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Pilot Study Using a Humanized CC49 Monoclonal Antibody (HuCC49°CH2) to Localize Recurrent Colorectal Carcinoma

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Abstract

Background: CC49 is a monoclonal antibody directed against a pancarcinoma antigen (TAG-72) expressed by colorectal cancers. The use of murine CC49 in radioimmunoguided surgery (RIGS) was problematic because of the human anti-mouse antibodies (HAMA) generated. This study was designed to assess the clearance, safety, and effectiveness of localization of a complimentarity determining region (CDR)-grafted humanized domain-deleted antitumor CC49 antibody (HuCC49°CH2).

Methods: After thyroid blockade, 1 mg of HuCC49°CH2 radiolabeled with 2 mCi of iodine-125 was administered. All patients subsequently underwent traditional exploration followed by a survey with the gamma-detecting probe. In five patients, exploration was performed 10 to 24 days after injection, when precordial counts were sufficiently low (<30 counts per 2 seconds [cp2s]). Traditionally suggestive and probe-positive tissue was biopsied or excised and examined for the presence of carcinoma, when considered appropriate by the operating surgeon. Serum was assessed for HAMA.

Results: Seventeen sites were identified as suggestive of carcinoma on traditional exploration and 21 by RIGS. Of these, pathologic correlation was obtained in 15. The sensitivity of RIGS was 92%, and the positive predictive value was 100%. None of the patients expressed significant HAMA.

Conclusions: This initial study indicates that the HuCC49°CH2 monoclonal antibody, when used with RIGS, is safe and sensitive in detecting recurrent intra-abdominal colon cancer.

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Correspondence to Edward W. Martin Jr. MD.

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Agnese, D.M., Abdessalam, S.F., Burak, W.E. et al. Pilot Study Using a Humanized CC49 Monoclonal Antibody (HuCC49°CH2) to Localize Recurrent Colorectal Carcinoma. Ann Surg Oncol 11, 197–202 (2004). https://doi.org/10.1245/ASO.2004.05.010

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  • DOI: https://doi.org/10.1245/ASO.2004.05.010

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