Sequential phase II Southwest Oncology Group studies (S0112 and S0301) of daunorubicin and cytarabine by continuous infusion, without and with ciclosporin, in older patients with previously untreated acute myeloid leukaemia

British Journal of Haematology

Volumn 148, Issue 1, 2010, Pages 48-58

  Chauncey, Thomas R ^a,b,c   Gundacker, Holly ^d   Shadman, Mazyar ^d   List, Alan F ^e   Dakhil, Shaker R ^f   Erba, Harry P ^g   Slovak, Marilyn L ^h   Chen, I Ming ⁱ   Willman, Cheryl L ⁱ   Kopecky, Kenneth J ^d   Appelbaum, Frederick R ^a,c  

^a UNIVERSITY OF WASHINGTON   (United States)

^b VA PUGET SOUND HEALTH CARE SYSTEM   (United States)

^c Fred Hutchinson Cancer Research Center   (United States)

^d SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER   (United States)

^e H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^f WICHITA COMMUNITY CLINICAL ONCOLOGY PROGRAM   (United States)

^g UNIVERSITY OF MICHIGAN   (United States)

^h CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF NEW MEXICO   (United States)

Author keywords

Acute myeloid leukaemia; Chemoresistance; Ciclosporin; Multi drug resistance; P glycoprotein

Indexed keywords

ACICLOVIR; CIPROFLOXACIN; CYCLOSPORIN; CYTARABINE; DAUNORUBICIN; FLUCONAZOLE; GRANULOCYTE COLONY STIMULATING FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; ANXIETY DISORDER; ARTICLE; BILIRUBIN BLOOD LEVEL; BLEEDING; BLOOD TOXICITY; BRAIN HEMORRHAGE; CLINICAL TRIAL; CONFUSION; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; HUMAN; INFECTION; LIVER TOXICITY; LUNG INFECTION; MAJOR CLINICAL STUDY; MALE; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SEQUENTIAL ANALYSIS; SIDE EFFECT; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOSPORINE; CYTARABINE; DAUNORUBICIN; DRUG RESISTANCE, MULTIPLE; DRUG RESISTANCE, NEOPLASM; EPIDEMIOLOGIC METHODS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; NEOPLASM PROTEINS; P-GLYCOPROTEIN; TREATMENT OUTCOME;

EID: 72549101193     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2009.07919.x     Document Type: Article

References (40)

