title: Treatment of patients with advanced mycosis fungoides and Sézary syndrome with alemtuzumab.
abstract: OBJECTIVE
  Alemtuzumab (anti-CD52, Campath-1H) has recently been shown to be effective in the treatment of a range of hematological malignancies, including B-cell chronic lymphocytic leukemia and T-cell prolymphocytic leukemia. We undertook a phase II study to evaluate the safety, tolerability and efficacy of alemtuzumab in patients with relapsed or refractory advanced stage cutaneous T-cell lymphoma.
  
  
  METHODS
  A total of eight patients were enrolled, seven with mycosis fungoides/Sézary syndrome (MF/SS) and one with large-cell transformation of MF. Seven patients had disease refractory to multiple previous therapies. Alemzumab (30 mg) was administered intravenously three times per week for 12 wk or until maximum response.
  
  
  RESULTS
  The overall response rate was 38%, with three patients achieving partial remission, two patients with stable disease and three patients with progressive disease (PD) during treatment. The time to progression was short, with all patients developing PD within 4 months of starting alemtuzumab. Response duration in the three PR patients was also brief, with responses lasting less than 3 months in all three cases. Significant hematological and immunosuppressive toxicity was observed, with both grade 3-4 cytopenias and significant infectious complications occurring in a majority of cases.
  
  
  CONCLUSIONS
  Our findings suggest that in heavily pretreated, refractory, advanced stage MF/SS, although alemtuzumab has biological activity, it is associated with significant toxicity and only modest clinical utility. As such, combination regimens incorporating alemtuzumab merit further investigation in this difficult to treat patient group.
authors.affiliation: Haematology Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: G A
authors.initials: GA
authors.lastname: Kennedy
authors.forename: J F
authors.initials: JF
authors.lastname: Seymour
authors.forename: M
authors.initials: M
authors.lastname: Wolf
authors.forename: H
authors.initials: H
authors.lastname: Januszewicz
authors.forename: J
authors.initials: J
authors.lastname: Davison
authors.forename: C
authors.initials: C
authors.lastname: McCormack
authors.forename: G
authors.initials: G
authors.lastname: Ryan
authors.forename: H M
authors.initials: HM
authors.lastname: Prince
mesh_terms: D000328:Adult; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D018450:Disease Progression; D006801:Humans; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy*; D012074:Remission Induction; D012751:Sezary Syndrome / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000970:Antineoplastic Agents; D018501:Antirheumatic Agents; D000074323:Alemtuzumab