胃癌肝转移手术切除的前瞻性单臂多中心介入研究；3年总生存期和无复发生存期。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2024-10-20 DOI:10.1016/j.ejca.2024.115080

Kazumasa Fujitani , Yukinori Kurokawa , Ryohei Wada , Atsushi Takeno , Ryohei Kawabata , Takeshi Omori , Hiroshi Imamura , Motohiro Hirao , Shunji Endo , Junji Kawada , Jeong Ho Moon , Shuji Takiguchi , Masaki Mori , Hidetoshi Eguchi , Yuichiro Doki , on behalf of the Osaka University Clinical Research Group for Gastroenterological Surgery

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引用次数: 0

摘要

目的：手术切除胃癌肝转移灶（LMGC）的潜在益处仍存在争议，因为之前的研究多为回顾性研究。我们在一项前瞻性单臂多中心干预研究中评估了化疗后手术切除 LMGC 的疗效：同步或近交LMGC患者接受2-4个周期的标准化疗，如果重新分期显示疾病无进展并有机会进行R0切除，则进行手术切除。主要终点是R0患者的3年OS，RFS为次要终点。R0患者的预后因素通过多变量Cox回归分析进行评估：2011年至2019年期间，共有70名患者入组。2名患者不符合条件，20名患者在手术前中止了治疗。在最终接受手术的48名患者中，43人完成了原发性和/或转移性GC的R0切除，1人完成了R2切除，4人被认为不符合条件。R0患者的中位和3年OS分别为39.8个月（95%置信区间[CI]，26.9至未达到）和58.1%（95% CI，43.1-71.8），而中位和3年RFS分别为14.9个月（95% CI 7.9-34.0）和34.9%（95% CI 22.2-50.1）。多变量分析显示，多发性肝转移和阳性结节状态（pN1-3）与OS呈负相关（多发性肝转移：危险比[HR]2.71（95 % CI，1.16-6.35），P = 0.022；pN1-3：HR 9.11（95 % CI，1.22-68.2），P = 0.031）：结论：LMGC化疗后行R0切除术可获得良好的生存率，多发肝转移和结节阳性是预后不良的重要指标：临床试验注册号：umin 000011445 (https://www.umin.ac.jp/ctr/)。

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Prospective single-arm multicenter interventional study of surgical resection for liver metastasis from gastric cancer; 3-year overall and recurrence-free survival

Objective

Potential benefit of surgical resection for liver metastasis from gastric cancer (LMGC) remains controversial because most previous studies were retrospective. We evaluated the outcomes of surgical resection following chemotherapy for LMGC in a prospective single-arm multicenter interventional study.

Methods

Patients with synchronous or metachronous LMGC received 2–4 cycles of standard chemotherapy and proceeded to surgical resection if restaging showed a non-progressive disease with a chance of R0 resection. The primary endpoint was 3-year OS of R0 patients, with RFS as secondary. Prognostic factors for R0 patients were evaluated by multivariable Cox regression analysis.

Results

Seventy patients were enrolled between 2011 and 2019. Two patients were ineligible, and 20 discontinued treatment before surgery. Of the 48 patients eventually undergoing surgery, 43 accomplished R0 resection of the primary and/or metastatic GC, while 1 ended in R2 resection and 4 were considered ineligible. Median and 3-year OS for R0 patients were 39.8 months (95 % confidence interval [CI], 26.9 to not reached) and 58.1 % (95 % CI, 43.1–71.8), respectively, while median and 3-year RFS were 14.9 months (95 % CI 7.9–34.0) and 34.9 % (95 % CI 22.2–50.1), respectively. On multivariable analysis, both multiple liver metastases and positive nodal status (pN1–3) were negatively associated with OS (multiple liver metastases: hazard ratio [HR] 2.71 (95 % CI, 1.16–6.35), P = 0.022; pN1–3: HR 9.11 (95 % CI, 1.22–68.2), P = 0.031).

Conclusion

R0 resection following chemotherapy for LMGC yielded promising survival, with multiple liver metastases and positive nodal status being significant indicators of poor prognosis. Clinical trial registration number: UMIN 000011445 (https://www.umin.ac.jp/ctr/).

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.