Abstract

Abstract 4032

Background:

Chronic myelomonocytic leukemia (CMML) is a rare yet indolent disease. The median survival duration in CMML is 12 to 18 months and patients with poor prognostic features do even worse, with median survival time ranging 3 to 6 months. Activity with decitabine in CMML has been previously reported. We sought to analyze the clinical experience of 17 adults with a diagnosis of CMML treated on two decitabine studies.

Methods:

A subset of patients with CMML from a pivotal phase III 3-day dosing and an open-label trial of 5-day dosing were identified and reviewed to determine the overall response rate (ORR, based on IWG 2006 criteria), duration of response, time to response, and overall survival (OS).

Results:

A total of 17 patients with CMML were included in this review. Mean age at diagnosis was 71 years (range, 47 to 81 years) with a mean time from diagnosis of 406.4 days. The majority of CMML patients had de novo (94.1%), good risk cytogenetics (58.8%) with an IPSS classification of Intermediate-1 (64.7%). Baseline mean white blood count (WBC), hemoglobin (HGB), and platelets (plts) were 7.5 × 103/μ L, 14.6 g/dL and 81.9 × 103/μ L, respectively. A larger proportion of CMML patients at baseline were plt and RBC transfusion independent. Objective response rate (ORR) was 41% [17.6% complete response (CR) and 23.5% marrowCR (mCR)]; Hematologic improvement (HI) was observed in 11.7% and stable disease in 29.4% of patients. Median survival was 391 (95% CI 239, 678) days and 2 (11.7%) patients progressed to AML. The adverse event profile was similar to observations in previous trials with myelosuppression and infectious complications.

Conclusions:

This retrospective review of responses in CMML patients supports previous findings of decitabine experience in this population. In this analysis an overall response rate of 41.4% was achieved. Decitabine provided anti-CMML activity with an acceptable safety profile.

Disclosures:

Jabbour:Eisai Inc.: Editorial and statistical support from Eisai Inc., Honoraria. Kantarjian:Novartis: Research Funding; Pfizer: Research Funding; Bristol Myers Squibb: Research Funding; Novartis: Consultancy. Ravandi:Eisai Inc.: Research Funding; Eisai Inc.: Honoraria. Borthakur:Eisai Inc.: Research Funding. Cortes:Novartis: Research Funding; Pfizer: Consultancy, Research Funding; Bristol Myers Squibb: Research Funding.

Table 1
Response Rates (N=17) 
Overall Response Rate (CR + mCR + PR) 41.1 
Overall improvement rate (CR + mCR +PR +HI) 52.9 
Complete Response (CR) 17.6 
Marrow Complete Response (mCR) 23.5 
Partial Response (PR) – – 
Hematologic Improvement (HI) 11.7 
Stable Disease (SD) 29.4 
Progressive Disease (PD) 5.8 
Response Rates (N=17) 
Overall Response Rate (CR + mCR + PR) 41.1 
Overall improvement rate (CR + mCR +PR +HI) 52.9 
Complete Response (CR) 17.6 
Marrow Complete Response (mCR) 23.5 
Partial Response (PR) – – 
Hematologic Improvement (HI) 11.7 
Stable Disease (SD) 29.4 
Progressive Disease (PD) 5.8 

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Author notes

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Asterisk with author names denotes non-ASH members.