Résumé
Experimental studies demonstrated efficiency of F(ab)′
2 antibody fragments to CEA labeled with Iodine 131 (131-I-F(ab)′
2 A phase I study was designed to determine the maximum tolerated dose (MTD) of 131-I- F(ab)′
2. Ten patients with liver metastases (LM) from colorectal cancer were treated with 13l-I-F(ab)′
2 ranging from 87 mCi to 300 mCi. No adverse event was observed during and just after infusion. The only toxicity was hematologic and no aplasia was observed up to 300 mCi infused. At this dose, the five patients presented grade 3 or 4 hematologic toxicity, the nadir for neutrophils and thrombocytes ranged from 25 to 35 days after infusion and bone marrow rescue was infused. In conclusion, this study demonstrated that MTD of 131-I-F(ab)′
2 is 300 mCi with bone marrow rescue.