Morbidity and mortality of early postoperative intraperitoneal chemotherapy as adjuvant therapy for gastric cancer.

Intraperitoneal chemotherapy (IC) is emerging as a valuable adjuvant therapeutic modality in patients with gastric cancer. The purpose of this study was to assess morbidity and mortality of early postoperative IC (EPIC) in gastric cancer patients. Two hundred forty-eight gastric cancer patients thought to have resectable cancer were randomized intraoperatively to receive EPIC with mitomycin C on postoperative day 1 and 5-fluorouracil on postoperative days 2 to 5 versus surgery only. Sixty-four patients who were stage IV at histopathologic examination remain in the analysis. Morbidity and mortality were compared using Fisher's exact test. All patients completed the therapy. In the study group, overall morbidity was higher than in the control group (28.8% versus 20.3%, respectively), although the difference was not significant (P = 0.121). Intra-abdominal sepsis without anastomotic leak (P = 0.008) and bleeding (P = 0.002) occurred significantly more often in the study group. Also, 37.6 per cent of patients who received EPIC experienced a variety of minor complications attributable to EPIC. Postoperative mortality was higher in the study group (5.6%) than in controls (0.8%), but not significantly (P = 0.299). Patients treated with EPIC stayed in the hospital an average of 4 days longer (P = 0.002); in patients with morbidity, however, there was no difference with the control group. A period analysis of the morbidity demonstrated that it followed the pattern of a learning curve. Surgery with EPIC tended to increase the postoperative morbidity and mortality. The therapy-associated risk must be justified by a significant improvement in survival of treated patients with stage III disease. Selective application of perioperative IC may be indicated.

RCT Entities:   Population Interventions Outcomes