Mylotarg has potent anti-leukaemic effect: a systematic review and meta-analysis of anti-CD33 antibody treatment in acute myeloid leukaemia

Annals of Hematology

Volumn 94, Issue 3, 2015, Pages 361-373

  Loke, J ^a   Khan, J N ^b   Wilson, J S ^c   Craddock, C ^a   Wheatley, K ^c  

^a QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^b UNIVERSITY OF WARWICK   (United Kingdom)

^c UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

Acute myeloid leukaemia; CD33 antigen; Gemtuzumab; Humanised monoclonal antibodies; Meta analysis; Mylotarg; Randomised clinical trials; Systematic review

Indexed keywords

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

ACUTE MYELOBLASTIC LEUKEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CYTOGENETICS; DRUG INDUSTRY; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; LEUKEMIA REMISSION; META ANALYSIS; OVERALL SURVIVAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENCE FREE SURVIVAL; RECURRENCE RISK; SYSTEMATIC REVIEW; TOXIC HEPATITIS; TREATMENT RESPONSE; VEIN OCCLUSION; ANTAGONISTS AND INHIBITORS; IMMUNOLOGY; LEUKEMIA, MYELOID, ACUTE;

AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; HUMANS; LEUKEMIA, MYELOID, ACUTE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SIALIC ACID BINDING IG-LIKE LECTIN 3;

EID: 84925519872     PISSN: 09395555     EISSN: 14320584     Source Type: Journal    
DOI: 10.1007/s00277-014-2218-6     Document Type: Article

References (38)

