Erratum: Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial (J Clin Oncol DOI: 10.1200/JCO.2015.64.0060);Gemtuzumab ozogamicin versus best supportive care in older patients with newly diagnosed acute myeloid leukemia unsuitable for intensive chemotherapy: Results of the randomized phase III EORTC-GIMEMA AML-19 Trial

Journal of Clinical Oncology

Volumn 34, Issue 9, 2016, Pages 972-979

  Amadori, Sergio ^a   Venditti, Adriano ^a   Voso, Maria Teresa ^a   Annino, Luciana ^b   De Fabritiis, Paolo ^c   Alimena, Giuliana ^d   Mancini, Marco ^d   Paoloni, Francesca ^e   Vignetti, Marco ^e   Fazi, Paola ^e   Aversa, Franco ^f   Gaidano, Gainluca ^g   Musso, Maurizio ^h   Mazzone, Carla ⁱ   Magro, Domenico ^j   Ramadan, Safaa Mahmoud ^k   Suciu, Stefan ^l   Meert, Liv ^l   Selleslag, Dominik ^m   Hagemeijer, Anne ⁿ   Baron, Frédéric ^o   Muus, Petra ^p   Dewitte, Theo ^p   Willemze, Roel ^q   more..

^a UNIVERSITY OF ROME TOR VERGATA   (Italy)

^b San Giovanni Addolorata Hospital   (Italy)

^c St Eugenio Hospital   (Italy)

^d SAPIENZA UNIVERSITY OF ROME   (Italy)

^e GIMEMA Foundation   (Italy)

^f UNIVERSITY HOSPITAL OF PARMA   (Italy)

^g UNIVERSITY OF EASTERN PIEDMONT   (Italy)

^h LA MADDALENA CANCER CENTER   (Italy)

ⁱ ANNUNZIATA HOSPITAL   (Italy)

^j PUGLIESE CIACCIO HOSPITAL   (Italy)

^k EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^l EORTC DATA CENTER   (Belgium)

^m General Hospital St Jan   (Belgium)

ⁿ UNIVERSITY OF LEUVEN   (Belgium)

^o UNIVERSITY OF LIÈGE   (Belgium)

^p RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^q LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CD33 ANTIGEN; GEMTUZUMAB OZOGAMICIN; HYDROXYUREA; AMINOGLYCOSIDE; ANTINEOPLASTIC AGENT; GEMTUZUMAB; MONOCLONAL ANTIBODY;

ACUTE MYELOBLASTIC LEUKEMIA; ADULT; AGED; ANTIGEN EXPRESSION; ARTICLE; BLEEDING; CANCER CHEMOTHERAPY; CANCER MORTALITY; CONTROLLED STUDY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GERIATRIC DISORDER; HEART DISEASE; HUMAN; INFECTION; INTENTION TO TREAT ANALYSIS; INTERMETHOD COMPARISON; KIDNEY DISEASE; LEUKEMIA REMISSION; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; METABOLIC DISORDER; OVERALL SURVIVAL; PANCYTOPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VEIN OCCLUSION; VERY ELDERLY; AGE; CLINICAL TRIAL; LEUKEMIA, MYELOID, ACUTE; MIDDLE AGED; MULTICENTER STUDY;

AGE FACTORS; AGED; AGED, 80 AND OVER; AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; FEMALE; HUMANS; HYDROXYUREA; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED;

EID: 84961671223     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.21.02939     Document Type: Erratum

References (31)

