De novo AML patients with favourable-intermediate karyotype may benefit from the addition of low-dose gemtuzumab ozogamicin (GO) to fludarabine, Ara-C and idarubicin (FLAI): A contribution to the reopened "gO question"

Annals of Hematology

Volumn 92, Issue 10, 2013, Pages 1309-1318

  Clavio, Marino ^a,b   Cruciani, Fabio ^a   Minetto, Paola ^a   Guolo, Fabio ^a   Ballerini, Filippo ^a   Marani, Carlo ^a   De Astis, Enrico ^a   Aquino, Sara ^a   Bergamaschi, Micaela ^a   Mitscheunig, Laura ^a   Grasso, Raffaella ^a   Colombo, Nicoletta ^a   Ghiggi, Chiara ^a   Lovera, Davide ^a   Pastori, Giordana ^a   Avenoso, Daniele ^a   Miglino, Maurizio ^a   Gobbi, Marco ^a  

^a UNIVERSITY OF GENOA   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

Author keywords

AML; Ara C; Fludarabine; Gemtuzumab ozogamicin; Idarubicin

Indexed keywords

CYTARABINE; FLUDARABINE; GEMTUZUMAB OZOGAMICIN; IDARUBICIN;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE HEART INFARCTION; ADULT; AGED; ARTICLE; ASPERGILLOSIS; CANCER COMBINATION CHEMOTHERAPY; CANCER PROGNOSIS; CANCER RECURRENCE; CONTROLLED STUDY; CYTOGENETICS; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG SAFETY; FEMALE; GASTROINTESTINAL SYMPTOM; HEART ATRIUM FIBRILLATION; HEART FAILURE; HUMAN; KARYOTYPE; LEUKOPENIA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; PLEURISY; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RECURRENCE RISK; SEPSIS; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA;

AGED; AGED, 80 AND OVER; AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL, HUMANIZED; CYTARABINE; FEMALE; HUMANS; IDARUBICIN; KARYOTYPE; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TREATMENT OUTCOME; VIDARABINE;

EID: 84883871342     PISSN: 09395555     EISSN: 14320584     Source Type: Journal    
DOI: 10.1007/s00277-013-1780-7     Document Type: Article

References (43)

