首页 > 文章详情

【2017ASCO GI】侵及浆膜下/浆膜的胃癌根治术：不推荐网膜囊切除

2017年01月29日

整理：Max

来源：医脉通肿瘤科

网膜囊切除（Bursectomy）是指解剖性剥离横结肠系膜前叶和胰腺包膜的手术操作。对于胃癌根治术，有观点认为，胃后壁肿瘤可通过细胞脱落的方式在网膜囊内形成转移病灶。因此，手术应将包括横结肠系膜前叶和胰腺包膜在内的网膜囊完整切除，有利于消灭微小转移病灶，改善胃癌患者预后。

近年来一些学术观点认为，胃后壁肿瘤如果存在细胞脱落，将可能种植于自由腹腔，形成远处转移，不属于可切除胃癌范畴。而且如果为了清扫淋巴结亦不需要完整网膜囊切除。

因此，切除网膜囊以预防腹膜转移在胃癌根治术中长期存在争议，但在东亚地区，其目前被作为一种推荐治疗方法，尤其是在侵犯浆膜层的情况下。

2017年1月ASCO胃肠肿瘤研讨会（GI）在美国旧金山召开。当地时间21日的口头报告上，来自日本静冈县癌症中心的Masanori Terashima教授以“Primary results of a phase III trial to evaluate bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001)”为题，报道了浆膜层/浆膜下层受累的胃癌行网膜囊切除的获益和并发症情况。

研究内容

JCOG1001研究是一项Ⅲ期临床试验，入组患者为组织学确诊为胃腺癌，临床评估侵及浆膜下层（cT3）或浆膜层（cT4a）。自2010年至2015年，日本57个医疗中心共纳入1204例胃癌患者，在D2根治术中随机行网膜囊切除（n=602）或不切除（n=602）。

主要终点是总生存。

在患者入组完成后，2016年9月启动第二次期中分析，保留网膜囊切除患者和切除网膜患者的3年生存率分别为86.0% vs 83.3%（HR=1.075）。最终分析支持网膜囊切除的预测概率只有12.7%。

基于数据和安全监测委员会的建议，上述结果直接导致研究提前终止。

在网膜囊切除组，患者的手术时间（254min vs 222min）和术中失血量（330ml vs 230ml）均高于保留网膜囊组，但输血率两组无明显差异（4.5% vs 4.8%）。

并发症方面，网膜囊切除组胰瘘发生率稍高（4.8% vs 2.5%），但两组≥3级并发症发生率无显著差异（13.3% vs 11.6%）。院内死亡在保留网膜囊组有5人，切除网膜囊组有1人。

结论

尽管网膜囊切除并没有增加胃癌根治术的死亡率和严重的并发症，但不将其作为cT3或cT4胃癌的推荐标准治疗。

Primary results of a phase III trial to evaluate bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).

J Clin Oncol 35, 2017 (suppl 4S; abstract 5)

Author(s):

Masanori Terashima, et al.

Abstract:

Background:

The role of bursectomy dissecting the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon for preventing peritoneal metastasis had long been controversial. We conducted a phase III trial evaluating the role of bursectomy in patients with subserosal (SS) / serosal (SE) gastric cancer. Patient accrual had been completed on Mar. 2015. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach; cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-bursectomy arm or bursectomy arm. Primary endpoint was overall survival. A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power.

Results:

Between Jun 2010 and Mar 2015, 1,204 patients were accrued from 57 institutions (non-bursectomy 602, bursectomy 602). Patients’ background and operative procedures were well balanced between the arms. After completion of patient enrollment, the second interim analysis was performed on Sep 2016, with 54% (196/363) of the expected events observed. The 3y-survival were 86.0% (95%CI, 82.7 to 88.7) in non-bursectomy arm and 83.3% (95%CI, 79.6 to 86.3) in bursectomy arm. Hazard ratio for bursectomy was 1.075 (98.5%CI: 0.760 to 1.520) with predictive probability in favor of bursectomy at the final analysis of 12.7%. These results led to early study termination based on the recommendation of the Data and Safety Monitoring Committee. Operation time was longer (median 222 min vs 254 min) and blood loss was larger (230 ml vs 330 ml) in bursectomy arm; however, the incidence of patients received blood transfusion was not different between the arms (4.8% vs 4.5%). Although the incidence of pancreatic fistula was a bit higher in bursectomy arm (2.5% vs 4.8%), the incidence of Grade 3 or higher complications was not different between the arms (11.6% vs 13.3%). Five patients in non-bursectomy arm and one patient in bursectomy showed in-hospital death.

Conclusions:

Although bursectomy can be safely performed without increasing morbidity and mortality, bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer.

Clinical trial information:

UMIN000003688.

参考文献：

Salah-Eddin Al-Batran. et al. J Clin Oncol 35, 2017 (suppl 4S; abstract 4)

编辑：肿瘤资讯-小编