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.
| Original language | English |
|---|---|
| Pages (from-to) | 3141-3146 |
| Number of pages | 6 |
| Journal | Blood |
| Volume | 100 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - Nov 1 2002 |
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ASJC Scopus subject areas
- Hematology
Cite this
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. / Avvisati, Giuseppe; Petti, Maria Concetta; Lo-Coco, Francesco; Vegna, Maria Luce; Amadori, Sergio; Baccarani, Michele; Cantore, Nicola; Bona, Eros Di; Ferrara, Felicetto; Fioritoni, Giuseppe; Gallo, Eugenio; Invernizzi, Rosangela; Lazzarino, Mario; Liso, Vincenzo; Mariani, Guglielmo; Ricciuti, Francesco; Selleri, Carmine; Sica, Simona; Veneri, Dino; Mandelli, Franco.
In: Blood, Vol. 100, No. 9, 01.11.2002, p. 3141-3146.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia
T2 - Final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up
AU - Avvisati, Giuseppe
AU - Petti, Maria Concetta
AU - Lo-Coco, Francesco
AU - Vegna, Maria Luce
AU - Amadori, Sergio
AU - Baccarani, Michele
AU - Cantore, Nicola
AU - Bona, Eros Di
AU - Ferrara, Felicetto
AU - Fioritoni, Giuseppe
AU - Gallo, Eugenio
AU - Invernizzi, Rosangela
AU - Lazzarino, Mario
AU - Liso, Vincenzo
AU - Mariani, Guglielmo
AU - Ricciuti, Francesco
AU - Selleri, Carmine
AU - Sica, Simona
AU - Veneri, Dino
AU - Mandelli, Franco
PY - 2002/11/1
Y1 - 2002/11/1
N2 - 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.
AB - 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.
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U2 - 10.1182/blood-2002-02-0352
DO - 10.1182/blood-2002-02-0352
M3 - Article
VL - 100
SP - 3141
EP - 3146
JO - Blood
JF - Blood
SN - 0006-4971
IS - 9
ER -