Combined intravenous and intraperitoneal chemotherapy with fluorouracil + leucovorin vs fluorouracil + levamisole for adjuvant therapy of resected colon carcinoma.

摘要: Adjuvant chemotherapy with fluorouracil (FU) and levamisole or FU/leucovorin (LV) has been established as effective adjuvant treatment for patients stage III colon cancer. Among several other promising strategies in resected cancer, intraperitoneal anti-cancer drug administration its appealing rationale of counteracting microscopic residual disease on peritoneal surfaces occult metachronous liver metastases by achieving high intraportal concentrations not yet undergone sufficient clinical evaluation. To determine whether a combination this locoregional therapeutic concept systemic intravenous FU/LV would yield better results than conventional chemoimmunotherapy FU/levamisole, the present randomized study was initiated. A total 241 high-risk II (T4N0M0) cancer were randomly assigned to 'standard therapy' FU levamisole, given duration 6 months, an investigational arm, consisting LV 200 mg m(-2) plus 350 m(-2), both administered intravenously (days 1-4) intraperitoneally 1 3) every 4 weeks six courses. In disease, no significant difference noted between two arms after median follow-up time years (range 2.5-6 years). 196 eligible however, comparative analysis groups suggested improvement disease-free survival (P = 0.0014) advantage 0.0005), estimated 43% reduction mortality rate (95% confidence interval 26-70%) favour arm. agreement theoretical rationale, combined particularly reducing tumour recurrences without organ site involvement (9 vs 25 FU/levamisole arm; P 0.005). Treatment-associated side-effects infrequent generally mild arms, although lower severe (WHO grade adverse reactions receiving (3% 12%; 0.01). The trial suggest that is strategy surgically carcinoma.