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替吉奥联合顺铂新辅助化疗后行 D2 胃切除术加腹主动脉旁淋巴结清扫治疗广泛淋巴结转移的胃癌。

Neoadjuvant chemotherapy with S-1 and cisplatin followed by D2 gastrectomy with para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis.

机构信息

Shonan Kamakura General Hospital, Kamakura, Tokyo, Japan.

出版信息

Br J Surg. 2014 May;101(6):653-60. doi: 10.1002/bjs.9484. Epub 2014 Mar 25.

Abstract

BACKGROUND

Locally advanced gastric cancer with extensive regional and/or para-aortic lymph node (PAN) metastases is typically unresectable and associated with poor outcomes. This study investigated the safety and efficacy of S-1 plus cisplatin followed by extended surgery with PAN dissection for gastric cancer with extensive lymph node metastasis.

METHODS

Patients with gastric cancer with bulky lymph node metastasis along the coeliac artery and its branches and/or PAN metastasis received two or three 28-day cycles of S-1 plus cisplatin, followed by gastrectomy with D2 plus PAN dissection. The primary endpoint was the percentage of complete resections with clear margins in the primary tumour (R0 resection). A target sample size of 50 with one-sided α of 0.105 and β of approximately 0.2 corresponded to an expected R0 rate of 65 per cent and a threshold of 50 per cent.

RESULTS

Between February 2005 and June 2007, 53 patients were enrolled, of whom 51 were eligible. The R0 resection rate was 82 per cent. Clinical and pathological response rates were 65 and 51 per cent respectively. The 3- and 5-year overall survival rates were 59 and 53 per cent respectively. During chemotherapy, grade 3/4 neutropenia occurred in 19 per cent and grade 3/4 non-haematological adverse events in 15.4 per cent. The incidence of grade 3/4 adverse events related to surgery was 12 per cent. There were no reoperations or treatment-related deaths.

CONCLUSION

For locally advanced gastric cancer with extensive lymph node metastasis, 4-weekly S-1 plus cisplatin followed by surgery including PAN dissection was safe and effective for some patients. Further investigation of this treatment strategy is warranted.

摘要

背景

广泛局部进展期胃癌伴广泛区域和/或主动脉旁淋巴结(PAN)转移通常无法切除,预后较差。本研究旨在探讨 S-1 联合顺铂治疗后行扩大手术伴 PAN 清扫治疗广泛淋巴结转移胃癌的安全性和有效性。

方法

对沿腹腔动脉及其分支和/或 PAN 转移存在大体积淋巴结转移的胃癌患者,给予两到三个 28 天周期的 S-1 联合顺铂治疗,然后行胃切除术加 D2 清扫伴 PAN dissection。主要终点是原发肿瘤(R0 切除)完全切除率,目标样本量为 50 例,单侧 α 值为 0.105,β 值约为 0.2,预期 R0 率为 65%,阈值为 50%。

结果

2005 年 2 月至 2007 年 6 月期间,共纳入 53 例患者,其中 51 例符合条件。R0 切除率为 82%。临床和病理反应率分别为 65%和 51%。3 年和 5 年总生存率分别为 59%和 53%。化疗期间,3/4 级中性粒细胞减少发生率为 19%,3/4 级非血液学不良事件发生率为 15.4%。与手术相关的 3/4 级不良事件发生率为 12%。无再次手术或治疗相关死亡。

结论

对于广泛淋巴结转移的局部进展期胃癌,4 周 S-1 联合顺铂治疗后行包括 PAN 清扫的手术是安全有效的,对于部分患者可能有益。需要进一步研究这种治疗策略。

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