1. Schlenk RF, Döhner K, Krauter J, Fröhling S, Corbacioglu A, Bullinger L, Habdank M, Späth D, Morgan M, Benner A, Schlegelberger B, Heil G, Ganser A, Döhner H, German-Austrian Acute Myeloid Leukemia Study Group (2008) Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia. N Engl J Med 358:1909-1918
2. Patel JP, Gönen M, Figueroa ME, Fernandez H, Sun Z, Racevskis J, Van Vlierberghe P, Dolgalev I, Thomas S, Aminova O, Huberman K, Cheng J, Viale A, Socci ND, Heguy A, Cherry A, Vance G, Higgins RR, Ketterling RP, Gallagher RE, Litzow M, van den Brink MR, Lazarus HM, Rowe JM, Luger S, Ferrando A, Paietta E, Tallman MS, Melnick A, Abdel-Wahab O, Levine RL (2012) Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Eng J Med 366:1079-1089
3. Amadori S, Papa G, Meloni G, Pacilli L, Mandelli F (1979) Daunorubicin cytosine arabinoside and 6-thioguanine (DAT) combination therapy for the treatment of acute non lymphocytic leukaemia. Leuk Res 3:147-152
4. Rai KR, Holland JF, Glidewell OJ, Weinberg V, Brunner K, Obrecht JP, Preisler HD, Nawabi IW, Prager D, Carey RW, Cooper MR, Haurani F, Hutchison JL, Silver RT, Falkson G, Wiernik P, Hoagland HC, Bloomfield CD, James GW, Gottlieb A, Ramanan SV, Blom J, Nissen NI, Bank A, Ellison RR, Kung F, Henry P, McIntyre OR, Kaan SK (1981) Treatment of acute myelocytic leukaemia: a study by cancer and leukemia group B. Blood 58:1203-1212
5. Berman E, Heller G, Santorsa J, McKenzie S, Gee T, Kempin S, Gulati S, Andreeff M, Kolitz J, Gabrilove J (1991) Results of a randomised trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukaemia. Blood 77:1666-1674
6. Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH (2006) Age and acute myeloid leukemia. Blood 107:3481-3486
7. Ferrara F (2011) Treatment of unfit patients with acute myeloid leukemia: a still open clinical challenge. Clin Lymphoma Myeloma Leuk 11:10-16
8. Walter RB, Kantarjian HM, Huang X, Pierce SA, Sun Z, Gundacker HM, Ravandi F, Faderl SH, Tallman MS, Appelbaum FR, Estey EH (2010) Effect of complete remission and responses less than complete remission on survival in acute myeloid leukemia: a combined Eastern Cooperative Oncology Group, Southwest Oncology Group, and M.D. Anderson Cancer Center study. J Clin Oncol 28:1766-1771
9. Löwenberg B, Ossenkoppele GJ, van Putten W, Schouten HC, Graux C, Ferrant A, Sonneveld P, Maertens J, Jongen-Lavrencic M, von Lilienfeld-Toal M, Biemond BJ, Vellenga E, van Marwijk Kooy M, Verdonck LF, Beck J, Döhner H, Gratwohl A, Pabst T, Verhoef G, Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON), German AML Study Group (AMLSG), Swiss Group for Clinical Cancer Research (SAKK)Collaborative Group (2009) High-dose daunorubicin in older patients with acute myeloid leukemia. N Eng J Med 361:1235-1248
10. Estey E, Plunkett W, Gandhi V, Rios MB, Kantarjian H, Keating M (1993) Fludarabine and arabinosylcytosine therapy of refractory and relapsed acute myeloid leukemia. Leuk Lymphoma 9:343-350
11. Clavio M, Carrara P, Miglino M, Pierri I, Canepa L, Balleari E, Gatti AM, Cerri R, Celesti L, Vallebella E, Sessarego M, Patrone F, Ghio R, Damasio E, Gobbi M (1996) High efficacy of fludarabine containing therapy (FLAG-FLANG) in poor risk acute myeloid leukemia. Haematologica 81:513-520
12. Clavio M, Gatto S, Beltrami G, Quintino S, Canepa L, Pierri I, Galbusera V, Carrara P, Miglino M, Varaldo R, Ballerini F, Venturino C, Cerri R, Risso M, Balleari E, Carella AM, Sessarego M, Ghio R, Bacigalupo A, Gobbi M (2001) First line therapy with fludarabine combinations in 42 patients with either post myelodysplastic syndrome or therapy related acute myeloid leukemia. Leuk Lymphoma 40:305-313
13. Russo D, Pricolo G, Michieli M, Michelutti A, Raspadori D, Bertone A, Marin L, Pierri I, Bucalossi A, Zuffa E, De Vivo A, Mazza P, Gobbi M, Lauria F, Zaccaria A, Baccarani M (2001) Fludarabine, arabinosyl cytosine and idarubicin (FLAI) for remission induction in poor-risk acute myeloid leukemia. Leuk Lymphoma 40:335-343
14. Sievers EL, Appelbaum FR, Spielberger RT, Forman SJ, Flowers D, Smith FO, Shannon-Dorcy K, Berger MS, Bernstein ID (1999) Selective ablation of AML using antibody-targeted chemotherapy: a phase I study of an anti-CD 33 calicheamicin immunoconjugate. Blood 93:3678-3684