1. Advani, R., Visani, G., Milligan, D., Saba, H., Tallman, M., Rowe, J.M., Wiernik, P.H., Ramek, J., Dugan, K., Lum, B., Villena, J., Davis, E., Paietta, E., Litchman, M., Covelli, A., Sikic, B. Greenberg, P. (1999) Treatment of poor prognosis AML patients using PSC833 (valspodar) plus mitoxantrone, etoposide, and cytarabine (PSC-MEC). Advances in Experimental Medicine and Biology, 457, 47 56.
2. Anderson, J.E., Kopecky, K.J., Willman, C.L., Head, D., O' Donnell, M.R., Luthardt, F.W., Norwood, T.H., Chen, I.M., Balcerzak, S.P., Johnson, D.B. Appelbaum, F.R. (2002) Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study. Blood, 100, 3869 3876.
3. Appelbaum, F.R., Gundacker, H., Head, D.R., Slovak, M.L., Willman, C.L., Godwin, J.E., Anderson, J.E. Petersdorf, S.H. (2006) Age and acute myeloid leukemia. Blood, 107, 3481 3485.
4. Baer, M.R., George, S.L., Dodge, R.K., O' Loughlin, K.L., Minderman, H., Caligiuri, M.A., Anastasi, J., Powell, B.L., Kolitz, J.E., Schiffer, C.A., Bloomfield, C.D. Larson, R.A. (2002) Phase 3 study of the multidrug resistance modulator PSC-833 in previously untreated patients 60 years of age and older with acute myeloid leukemia: Cancer and Leukemia Group B Study 9720. Blood, 100, 1224 1232.
5. Becton, D., Dahl, G.V., Ravindranath, Y., Chang, M.N., Behm, F.G., Raimondi, S.C., Head, D.R., Stine, K.C., Lacayo, N.J., Sikic, B.I., Arceci, R.J. Weinstein, H. Pediatric Oncology Group 2006) Randomized use of cyclosporin A (CsA) to modulate P-glycoprotein in children with AML in remission: Pediatric Oncology Group Study 9421. Blood, 107, 1315 1324.
6. Burnett, A.K., Milligan, D., Goldstone, A., Prentice, A., McMullin, M.F., Dennis, M., Sellwood, E., Pallis, M., Russell, N., Hills, R.K. Wheatley, K. United Kingdom National Cancer Research Institute Haematological Oncology Study Group 2009) The impact of dose escalation and resistance modulation in older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome: the results of the LRF AML14 trial. British Journal of Haematology, 145, 318 332.
7. Chauncey, T.R., Rankin, C., Anderson, J.E., Chen, I., Kopecky, K.J., Godwin, J.E., Kalaycio, M.E., Moore, D.F., Shurafa, M.S., Petersdorf, S.H., Kraut, E.H., Leith, C.P., Head, D.R., Luthardt, F.W., Willman, C.L. Appelbaum, F.R. (2000) A phase I study of induction chemotherapy for older patients with newly diagnosed acute myeloid leukemia (AML) using mitoxantrone, etoposide, and the MDR modulator PSC 833: a Southwest Oncology Group study 9617. Leukemia Research, 24, 567 574.
8. Cheson, B.D., Cassileth, P.A., Head, D.R., Schiffer, C.A., Bennett, J.M., Bloomfield, C.D., Brunning, R., Gale, R.P., Grever, M.R., Keating, M.J., Sawitsky, A., Stass, S., Weinstein, H. Woods, W.G. (1990) Report of the national cancer institute-sponsored workshop on definitions of diagnosis and response in acute myeloid leukemia. Journal of Clinical Oncology, 8, 813 819.
9. Cheson, B.D., Bennett, J.M., Kopecky KJ, Büchner.T., Willman, C.L., Estey, E.H., Schiffer, C.A., Doehner, H., Tallman, M.S., Lister, T.A., Lo-Coco, F., Willemze, R., Biondi, A., Hiddemann, W., Larson RA, Löwenberg.B., Sanz, M.A., Head, D.R., Ohno, R. Bloomfield, C.D. International Working Group for Diagnosis, Standardization of Response criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia 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. Journal of Clinical Oncology, 21, 4642 4649.
