ObjectiveSurgeons 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 DataSurgical 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. MethodsIn 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 11 or stage Ill 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 1, 50 with stage 11, 95 with stage 111, and 64 with resected stage IV cancer. ResultsThe 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 1, stage 11, and stage IV disease showed no statistically significant difference in survival. The 5-year survival rate of patients with stage Ill 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). ConclusionsIn a subset analysis, patients with stage Ill 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.

Previous analysis of this prospective randomized trial and meta-analysis of published randomized trials of adjuvant intraperitoneal chemotherapy demonstrated improved survival in patients with advanced gastric cancer. Simple criteria applicable at the time of surgery for patient selection were sought in this analysis. From 1990 to 1995 a series of 248 patients with biopsy-proven gastric cancer were randomized intraoperatively to receive early postoperative intraperitoneal mitomycin C and 5-fluorouracil (125 patients) versus surgery only (123 patients). Gastric resection plus early postoperative intraperitoneal chemotherapy showed improved overall survival compared to surgery only (54% and 38%, respectively; p = 0.0278). There were statistically significant differences in patients with stage III (57% and 23%, respectively; p = 0.0024) and in those with stage IV (28% and 5%, respectively; p = 0.0098) gastric cancer. The improvement in survival rate was statistically significant for the subgroup of patients with gross serosal invasion (52% and 25%, respectively; p = 0.0004) and patients with lymph node metastasis (46% and 22%, respectively; p = 0.0027). The surgeons' impression about lymph node status was unreliable, but assessment of serosal invasion was accurate in 80% of cases. Gross serosal invasion with or without frozen section evaluation of lymph nodes can be used as the major selection criteria for early postoperative intraperitoneal chemotherapy of advanced gastric cancer.

The classification of metastasis to the regional lymph nodes as N0 (no nodal metastasis), N1 (metastasis in 1-25 per cent of dissected nodes) and N2 (metastasis in more than 25 per cent of dissected nodes) would be a simple, convenient, reproducible staging system with an ability to predict surgical results.

The classification of metastasis to the regional lymph nodes as N0 (no nodal metastasis), N1 (metastasis in 1-25 per cent of dissected nodes) and N2 (metastasis in more than 25 per cent of dissected nodes) would be a simple, convenient, reproducible staging system with an ability to predict surgical results.

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