1. Burnett AK: Treatment of acute myeloid leukemia: Are we making progress? Hematology (Am Soc Hematol Educ Program) 2012:1-6, 2012.
2. Walter RB, Estey EH: Management of older or unfit patients with acute myeloid leukemia. Leukemia 29:770-775, 2015.
3. Pollyea DA, Kohrt HE, Medeiros BC: Acute myeloid leukaemia in the elderly: A review. Br J Haematol 152:524-542, 2011.
4. Oran B, Weisdorf DJ: Survival for older patients with acute myeloid leukemia: A populationbased study. Haematologica 97:1916-1924, 2012.
5. Sievers EL, Larson RA, Stadtmauer EA, et al: Mylotarg Study Group: Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 19:3244-3254, 2001.
6. Bross PF, Beitz J, Chen G, et al: Approval summary: Gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res 7:1490-1496, 2001.
7. Estey EH, Thall PF, Giles FJ, et al: Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: Comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside. Blood 99:4343-4349, 2002.
8. Nabhan C, Rundhaugen LM, Riley MB, et al: Phase II pilot trial of gemtuzumab ozogamicin (GO) as first line therapy in acute myeloid leukemia patients age 65 or older. Leuk Res 29: 53-57, 2005.
9. Amadori S, Suciu S, Stasi R, et al: Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: Final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups. Leukemia 19:1768-1773, 2005.
10. Amadori S, Suciu S, Selleslag D, et al: Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukaemia groups (AML-19). Br J Haematol 149:376-382, 2010.
11. 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. J Clin Oncol 21:4642-4649, 2003.
12. Walter RB, Raden BW, Kamikura DM, et al: Influence of CD33 expression levels and ITIMdependent internalization on gemtuzumab ozogamicininduced cytotoxicity. Blood 105:1295-1302, 2005.
13. Burnett AK, Hills RK, Milligan D, et al: Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: Results of the MRC AML15 trial. J Clin Oncol 29:369-377, 2011.
14. Castaigne S, Pautas C, Terré C, et al: Acute Leukemia French Association: Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): A randomised, open-label, phase 3 study. Lancet 379: 1508-1516, 2012.
15. Hills RK, Castaigne S, Appelbaum FR, et al: Addition of gemtuzumab ozogamicin to induction chemotherapy in adult patients with acute myeloid leukaemia: A meta-analysis of individual patient data from randomised controlled trials. Lancet Oncol 15: 986-996, 2014.
16. 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 109:1114-1124, 2007.
17. 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 25:1122-1127, 2011.
18. 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 158:519-522, 2012.
19. 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 27:75-81, 2013.
20. 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 122:1384-1394, 2013.
21. Dennis M, Russell N, Hills RK, et al: Vosaroxin and vosaroxin plus low-dose Ara-C (LDAC) vs lowdose Ara-C alone in older patients with acute myeloid leukemia. Blood 125:2923-2932, 2015.
22. Döhner H, Lübbert M, Fiedler W, et al: Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. Blood 124:1426-1433, 2014.
23. 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 28:562-569, 2010.
24. Maurillo L, Venditti A, Spagnoli A, et al: Azacitidine for the treatment of patients with acute myeloid leukemia: Report of 82 patients enrolled in an Italian Compassionate Program. Cancer 118: 1014-1022, 2012.
25. Cashen AF, Schiller GJ, O'Donnell MR, et al: Multicenter, phase II study of decitabine for the firstline treatment of older patients with acute myeloid leukemia. J Clin Oncol 28:556-561, 2010.
26. 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 30:2670-2677, 2012.
27. Dombret H, Seymour JF, Butrym A, et al: International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with .30% blasts. Blood 126: 291-299, 2015.
28. Nand S, Othus M, Godwin JE, et al: A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia. Blood 122:3432-3439, 2013.
29. Kurimoto M, Matsuoka H, Hanaoka N, et al: Pretreatment of leukemic cells with low-dose decitabine markedly enhances the cytotoxicity of gemtuzumab ozogamicin. Leukemia 27:233-235, 2013.
30. Petersdorf SH, Kopecky KJ, Slovak M, et al: A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia. Blood 121: 4854-4860, 2013.
31. Ravandi F, Estey EH, Appelbaum FR, et al: Gemtuzumab ozogamicin: Time to resurrect? J Clin Oncol 30:3921-3923, 2012.