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Outcome Of Patients (pts) With Low and Intermediate-1 Risk Myelodysplastic Syndrome (MDS) After Hypomethylating Agent (HMA) Failure

ASH 2013 Annual Meeting Abstract 388 (Oral Presentation)

Session:633. Myelodysplastic Syndromes: Novel Therapies and Clinical Outcomes
Time:Monday, December 9, 2013: 11:15 AM
Location:New Orleans Theater AB (Ernest N. Morial Convention Center)

Elias Jabbour, MD1, Guillermo Garcia-Manero, MD1, Lianchun Xiao2, Al Ali Najla3, Asmita Mishra, MD4, Eric Padron, MD5, Jeffrey E Lancet, MD5, Jeffery Bryan1, Hillary Prescott1, David P. Steensma, MD6, Mikkael A. Sekeres, MD, MS7, Gail J. Roboz, MD8, Alan List, MD9, Hagop M Kantarjian, MD1 and Rami S Komrokji, MD5

Affiliations: 1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, 2Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, 3Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, 4Bone Marrow Transplantation, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, 5Malignant Hematology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, 6Dana-Farber Cancer Institute, Boston, MA, 7Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, 8Leukemia Program, Weill Cornell Medical Center and The New York Presbyterian Hospital, New York, NY, 9H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL

Background: HMA are standard of care in pts with high-risk MDS and commonly used in pts with lower risk. Pts with high-risk disease post HMA failure have a poor prognosis with a median survival of 4-6 months. The prognosis of pts with low and intermediate-1 risk MDS by the International Prognostic Scoring System (IPSS) after HMA failure is not known.

Aims:To assess outcome of pts with low and intermediate-1 risk disease post HMA failure that might benefit from specific strategies or investigational agents.

Methods: Data from 423 pts with low (n= 141, 33%) and intermediate-1 risk disease (n=282, 67%) by IPSS score treated with HMA at MD Anderson Cancer Center (MDACC; n=144) and Moffitt Cancer Center (MCC; n=279) between 2000 and 2011 were analyzed.

Results: Median age was 69 years. 294 (69%) pts had a diploid cytogenetic analysis. 63 (15%) pts had therapy-related MDS. 282 (67%) pts received azacitidine, 87 (21%) decitabine, and 54 (12%) both. Median number of cycles of HMA administered was 6 (range, 1-64) for a median duration of therapy of 7 months (range, 1- 74). Best response to HMA was complete response (CR) in 39 (9%) pts, partial response (PR) in 13 (3%), a bone marrow CR in 6 (1%), and hematologic improvement (HI) in 90 (21%) pts. Pts had discontinued HMA because of primary resistance in 198 (47%) pts, loss of response in 141 pts (33%), intolerance in 13 pts (3%) and other reasons in 71 pts (17%). At the time of HMA failure, 81 (19%) pts transformed into acute myeloid leukemia (AML). Of the 302 remaining pts evaluable by IPSS, 67 (22%) pts were of low-risk, 158 (53%) of intermediate-1 risk, 48 (16%) of intermediate-2 risk, and 29 (9%) of high-risk disease. By the revised IPSS (R-IPSS), the percentage of pts with low, very low, intermediate, high, and very high risk disease were 11%, 29%, 30%, 20%, and 10%, respectively. By the MDACC global prognostic scoring system (MDGPSS) 18%, 35%, 29%, and 18%, of the pts were of low-risk, intermediate-1, intermediate-2, and high-risk disease, respectively. After a median follow-up of 16 months from HMA failure, 117 (28%) pts remained alive.  The median overall survival (OS) was 15 months (95% CI: 12-18) with estimated 1- and 3-year OS rates of 55% and 27%, respectively. Both, the R-IPSS and the MDGPSS were predictive of survival post HMA failure (Table 1).

Conclusion:In the largest cohort of lower risk MDS pts treated with HMA, the outcome after HMA failure is poor. Treatment of those patients remains an unmet medical need. OS is a reasonable primary endpoint for clinical studies targeting this population.

Table 1. Survival from HMA failure by risk group

 

 

 

Survival

 

Risk group

Category

Percentage

Median (mos)

% 1-year

% 3-year

p-value

MDGPSS

Low

18

34

68

48

p<0.001

 

Intermediate-1

35

29

75

39

 

Intermediate-2

29

12

49

14

 

High

18

7

31

8

R-IPSS

Very low

11

51

83

60

p<0.001

 

Low

29

31

76

38

 

Intermediate

30

21

60

30

 

High

20

9

39

12

 

Very high

10

6

25

11

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