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Alemtuzumab (anti-CD52 monoclonal antibody) as single-agent therapy in patients with relapsed/refractory chronic lymphocytic leukaemia (CLL)—a single region experience on consecutive patients

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Abstract

Alemtuzumab, a humanized anti-CD52 monoclonal antibody, is used in patients with refractory chronic lymphocytic leukaemia (CLL). We report results in health care with alemtuzumab on consecutive, advanced-stage patients from a well-defined geographical region. Records from 1,301 patients (Stockholm-Cancer-Registry 1991–2010) identified 56 relapsed/refractory patients treated with alemtuzumab. Median age was 69 years, 88 % had advanced Rai-stage with median 3 prior therapies. One fourth had bulky lymphadenopathy and 73 % were refractory to purine analogues. Median treatment length was 11.6 weeks. Median cumulative dose was 930 mg, significantly higher (p = 0.0277) for responders. Overall response-rate (ORR) was 43 %; 32.5 %, 50 % and 87.5 % in the Refractory, Purine analogue relapsed and Relapsed/Other subgroup, respectively. Response rate was significantly associated with subgroup (p = 0.0104). Good performance status (PS) was associated with better response rate (p = 0.0227). Median time-to-treatment-failure (TTF) (months) was 7.8 months, significantly (p < 0.0001) longer for responders (13.4) Major infections occurred in 36 %. Median overall survival was 22.5 months (range 0.4–74.3). Positive predictive factors were good PS (p < 0.0001) and fewer previous therapies (p = 0.0038). Twenty percent were retreated with alemtuzumab with an ORR of 54.5 %, and a TTF of 7.1 months. A high cumulative dose/longer duration of therapy and a relatively high response rate was observed compared to previous reports. Optimal patient identification and management may result in avoidance of early discontinuation and possibly better outcomes.

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Acknowledgments

This study was supported by grants from the Swedish Cancer Society, the Cancer Society in Stockholm, King Gustav V Jubilee Fund, the Cancer and Allergy Foundation, the Karolinska Institutet Foundations including Immunomodulatory Therapies against Autoimmunity and Cancer (IMTAC) and the Strategic Research Programme in Cancer (StratCan) Networks, the Stockholm County Council and GlaxoSmithKline Ltd. We thank Leila Relander for expert secretarial help.

Ethical standards

Independent ethics committee approval was obtained for all sites prior to commencement of the study (www.epn.se). As this was a retrospective observational study no informed patient consent was required. The study was performed in accordance with the ethical principles of the Declaration of Helsinki in the current Edinburgh version (2000), Guidelines on Good Epidemiological Practice (GEP) and in compliance with national laws.

Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Departments of Hematology and Oncology, Karolinska University Hospital, Stockholm, Sweden

    S. Eketorp Sylvan, J. Lundin, M. Palma, C. Karlsson & L. Hansson

  2. Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

    S. Eketorp Sylvan, J. Lundin, M. Palma, C. Karlsson & L. Hansson

  3. Biostatistics, Parexel International, Berlin, Germany

    M. Ipek

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  1. S. Eketorp Sylvan
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Correspondence to S. Eketorp Sylvan.

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Eketorp Sylvan, S., Lundin, J., Ipek, M. et al. Alemtuzumab (anti-CD52 monoclonal antibody) as single-agent therapy in patients with relapsed/refractory chronic lymphocytic leukaemia (CLL)—a single region experience on consecutive patients. Ann Hematol 93, 1725–1733 (2014). https://doi.org/10.1007/s00277-014-2105-1

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