Radioimmunoscintigraphy of recurrent, metastatic, or occult colorectal cancer with technetium Tc 99m 88BV59H21-2V67-66 (HumaSPECT®-Tc), a totally Human monoclonal antibody-patient management benefit from a phase III multicenter study

PURPOSE: The study contained herein was undertaken to evaluate the accuracy of radiolabeled human monoclonal antibody, 88BV59H21-2V67-66 (88BV59 or HumaSPECT®-Tc), in predicting disease resectability in presurgical subjects with recurrent, metastatic, or occult colorectal carcinoma. METHODS: A total of 219 patients with disease visualized on computed tomographic scan (recurrent or metastatic disease) or with negative or equivocal computed tomographic scan and rising carcinoembryonic antigen serum levels (occult group) received technetium Tc 99m-labeled 88BV59 intravenously. Planar and single photon emission computed tomographic images were obtained 14 to 20 hours postinfusion, before surgery. The ability of computed tomographic and HumaSPECT®-Tc imaging to define the extent of disease and to predict resectability was evaluated based on surgical and histopathologic results. RESULTS: In patients with recurrent or metastatic disease (170 evaluable patients), the accuracy of predicting non-resectability of disease was significantly greater (P<0.001) for HumaSPECT®-Tc than for computed tomography (60vs. 29 percent). Computed tomography understaged 41 percent of patients believed to have resectable disease compared with 27 percent for HumaSPECT®-Tc (P<0.001). In occult disease patients (29 computed tomographic and 28 HumaSPECT®-Tc evaluable patients), the overall accuracy of predicting resectability/nonresectability was 68 percent for HumaSPECT®-Tc compared with 24 percent for computed tomography. Administration of HumaSPECT®-Tc had no effect on monoclonal antibody-basedin vitro diagnostic assays. Only a single patient demonstrated an anti-antibody response (90 ng/ml) at nine weeks postinfusion. CONCLUSION: HumaSPECT®-Tc was more accurate than computed tomography in determining disease resectability in patients with metastatic, recurrent, or occult cancer. The addition of HumaSPECT®-Tc imaging can play a significant role in patient management decisions.