Journal of Clinical Oncology, Vol 14, 2295-2305, Copyright © 1996 by American Society of Clinical Oncology
Clinical utility of external immunoscintigraphy with the IMMU-4 technetium-99m Fab' antibody fragment in patients undergoing surgery for carcinoma of the colon and rectum: results of a pivotal, phase III trial. The Immunomedics Study Group
FL Moffat Jr, CM Pinsky, L Hammershaimb, NJ Petrelli, YZ Patt, FS Whaley and DM Goldenberg
Department of Surgery, University of Miami School of Medicine, FL, USA.
PURPOSE: To assess the performance and the potential clinical impact of a
new antibody imaging agent, CEA-Scan (Immunomedics Inc, Morris Plains, NJ),
in 210 presurgical patients with advanced recurrent or metastatic
colorectal carcinomas. METHODS: CEA-Scan, an anti- carcinoembryonic antigen
(CEA) Fab antibody fragment labeled with technetium-99m-pertechnetate
(99mTc), was injected intravenously (IV), and external scintigraphy was
performed 2 to 5 and 18 to 24 hours later. Imaging with conventional
diagnostic modalities (CDM) was also performed, and findings were confirmed
by surgery and histology. RESULTS: The sensitivity of CEA-Scan was superior
to that of CDM in the extrahepatic abdomen (55% v 32%; P = .007) and pelvis
(69% v 48%; P = .005), and CEA-Scan findings complemented those of CDM in
the liver. Among 122 patients with known disease, the positive predictive
value was significantly higher when both modalities were positive (98%)
compared with each alone (68% to 70%), potentially obviating the need for
histologic confirmation when both tests are positive. Imaging accuracy also
was significantly improved by adding CEA-Scan to CDM. In 88 patients with
occult cancer, imaging accuracy was enhanced significantly by CEA-Scan
combined with CDM (61% v 33%). Potential clinical benefit from CEA-Scan was
demonstrated in 89 of 210 patients. Only two patients developed human
antimouse antibodies (HAMA) to CEA- Scan after a single injection, and none
of 19 assessable patients after two injections. CONCLUSION: CEA-Scan
affords high-quality, same-day imaging, uses an inexpensive and readily
available radio-nuclide, adds clinically significant information in
assessing extent and location of disease in colorectal cancer patients, and
only rarely induces a HAMA response.
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