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Haematologica. 2019 Apr;104(4):700-709. doi: 10.3324/haematol.2018.201152. Epub 2018 Dec 13.

Azacitidine with or without lenalidomide in higher risk myelodysplastic syndrome & low blast acute myeloid leukemia.

Author information

1
Cabrini Health, Melbourne melita.kenealy@thebloodunit.com.au.
2
Monash University, Melbourne.
3
Prince of Wales Hospital, Randwick, Sydney.
4
Westmead Hospital, Sydney.
5
Icon Cancer Care, Brisbane.
6
Concord Hospital University of Sydney.
7
University of Sydney.
8
Royal North Shore Hospital, St Leonards.
9
Haematology Department, Royal Adelaide Hospital.
10
School of Medicine, Univeristy of Adelaide.
11
Cancer Theme, South Australian Health and Medical Research (SAHMRI), Adelaide.
12
Border Medical Oncology, Albury.
13
Austin Health, Melbourne.
14
Andrew Love Cancer Centre, University Hospital, Geelong.
15
Victorian Cancer Cytogenetics Service, St Vincent's Hospital, Fitzroy, Victoria.
16
Department of Medicine, St Vincent's Hospital, University of Melbourne, Fitzroy, Victoria.
17
St Vincent's Institute of Medical Research, Fitzroy, Victoria.
18
Peter MacCallum Cancer Centre, Melbourne.
19
Sir Peter MacCallum Department of Oncology, University of Melbourne.
20
Australasian Leukaemia and Lymphoma Group, Richmond.
21
Systems Biology and Personalised Medicine Division, The Walter and Eliza Hall Institute of Medical Research, Melbourne.
22
Department of Medical Biology, University of Melbourne.
23
University of Melbourne, Australia.

Abstract

Standard treatment for higher risk myelodysplastic syndromes, chronic myelomonocytic leukemia and low blast acute myeloid leukemia is azacitidine. In single arm studies, adding lenalidomide had been suggested to improve outcomes. The ALLG MDS4 phase II trial randomized such patients to standard azacitidine or combination azacitidine (75mg/m2/d days 1 to 5) with lenalidomide (10mg days 1-21 of 28-day cycle from cycle 3) to assess clinical benefit (alive without progressive disease) at 12 months. A total of 160 patients were enrolled; median age 70.7 years (range 42.5-87.2), 31.3% female with 14% chronic myelomonocytic leukemia, 12% acute myeloid leukemia and 74% myelodysplastic syndromes. Adverse events were similar in both arms. There was excellent delivery of protocol therapy (median azacitidine cycles 11 both arms) with few dose reductions, delays or early cessations. At median follow up 33.1 months (range 0.7-59.5), the rate of clinical benefit at 12 months was 65% azacitidine arm and 54% lenalidomide+azacitidine arm (P=0.2). There was no difference in clinical benefit between each arm according to WHO diagnostic subgroup or IPSS-R. Overall response rate was 57% in azacitidine arm and 69% in lenalidomide+azacitidine (P=0.14). There was no difference in progression- free or overall survival between the arms (each P>0.12). Although the combination of lenalidomide and azacitidine was tolerable, there was no improvement in clinical benefit, response rates or overall survival in higher risk myelodysplastic syndrome, chronic myelomonocytic leukemia or low blast acute myeloid leukemia patients compared to treatment with azacitidine alone. This trial was registered at www.anzc-tr.org.au as ACTRN12610000271000.

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