10. Cripe, L.D., Li, X., Litzow, M., Paietta, E., Rowe, J.M., Luger, S. Tallman, M. (2006) A randomized placebo-controlled, double blind trial of the MDR modulator, zosuquidar, during conventional induction and post-remission therapy for pts >60 years of age with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): ECOG 3999. Blood, (ASH Annual Meeting Abstracts), 108, 423a.
11. Farag, S.S., Archer, K.J., Mrózek, K., Ruppert, A.S., Carroll, A.J., Vardiman, J.W., Pettenati, M.J., Baer, M.R., Qumsiyeh, M.B., Koduru, P.R., Ning, Y., Mayer, R.J., Stone, R.M., Larson, R.A. Bloomfield, C.D. (2006) Pretreatment cytogenetics add to other prognostic factors predicting complete remission and long-term outcome in patients 60 years of age or older with acute myeloid leukemia: results from Cancer and Leukemia Group B 8461. Cancer and Leukemia Group B 8461. Blood, 108, 63 73.
12. Godwin, J.E., Kopecky, K.J., Head, D.R., Willman, C.L., Leith, C.P., Hynes, H.E., Balcerzak, S.P. Appelbaum, F.R. (1998) A double blind placebo controlled trial of G-CSF in elderly patients with previously untreated acute myeloid leukemia. A Southwest Oncology Group study (9031). Blood, 91, 3607 3615.
13. Goldstone, A.H., Burnett, A.K., Wheatley, K., Smith, A.G., Hutchinson, R.M. Clark, R.E. Medical Research Council Adult Leukemia Working Party 2001) Attempts to improve treatment outcomes in acute myeloid leukemia (AML) in older patients: the results of the United Kingdom Medical Research Council AML11 trial. Blood, 98, 1302 1311.
14. Greenberg, P.L., Lee, S.J., Advani, R., Tallman, M.S., Sikic, B.I., Letendre, L., Dugan, K., Lum, B., Chin, D.L., Dewald, G., Paietta, E., Bennett, J.M. Rowe, J.M. (2004) Mitoxantrone, etoposide, and cytarabine with or without valspodar in patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome: a phase III trial (E2995). Journal of Clinical Oncology, 22, 1078 1086.
15. van den Heuvel- Eibrink, M.M., Wiemer, E.A., de Boevere, M.J., van der Holt, B., Vossebeld, P.J., Pieters, R. Sonneveld, P. (2001) MDR1 gene-related clonal selection and P-glycoprotein function and expression in relapsed or refractory acute myeloid leukemia. Blood, 97, 3605 3611.
16. van den Heuvel- Eibrink, M.M., Wiemer, E.A., Prins, A., Meijerink, J.P., Vossebeld, P.J., van der Holt, B., Pieters, R. Sonneveld, P. (2002) Increased expression of the breast cancer resistance protein (BCRP) in relapsed or refractory acute myeloid leukemia (AML). Leukemia, 16, 833 839.
17. van den Heuvel- Eibrink, M.M., van der Holt, B., Burnett, A.K., Knauf, W.U., Fey, M.F., Verhoef, G.E., Vellenga, E., Ossenkoppele GJ, Löwenberg.B. Sonneveld, P. (2007) CD34-related coexpression of MDR1 and BCRP indicates a clinically resistant phenotype in patients with acute myeloid leukemia (AML) of older age. Annals of Hematology, 86, 329 337.
18. van der Holt, B., Löwenberg, B., Burnett, A.K., Knauf, W.U., Shepherd, J., Piccaluga, P.P., Ossenkoppele, G.J., Verhoef, G.E., Ferrant, A., Crump, M., Selleslag, D., Theobald, M., Fey, M.F., Vellenga, E., Dugan, M. Sonneveld, P. (2005) The value of the MDR1 reversal agent PSC-833 in addition to daunorubicin and cytarabine in the treatment of elderly patients with previously untreated acute myeloid leukemia (AML), in relation to MDR1 status at diagnosis. Blood, 106, 2646 2654.
19. van der Holt, B., Breems, D.A., Berna Beverloo, H., van den Berg, E., Burnett, A.K., Sonneveld, P. Löwenberg, B. (2007) Various distinctive cytogenetic abnormalities in patients with acute myeloid leukaemia aged 60 years and older express adverse prognostic value: results from a prospective clinical trial. British Journal of Haematology, 136, 96 105.
