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Phase II Trial of Carcinoembryonic Antigen Radioimmunotherapy With ¹³¹I-Labetuzumab After Salvage Resection of Colorectal Metastases in the Liver: Five-Year Safety and Efficacy Results

From the Departments of General Surgery, Nuclear Medicine, and Genetic Epidemiology, University of Göttingen, Germany; Immunomedics, Inc, Morris Plains; and Garden State Cancer Center, Center for Molecular Medicine and Immunology, Belleville, NJ

Address reprint requests to Torsten Liersch, MD, Department of General Surgery, Medical Center of the Georg-August University, Robert Koch Str 40, 37099 Göttingen, Germany; e-mail: tliersc{at}gwdg.de

PURPOSE: Although complete resection (R0) of liver metastases (LM) remains the treatment of choice for colorectal cancer (CRC) patients amenable to curative therapy, only approximately one third survive for 5 years. The objective of this phase II study was to evaluate the safety and efficacy of radioimmunotherapy (RAIT) after salvage resection of LM.

PATIENTS AND METHODS: Twenty-three patients who underwent surgery for LM of CRC received a dose of 40 to 60 mCi/m² of ¹³¹I-labetuzumab, which is a humanized monoclonal antibody against carcinoembryonic antigen. Safety (n = 23), disease-free survival (DFS; n = 19), and overall survival (OS; n = 19) were determined.

RESULTS: With a median follow-up of 64 months, the median OS time from the first liver resection for RAIT patients was 68.0 months (95% CI, 46.0 months to infinity), and the median DFS time was 18.0 months (95% CI, 11.0 to 31.0 months). The 5-year survival rate was 51.3%. RAIT benefited patients independently of bilobar involvement, size and number of LM, and resection margins. The major adverse effect was transient myelosuppression, resulting mostly in grade 3 neutropenia and/or thrombocytopenia.

CONCLUSION: Because both the median OS and 5-year survival rates seem to be improved with adjuvant RAIT after complete LM resection in CRC, compared with historical and contemporaneous controls not receiving RAIT, these results justify further evaluation of this modality in a multicenter, randomized trial.

Presented in part at the 2005 Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology, American Gastroenterological Association, American Society for Therapeutic Radiology and Oncology, and Society of Surgical Oncology, in Hollywood, FL, January 27-29, 2005.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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