title: An Italian retrospective study on the routine clinical use of low-dose alemtuzumab in relapsed/refractory chronic lymphocytic leukaemia patients.
abstract: Low-dose alemtuzumab has shown a favourable toxicity profile coupled with good results in terms of efficacy in relapsed/refractory chronic lymphocytic leukaemia (CLL). We conducted a multicentre retrospective study on the routine clinical use of low-dose alemtuzumab in this patient setting. One hundred and eight relapsed/refractory CLL patients from 11 Italian centres were included in the analysis. All patients had an Eastern Cooperative Oncology Group performance status ≤2 and the majority (84%) had adenopathies <5 cm. Low-dose alemtuzumab was defined as a total weekly dose ≤45 mg and a cumulative dose ≤600 mg given for up to 18 weeks. The overall response rate was 56% (22% complete remissions). After a median follow-up of 42.2 months, the median overall survival and progression-free survival were 39.0 and 19.4 months, respectively. In univariate analysis, response was inversely associated with lymph node (P = 0.01) and spleen (P = 0.02) size, fludarabine-refractoriness (P = 0.01) and del(11q) (P = 0.009). Advanced age and del(17p) were not associated with a worse outcome. Cumulative dose of alemtuzumab was not associated to response. Toxicities were usually mild and manageable; severe infections occurred in seven patients (7%) during therapy. This retrospective analysis confirms that low-dose alemtuzumab is a valid and currently used therapeutic option for the treatment of relapsed/refractory CLL.
authors.affiliation: Haematology-BMT Unit, IRCCS Ca'Granda Ospedale Maggiore Policlinico Foundation, Milan, Italy. agostino.cortelezzi@unimi.it
authors.forename: Agostino
authors.initials: A
authors.lastname: Cortelezzi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gritti
authors.forename: Luca
authors.initials: L
authors.lastname: Laurenti
authors.forename: Antonio
authors.initials: A
authors.lastname: Cuneo
authors.forename: Stefania
authors.initials: S
authors.lastname: Ciolli
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Francesca R
authors.initials: FR
authors.lastname: Mauro
authors.forename: Nicola
authors.initials: N
authors.lastname: Cascavilla
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Falchi
authors.forename: Francesco
authors.initials: F
authors.lastname: Zallio
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Callea
authors.forename: Francesco
authors.initials: F
authors.lastname: Maura
authors.forename: Sara
authors.initials: S
authors.lastname: Martinelli
authors.forename: Alfonso
authors.initials: A
authors.lastname: Piciocchi
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Reda
authors.forename: Robin
authors.initials: R
authors.lastname: Foà
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000074323:Alemtuzumab; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007558:Italy; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000074323:Alemtuzumab