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

Melita Kenealy, Mark Hertzberg, Warwick Benson, Kerry Taylor, Ilona Cunningham, Will Stevenson, Devendra Hiwase, Richard Eek, Daniela Zantomio, Steve Jong, Meaghan Wall, Piers Blombery, Tracey Gerber, Marlyse Debrincat, Diana Zannino, John F. Seymour

Research output: Contribution to journalArticle

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/m 2 /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% lenalido-mide+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 lenalido-mide+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.

LanguageEnglish
Pages700-709
Number of pages10
JournalHaematologica
Volume104
Issue number4
DOIs
Publication statusPublished - 31 Mar 2019

ASJC Scopus subject areas

  • Hematology

Cite this

Kenealy, M., Hertzberg, M., Benson, W., Taylor, K., Cunningham, I., Stevenson, W., ... Seymour, J. F. (2019). Azacitidine with or without lenalidomide in higher risk myelodysplastic syndrome & low blast acute myeloid leukemia. Haematologica, 104(4), 700-709. https://doi.org/10.3324/haematol.2018.201152
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. / Azacitidine with or without lenalidomide in higher risk myelodysplastic syndrome & low blast acute myeloid leukemia. In: Haematologica. 2019 ; Vol. 104, No. 4. pp. 700-709.
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Kenealy, M, Hertzberg, M, Benson, W, Taylor, K, Cunningham, I, Stevenson, W, Hiwase, D, Eek, R, Zantomio, D, Jong, S, Wall, M, Blombery, P, Gerber, T, Debrincat, M, Zannino, D & Seymour, JF 2019, 'Azacitidine with or without lenalidomide in higher risk myelodysplastic syndrome & low blast acute myeloid leukemia', Haematologica, vol. 104, no. 4, pp. 700-709. https://doi.org/10.3324/haematol.2018.201152

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

In: Haematologica, Vol. 104, No. 4, 31.03.2019, p. 700-709.

Research output: Contribution to journalArticle

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AU - Cunningham, Ilona

AU - Stevenson, Will

AU - Hiwase, Devendra

AU - Eek, Richard

AU - Zantomio, Daniela

AU - Jong, Steve

AU - Wall, Meaghan

AU - Blombery, Piers

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