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. Neurology (R) 2011; 77: 1887-1895

Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone / Martinelli, V.; Cocco, E.; Capra, R.; Salemi, G.; Gallo, P.; Capobianco, M.; Pesci, I.; Ghezzi, A.; Pozzilli, Carlo; Lugaresi, A.; Bellantonio, P.; Amato, M. P.; Grimaldi, L. M.; Trojano, M.; Mancardi, G. L.; Bergamaschi, R.; Gasperini, Claudio; Rodegher, M.; Straffi, L.; Ponzio, M.; Comi, G.; For The Italian Mitoxantrone Group, ; Radaelli, M; Esposito, F; Moiola, L; Colombo, B; Rossi, P; Marrosu, Mg; Frau, J; Lorefice, L; Coghe, G; Savettieri, Giovanni; 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, Luca; 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; Cavaletti, G.. - In: NEUROLOGY. - ISSN 0028-3878. - STAMPA. - 77:21(2011), pp. 1887-1895. [10.1212/wnl.0b013e318238ee00]

Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone

Carlo Pozzilli;P. Bellantonio;Claudio Gasperini;G. Comi;SAVETTIERI, GIOVANNI;Salvetti M
Membro del Collaboration Group
;
Buttinelli C;AUSILI CEFARO, LUCA;Tedeschi G
Membro del Collaboration Group
;
2011

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. Neurology (R) 2011; 77: 1887-1895
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/477761
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