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Laboratory of Molecular Biology, Division of Basic Sciences [L. H. P-S., I. P.], and Laboratory of Molecular Signaling and Oncogenesis [J. V., E. L.] and Medicine Branch [D. P., T. W.], Division of Clinical Sciences National Cancer Institute, NIH, Bethesda, Maryland 20892; and Department of Pathology, Wake Forest University, Winston-Salem, North Carolina 27157 [M. C. W.]
To exploit overexpression of erbB2 in human cancers, we constructed a single-chain immunotoxin (erb-38) that contains the Fv portion of monoclonal antibody e23 fused to a truncated form of Pseudomonas exotoxin A. In a Phase I study, five breast cancer patients and one esophageal cancer patient received three doses of erb-38 at 1.0 and 2.0 µg/kg. Hepatotoxicity was observed in all patients. Immunohistochemistry showed the presence of erbB2 on hepatocytes explaining the liver toxicity of erb-38. We suggest that targeting of tumors with antibodies to erbB2 armed with radioisotopes or other toxic agents may result in unexpected organ toxicities due to erbB2 on normal cells.
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