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Title: Azacitidine with or without lenalidomide in higher risk myelodysplastic syndrome & low blast acute myeloid leukemia.
Austin Authors: Kenealy, Melita;Hertzberg, Mark;Benson, Warwick;Taylor, Kerry;Cunningham, Ilona;Stevenson, Will;Hiwase, Devendra;Eek, Richard;Zantomio, Daniela ;Jong, Steve;Wall, Meaghan;Blombery, Piers;Gerber, Tracey;Debrincat, Marlyse;Zannino, Diana;Seymour, John F
Affiliation: Cabrini Health, Melbourne, Australia
Prince of Wales Hospital, Randwick, Sydney, Australia
Westmead Hospital, Sydney, Australia
Icon Cancer Care, Brisbane, Australia
Concord Hospital University of Sydney, Concord, Australia
Royal North Shore Hospital, St Leonards, Australia
Royal Adelaide Hospital, Adelaide, Australia
Border Medical Oncology, Albury, Australia
Department of Clinical Haematology, Austin Health, Heidelberg, Victoria, Australia
Andrew Love Cancer Centre, University Hospital, Geelong, Australia
St Vincent Hospital, Fitzroy, Australia
Peter MacCallum Cancer Centre, Melbourne, Australia
Australasian Leukaemia and Lymphoma Group, Richmond, Australia
Peter MacCallum Cancer Centre, Melbourne, Australia
Issue Date: 2019
Date: 2018-12-13
Publication information: Haematologica 2019; 104(4): 700-709
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 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 as ACTRN12610000271000.
DOI: 10.3324/haematol.2018.201152
Journal: Haematologica
PubMed URL: 30545923
Type: Journal Article
Subjects: Clinical trial
Myelodysplastic Syndromes
Appears in Collections:Journal articles

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