title: Idarubicin in combination with intermediate-dose cytarabine and VP-16 in the treatment of refractory or rapidly relapsed patients with acute myeloid leukemia. The GIMEMA Cooperative Group.
abstract: Ninety-seven patients with refractory or relapsed acute myelogenous leukemia (AML), median age 37 years, received as salvage therapy a single course of idarubicin 6 mg/m2 as an intravenous (i.v.) bolus daily for 5 days, cytarabine (Ara-C) 600 mg/m2 i.v. for a period of 2 hours daily for 5 days and etoposide (VP-16) 150 mg/m2 for a period of 2 hours daily for 3 days (ICE protocol). Thirty-six patients were primarily resistant to standard inductive therapy with daunorubicin and Ara-C; 50 patients were in first relapse, three patients in second or third relapse, and eight patients in relapse after transplants. Forty-two (43%) out of 97 patients achieved complete remission, 11 patients died of infection or hemorrhage during induction, and 44 patients (45%) had resistant disease. Of the various variables examined, only disease status (i.e. refractory versus relapsed AML) was predictive for a significantly lower response rate. The median remission duration was 16 weeks; the overall median survival was 10 weeks. Nausea, vomiting, and oral mucositis were common but were rarely severe. No patient experienced treatment-related cardiac toxicity. In conclusion, the ICE protocol is a tolerable regimen providing effective antileukemic activity in patients with advanced AML. The evolution of this protocol in previously untreated patients with AML appears indicated.
authors.affiliation: ABMT Section, Genova-Quarto, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Carella
authors.forename: P
authors.initials: P
authors.lastname: Carlier
authors.forename: E
authors.initials: E
authors.lastname: Pungolino
authors.forename: L
authors.initials: L
authors.lastname: Resegotti
authors.forename: V
authors.initials: V
authors.lastname: Liso
authors.forename: R
authors.initials: R
authors.lastname: Stasi
authors.forename: M
authors.initials: M
authors.lastname: Montillo
authors.forename: P
authors.initials: P
authors.lastname: Iacopino
authors.forename: S
authors.initials: S
authors.lastname: Mirto
authors.forename: L
authors.initials: L
authors.lastname: Pagano
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003561:Cytarabine / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004351:Drug Resistance; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction
chemical_list: D003561:Cytarabine; D005047:Etoposide; D015255:Idarubicin