Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone.
- Autori: Radaelli, M; Esposito, F; Moiola, L; Colombo, B; Rossi, P; Marrosu, MG; Frau, J; Lorefice, L; Coghe, G; Savettieri, G; Ragonese, P; Cusimano, V; Perini, P; Rinaldi, F; Vidali, A; Bertolotto, A; Malucchi, S; Di Sapio, A; Montanari, E; Guareschi, A; Rizzo, A; Zaffaroni, M; Baldini, S; De Rossi, N; Cordioli, C; Rasia, S; Salvetti, M; Buttinelli, C; Ausili Cefaro, L; De Luca, G; Tommaso, D; Farina, D; Fantozzi, R; Ruggieri, S; Amato, MP; Hakiki, B; Zipoli, V; Portaccio, E; Bartolozzi, ML; Scandellari, C; Stecchi, S; Marchello, LP; Palmeri, B; Vitello, G; Iaffaldano, P, Lucchese G, Dattola V, Buccafusca M; Sola, P; Simone, AM; Barreca, F; Patti, F; Laisa, P; Cavalla, P; Masera, S; Tavazzi, E; Galgani, S; Tedeschi, G; Sacco, R; Provinciali, L; Maura, D; Lus, G; Alfieri, G; Ticca, A; Piras, ML; Maimone, D; Bianca, M; Iudice, A; Giro, ME; Galeotti, M; Florio, C; Spitalieri, P; La Mantia, L; Motti, L; Rottoli, MR; Granella, F; Solaro, C; Scarpini, E; Servillo, G; Cavalletti, G; Salemi, G
- Anno di pubblicazione: 2011
- Tipologia: Articolo in rivista (Articolo in rivista)
- Parole Chiave: Acute Myelocytic Leukemia; Mitoxantrone; Multiple Sclerosis
- OA Link: http://hdl.handle.net/10447/61973
Abstract
OBJECTIVES: To evaluate the incidence and dose-dependency of mitoxantrone (MTX)-associated acute myelocytic leukemia (AML) in the network of Italian multiple sclerosis (MS) clinics. METHODS: We performed a multicenter retrospective cohort study of patients treated with MTX in MS centers under the Italian national health care system between 1998 and 2008. Demographic, disease, treatment, and follow-up information were collected using hospital records. RESULTS: Data were available for 3,220 patients (63% women) from 40 Italian centers. Follow-up (mean ± SD) was 49 ± 29 months (range 12-140 months). We observed 30 cases of AML (incidence 0.93% [95% confidence interval 0.60%-1.26%]). The mean cumulative dose was higher in patients with AML (78 vs 65 mg/m(2), p = 0.028). The median interval from the start of therapy to AML diagnosis was longer than expected at 33 months (range 13-84 months); 8 patients (27%) developed AML 4 years or more after the first MTX infusion. The rate of mortality associated with AML was 37%. CONCLUSIONS: This higher than expected risk of AML and related mortality requires that treatment decisions must be made jointly between clinicians and patients who understand their prognosis, treatment options, and treatment-related risks. The now large exposed MS population must be monitored for hematologic abnormalities for at least 6 years from the end of therapy, to ensure the rapid actions needed for early diagnosis and treatment of AML.