Therapy of refractory or recurrent childhood acute myeloid leukemia using amsacrine and etoposide with or without azacitidine: a Pediatric Oncology Group randomized phase II study. J Clin Oncol 1996 May;14(5):1521-5
Date
05/01/1996Pubmed ID
8622066DOI
10.1200/JCO.1996.14.5.1521Scopus ID
2-s2.0-0029963320 (requires institutional sign-in at Scopus site) 35 CitationsAbstract
PURPOSE: A randomized study compared the combination of amsacrine (100 mg/m2/d on days 1 to 5) and etoposide (200 mg/m2/d on days 1 to 3) with the same two agents plus azacitidine (250 mg/m2/d on days 4 to 50) for the therapy of induction-resistant or relapse childhood acute myeloid leukemia (AML).
PATIENTS AND METHODS: One hundred sixty-seven assessable children with AML who either had failed to respond to primary induction therapy (group 1, n = 41) or had relapsed (group 2, n = 126) were randomized.
RESULTS: Overall, there were 56 complete responses (34%; SE 4%). Among primary refractory patients (group 1), the complete response rate was higher with the three-drug regimen (18% vs 53%, P = .03). In the relapsed patients (group 2), there was no difference in complete response rates related to treatment (31% vs 35%, P = .3). There were 17 early deaths. The major toxicities for both regimens were myelosuppression and infection.
CONCLUSION: The overall complete response rate of 34% in this patient population is indicative of effective antileukemic activity. For patients with relapsed leukemia, the addition of azacitidine to etoposide and amsacrine did not improve response. The suggested advantage of the three-drug regimen for induction failures warrants further investigation.
Author List
Steuber CP, Krischer J, Holbrook T, Camitta B, Land V, Sexauer C, Mahoney D, Weinstein HMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Amsacrine
Antineoplastic Combined Chemotherapy Protocols
Azacitidine
Child
Child, Preschool
Dose-Response Relationship, Drug
Etoposide
Female
Humans
Infant
Leukemia, Myeloid, Acute
Male
Neoplasm Recurrence, Local