1. Burnett AK (2012) Treatment of acute myeloid leukemia: are we making progress? Hematol Am Soc Hematol Educ Program 2012:1–6
2. Coiffier B, Lepage E, Briére J, Herbrecht R, Tilly H, Bouabdallah R et al (2002) CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 346:235–242
3. Tanimoto M, Scheinberg DA, Cordon-Cardo C, Huie D, Clarkson BD, Old LJ (1989) Restricted expression of an early myeloid and monocytic cell surface antigen defined by monoclonal antibody M195. Leukemia 3:339–348
4. Zein N, Poncin M, Nilakantan R, Ellestad GA (1989) Calicheamicin gamma 1I and DNA: molecular recognition process responsible for site-specificity. Science 244:697–699
5. Sievers EL, Larson RA, Stadtmauer EA, Estey E, Löwenberg B, Dombret H et al (2001) Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 19:3244–3254
6. US Food and Drug Administration: FDA: Pfizer voluntarily withdraws cancer treatment Mylotarg from US market. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm216448.htm. 2012. Accessed 29th September, 2012
7. Moher D, Liberati A, Tetzlaff J, Altman D (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339:b2535. doi:10.1136/bmj.b2535
8. Cheson BD, Bennett JM, Kopecky KJ, Büchner T, Willman CL, Estey EH et al (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 21:4642–4649
9. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org
10. Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR (2007) Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 8:16
11. Parmar MK, Torri V, Stewart L (1998) Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 17:2815–2834
12. Feldman EJ, Brandwein J, Stone R, Kalaycio M, Moore J, O’Connor J et al (2005) Phase III randomized multicenter study of a humanized anti-CD33 monoclonal antibody, lintuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia. J Clin Oncol 23:4110–4116
13. Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL et al (2013) Randomized, phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica 98:119–128
14. Burnett AK, Hills RK, Grimwade D, Jovanovic JV, Craig J, McMullin MF et al (2013) Inclusion of chemotherapy in addition to anthracycline in the treatment of acute promyelocytic leukaemia does not improve outcomes: results of the MRC AML15 trial. Leukemia 27(4):843–51
15. Burnett AK, Hills RK, Hunter AE, Milligan D, Kell WJ, Wheatley K et al (2013) 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(1):75–81
16. Burnett AK, Russell NH, Hills RK, Kell J, Freeman S, Kjeldsen L et al (2012) Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in older patients with acute myeloid leukemia. J Clin Oncol 30(32):3924–31
17. Burnett AK, Hills RK, Milligan D, Kjeldsen L, Kell J, Russell NH et al (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
18. Castaigne S, Pautas C, Terre C, Raffoux E, Bordessoule D, Bastie JN et al (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
19. Brunnberg U, Mohr M, Noppeney R, Durk HA, Sauerland MC, Muller-Tidow C et al (2012) Induction therapy of AML with ara-C plus daunorubicin versus ara-C plus gemtuzumab ozogamicin: a randomized phase II trial in elderly patients. Ann Oncol 23(4):990–6
20. Amadori S, Suciu S, Stasi R, Salih HR, Selleslag D, Muus P et al (2013) Sequential combination of gemtuzumab ozogamicin and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia: results of a randomized phase III trial by the EORTC and GIMEMA consortium (AML-17). J Clin Oncol 31(35):4424–30
21. Litzow MR, Othus M, Cripe LD, Gore SD, Lazarus HM, Lee SJ et al (2010) Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group. Br J Haematol 148:217–225
22. Hasle H, Abrahamsson J, Forestier E, Ha SY, Heldrup J, Jahnukainen K et al (2012) Gemtuzumab ozogamicin as postconsolidation therapy does not prevent relapse in children with AML: results from NOPHO-AML 2004. Blood 120:978–984
23. Lowenberg B, Beck J, Graux C, van Putten W, Schouten HC, Verdonck LF et al (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
24. Fernandez HF, Sun Z, Litzow MR, Luger SM, Paietta EM, Racevskis J et al (2011) Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin. Blood 117:5306–5313
25. Petersdorf SH, Kopecky KJ, Slovak M, Willman C, Nevill T, Brandwein J et al (2013) A phase III study of gemtuzumab ozogamicin during induction and post-consolidation therapy in younger patients with acute myeloid leukemia. Blood 121(24):4854–60
26. Delaunay J, Recher C, Pigneux A, Witz F, Vey N, Blanchet O et al (2011) Addition of gemtuzumab ozogamycin to chemotherapy improves event-free survival but not overall survival of AML patients with intermediate cytogenetics not eligible for allogeneic transplantation. Results of the GOELAMS AML 2006 IR Study. ASH Annu Meet Abstr 2011, 118: 79
27. Gamis A, Aplenc R, Alonzo TA, Sung L, Meshinchi S, Gerbing RB et al (2013) Gemtuzumab ozogamicin (GO) in children with de novo acute myeloid leukemia (AML) improves event-free survival (EFS) by reducing relapse risk results from the randomized phase III Childrens Oncology Group (COG) trial, AAML0531. ASH Annu Meet Abstr 122:355
28. A phase III study of the addition of gemtuzumab ozogamicin (Mylotarg®) induction therapy versus standard induction with daunomycin and cytosine arabinoside followed by consolidation and subsequent randomization to post-consolidation therapy with gemtuzumab ozogamicin (Mylotarg®) or no additional therapy for patients under age 61 with previously untreated de novo acute myeloid leukemia (AML). http://www.mhlw.go.jp/stf/shingi/2r9852000000vrz2-att/2r9852000000vs34.pdf. Accessed 25th March 2013
29. Giles FJ, Kantarjian HM, Kornblau SM, Thomas DA, Garcia-Manero G, Waddelow TA et al (2001) Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation. Cancer 92:406–413
30. Wadleigh M, Richardson PG, Zahrieh D, Lee SJ, Cutler C, Ho V et al (2003) Prior gemtuzumab ozogamicin exposure significantly increases the risk of veno-occlusive disease in patients who undergo myeloablative allogeneic stem cell transplantation. Blood 102:1578–1582
31. Hills RK, Castaigne S, Appelbaum FR, Delaunay J, Petersdorf S, Othus M et al (2014) 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
32. Li X, Xu SN, Qin DB, Tan Y, Gong Q, Chen JP (2014) Effect of adding gemtuzumab ozogamicin to induction chemotherapy for newly diagnosed acute myeloid leukemia: a meta-analysis of prospective randomized phase III trials. Ann Oncol 25:455–461
33. Kharfan-Dabaja MA, Hamadani M, Reljic T, Pyngolil R, Komrokji RS, Lancet JE et al (2013) Gemtuzumab ozogamicin for treatment of newly diagnosed acute myeloid leukaemia: a systematic review and meta-analysis. Br J Haematol 163:315–325
34. Lambert J, Lambert J, Nibourel O, Pautas C, Hayette S, Cayuela JM et al (2012) Minimal residual disease assessed by WT1 expression and NPM1 mutations specific RQ-PCR assays identifies patients with distinct outcomes in the ALFA 0701 trial and is decreased by treatment with gemtuzumab ozogamicin. ASH Annu Meet Abstr 120:659
35. Cornelissen JJ, Breems D, van Putten WL, Gratwohl AA, Passweg JR, Pabst T et al (2012) Comparative analysis of the value of allogeneic hematopoietic stem-cell transplantation in acute myeloid leukemia with monosomal karyotype versus other cytogenetic risk categories. J Clin Oncol 30:2140–2146
36. Burnett AK, Goldstone A, Hills RK, Milligan D, Prentice A, Yin J et al (2013) Curability of patients with acute myeloid leukemia who did not undergo transplantation in first remission. J Clin Oncol 31(10):1293–301
37. Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE et al (2006) Age and acute myeloid leukemia. Blood 107:3481–3485
38. Walter RB, Laszlo GS, Lionberger JM, Pollard JA, Harrington KH, Gudgeon CJ et al (2014) Heterogeneity of clonal expansion and maturation-linked mutation acquisition in hematopoietic progenitors in human acute myeloid leukemia. Leukemia. doi:10.1038/leu.2014.107