15. Piccaluga PP, Martinelli G, Rondoni M, Malagola M, Gaitani S, Isidori A, Bonini A, Gugliotta L, Luppi M, Morselli M, Sparaventi G, Visani G, Baccarani M (2004) Gemtuzumab ozogamicin for relapsed and refractory acute myeloid leukemia and myeloid sarcomas. Leuk Lymphoma 45:1791-1795
16. Amadori S, Suciu S, Willemze R, Mandelli F, Selleslag D, Stauder R, Ho A, Denzlinger C, Leone G, Fabris P, Muus P, Vignetti M, Hagemeijer A, Beeldens F, Anak O, De Witte T (2004) Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups. Haematologica 89:950-956
17. Piccaluga PP, Martinelli G, Rondoni M, Malagola M, Gaitani S, Visani G, Baccarani M (2004) First experience with gemtuzumab ozogamicin plus cytarabine as continuous infusion for elderly acute myeloid leukaemia patients. Leuk Res 28:987-990
18. Petersdorf S, Kopecky K, Stuart RK, Larson RA, Nevill TJ, Stenke L, Slovak ML, Tallman MS, Willman CL, Erba H, Appelbaum FR (2009) Preliminary results of Southwest Oncology Group Study S0106: an international intergroup phase 3 randomized trial comparing the addition of gemtuzumab ozogamicin to standard induction therapy versus post-consolidation gemtuzumab ozogamicin versus no additional therapy for previously untreated acute myeloid leukemia. Blood 114:326-327, abstr 790
19. Burnett AK, Hills RK, Milligan D, Kjeldsen L, Kell J, Russell NH, Yin JA, Hunter A, Goldstone AH, Wheatley K (2011) 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
20. Burnett AK, Russell NH, Hills RK, Kell J, Freeman S, Kjeldsen L, Hunter AE, Yin J, Craddock CF, Dufva IH, Wheatley K, Milligan D (2012) Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in older patients with acute myeloid leukemia. J Clin Oncol 10:3924-3931
21. Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, Legrand O, Thomas X, Turlure P, Reman O, de Revel T, Gastaud L, de Gunzburg N, Contentin N, Henry E, Marolleau JP, Aljijakli A, Rousselot P, Fenaux P, Preudhomme C, Chevret S, Dombret H, Acute Leukemia French Association (2012) 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
22. Clavio M, Vignolo L, Albarello A, Varaldo R, Pierri I, Catania G, Balocco M, Michelis G, Miglino M, Manna A, Balleari E, Carella AM, Sessarego M, Van Lint MT, Bacigalupo A, Gobbi M (2007) Adding low-dose gemtuzumab ozogamicin to fludarabine, Ara-C and idarubicin (MY-FLAI) may improve disease-free and overall survival in elderly patients with non-M3 acute myeloid leukaemia: results of a prospective, pilot, multi-centre trial and comparison with a historical cohort of patients. Br J Haematol 138:186-195
23. Grimwade D, Walker H, Harrison G, Oliver F, Chatters S, Harrison CJ, Wheatley K, Burnett AK, Goldstone AH, Medical Research Council Adult Leukemia Working Party (2001) The predictive value of hierarchical cytogenetic classification in older adults with acute myeloid leukemia (AML): analysis of 1,065 patients entered into the United Kingdom Medical Research Council AML11 trial. Blood 98:1312-1320
24. Kiyoi H, Naoe T, Nakano Y, Yokota S, Minami S, Miyawaki S, Asou N, Kuriyama K, Jinnai I, Shimazaki C, Akiyama H, Saito K, Oh H, Motoji T, Omoto E, Saito H, Ohno R, Ueda R (1999) Prognostic implication of FLT3 and N-RAS gene mutations in acute myeloid leukemia. Blood 93:3074-3080
25. Amadori S, Arcese W, Isacchi G, Meloni G, Petti MC, Monarca B, Testi AM, Mandelli F (1991) Mitoxantrone, etoposide, and intermediate-dose cytarabine: an effective and tolerable regimen for the treatment of refractory acute myeloid leukaemia. J Clin Oncol 9:1210-1214
26. Pierri I, Clavio M, Miglino M, Cavaliere M, Pietrasanta D, Gobbi M (1999) GM-IVA, a short induction course for de novo acute myeloid leukemia, suitable for the elderly. Haematologica 84:562-563
27. Cheson BD, Bennett JM, Kopecky KJ, Büchner T, Willman CL, Estey EH, Schiffer CA, Doehner H, Tallman MS, Lister TA, Lo-Coco F, Willemze R, Biondi A, Hiddemann W, Larson RA, Löwenberg B, Sanz MA, Head DR, Ohno R, Bloomfield CD (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. J Clin Oncol 15:4642-4649
28. Alvarado Y, Tsimberidou A, Kantarjian H, Cortes J, Garcia-Manero G, Faderl S, Thomas D, Estey E, Giles FJ (2003) Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukaemia. Cancer Chemother Pharmacol 51:87-90
