复手术是不必要的,手术相关的死亡没有发生。5 年无进展生存期 (PFS) 和总生存期 (OS) 率分别为 84.6% 和 92.2%。 结论: 对于临床III期ESCC患者,我们证明了NAC-SP的安全性,但不是其疗效。随后的食管切除术是安全的。

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影响因子:1.24
发表时间:2020-01-01
DOI:10.3892/etm.2019.8190
作者列表:["Shang L","Pei QS","Xu D","Liu JY","Liu J"]

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翻译标题与摘要 下载文献
影响因子:2.64
发表时间:2020-01-01
DOI:10.1007/s11605-019-04456-x
作者列表:["Campos VJ","Mazzini GS","Juchem JF","Gurski RR"]

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