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Clinical
radioimmunodetection, 1978-1988: overview and suggestions for standardization of
clinical trials
Larson SM
Department of Medical Imaging, Memorial Sloan-Kettering Cancer
Center, New York, New York 10021.
In the last decade of radioimmunodetection studies the radiolabeled antibody
preparations used have gradually changed from polyclonal antibodies labeled
predominantly with 131I to monoclonal antibodies labeled with diverse
radionuclides including 131I, 111In, 123I, and 99mTc.
Over this period progressive improvement in tumor imaging has been observed when
one compares the best examples of early studies, performed with 131I labeled
heterosera, to the best of modern images, obtained with 123I, 99mTc, or 111In
labeled monoclonal antibodies.
Important findings in 61 clinical studies reviewed include the reports from
several centers which demonstrate occult disease in patients with carcinoma of
colon, melanoma, and lymphoma, and the improved sensitivity and specificity of
radioimmunodetection in comparison to transmission computerized tomography in
the lymph nodes and abdomen, in lymphoma and colon cancer, and ovarian
cancer.
Evaluation of the liver remains a difficult problem with this technique and
standard approaches are superior in most reports.
The general principle of targeting radioactivity to tumor with radiolabeled
antitumor antibody and the feasibility of developing practical clinical
methodology which will add new diagnostic information have clearly been
established.
Toxicity, particularly for index studies, is reassuringly limited. In all the
studies with surgical confirmation after i.v. injection, uptake in tumor is in
the range of 0.005% injected dose/g tumor, and this low tumor uptake remains the
single greatest limitation of the method.
A second important problem is the prompt development of human anti-mouse
antibody, which reduces the usefulness of follow-up studies.
A serious criticism of the information currently available on
radioimmunodetection is that the clinical studies reported to date vary greatly
in approach and results.
The vast majority of studies are early Phase I clinical trials, from which
toxicity information and biodistribution data can be derived but which give
limited information about impact on clinical management.
Standardization in the study design is needed in order to establish the efficacy
of radioimmunodetection in adequate and well controlled clinical trials.
PMID:
2404583 [PubMed - indexed for MEDLINE]
Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2404583&dopt=Abstract |