Yonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T
School of Medicine, Kanazawa University, 13-1 Takara-Machi, Kanazawa City, Japan.
Hepatogastroenterology. 2001 Nov-Dec;48(42):1776-82.
BACKGROUND/AIMS: Although the most frequent cause of death after curative resection of advanced gastric cancer is peritoneal recurrence, there was no effective therapy for the prevention of peritoneal recurrence. This randomized trial sought to determine whether intraoperative chemohyperthermic peritoneal perfusion could eliminate microscopic residual disease and thereby improve survival of patients with advanced gastric cancer.
One-hundred and thirty-nine patients with T2-4 gastric cancer underwent curative gastrectomy with extended lymphadenectomy. These patients were randomly allocated into the following three groups. Patients in the CHPP group received surgery + chemohyperthermic peritoneal perfusion, and those in the CNPP group underwent surgery + chemonormothermic peritoneal perfusion. The third group was surgery alone group. In the CHPP and CNPP groups, peritoneal cavity was perfused with 6-8 liters of heated saline at, respectively, 42-43 degrees C and 37 degrees C with 30 mg of mitomycin C and 300 mg of cisplatin by a extracorporeal circulation machine.
Major operative complication occurred in 19% (9/48), 14% (6/44) and 19% (9/47) of the CHPP, CNPP and surgery alone group, respectively. Complication which uniquely developed after chemohyperthermic peritoneal perfusion was bowel perforation. Mortality rates of each group were 4% (2/48), 0% (0/44) and 4% (2/47) in the CHPP, CNPP and surgery alone group, respectively. Overall 5-year survival rates of CHPP, CNPP and surgery alone groups were 61%, 43% and 42%, respectively. In a subset analysis, patients with gastric cancer having serosal invasion or lymph node metastasis have shown a statistically significant improvement in survival when treated with chemohyperthermic peritoneal perfusion. However, chemonormothermic peritoneal perfusion had no survival benefit. By analyzing with Cox proportional hazard model, chemohyperthermic peritoneal perfusion emerged as an independent prognostic factor for good survival. Surgery alone had three-fold higher risk of death than chemohyperthermic peritoneal perfusion.
Chemohyperthermic peritoneal perfusion had an efficiency for the prophylaxis of recurrence after curative resection of advanced gastric cancer, and is indicated for patients with tumor infiltrating beyond serosal layer and node positive tumor.
背景/目的:尽管进展期胃癌根治性切除术后最常见的死亡原因是腹膜复发,但尚无有效的预防腹膜复发的治疗方法。这项随机试验旨在确定术中化疗热灌注能否消除微小残留病灶,从而提高进展期胃癌患者的生存率。
139例T2-4期胃癌患者接受了根治性胃切除术及扩大淋巴结清扫术。这些患者被随机分为以下三组。CHPP组患者接受手术+化疗热灌注,CNPP组患者接受手术+化疗常温灌注。第三组为单纯手术组。在CHPP组和CNPP组中,通过体外循环机分别以42-43摄氏度和37摄氏度向腹腔灌注6-8升热盐水,分别加入30毫克丝裂霉素C和300毫克顺铂。
CHPP组、CNPP组和单纯手术组的主要手术并发症发生率分别为19%(9/48)、14%(6/44)和19%(9/47)。化疗热灌注后特有的并发症是肠穿孔。CHPP组、CNPP组和单纯手术组的死亡率分别为4%(2/48)、0%(0/44)和4%(2/47)。CHPP组、CNPP组和单纯手术组的总体5年生存率分别为61%、43%和42%。在亚组分析中,有浆膜侵犯或淋巴结转移的胃癌患者接受化疗热灌注治疗后,生存率有统计学意义的提高。然而,化疗常温灌注没有生存获益。通过Cox比例风险模型分析,化疗热灌注是良好生存的独立预后因素。单纯手术的死亡风险比化疗热灌注高三倍。
化疗热灌注对进展期胃癌根治性切除术后的复发预防有效,适用于肿瘤浸润超过浆膜层和淋巴结阳性的患者。