title: Low-dose intermittent alemtuzumab in the treatment of Sézary syndrome: clinical and immunologic findings in 14 patients.
abstract: OBJECTIVE
  Alemtuzumab may be effective in Sézary syndrome (SS), an aggressive cutaneous T-cell lymphoma, but is associated with severe hematologic toxicity and infections. This study investigated whether low-dose subcutaneous alemtuzumab can induce hematologic, immunologic, and clinical responses similar to those obtained with the standard regimen, but with less toxicity.
  
  
  METHODS
  Fourteen SS patients were enrolled: 11 had relapsed/refractory disease and three had untreated SS with high counts of circulating Sézary cells (SC). Four received 3 mg alemtuzumab on day 1, 10 mg on day 3, then 15 mg on alternating days; circulating SC were evaluated after the fourth 15 mg dose and treatment was interrupted in the presence of counts <1,000/mm (3). A reduced dosage (3 mg on day 1, then 10 mg on alternating days) was administered to the remaining patients, with SC counted before every injection, until a reduction to values of <1,000/mm (3).
  
  
  RESULTS
  The median SC count decreased by 95.5%. Overall, 12/14 patients (85.7%) achieved a clinical response, with three complete responses (21.4%). After a median follow-up of 16 months, the median time-to-treatment failure is 12 months. Infectious complications occurred in 28.6% of patients, all included in the group treated with 15 mg. No patient in the group treated with 10 mg developed hematologic toxicity or infections. An early recovery of circulating NK, B and CD3+CD8+ cells occurred after the first cycle.
  
  
  CONCLUSIONS
  Subcutaneous alemtuzumab at very low doses (10 mg maximum per administration), given for a short period based on SC levels, has a good toxicity profile, high response rate and causes durable remissions in SS patients with high tumor burden in the peripheral blood.
authors.affiliation: Department of Biomedical Sciences and Human Oncology, Section of Dermatology, 1st Dermatologic Division, University of Turin, Turin, Italy. mariagrazia.bernengo@unito.it
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Bernengo
authors.forename: Pietro
authors.initials: P
authors.lastname: Quaglino
authors.forename: Alessandra
authors.initials: A
authors.lastname: Comessatti
authors.forename: Michela
authors.initials: M
authors.lastname: Ortoncelli
authors.forename: Mauro
authors.initials: M
authors.lastname: Novelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Lisa
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Fierro
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000633:toxicity; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage* / Q000633:toxicity; D002452:Cell Count; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007107:Immune System / Q000166:cytology; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012751:Sezary Syndrome / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000074323:Alemtuzumab