29. McKoy JM, Angelotta C, Bennett CL, Tallman MS, Wadleigh M, Evens AM, Kuzel TM, Trifilio SM, Raisch DW, Kell J, Deangelo DJ, Giles FJ (2007) Gemtuzumab ozogamicin-associated sinusoidal obstructive syndrome (SOS): an overview from the research on adverse drug events and reports (RADAR) project. Leuk Res 31:599-604
30. Candoni A, Martinelli G, Toffoletti E, Chiarvesio A, Tiribelli M, Malagola M, Piccaluga PP, Michelutti A, Simeone E, Damiani D, Russo D, Fanin R (2008) Gemtuzumab-ozogamicin in combination with fludarabine, cytarabine, idarubicin (FLAI-GO) as induction therapy in CD33-positive AML patients younger than 65 years. Leuk Res 32:1800-1808
31. Tavor S, Rahamim E, Sarid N, Rozovski U, Gibstein L, Aviv F, Kirsner I, Naparstek E (2012) High response rate for treatment with gemtuzumab ozogamicin and cytarabine in elderly patients with acute myeloid leukemia and favorable and intermediate-I cytogenetic risk. Clin Lymphoma Myeloma Leuk 12:438-443
32. Jabbour E, Garcia-Manero G, Cortes J, Ravandi F, Plunkett W, Gandhi V, Faderl S, O'Brien S, Borthakur G, Kadia T, Burger J, Konopleva M, Brandt M, Huang X, Kantarjian H (2012) Twice-daily fludarabine and cytarabine combination with or without gentuzumab ozogamicin is effective in patients with relapsed/refractory acute myeloid leukemia, high-risk myelodysplastic syndrome, and blast-phase chronic myeloid leukemia. Clin Lymphoma Myeloma Leuk 12:244-251
33. Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E (1994) Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and leukemia group B. N Eng J Med 331:896-903
34. Löwenberg B, Beck J, Graux C, van Putten W, Schouten HC, Verdonck LF, Ferrant A, Sonneveld P, Jongen-Lavrencic M, von Lilienfeld-Toal M, Biemond BJ, Vellenga E, Breems D, de Muijnck H, Schaafsma R, Verhoef G, Döhner H, Gratwohl A, Pabst T, Ossenkoppele GJ, Maertens J, Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON), German Austrian AML Study Group (AMLSG), Swiss Group for Clinical Cancer Research Collaborative Group (SAKK) (2010) Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more: results of a multicenter phase 3 study. Blood 115:2586-2591
35. Apostolidou E, Cortes J, Tsimberidou A, Estey E, Kantarjian H, Giles FJ (2003) Pilot study of gemtuzumab ozogamicin, liposomal daunorubicin, cytarabine and cyclosporine regimen in patients with refractory acute myelogenous leukemia. Leuk Res 27:887-891
36. Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR (2009) International vidaza high-risk MDS survival study group. Lancet Oncol 10:223-232
37. Sekeres MA, Gundacker H, Lancet J, Advani A, Petersdorf S, Liesveld J, Mulford D, Norwood T, Willman CL, Appelbaum FR, List AF (2011) A phase 2 study of lenalidomide monotherapy in patients with deletion 5q acute myeloid leukemia: Southwest Oncology Group Study S0605. Blood 118:523-528
38. Leith CP, Kopechy KJ, Godwin J, McConnel T, Slovak ML, Ming CI, Head DR, Appelbaum FR, Willman CL (1997) Acute myeloid leukemia in the elderly: assessment of multidrugs resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct response to standard chemotherapy: a Southwest Oncology Group study. Blood 89:3323-3329
39. Wheatley K, Brookes CL, Howman AJ, Goldstone AH, Milligan DW, Prentice AG, Moorman AV, Burnett AK, United Kingdom National Cancer Research Institute Haematological Oncology Clinical Studies Group and Acute Myeloid Leukaemia Subgroup (2009) Prognostic factor analysis of the survival of elderly patients with AML in the MRC AML11 and LRF AML14 trials. Br J Haematol 145:598-605
40. Becker H, Marcucci G, Maharry K, Radmacher MD, Mro'zek K, Margeson D, Whitman SP, Wu YZ, Schwind S, Paschka P, Powell BL, Carter TH, Kolitz JE, Wetzler M, Carroll AJ, Baer MR, Caligiuri MA, Larson RA, Bloomfield CD (2010) Favorable prognostic impact of NPM1 mutations in older patients with cytogenetically normal de novo acute myeloid leukemia and associated gene- and micro RNA-expression signatures. J Clin Oncol 28:596-604
41. Yanada M, Matsuo K, Suzuki T, Kiyoi H, Naoe T (2005) Prognostic significance of FLT3 internal tandem duplication and tyrosine kinase domain mutations for acute myeloid leukemia: a meta analysis. Leukemia 19:1345-1349
42. Estey E (2012) Treatment of AML: resurrection for gemtuzumab ozogamicin? Lancet 379:1468-1469
43. Ravandi F, Estey EH, Appelbaum FR, Lo-Coco F, Schiffer CA, Larson RA, Burnett AK, Kantarjian HM (2012) Gemtuzumab ozogamicin: time to resurrect? J Clin Oncol 30:3921-3923