Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale

Blood Cancer Journal

Volumn 1, Issue 3, 2011, Pages

  Brown, J T ^a   Laosinchai Wolf, W ^a   Hedges, J B ^a   Watt, C D ^b   Van Deerlin, V M ^b   Fletcher, L ^c   Branford, S ^c   Labourier, E ^a  

^a ASURAGEN INC   (United States)

^b HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF ADELAIDE   (Australia)

Author keywords

BCR ABL1; E1a2; International scale; Monitoring; Tyrosine kinase inhibitor

Indexed keywords

BCR ABL PROTEIN; RNA;

ARTICLE; HUMAN; HUMAN CELL; HUMAN TISSUE; LEUKEMIA; LIMIT OF QUANTITATION; MULTIPLEX ASSAY SYSTEM; PROTEIN ANALYSIS; PROTEIN DETERMINATION; REAL TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION;

EID: 84864050814     PISSN: None     EISSN: 20445385     Source Type: Journal    
DOI: 10.1038/bcj.2011.10     Document Type: Article

References (42)

1. Birg F, Courcoul M, Rosnet O, Bardin F, Pebusque MJ, Marchetto S et al. Expression of the FMS/KIT-like gene FLT3 in human acute leukemias of the myeloid and lymphoid lineages. Blood 1992; 80: 2584-2593.
2. Carow CE, Levenstein M, Kaufmann SH, Chen J, Amin S, Rockwell P et al. Expression of the hematopoietic growth factor receptor FLT3 (STK-1/Flk2) in human leukemias. Blood 1996; 87: 1089-1096. (Pubitemid 26043536)
3. Small D. FLT3 mutations: biology and treatment. Hematol Am Soc Hematol Educ Program 2006; 1: 178-184.
4. Schnittger S, Schoch C, Dugas M, Kern W, Staib P, Wuchter C et al. Analysis of FLT3 length mutations in 1003 patients with acute myeloid leukemia: correlation to cytogenetics, FAB subtype, and prognosis in the AMLCG study and usefulness as a marker for the detection of minimal residual disease. Blood 2002; 100: 59-66. (Pubitemid 35177429)
5. Seedhouse CH, Pallis M, Grundy M, Shang S, Russell NH. FLT3-ITD expression levels and their effect on STAT5 in AML with and without NPM mutations. Br J Haematol 2009; 147: 653-661.
6. Yokota S, Kiyoi H, Nakao M, Iwai T, Misawa S, Okuda T et al. Internal tandem duplication of the FLT3 gene is preferentially seen in acute myeloid leukemia and myelodysplastic syndrome among various hematological malignancies. A study on a large series of patients and cell lines. Leukemia 1997; 11: 1605-1609. (Pubitemid 27458595)
7. Yamamoto Y, Kiyoi H, Nakano Y, Suzuki R, Kodera Y, Miyawaki S et al. Activating mutation of D835 within the activation loop of FLT3 in human hematologic malignancies. Blood 2001; 97: 2434-2439. (Pubitemid 32291491)
8. Tong FK, Chow S, Hedley D. Pharmacodynamic monitoring of BAY 43-9006 (Sorafenib) in phase I clinical trials involving solid tumor and AML/MDS patients, using flow cytometry to monitor activation of the ERK pathway in peripheral blood cells. Cytometry B 2006; 70: 107-114.
9. Stopeck A, Sheldon M, Vahedian M, Cropp G, Gosalia R, Hannah A. Results of a phase I dose-escalating study of the antiangiogenic agent, SU5416, in patients with advanced malignancies. Clin Cancer Res 2002; 8: 2798-2805. (Pubitemid 35025722)
10. Fiedler W, Serve H, Dohner H, Schwittay M, Ottmann OG, O'Farrell AM et al. A phase 1 study of SU11248 in the treatment of patients with refractory or resistant acute myeloid leukemia (AML) or not amenable to conventional therapy for the disease. Blood 2005; 105: 986-993. (Pubitemid 40170865)
11. O'Farrell AM, Foran JM, Fiedler W, Serve H, Paquette RL, Cooper MA et al. An innovative phase I clinical study demonstrates inhibition of FLT3 phosphorylation by SU11248 in acute myeloid leukemia patients. Clin Cancer Res 2003; 9: 5465-5476. (Pubitemid 37499464)