20. Kaplan, E.L. Meier, P. (1958) Nonparametric estimation from incomplete observations. Journal of the American Statistical Assocication, 53, 457 481.
21. Kolitz, J.E., George, S.L., Dodge, R.K., Hurd, D.D., Powell, B.L., Allen, S.L., Velez-Garcia, E., Moore, J.O., Shea, T.C., Hoke, E., Caligiuri, M.A., Vardiman, J.W., Bloomfield, C.D. Larson, R.A. Cancer and Leukemia Group B 2004) Dose escalation studies of cytarabine, daunorubicin, and etoposide with and without multidrug resistance modulation with PSC-833 in untreated adults with acute myeloid leukemia younger than 60 years: final induction results of Cancer and Leukemia Group B Study 9621. Journal of Clinical Oncology, 22, 4290 4301.
22. Kolitz, J.E., George, S.L., Marcucci, G., Vij, Ravi., Bayard Powell BL, L., Allen, S.L., De Angelo, D.J., Shea, T., Stock, W., Hars, V., Hoke, E., Vardiman, J.W., Bloomfield, C.D. Larson, R.A. (2005) A randomized comparison of induction therapy for untreated acute myeloid leukemia (AML) in patients <60 years using P-glycoprotein (Pgp) modulation with valspodar (PSC833): preliminary results of cancer and leukemia group B study 19808 ASH #157.
23. Lancet, J.E., Baer, M.R., Duran, G.E., List, A.F., Fielding, R., Marcelletti, J.F., Multani, P.S. Sikic, B.I. (2009) A phase I trial of continuous infusion of the multidrug resistance inhibitor zosuquidar with daunorubicin and cytarabine in acute myeloid leukemia. Leukemia Research, 33, 1055 1061.
24. Lee, E.J., George, S.L., Caligiuri, M., Szatrowski, T.P., Powell, B.L., Lemke, S., Dodge, R.K., Smith, R., Baer, M. Schiffer, C.A. (1999) Parallel phase I studies of daunorubicin given with cytarabine and etoposide with or without the multidrug resistance modulator PSC-833 in previously untreated patients 60 years of age or older with acute myeloid leukemia: Results of Cancer and leukemia group B study 9420. Journal of Clinical Oncology, 17, 2831 2839.
25. Leith, C.P., Kopecky, K.J., Godwin, J., McConnell, T., Slovak, M.L., Chen, I.M., Head, D.R., Appelbaum, F.R. Willman, C.L. (1997) Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A Southwest Oncology Group study. Blood, 89, 3323 3329.
26. Leith, C.P., Kopecky, K.J., Chen, I.M., Eijdems, L., Slovak, M.L., McConnell, T.S., Head, D.R., Weick, J., Grever, M.R., Appelbaum, F.R. Willman, C.L. (1999) Frequency and clinical significance of the expression of the multidrug resistance proteins MDR1/P-glycoprotein, MRP1, and LRP in acute myeloid leukemia: a Southwest Oncology Group Study. Blood, 94, 1086 1099.
27. List, A.F., Kopecky, K.J., Willman, C.L., Head, D.R., Persons, D.L., Slovak, M.L., Dorr, R., Karanes, C., Hynes, H.E., Doroshow, J.H., Shurafa, M. Appelbaum, F.R. (2001) Benefit of cyclosporine modulation of drug resistance in patients with poor-risk acute myeloid leukemia: a Southwest Oncology Group study. Blood, 98, 3212 3220.
28. List, A.F., Kopecky, K.J., Willman, C.L., Head, D.R., Slovak, M.L., Douer, D., Dakhil, S.R. Appelbaum, F.R. (2002) Cyclosporine inhibition of P-glycoprotein in chronic myeloid leukemia blast phase. Blood, 100, 1910 1912.
29. Liu Yin, J.A., Wheatley, K., Rees, J.K. Burnett, A.K. UK MRC Adult Leukemia Working Party 2001) Comparison of 'sequential' versus 'standard' chemotherapy as re-induction treatment, with or without cyclosporine, in refractory/relapsed acute myeloid leukaemia (AML): Results of the UK Medical Research Council AML-R trial. British Journal of Haematology, 113, 713 726.
