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新辅助化疗胃癌患者术后感染并发症的预后影响:JCOG0501 随机对照试验的事后分析。

Prognostic Impact of Post-operative Infectious Complications in Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy: Post Hoc Analysis of a Randomized Controlled Trial, JCOG0501.

机构信息

Department of Surgery, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan.

Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

出版信息

J Gastrointest Cancer. 2024 Sep;55(3):1125-1133. doi: 10.1007/s12029-024-01061-3. Epub 2024 May 4.

DOI:10.1007/s12029-024-01061-3
PMID:38703333
Abstract

PURPOSE

Post-operative infectious complication (IC) is a well-known negative prognostic factor, while showing neoadjuvant chemotherapy (NAC) may cancel out the negative influence of IC. This analysis compared the clinical impacts of IC according to the presence or absence of NAC in gastric cancer patients enrolled in the phase III clinical trial (JCOG0501) which compared upfront surgery (arm A) and NAC followed by surgery (arm B) in type 4 and large type 3 gastric cancer.

METHODS

The subjects were 224 patients who underwent R0 resection out of 316 patients enrolled in JCOG0501. The prognoses of the patients with or without ICs in each arm were investigated by univariable and multivariable Cox regression analyses.

RESULTS

There were 21 (20.0%) IC occurrences in arm A and 15 (12.6%) in arm B. In arm A, the overall survival (OS) of patients with ICs was slightly worse than those without IC (3-year OS, 57.1% in patients with ICs, 79.8% in those without ICs; adjusted hazard ratio (95% confidence interval), 1.292 (0.655-2.546)). In arm B, patients with ICs showed a trend of better survival than those without ICs (3-year OS, 80.0% in patients with IC, 74.0% in those without IC; adjusted hazard ratio, 0.573 (0.226-1.456)).

CONCLUSION

This study could not indicate the negative prognostic influence of ICs in gastric cancer patients receiving NAC, which might be canceled by NAC. To build exact evidence, further investigation with prospective and large numbers of data might be expected.

摘要

目的

术后感染并发症(IC)是一个众所周知的预后不良因素,但新辅助化疗(NAC)的显示可能会抵消 IC 的负面影响。本分析比较了 III 期临床试验(JCOG0501)中接受 NAC 的胃癌患者与未接受 NAC 的患者的 IC 存在与否的临床影响,该试验比较了直接手术(A 组)和 NAC 后手术(B 组)在 4 型和大型 3 型胃癌中的疗效。

方法

JCOG0501 共入组 316 例患者,其中 224 例患者行 R0 切除。通过单变量和多变量 Cox 回归分析,研究了各臂中有无 IC 的患者的预后。

结果

A 组中 IC 发生率为 21.0%(21/100),B 组为 12.6%(15/119)。在 A 组中,IC 患者的总生存期(OS)略差于无 IC 患者(3 年 OS,IC 患者为 57.1%,无 IC 患者为 79.8%;调整后的危险比(95%置信区间)为 1.292(0.655-2.546))。在 B 组中,IC 患者的生存情况好于无 IC 患者(3 年 OS,IC 患者为 80.0%,无 IC 患者为 74.0%;调整后的危险比为 0.573(0.226-1.456))。

结论

本研究不能表明接受 NAC 的胃癌患者 IC 的预后不良影响可能被 NAC 抵消。为了建立确切的证据,可能需要进行前瞻性和大数据量的进一步研究。

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本文引用的文献

1
Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open-label, phase 3, randomized controlled trial.胃切除术联合或不联合新辅助 S-1 顺铂治疗 4 型或大型 3 型胃癌(JCOG0501):一项开放标签、3 期、随机对照临床试验。
Gastric Cancer. 2021 Mar;24(2):492-502. doi: 10.1007/s10120-020-01136-7. Epub 2020 Nov 16.
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Impact of postoperative complications on survival outcomes in patients with gastric cancer: exploratory analysis of a randomized controlled JCOG1001 trial.胃癌患者术后并发症对生存结局的影响:一项随机对照 JCOG1001 试验的探索性分析。
Gastric Cancer. 2021 Jan;24(1):214-223. doi: 10.1007/s10120-020-01102-3. Epub 2020 Jun 29.
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Impact of type and severity of postoperative complications on long-term outcomes after colorectal liver metastases resection.
结直肠肝转移术后并发症的类型和严重程度对长期预后的影响。
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Impact of postoperative complications on survival after oesophagectomy for oesophageal cancer.术后并发症对食管癌食管切除术后生存的影响。
BJS Open. 2020 Jun;4(3):405-415. doi: 10.1002/bjs5.50264. Epub 2020 Feb 17.
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Does neoadjuvant chemotherapy cancel out the negative survival impact induced by surgical complications after gastrectomy?新辅助化疗是否能消除胃切除术后手术并发症导致的生存负面影响?
Gastric Cancer. 2019 Nov;22(6):1274-1284. doi: 10.1007/s10120-019-00957-5. Epub 2019 Apr 3.
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Preoperative Therapy for Gastric Adenocarcinoma is Protective for Poor Oncologic Outcomes in Patients with Complications After Gastrectomy.胃腺癌术前治疗可改善胃切除术后并发症患者的不良肿瘤学结局。
Ann Surg Oncol. 2018 Sep;25(9):2720-2730. doi: 10.1245/s10434-018-6638-8. Epub 2018 Jul 9.
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