早期术后腹腔内化疗作为可切除胃癌辅助治疗的前瞻性随机试验。
Prospective randomized trial of early postoperative intraperitoneal chemotherapy as an adjuvant to resectable gastric cancer.
作者信息
Yu W, Whang I, Suh I, Averbach A, Chang D, Sugarbaker P H
机构信息
Department of Surgery, Kyungpook National University, Taegu, Korea.
出版信息
Ann Surg. 1998 Sep;228(3):347-54. doi: 10.1097/00000658-199809000-00007.
OBJECTIVE
Surgeons have postulated on numerous occasions that cancer resection may participate in the dissemination of a malignancy. This randomized trial sought to determine whether a large volume of chemotherapy solution used perioperatively to flood the peritoneal cavity could eliminate microscopic residual disease and thereby improve survival of patients with gastric cancer.
SUMMARY BACKGROUND DATA
Surgical treatment failures in patients with gastric cancer are confined to the abdomen in most patients. Resection site and peritoneal surface spread, along with liver metastases, are the most common areas of recurrence. Survival and quality of life of patients with gastric cancer would be improved if disease progression at these anatomic sites was reduced.
METHODS
In a prospective randomized trial of 248 patients, intraperitoneal mitomycin C on day 1 and intraperitoneal 5-fluorouracil on days 2 through 5 were administered after gastric cancer resection. Patients who were thought to have stage II or stage III disease were randomized after resection to surgery alone versus surgery plus early postoperative intraperitoneal chemotherapy. After final pathologic examinations, there were 39 patients with stage I, 50 with stage II 95 with stage III, and 64 with resected stage IV cancer.
RESULTS
The 5-year survival of the surgery-only group was 29.3%, and the surgery-plus-intraperitoneal chemotherapy group was 38.7% (p = 0.219). In a subset analysis, the patients with stage I, stage II, and stage IV disease showed no statistically significant difference in survival. The 5-year survival rate of patients with stage III disease who underwent surgery only was 18.4% versus a survival rate of 49.1% for patients who underwent surgery plus intraperitoneal chemotherapy (p = 0.011).
CONCLUSIONS
In a subset analysis, patients with stage III gastric cancer have shown a statistically significant improvement in survival when treated with perioperative intraperitoneal chemotherapy. Further studies in patients with gastric cancer with surgically directed chemotherapy are suggested.
目的
外科医生曾多次推测癌症切除术可能会促使恶性肿瘤扩散。这项随机试验旨在确定围手术期用于冲洗腹腔的大量化疗溶液是否能够清除微小残留病灶，从而提高胃癌患者的生存率。
总结背景数据
大多数胃癌患者的手术治疗失败局限于腹部。切除部位和腹膜表面扩散以及肝转移是最常见的复发部位。如果这些解剖部位的疾病进展得到减缓，胃癌患者的生存率和生活质量将会得到提高。
方法
在一项针对248例患者的前瞻性随机试验中，胃癌切除术后第1天给予腹腔内丝裂霉素C，第2天至第5天给予腹腔内5-氟尿嘧啶。被认为患有II期或III期疾病的患者在切除术后被随机分为单纯手术组和手术加术后早期腹腔内化疗组。最终病理检查后，有39例I期患者、50例II期患者、95例III期患者和64例已切除的IV期癌症患者。
结果
单纯手术组的5年生存率为29.3%，手术加腹腔内化疗组为38.7%（p = 0.219）。在亚组分析中，I期、II期和IV期疾病患者的生存率无统计学显著差异。仅接受手术的III期疾病患者的5年生存率为18.4%，而接受手术加腹腔内化疗的患者的生存率为49.1%（p = 0.011）。
结论
在亚组分析中，III期胃癌患者接受围手术期腹腔内化疗后生存率有统计学显著提高。建议对胃癌患者进行手术导向化疗的进一步研究。
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