Evaluation of a polychemotherapeutic regimen including Idarubicin (4-demethoxydaunorubicin) in relapsed acute lymphocytic leukemia
Mandelli, F.; Testi, A.M.; Aloe Spiriti, M.A.; Giona, F.; Meloni, G.; Moleti, M.L.; Amadori, S.; Pacciarini, M.A.
Haematologica 71(1): 34-38
1986
ISSN/ISBN: 0390-6078 PMID: 3084353 Document Number: 4104
Twenty patients with relapsed ALL (12 adults and 8 children) were treated with Idarubicin included in a combination chemotherapy regimen. All patients had previously received conventional chemotherapy regimens including anthracyclines (mean prior total dose: 289 mg/sqm) and were in first or subsequent relapse. The induction schedule consisted of four weekly doses of Vincristine (2 mg/sqm) and Idarubicin (10 mg/sqm); in addition L-Asparaginase (6000 I.U./sqm) was administered every other day, starting from day 4 for a total of 9 doses. Prednisone (40 mg/sqm) was given orally for 4 weeks. All patients without evidence of central nervous system (CNS) leukemic involvement received intrathecal Methotrexate (MTX) plus Cytosine arabinoside (CA) on day 1 and 29. In patients with CNS involvement, intrathecal therapy was given weekly until 2 successive cerebrospinal fluid examinations were normal. Nineteen of the 20 patients who entered the study were evaluable for response and toxicity. Eleven of the 19 patients achieved CR for a response rate of 58%. The CR rate was higher in children than in adults (75% vs 45.5%). Six additional patients showed a significant reduction in bone marrow blasts. The median duration of CR was of 15 weeks (range 11-30 weeks) and the overall median survival for the 19 evaluable patients was 27 weeks (range 12.9-53.6). Nausea and vomiting were not observed. Bone marrow function was profoundly depressed in 17 out of 19 evaluable patients. Seventeen patients experienced granulocytopenia (PMN<500/mm3) for a median duration of 18 days (range 10-39), while 12 patients had thrombocytopenia (PLTS<50,000/mm3) for a median duration of 15 days (range 2-39). During the hypoplastic phase 10 patients developed mild to severe stomatitis. Infectious complications were observed in almost all patients along with transient liver dysfunction. No patient developed clinical evidence of congestive heart failure.
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