Phase II study of tosedostat with cytarabine or decitabine in newly diagnosed older patients with acute myeloid leukaemia or high-risk MDS

British Journal of Haematology

Volumn 172, Issue 2, 2016, Pages 238-245

  Mawad, Raya ^a,b   Becker, Pamela S ^a,b   Hendrie, Paul ^a,b   Scott, Bart ^a,b   Wood, Brent L ^a,b   Dean, Carol ^a   Sandhu, Vicky ^a   Deeg, Hans Joachim ^a,b   Walter, Roland ^a,b   Wang, Lixia ^c   Myint, Han ^c   Singer, Jack W ^b,c   Estey, Elihu ^a,b   Pagel, John M ^a,b  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c CTI BIOPHARMA CORP   (United States)

Author keywords

Acute myeloid leukaemia; Elderly; Myelodysplastic syndrome

Indexed keywords

ANTINEOPLASTIC AGENT; AZACITIDINE; CYTARABINE; DECITABINE; GLYCINE; HYDROXAMIC ACID; TOSEDOSTAT;

AGED; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; GENETICS; HUMAN; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AZACITIDINE; CYTARABINE; FEMALE; GLYCINE; HUMANS; HYDROXAMIC ACIDS; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; REMISSION INDUCTION; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84954026785     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/bjh.13829     Document Type: Article

References (16)

