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27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

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Phase II Trial of Repeated Carcinoembryonic Antigen (CEA) Radioimmunotherapy (RAIT) with 131I-Labetuzumab Post Salvage Resection of Colorectal Liver Metastases

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  • corresponding author presenting/speaker Torsten Liersch - Klinik und Poliklinik für Allgemeinchirurgie, Universitätsklinikum, Göttingen , Deutschland
  • Johannes Meller - Abt. Nuklearmedizin, Universitätsklinikum, Göttingen
  • Thomas Lorf - Klinik und Poliklinik für Allgemeinchirurgie, Universitätsklinikum, Göttingen
  • Carsten-Oliver Sahlmann - Abt. Nuklearmedizin, Universitätsklinikum, Göttingen
  • Claus Langer - Klinik und Poliklinik für Allgemeinchirurgie, Universitätsklinikum, Göttingen
  • B. Michael Ghadimi - Klinik und Poliklinik für Allgemeinchirurgie, Universitätsklinikum, Göttingen
  • William A. Wegener - Immunomedics, Inc., Morris Plaines, New Jersey, USA
  • Heinz Becker - Klinik und Poliklinik für Allgemeinchirurgie, Universitätsklinikum, Göttingen
  • David M. Goldenberg - Garden State Cancer Center, Center for Molecular Medicine and Immunology, Belleville, New Jersey, USA

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocOP177

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dkk2006/06dkk287.shtml

Published: March 20, 2006

© 2006 Liersch et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Background: Complete (R0) resection of liver metastases (LM) remains the treatment of choice for colorectal cancer (CRC) patients. As shown recently (Liersch et al., JCO 2005; 23:6763-70), a single application of RAIT improved both the median overall survival (OS) and 5-year survival rates compared with historical or contemporaneous controls not receiving RAIT (P=0.004). The major adverse side effect was transient myelosuppression, mostly grade <= 3 neutropenia and/or thrombocytopenia in patients receiving a dose of 40 to 60 mCi/m2 of 131I-labetuzumab. These encouraging results after single-dose adjuvant RAIT post complete LM resection in CRC stimulated the current ongoing Phase-II trial to evaluate the safety of repeated RAIT at doses of 2 x 50 mCi/m2 (3 mos apart), post salvage resection of LM.

Methods: At present, 12/15 planned patients who underwent surgery for LM of CRC have received the first dose of 50 mCi/m2 131I-labetuzumab, a humanized monoclonal antibody against CEA, within 2 months of LM surgery. Three months after the first RAIT, a second infusion of 50 mCi/m2 has already been given to 7 patients, after completion of standardized re-staging procedures, and other patients are accruing rapidly.

Results: In the previous trial, at a median follow-up of 67 months, the median OS from the first liver resection for 19 patients treated with single-dose RAIT was 68.0 mos and median DFS was 18.0 mos. Also, 5-year survival was achieved by 51.3% of RAIT patients independently of bilobar involvement, the size and number of LM, or the resection margins. In the current study with repeated RAIT, transient grade-4 myelosuppression occurred in 4/12 patients after the first dose, but no cumulative toxicity was seen after repeated RAIT, with complete bone marrow recovery observed in all cases so far. As of Dec. 05, 2005, no cancer recurrence has been detected (median follow-up to 4 months) and patient compliance was 100%.

Conclusion: RAIT re-treatment to-date appears to be safe, feasible, and well accepted. Extended follow-up data will be presented.