PROSPECTIVE RANDOMIZED TRIAL OF EARLY POSTOPERATIVE INTRAPERITONEAL CHEMOTHERAPY AS AN ADJUVANT TO RESECTABLE GASTRIC-CANCER

Objective Surgeons have postulated on numerous occasions that cancer r esection may participate in the dissemination of a malignancy. This ra ndomized trial sought to determine whether a large volume of chemother apy solution used perioperatively to flood the peritoneal cavity could eliminate microscopic residual disease and thereby improve survival o f patients with gastric cancer. Summary Background Data Surgical treat ment failures in patients with gastric cancer are confined to the abdo men in most patients. Resection site and peritoneal surface spread, al ong with liver metastases, are the most common areas of recurrence. Su rvival and quality of life of patients with gastric cancer would be im proved if disease progression at these anatomic sites was reduced. Met hods In a prospective randomized trial of 248 patients, intraperitonea l mitomycin C on day 1 and in 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 postoperat ive intraperitoneal chemotherapy. After final pathologic examinations, there were 39 patients with stage 1, 50 with stage II, 55 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-intraperito neal chemotherapy group was 38.7% (p = 0.219). In a subset analysis, t he patients with stage II stage II, and stage IV disease showed no sta tistically significant difference in survival. The 5-year survival rat e of patients wi-ih stage ill disease who underwent surgery only was 1 8.4% versus a survival rate of 49.1% for patients who underwent surger y plus intraperitoneal chemotherapy (p = 0.011). Conclusions In a subs et analysis, patients with stage III gastric cancer have shown a stati stically significant improvement in survival when treated with periope rative intraperitoneal chemotherapy. Further studies in patients with gastric cancer with surgically directed chemotherapy are suggested.