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Adjuvant Radioimmunotherapy Trial with Iodine-131–Labeled Anti–Carcinoembryonic Antigen Monoclonal Antibody F6 F(ab')₂ after Resection of Liver Metastases from Colorectal Cancer

Authors' Affiliations: ¹ Institut de Recherche en Cancérologie de Montpellier (IRCM); ² Institut National de la Sante et de la Recherche Medicale U896; ³ Université Montpellier1; ⁴ CRLC Val d'Aurelle-Paul Lamarque, Montpellier, France; ⁵ Schering-CIS Biointernational, Gif-sur-Yvette, France; ⁶ Département de Biochimie, Université de Lausanne, Epalinges, Switzerland; and ⁷ Department of Radiation Oncology, Maisonneuve-Rosemont Hospital, Montreal, Canada

Requests for reprints: André Pèlegrin, Institut de Recherche en Cancérologie de Montpellier, CRLC Val d'Aurelle-Paul Lamarque, 34298 Montpellier Cedex 5, France. Phone: 33-4-67-61-30-32; Fax: 33-4-67-61-37-87; E-mail: Andre.Pelegrin{at}valdorel.fnclcc.fr.

Purpose: To evaluate the feasibility of radioimmunotherapy (RIT) with radiolabeled anti–carcinoembryonic antigen antibodies after complete resection of liver metastases (LM) from colorectal cancer.

Patients and Methods: Twenty-two patients planned for surgery of one to four LM received a preoperative diagnostic dose of a ¹³¹I-F(ab')₂–labeled anti-carcinoembryonic antigen monoclonal antibody F6 (8-10 mCi/5 mg). ¹³¹I-F(ab')₂ uptake was analyzed using direct radioactivity counting, and tumor-to-normal liver ratios were recorded. Ten patients with tumor-to-normal liver ratios of >5 and three others were treated with a therapeutic injection [180-200 mCi ¹³¹I/50 mg F(ab')₂] 30 to 64 days after surgery.

Results: Median ¹³¹I-F(ab')₂ immunoreactivity in patient serum remained at 91% of initial values for up to 96 hours after injection. The main and dose-limiting-toxicity was hematologic, with 92% and 85% grades 3 to 4 neutropenia and thrombocytopenia, respectively. Complete spontaneous recovery occurred in all patients. No human anti-mouse antibody response was observed after the diagnosis dose; however, 10 of the 13 treated patients developed human anti-mouse antibody 3 months later. Two treated patients presented extrahepatic metastases at the time of RIT (one bone and one abdominal node) and two relapsed within 3 months of RIT (one in the lung and the other in the liver). Two patients are still alive, and one of these is disease-free at 93 months after resection. At a median follow-up of 127 months, the median disease-free survival is 12 months and the median overall survival is 50 months.

Conclusion: RIT is feasible in an adjuvant setting after complete resection of LM from colorectal cancer and should be considered for future trials, possibly in combination with chemotherapy, because of the generally poor prognosis of these patients.