Vosaroxin and vosaroxin plus low-dose Ara-C (LDAC) vs low-dose Ara-C alone in older patients with acute myeloid leukemia

Blood

Volumn 125, Issue 19, 2015, Pages 2923-2932

  Dennis, Mike ^a   Russell, Nigel ^b   Hills, Robert K ^c   Hemmaway, Claire ^d   Panoskaltsis, Nicki ^e   McMullin, Mary Frances ^f   Kjeldsen, Lars ^g   Dignum, Helen ^h   Thomas, Ian F ^c   Clark, Richard E ⁱ   Milligan, Don ^j   Burnett, Alan K ^c  

^a CHRISTIE HOSPITAL   (United Kingdom)

^b NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^c CARDIFF UNIVERSITY SCHOOL OF MEDICINE   (United Kingdom)

^d QUEEN S HOSPITAL   (United Kingdom)

^e NORTHWICK PARK HOSPITAL   (United Kingdom)

^f BELFAST CITY HOSPITAL   (United Kingdom)

^g Rigshospitalet   (Denmark)

^h QUEEN ALEXANDRA HOSPITAL   (United Kingdom)

ⁱ ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

^j BIRMINGHAM HEARTLANDS HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; CYTARABINE; VOSAROXIN; ANTINEOPLASTIC AGENT; NAPHTHYRIDINE DERIVATIVE; THIAZOLE DERIVATIVE;

ACUTE MYELOBLASTIC LEUKEMIA; ADULT; AGED; ANTIBIOTIC THERAPY; ARTICLE; BLOOD TRANSFUSION; CANCER MORTALITY; CANCER SURVIVAL; CONTROLLED STUDY; DIARRHEA; DRUG INDUCED DISEASE; EXPLORATORY RESEARCH; FEMALE; FOLLOW UP; GASTROINTESTINAL TOXICITY; HUMAN; LEUKEMIA RELAPSE; LIVER TOXICITY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NEUTROPHIL COUNT; ORAL TOXICITY; OVERALL SURVIVAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SURVIVAL TIME; THROMBOCYTE TRANSFUSION; TREATMENT OUTCOME; TREATMENT RESPONSE; VERY ELDERLY; CANCER STAGING; COMPARATIVE STUDY; DOSE RESPONSE; LEUKEMIA, MYELOID, ACUTE; MIDDLE AGED; MORTALITY; NEOPLASM RECURRENCE, LOCAL; PATHOLOGY; PROGNOSIS; REMISSION; SURVIVAL RATE;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYTARABINE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; NAPHTHYRIDINES; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROGNOSIS; PROSPECTIVE STUDIES; REMISSION INDUCTION; SURVIVAL RATE; THIAZOLES;

EID: 84929170526     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2014-10-608117     Document Type: Article

References (24)

