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Clin Cancer Res ; 6(2): 406-14, 2000 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-10690517

RESUMO

A Phase II study of yttrium-90-tetra-azacyclododecanetetra-acetic acid-biotin (90Y-DOTA-biotin) pretargeted by NR-LU-10 antibody/streptavidin (SA) was performed. The primary objectives of the study were to evaluate the efficacy and safety of this therapy in patients with metastatic colon cancer. Twenty-five patients were treated with a single dose of 110 mCi/m2 (mean administered dose, 106.5 +/- 10.3 mCi/m2) of 90Y-DOTA-biotin. There were three components of the therapy. Patients first received NR-LU-10/SA on day 1. A clearing agent (biotin-galactose-human serum albumin) was administered approximately 48 h after the NR-LU-10/SA to remove residual circulating unbound NR-LU-10/SA. Lastly, 24 h after administration of clearing agent, patients received biotin-DOTA-labeled with 110 mCi/m2 90Y. All three components of the therapy were administered i.v. Both hematological and nonhematological toxicities were observed. Diarrhea was the most frequent grade 4 nonhematological toxicity (16%; with 16% grade 3 diarrhea). Hematological toxicity was less severe with 8% grade 3 and 8% grade 4 neutropenia and 8% grade 3 and 16% grade 4 thrombocytopenia. The overall response rate was 8%. Two partial responders had freedom from progression of 16 weeks. Four patients (16%) had stable disease with freedom from progression of 10-20 weeks. Despite the relatively disappointing results of this study in terms of therapeutic efficacy and toxicity, proof of principle was obtained for the pretargeting approach. In addition, valuable new information was obtained about normal tissue tolerance to low-dose-rate irradiation that will help to provide useful guidelines for future study designs.


Assuntos
Anticorpos Monoclonais/toxicidade , Neoplasias do Colo/radioterapia , Radioimunoterapia , Compostos Radiofarmacêuticos/uso terapêutico , Adulto , Idoso , Anemia/etiologia , Anticorpos Monoclonais/efeitos adversos , Biotina/administração & dosagem , Biotina/análogos & derivados , Neoplasias do Colo/patologia , Feminino , Humanos , Leucopenia/etiologia , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Compostos Organometálicos/administração & dosagem , Compostos Radiofarmacêuticos/efeitos adversos , Trombocitopenia/etiologia , Radioisótopos de Ítrio/efeitos adversos , Radioisótopos de Ítrio/uso terapêutico
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