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Prepublished online as a Blood First Edition Paper on January 23, 2003; DOI 10.1182/blood-2002-09-2802.
Submitted September 17, 2002
Accepted November 8, 2002
Phase II study of alemtuzumab (anti-CD52 monoclonal antibody, Campath-1H) in patients with advanced mycosis fungoides/Sezary syndrome
Jeanette Lundin, Hans Hagberg, Roland Repp, Eva Cavallin-Stahl, Susanne Freden, Gunnar Juliusson, Eija Rosenblad, Geir Tjonnfjord, Tom Wiklund, and Anders Osterborg*
Departments of Oncology, Hematology, and Dermatology, Karolinska Hospital, Stockholm, Sweden
Departments of Oncology, Hematology, Uppsala University Hospital, Uppsala, Sweden
University of Erlangen, Erlangen, Germany
Lund University Hospital, Lund, Sweden
Ryhov Hospital, Jonkoping, Sweden
Linkoping University Hospital, Linkoping, Sweden
* Corresponding author; email: anders.osterborg{at}ks.se.
This phase II study evaluated the safety and efficacy of alemtuzu-mab (Campath-1H) in 22 patients with advanced mycosis fungoides/Sezary syndrome (MF/SS). Most patients had stage III or IV disease, reduced performance status and severe itching. The overall response (OR) rate was 55%, with 32% complete remission (CR) and 23% partial remission (PR). Sezary cells were cleared from blood in 6/7 patients (86%) and CR in lymph nodes was observed in 6/11 patients (55%). The effect was better on erythroderma (OR 69%) than on plaque or skin tumors (OR 40%), and in patients who had received 1 - 2 previous regimens (OR 80%) than in those who had received  3 prior regimens (OR 33%). Itching, self-assessed on a 0 - 10 visual analog scale, was reduced from a median of eight before treatment to two at end of therapy. Median time to treatment failure was 12 months (range 5 - 32+). Cytomegalo-virus (CMV) reactivation (causing fever without pneumonitis and responding to ganciclovir) occurred in four patients (18%). Six additional patients had suspect or manifest infection (fever of unknown origin, three; generalized herpes simplex, one; and fatal aspergillosis, one). One patient had fatal mycobacterium pneumonia at 10+ months. All serious infectious adverse events (except CMV) occurred in patients who had received 3 prior regimens. Progression of squamous cell skin carcinoma was noted in one patient. Alemtuzumab shows promising clinical activity and an acceptable safety profile in patients with advanced MF/SS, particularly in patients with erythroderma and severe itching, and those who were not heavily pretreated.
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