Kuramoto Masafumi, Shimada Shinya, Ikeshima Satosi, Matsuo Akinobu, Yagi Yasushi, Matsuda Masakazu, Yonemura Yutaka, Baba Hideo
Department of Surgery, Yatsushiro Social Insurance General Hospital, Kumamoto, Japan.
Ann Surg. 2009 Aug;250(2):242-6. doi: 10.1097/SLA.0b013e3181b0c80e.
This prospective randomized multicenter study aims to evaluate the efficacy of extensive intraoperative peritoneal lavage followed by intraperitoneal chemotherapy (EIPL-IPC) on the overall 5-year survival of advanced gastric cancer patients with intraperitoneal free cancer cells without overt peritoneal metastasis (CY+/P-). The study also aims to determine the merit and reliability of EIPL-IPC therapy as a prophylactic strategy for peritoneal metastasis.
Although the prognosis of advanced gastric cancer patients with CY+/P- is extremely poor, a suitable standard regimen for treating such patients has not yet been established.
A total of 88 patients with CY+/P- from 1522 patients with advanced gastric cancer at multicenters were enrolled in this study and were randomly allocated to 3 groups: surgery alone group, surgery plus intraperitoneal chemotherapy (IPC) group, and surgery plus EIPL and IPC (EIPL-IPC) group. Prognostic significance of EIPL-IPC therapy was evaluated by Kaplan-Meier curves, and its value as an independent prognostic factor was assessed by univariate and multivariate analyses.
The overall 5-year survival rate of the patients with EIPL-IPC was 43.8%, and this data were significantly better than that of the IPC group (4.6%, P < 0.0001) and the surgery alone group (0%, P < 0.0001). Among various recurrent patterns, the EIPL-IPC group had a significantly lower incidence of peritoneal recurrence than both of the other groups (P < 0.0001). Univariate and multivariate analyses revealed that EIPL was the most significant impact factor.
The present study clearly revealed that EIPL-IPC therapy significantly improved the 5-year survival span of advanced gastric cancer patients with CY+/P-. Thus, EIPL-IPC therapy is strongly recommended as a standard prophylactic strategy for peritoneal dissemination.
本前瞻性随机多中心研究旨在评估广泛术中腹腔灌洗联合腹腔内化疗(EIPL-IPC)对无明显腹膜转移的腹腔游离癌细胞(CY+/P-)的晚期胃癌患者总体5年生存率的疗效。该研究还旨在确定EIPL-IPC疗法作为预防腹膜转移策略的优点和可靠性。
尽管CY+/P-的晚期胃癌患者预后极差,但尚未建立适合此类患者的标准治疗方案。
本研究纳入了来自多中心1522例晚期胃癌患者中的88例CY+/P-患者,并将其随机分为3组:单纯手术组、手术加腹腔内化疗(IPC)组和手术加EIPL及IPC(EIPL-IPC)组。通过Kaplan-Meier曲线评估EIPL-IPC疗法的预后意义,并通过单因素和多因素分析评估其作为独立预后因素的价值。
EIPL-IPC组患者的总体5年生存率为43.8%,该数据显著优于IPC组(4.6%,P<0.0001)和单纯手术组(0%,P<0.0001)。在各种复发模式中,EIPL-IPC组的腹膜复发发生率明显低于其他两组(P<0.0001)。单因素和多因素分析显示EIPL是最显著的影响因素。
本研究清楚地表明,EIPL-IPC疗法显著提高了CY+/P-的晚期胃癌患者的5年生存期。因此,强烈推荐EIPL-IPC疗法作为预防腹膜播散的标准策略。