12. Giles FJ, Stopeck AT, Silverman LR, Lancet JE, Cooper MA, Hannah AL et al. SU5416, a small molecule tyrosine kinase receptor inhibitor, has biologic activity in patients with refractory acute myeloid leukemia or myelodysplastic syndromes. Blood 2003; 102: 795-801. (Pubitemid 36917765)
13. Smith BD, Levis M, Beran M, Giles F, Kantarjian H, Berg K et al. Single-agent CEP-701, a novel FLT3 inhibitor, shows biologic and clinical activity in patients with relapsed or refractory acute myeloid leukemia. Blood 2004; 103: 3669-3676. (Pubitemid 38596280)
14. Knapper S, Burnett AK, Littlewood T, Kell WJ, Agrawal S, Chopra R et al. A phase 2 trial of the FLT3 inhibitor lestaurtinib (CEP701) as first-line treatment for older patients with acute myeloid leukemia not considered fit for intensive chemotherapy. Blood 2006; 108: 3262-3270.
15. Stone RM, DeAngelo DJ, Klimek V, Galinsky I, Estey E, Nimer SD et al. Patients with acute myeloid leukemia and an activating mutation in FLT3 respond to a small-molecule FLT3 tyrosine kinase inhibitor, PKC412. Blood 2005; 105: 54-60. (Pubitemid 40053063)
16. DeAngelo DJ, Stone RM, Heaney ML, Nimer SD, Paquette RL, Klisovic RB et al. Phase 1 clinical results with tandutinib (MLN518), a novel FLT3 antagonist, in patients with acute myelogenous leukemia or high-risk myelodysplastic syndrome: safety, pharmacokinetics, and pharmacodynamics. Blood 2006; 108: 3674-3681. (Pubitemid 44864544)
17. Levis M, Pham R, Smith BD, Small D. In vitro studies of a FLT3 inhibitor combined with chemotherapy: sequence of administration is important to achieve synergistic cytotoxic effects. Blood 2004; 104: 1145-1150. (Pubitemid 39038036)
18. Porter DL, Collins Jr RH, Hardy C, Kernan NA, Drobyski WR, Giralt S et al. Treatment of relapsed leukemia after unrelated donor marrow transplantation with unrelated donor leukocyte infusions. Blood 2000; 95: 1214-1221. (Pubitemid 30099829)
19. Graf C, Heidel F, Tenzer S, Radsak MP, Solem FK, Britten CM et al. A neoepitope generated by an FLT3 internal tandem duplication (FLT3-ITD) is recognized by leukemia-reactive autologous CD8+ T cells. Blood 2007; 109: 2985-2988. (Pubitemid 46482098)
20. Scheich F, Duyster J, Peschel C, Bernhard H. The immunogenicity of Bcr-Abl expressing dendritic cells is dependent on the Bcr-Abl kinase activity and dominated by Bcr-Abl regulated antigens. Blood 2007; 110: 2556-2560. (Pubitemid 47523178)
21. Scheibenbogen C, Letsch A, Thiel E, Schmittel A, Mailaender V, Baerwolf S et al. CD8 T-cell responses to Wilms tumor gene product WT1 and proteinase 3 in patients with acute myeloid leukemia. Blood 2002; 100: 2132-2137. (Pubitemid 35001248)
22. Neudorfer J, Schmidt B, Huster KM, Anderl F, Schiemann M, Holzapfel G et al. Reversible HLA multimers (Streptamers) for the isolation of human cytotoxic T lymphocytes functionally active against tumor-and virus-derived antigens. J Immunol Methods 2007; 320: 119-131. (Pubitemid 46349106)
23. Meyer zum Buschenfelde C, Nicklisch N, Rose-John S, Peschel C, Bernhard H. Generation of tumor-reactive CTL against the tumorassociated antigen HER2 using retrovirally transduced dendritic cells derived from CD34+ hemopoietic progenitor cells. J Immunol 2000; 165: 4133-4140. (Pubitemid 32057326)
24. Dengler R, Munstermann U, al-Batran S, Hausner I, Faderl S, Nerl C et al. Immunocytochemical and flow cytometric detection of proteinase 3 (myeloblastin) in normal and leukaemic myeloid cells. Br J Haematol 1995; 89: 250-257.
25. Miwa H, Beran M, Saunders GF. Expression of the Wilms' tumor gene (WT1) in human leukemias. Leukemia 1992; 6: 405-409.
26. Miyagi T, Ahuja H, Kubota T, Kubonishi I, Koeffler HP, Miyoshi I. Expression of the candidate Wilm's tumor gene, WT1, in human leukemia cells. Leukemia 1993; 7: 970-977. (Pubitemid 23230975)
