Shortly before the all-trans retinoic acid (ATRA) era, the GIMEMA cooperative group initiated a randomized study comparing idarubicin (IDA) alone with IDA plus arabinosylcytosine (Ara-C) as induction treatment in patients with newly diagnosed hypergranular acute promyelocytic leukemia (APL). Of the 257 patients evaluable for induction treatment, 131 were randomized to receive IDA alone (arm A) and 126 to receive IDA + Ara-C (arm B). Treatment in arm A consisted of 10 mg/m2 IDA daily for 6 consecutive days, whereas in arm B it consisted of 12 mg/m2 IDA daily for 4 days combined with 200 mg/m2 Ara-C daily in continuous infusion for 7 days. Once in complete remission (CR), patients received 3 consolidation courses of standard chemotherapy, and those still in CR at the end of the consolidation were randomized to receive or not receive 1 mg/kg 6-mercaptopurine daily and intramuscular injections of 0.25 mg/kg methotrexate weekly for 2 years. Overall, 100 (76.3%) patients in arm A and 84 (66.6%) patients in arm B achieved CR (P= NS). Event-free survival (EFS) rates were 35% and 23% for patients in arm A and arm B, respectively (P = .0352). Multivariate analysis revealed that EFS was favorably influenced by induction treatment with IDA alone (P = .0352) and unfavorably influenced by white blood cell (WBC) counts greater than 3000/μL (P = .0001) and increasing age (P = .0251). These results indicate that anthracycline monochemotherapy with IDA favorably influences the EFS of patients with newly diagnosed hypergranular APL. © 2002 by The American Society of Hematology.

Avvisati, G., Petti, M.c., LO COCO, F., Vegna, M.l., Amadori, S., Baccarani, M., et al. (2002). Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia: Final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up, 100(9), 3141-3146 [10.1182/blood-2002-02-0352].

Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia: Final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up

LO COCO, FRANCESCO;AMADORI, SERGIO;
2002-01-01

Abstract

Shortly before the all-trans retinoic acid (ATRA) era, the GIMEMA cooperative group initiated a randomized study comparing idarubicin (IDA) alone with IDA plus arabinosylcytosine (Ara-C) as induction treatment in patients with newly diagnosed hypergranular acute promyelocytic leukemia (APL). Of the 257 patients evaluable for induction treatment, 131 were randomized to receive IDA alone (arm A) and 126 to receive IDA + Ara-C (arm B). Treatment in arm A consisted of 10 mg/m2 IDA daily for 6 consecutive days, whereas in arm B it consisted of 12 mg/m2 IDA daily for 4 days combined with 200 mg/m2 Ara-C daily in continuous infusion for 7 days. Once in complete remission (CR), patients received 3 consolidation courses of standard chemotherapy, and those still in CR at the end of the consolidation were randomized to receive or not receive 1 mg/kg 6-mercaptopurine daily and intramuscular injections of 0.25 mg/kg methotrexate weekly for 2 years. Overall, 100 (76.3%) patients in arm A and 84 (66.6%) patients in arm B achieved CR (P= NS). Event-free survival (EFS) rates were 35% and 23% for patients in arm A and arm B, respectively (P = .0352). Multivariate analysis revealed that EFS was favorably influenced by induction treatment with IDA alone (P = .0352) and unfavorably influenced by white blood cell (WBC) counts greater than 3000/μL (P = .0001) and increasing age (P = .0251). These results indicate that anthracycline monochemotherapy with IDA favorably influences the EFS of patients with newly diagnosed hypergranular APL. © 2002 by The American Society of Hematology.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/15 - Malattie del Sangue
English
cytarabine; idarubicin; mercaptopurine; methotrexate; tioguanine; adult; article; bleeding; cancer combination chemotherapy; cancer diagnosis; cancer regression; cancer survival; clinical trial; controlled clinical trial; controlled study; diarrhea; drug induced disease; drug infusion; female; follow up; heart failure; human; infection; kidney failure; leukocyte count; liver failure; major clinical study; male; monotherapy; mucosa inflammation; multicenter study; multivariate analysis; priority journal; promyelocytic leukemia; randomized controlled trial; survival time; vomiting; 6-Mercaptopurine; Adolescent; Adult; Age Factors; Antibiotics, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Child; Cytarabine; Disease-Free Survival; Female; Follow-Up Studies; Hemorrhage; Hepatitis, Toxic; Humans; Idarubicin; Infection; Leukemia, Promyelocytic, Acute; Leukocyte Count; Male; Methotrexate; Middle Aged; Remission Induction; Treatment Outcome; Vomiting
Avvisati, G., Petti, M.c., LO COCO, F., Vegna, M.l., Amadori, S., Baccarani, M., et al. (2002). Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia: Final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up, 100(9), 3141-3146 [10.1182/blood-2002-02-0352].
Avvisati, G; Petti, Mc; LO COCO, F; Vegna, Ml; Amadori, S; Baccarani, M; Cantore, N; Bona, Ed; Ferrara, F; Fioritoni, G; Gallo, E; Invernizzi, R; Lazzarino, M; Liso, V; Mariani, G; Ricciuti, F; Selleri, C; Sica, S; Veneri, D; Mandelli, F
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/50982
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