1. Burnett AK, Milligan D, Prentice AG, et al. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007;109(6):1114-1124.
2. Fenaux P, Mufti GJ, Hellström-Lindberg E, et al. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010;28(4):562-569.
3. Kantarjian HM, Thomas XG, Dmoszynska A, et al. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012;30(21):2670-2677.
4. Hawtin RE, Stockett DE, Byl JA, et al. Voreloxin is an anticancer quinolone derivative that intercalates DNA and poisons topoisomerase II. PLoS ONE. 2010;5(4):e10186.
5. Gewirtz DA. A critical evaluation of the mechanisms of action proposed for the antitumor effects of the anthracycline antibiotics adriamycin and daunorubicin. Biochem Pharmacol. 1999;57(7):727-741.
6. Advani RH, Hurwitz HI, Gordon MS, et al. Voreloxin, a first-in-class anticancer quinolone derivative, in relapsed/refractory solid tumors: a report on two dosing schedules. Clin Cancer Res. 2010;16(7):2167-2175.
7. Evanchik MJ, Allen D, Yoburn JC, Silverman JA, Hoch U. Metabolism of (+)-1,4-dihydro-7-(trans-3-methoxy-4-methylamino-1-pyrrolidinyl)-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid (voreloxin; formerly SNS-595), a novel replication-dependent DNA-damaging agent. Drug Metab Dispos. 2009;37(3):594-601.
8. Hoch U, Lynch J, Sato Y, et al. Voreloxin, formerly SNS-595, has potent activity against a broad panel of cancer cell lines and in vivo tumor models. Cancer Chemother Pharmacol. 2009;64(1):53-65.
9. Lancet JE, Ravandi F, Ricklis RM, et al. A phase Ib study of vosaroxin, an anticancer quinolone derivative, in patients with relapsed or refractory acute leukemia. Leukemia. 2011;25(12):1808-1814.
10. Walsby EJ, Coles SJ, Knapper S, Burnett AK. The topoisomerase II inhibitor voreloxin causes cell cycle arrest and apoptosis in myeloid leukemia cells and acts in synergy with cytarabine. Haematologica. 2011;96(3):393-399.
11. Stuart RK, Ravandi Kashani F, Cripe LD, et al. Voreloxin single-agent treatment of older patients (60 years or older) with previously untreated acute myeloid leukemia: final results from a phase II study with three schedules [abstract]. J Clin Oncol. 2010;28(15s). Abstract 6525.
12. Ravandi F, Kantarjian HM, Cripe LD, et al. A phase 2 dose regimen optimization study of three schedules of voreloxin as single agent therapy for elderly patients with newly diagnosed acute myeloid leukemia. ASH Annual Meeting Abstracts 2009;114(22):1037.
13. Hills RK, Burnett AK. Applicability of a "Pick a Winner" trial design to acute myeloid leukemia. Blood. 2011;118(9):2389-2394.
14. Sorror ML, Giralt S, Sandmaier BM, et al. Hematopoietic cell transplantation specific comorbidity index as an outcome predictor for patients with acute myeloid leukemia in first remission: combined FHCRC and MDACC experiences. Blood. 2007;110(13):4606-4613.
15. Wheatley K, Brookes CL, Howman AJ, et al United Kingdom National Cancer Research Institute Haematological Oncology Clinical Studies Group and Acute Myeloid Leukaemia Subgroup. Prognostic factor analysis of the survival of elderly patients with AML in the MRC AML11 and LRF AML14 trials. Br J Haematol. 2009;145(5):598-605.
16. Cheson BD, Bennett JM, Kopecky KJ, et al International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. 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 [published correction appears in J Clin Oncol. 2004;22(3):576]. J Clin Oncol. 2003;21(24):4642-4649.
17. Kantarjian HM, Erba HP, Claxton D, et al. Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors. J Clin Oncol. 2010;28(4):549-555.
18. Burnett AK, Russell NH, Kell J, et al. European development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy. J Clin Oncol. 2010;28(14):2389-2395.
19. Burnett AK, Russell NH, Culligan D, et al AML Working Group of the UK National Cancer Research Institute. The addition of the farnesyl transferase inhibitor, tipifarnib, to low dose cytarabine does not improve outcome for older patients with AML. Br J Haematol. 2012;158(4):519-522.
20. Burnett AK, Hills RK, Hunter A, et al. The addition of arsenic trioxide to low-dose Ara-C in older patients with AML does not improve outcome. Leukemia. 2011;25(7):1122-1127.
21. Burnett AK, Hills RK, Hunter AE, et al UK National Cancer Research Institute AML Working Group. The addition of gemtuzumab ozogamicin to low-dose Ara-C improves remission rate but does not significantly prolong survival in older patients with acute myeloid leukaemia: results from the LRF AML14 and NCRI AML16 pick-a-winner comparison. Leukemia. 2013;27(1):75-81.
22. Burnett AK, Russell NH, Hunter AE, et al UK National Cancer Research Institute AML Working Group. Clofarabine doubles the response rate in older patients with acute myeloid leukemia but does not improve survival. Blood. 2013;122(8):1384-1394.
23. Lazenby M, Gilkes AF, Marrin C, Evans A, Hills RK, Burnett AK. The prognostic relevance of flt3 and npm1 mutations on older patients treated intensively or non-intensively: a study of 1312 patients in the UK NCRI AML16 trial. Leukemia. 2014;28(10):1953-1959.
24. th ASH Annual Meeting and Exposition. December 9, 2014. San Francisco, CA.