1. Appelbaum, F.R., Gundacker, H., Head, D.R., Slovak, M.L., Willman, C.L., Godwin, J.E., Anderson, J.E. & Petersdorf, S.H. (2006) Age and acute myeloid leukemia. Blood, 107, 3481-3485.
2. Blum, W., Garzon, R., Klisovic, R.B., Schwind, S., Walker, A., Geyer, S., Liu, S., Havelange, V., Becker, H., Schaaf, L., Mickle, J., Devine, H., Kefauver, C., Devine, S.M., Chan, K.K., Heerema, N.A., Bloomfield, C.D., Grever, M.R., Byrd, J.C., Villalona-Calero, M., Croce, C.M. & Marcucci, G. (2010) Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proceedings of the National Academy of Sciences of the United States of America, 107, 7473-7478.
3. Byrd, J.C., Mrózek, K., Dodge, R.K., Carroll, A.J., Edwards, C.G., Arthur, D.C., Pettenati, M.J., Patil, S.R., Rao, K.W., Watson, M.S., Koduru, P.R., Moore, J.O., Stone, R.M., Mayer, R.J., Feldman, E.J., Davey, F.R., Schiffer, C.A., Larson, R.A. & Bloomfield, C.D.; Cancer and Leukemia Group B (CALGB 8461). (2002) Pretreatment cytogenetic abnormalities are predictive of induction success, cumulative incidence of relapse, and overall survival in adult patients with de novo acute myeloid leukemia: results from Cancer and Leukemia Group B (CALGB 8461). Blood, 100, 4325-4336.
4. Cheson, B.D., Bennett, J.M., Kopecky, K.J., Büchner, T., Willman, C.L., Estey, E.H., Schiffer, C.A., Doehner, H., Tallman, M.S., Lister, T.A., Lo-Coco, F., Willemze, R., Biondi, A., Hiddemann, W., Larson, R.A., Löwenberg, B., Sanz, M.A., Head, D.R., Ohno, R. & Bloomfield, C.D.; International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. (2003) Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. Journal of Clinical Oncology, 21, 4642-4649.
5. Cortes, J., Feldman, E., Yee, K., Rizzieri, D., Advani, A.S., Charman, A., Spruyt, R., Toal, M. & Kantarjian, H. (2013) Two dosing regimens of tosedostat in elderly patients with relapsed or refractory acute myeloid leukaemia (OPAL): a randomised open-label phase 2 study. The Lancet Oncology, 14, 354-362.
6. Döhner, H., Estey, E.H., Amadori, S., Appelbaum, F.R., Büchner, T., Burnett, A.K., Dombret, H., Fenaux, P., Grimwade, D., Larson, R.A., Lo-Coco, F., Naoe, T., Niederwieser, D., Ossenkoppele, G.J., Sanz, M.A., Sierra, J., Tallman, M.S., Löwenberg, B. & Bloomfield, C.D.; European LeukemiaNet. (2010) Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood, 115, 453-474.
7. van Herpen, C.M., Eskens, F.A., de Jonge, M., Desar, I., Hooftman, L., Bone, E.A., Timmer-Bonte, J.N. & Verweij, J. (2010) A Phase Ib dose-escalation study to evaluate safety and tolerability of the addition of the aminopeptidase inhibitor tosedostat (CHR-2797) to paclitaxel in patients with advanced solid tumours. British Journal of Cancer, 103, 1362-1368.
8. Krige, D., Needham, L.A., Bawden, L.J., Flores, N., Farmer, H., Miles, L.E., Stone, E., Callaghan, J., Chandler, S., Clark, V.L., Kirwin-Jones, P., Legris, V., Owen, J., Patel, T., Wood, S., Box, G., Laber, D., Odedra, R., Wright, A., Wood, L.M., Eccles, S.A., Bone, E.A., Ayscough, A. & Drummond, A.H. (2008) CHR-2797: an antiproliferative aminopeptidase inhibitor that leads to amino acid deprivation in human leukemic cells. Cancer Research, 68, 6669-6679.
9. Lang, K., Earle, C.C., Foster, T., Dixon, D., Van Gool, R. & Menzin, J. (2005) Trends in the treatment of acute myeloid leukaemia in the elderly. Drugs and Aging, 22, 943-955.
10. Lowenberg, B., Morgan, G., Ossenkoppele, G.J., Burnett, A.K., Zachée, P., Dührsen, U., Dierickx, D., Müller-Tidow, C., Sonneveld, P., Krug, U., Bone, E., Flores, N., Richardson, A.F., Hooftman, L., Jenkins, C., Zweegman, S. & Davies, F. (2010) Phase I/II clinical study of Tosedostat, an inhibitor of aminopeptidases, in patients with acute myeloid leukemia and myelodysplasia. Journal of Clinical Oncology, 28, 4333-4338.
11. Mawad, R., Gooley, T.A., Sandhu, V., Lionberger, J., Scott, B., Sandmaier, B.M., O'Donnell, P., Becker, P.S., Petersdorf, S., Dorcy, K.S., Hendrie, P., Sorror, M.L., Walter, R.B., Deeg, H.J., Appelbaum, F.R., Estey, E.H. & Pagel, J.M. (2013) Frequency of allogeneic hematopoietic cell transplantation among patients with high- or intermediate-risk acute myeloid leukemia in first complete remission. Journal of Clinical Oncology, 31, 3883-3888.
12. Medeiros, B.C., Othus, M., Fang, M., Roulston, D. & Appelbaum, F.R. (2010) Prognostic impact of monosomal karyotype in young adult and elderly acute myeloid leukemia: the Southwest Oncology Group (SWOG) experience. Blood, 116, 2224-2228.
13. Reid, A.H., Protheroe, A., Attard, G., Hayward, N., Vidal, L., Spicer, J., Shaw, H.M., Bone, E.A., Carter, J., Hooftman, L., Harris, A. & De Bono, J.S. (2009) A first-in-man phase i and pharmacokinetic study on CHR-2797 (Tosedostat), an inhibitor of M1 aminopeptidases, in patients with advanced solid tumors. Clinical Cancer Research, 15, 4978-4985.
14. Ritchie, E.K., Feldman, E.J., Christos, P.J., Rohan, S.D., Lagassa, C.B., Ippoliti, C., Scandura, J.M., Carlson, K. & Roboz, G.J. (2013) Decitabine in patients with newly diagnosed and relapsed acute myeloid leukemia. Leukaemia & Lymphoma, 54, 2003-2007.
15. Saric, T., Graef, C.I. & Goldberg, A.L. (2004) Pathway for degradation of peptides generated by proteasomes: a key role for thimet oligopeptidase and other metallopeptidases. Journal of Biological Chemistry, 279, 46723-46732.
16. Stone, R.M., O'Donnell, M.R. & Sekeres, M.A. (2004) Acute myeloid leukemia. Hematology/The Education Program of the American Society of Hematology, 2004, 98-117.