27. Rosenfeld C, Cheever MA, Gaiger A. WT1 in acute leukemia, chronic myelogenous leukemia and myelodysplastic syndrome: therapeutic potential of WT1 targeted therapies. Leukemia 2003; 17: 1301-1312. (Pubitemid 36857337)
28. Carter BZ, Milella M, Altieri DC, Andreeff M. Cytokine-regulated expression of survivin in myeloid leukemia. Blood 2001; 97: 2784-2790.
29. Greiner J, Schmitt M, Li L, Giannopoulos K, Bosch K, Schmitt A et al. Expression of tumor-associated antigens in acute myeloid leukemia: Implications for specific immunotherapeutic approaches. Blood 2006; 108: 4109-4117. (Pubitemid 44913282)
30. Yee KW, O'Farrell AM, Smolich BD, Cherrington JM, McMahon G, Wait CL et al. SU5416 and SU5614 inhibit kinase activity of wild-type and mutant FLT3 receptor tyrosine kinase. Blood 2002; 100: 2941-2949.
31. Fukuda S, Singh P, Moh A, Abe M, Conway EM, Boswell HS et al. Survivin mediates aberrant hematopoietic progenitor cell proliferation and acute leukemia in mice induced by internal tandem duplication of Flt3. Blood 2009; 114: 394-403.
32. Pollard JA, Alonzo TA, Gerbing RB, Woods WG, Lange BJ, Sweetser DA et al. FLT3 internal tandem duplication in CD34+/ CD33-precursors predicts poor outcome in acute myeloid leukemia. Blood 2006; 108: 2764-2769.
33. Conrad H, Gebhard K, Kronig H, Neudorfer J, Busch DH, Peschel C et al. CTLs directed against HER2 specifically crossreact with HER3 and HER4. J Immunol 2008; 180: 8135-8145.
34. Kronig H, Hofer K, Conrad H, Guilaume P, Muller J, Schiemann M et al. Allorestricted T lymphocytes with a high avidity T-cell receptor towards NY-ESO-1 have potent anti-tumor activity. Int J Cancer 2009; 125: 649-655.
35. Greiner J, Ringhoffer M, Taniguchi M, Li L, Schmitt A, Shiku H et al. mRNA expression of leukemia-associated antigens in patients with acute myeloid leukemia for the development of specific immunotherapies. Int J Cancer 2004; 108: 704-711. (Pubitemid 38076402)
36. Oka Y, Tsuboi A, Taguchi T, Osaki T, Kyo T, Nakajima H et al. Induction of WT1 (Wilms' tumor gene)-specific cytotoxic T lymphocytes by WT1 peptide vaccine and the resultant cancer regression. Proc Natl Acad Sci USA 2004; 101: 13885-13890. (Pubitemid 39298502)
37. Heslop HE, Stevenson FK, Molldrem JJ. Immunotherapy of hematologic malignancy. Hematol Am Soc Hematol Educ Program 2003; 1: 331-349.
38. Rezvani K, Yong AS, Mielke S, Savani BN, Musse L, Superata J et al. Leukemia-associated antigen-specific T-cell responses following combined PR1 and WT1 peptide vaccination in patients with myeloid malignancies. Blood 2008; 111: 236-242.
39. Schmitt M, Schmitt A, Rojewski MT, Chen J, Giannopoulos K, Fei F et al. RHAMM-R3 peptide vaccination in patients with acute myeloid leukemia, myelodysplastic syndrome, and multiple myeloma elicits immunologic and clinical responses. Blood 2008; 111: 1357-1365. (Pubitemid 351213422)
40. Greiner J, Dohner H, Schmitt M. Cancer vaccines for patients with acute myeloid leukemiaFdefinition of leukemia-associated antigens and current clinical protocols targeting these antigens. Haematologica 2006; 91: 1653-1661. (Pubitemid 46039635)
41. Choudhury BA, Liang JC, Thomas EK, Flores-Romo L, Xie QS, Agusala K et al. Dendritic cells derived in vitro from acute myelogenous leukemia cells stimulate autologous, antileukemic T-cell responses. Blood 1999; 93: 780-786. (Pubitemid 29067842)
42. Kremser A, Dressig J, Grabrucker C, Liepert A, Kroell T, Scholl N et al. Dendritic cells (DCs) can be successfully generated from leukemic blasts in individual patients with AML or MDS: an evaluation of different methods. J Immunother 2010; 33: 185-199.