Publication Date:
2019-11-13
Description:
Background: Patients (pts) with secondary acute myeloid leukemia (s-AML) or relapsed/refractory (r/r) AML represent a high-risk populations with poor long-term outcomes following standard induction chemotherapy with 7+3. Until 2017, there was no standard regimen for these patients. CLAG ± M has been described in the literature to result in significant responses in r/r AML (Wierzbowska et al, Eur J Haematol 2008), and as front-line therapy for s-AML following azanucleoside failure (Jagal et al, Leuk Res 2014). Here we describe our institutional experience (RP) with CLAG±M as a standard induction/re-induction strategy for r/r and s-AML patients. We further compare our institutional data for s-AML patients treated on label with CPX-351 compared to CLAG±M. Methods: Medical records were retrospectively reviewed to identify pts treated with CLAG±M for r/r or untreated s-AML. S-AML pts treated with CPX-351 as induction therapy following FDA approval for these indications were also identified as a comparator cohort. Treatment, demographics, disease-specific variables, and overall survival outcomes were collected under an institutional review board approved protocol. Results: 60 pts with r/r (n=44; 73.3%) or s-AML (n=16; 26.7%) were treated with CLAG±M between 2003-18. 12 pts (19%) did not receive mitoxantrone. The median age of treated pts was 65 years (y;range 21 - 77) and 40 were male (63.5%). Cytogenetics were high-risk in 26 pts (41.3%) and intermediate risk in 37 pts(58.7%), 10 (15.9%) had 17p abnormalities. 41 (65.1%) pts had previously received hypomethylating (HMA) therapy. The overall response rate (ORR=CR+CRi+PR) was 81.7%; 41 pts achieved CR/CRi (68.3%), and 8 achieved PR (12.7%), 25 (39.7%) went on to allogenic stem cell transplant (AlloT). The most common adverse event (AE) was infection (58.7%, n=37). Thirty-day (d) mortality was 5%, and 60-d mortality was 14%. Median overall survival (OS) was 313 d (range 172 - 503), median progression-free survival (PFS) was 225 d (range 135 - 423). Similar response rates, OS and PFS were seen comparing pts with intermediate and high-risk cytogenetics, r/r and s-AML, and those with 17p abnormalities. The addition of mitoxantrone did not impact outcome (Table 1). Younger pts (
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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