30. Mahadevan, D. List, A.F. (2004) Targeting the multidrug resistance-1 transporter in AML: molecular regulation and therapeutic strategies. Blood, 104, 1940 1951.
31. Qadir, M., O'Loughlin, K.L., Fricke, S.M., Williamson, N.A., Greco, W.R., Minderman, H. Baer, M.R. (2005) Cyclosporin A is a broad-spectrum multidrug resistance modulator. Clinical Cancer Research, 11, 2320 2326.
32. Ross, D.D., Wooten, P.J., Sridhara, R., Ordóñez, J.V., Lee, E.J. Schiffer, C.A. (1993) Enhancement of daunorubicin accumulation, retention, and cytotoxicity by verapamil or cyclosporin A in blast cells from patients with previously untreated acute myeloid leukemia. Blood, 82, 1288 1299.
33. Ross, D.D., Wooten, P.J., Tong, Y., Cornblatt, B., Levy, C., Sridhara, R., Lee, E.J. Schiffer, C.A. (1994) Synergistic reversal of multidrug-resistance phenotype in acute myeloid leukemia cells by cyclosporin A and cremophor EL. Blood, 83, 1337 1347.
34. Schilthuizen, C., Broyl, A., van der Holt, B., de Knegt, Y., Lokhorst, H. Sonneveld, P. (2007) Influence of genetic polymorphisms in CYP3A4, CYP3A5, GSTP1, GSTM1, GSTT1 and MDR1 genes on survival and therapy-related toxicity in multiple myeloma. Haematologica, 92, 277 278.
35. Slovak, M.L., Kopecky, K.J., Cassileth, P.A., Harrington, D.H., Theil, K.S., Mohamed, A., Paietta, E., Willman, C.L., Head, D.R., Rowe, J.M., Forman, S.J. Appelbaum, F.R. (2000) Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group Study. Blood, 96, 4075 4083.
36. Solary, E., Witz, B., Caillot, D., Moreau, P., Desablens, B., Cahn, J.Y., Sadoun, A., Pignon, B., Berthou, C., Maloisel, F., Guyotat, D., Casassus, P., Ifrah, N., Lamy, Y., Audhuy, B., Colombat, P. Harousseau, J.L. (1996) Combination of quinine as a potential reversing agent with mitoxantrone and cytarabine for the treatment of acute leukemias: a randomized multicenter study. Blood, 88, 1198 1205.
37. Solary, E., Drenou, B., Campos, L., de Crémoux, P., Mugneret, F., Moreau, P., Lioure, B., Falkenrodt, A., Witz, B., Bernard, M., Hunault-Berger, M., Delain, M., Fernandes, J., Mounier, C., Guilhot, F., Garnache, F., Berthou, C., Kara-Slimane, F. Harousseau, J.L. Groupe Ouest Est Leucémies Aiguës Myéloblastiques 2003) Quinine as a multidrug resistance inhibitor: a phase 3 multicentric randomized study in adult de novo acute myelogenous leukemia. Blood, 102, 1202 1210.
38. Tallman, M.S., Lee, S., Sikic, B.I., Paietta, E., Wiernik, P.H., Bennett, J.M. Rowe, J.M. (1999) Mitoxantrone, etoposide, and cytarabine plus cyclosporine for patients with relapsed or refractory acute myeloid leukemia: An Eastern Cooperative Oncology Group pilot study. Cancer, 85, 358 367.
39. Wilson, C.S., Davidson, G.S., Martin, S.B., Andries, E., Potter, J., Harvey, R., Ar, K., Xu, Y., Kopecky, K.J., Ankerst, D.P., Gundacker, H., Slovak, M.L., Mosquera-Caro, M., Chen, I.M., Stirewalt, D.L., Murphy, M., Schultz, F.A., Kang, H., Wang, X., Radich, J.P., Appelbaum, F.R., Atlas, S.R., Godwin, J. Willman, C.L. (2006) Gene expression profiling of adult acute myeloid leukemia identifies novel biologic clusters for risk classification and outcome prediction. Blood, 108, 685 696.
40. Young, I.T. (1977) Proof without prejudice: use of the Kolmogorov-Smirnov test for the analysis of histograms from flow systems and other sources. Journal of Histochemistry and Cytochemistry, 25, 935.