Leukemia Research
Volume 27, Issue 1 , Pages 35-44 , January 2003

A phase I and pharmacodynamic study of sequential topotecan and etoposide in patients with relapsed or refractory acute myelogenous and lymphoblastic leukemia

Received 23 January 2002 ,Accepted 30 April 2002.

References 

  1. Rowinsky EK, Adjei A, Donehower RC, Gore SD, Jones RJ, Burke PJ, et al.  Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia. J. Clin. Oncol. 1994;2:2193–2203
  2. Kantarjian HM, Beran M, Ellis A, et al.  Phase I study of topotecan, a new topoisomerase I inhibitor in patients with refractory or relapsed acute leukemia. Blood. 1993;81:1146–1151
  3. Beran M, Kantarjian H, Keating M, et al.  Results of topotecan and high dose cytosine arabinoside (ara-C) in previously untreated patients with high-risk myelodysplastic syndrome and chronic myelomonocytic leukemia. Blood. 1997;90:2593a
  4. Crump M, Lipton J, Hedley D, Sutton D, Shepherd F, Minden M, et al.  Phase I trial of sequential topotecan followed by etoposide in adults with myeloid leukemia. A National Cancer Institute of Canada Clinical Trials Group Study. Leukemia. 1999;13:343–347
  5. Seiter K, Feldman EJ, Halick D, Traganos F, Darzynkiewicz A, Lake D, et al.  Phase I clinical and laboratory evaluation of topotecan and cytarabine in patients with acute leukemia. J. Clin. Oncol. 1997;15:44–51
  6. Hertzberg RP, Carang MJ, Hecht SM. On the mechanism of topoisomerase I inhibition by camptothecin: evidence for binding to an enzyme DNA complex. Biochemistry. 1989;28:4629–4638
  7. Bjornsti MA, Benedetti P, Viglianti GA. Expression of human DNA topoisomerase I in yeast cells lacking yeast DNA topoisomerase I: restoration of sensitivity of the cells to the anti-tumor drug camptothecin. Cancer Res. 1989;49:6318–6323
  8. Madden KR, Champoux JJ. Overexpression of human topoisomerase I in baby hamster kidney cells: hypersensitivity of clonal isolates to camptothecin. Cancer Res. 1992;52:525–532
  9. Kano Y, Suzuki K, Akutsu M, Suda K, Inoue Y, Yoshida M, et al.  Effects of CPT-11 in combination with other anti-cancer agents in culture. Int. J. Cancer. 1992;50:604–610
  10. Bertrand R, O’Connor PM, Kerrigan D, Pommier Y. Sequential administration of camptothecin and etoposide circumvents the antagonistic cytotoxicity of simultaneous drug administration in slowly growing human colon carcinoma HT-29 cells. Eur. J. Cancer. 1992;28A:743–748
  11. Kim R, Hirabayashi N, Nishiyama M, Jinushi K, Toge T, Okada K. Experimental studies on biochemical modulation targeting topoisomerase I and II in human tumor xenografts in nude mice. Int. J. Cancer. 1992;50:760–766
  12. Eder JP, Chan V, Wong J, Wong YW, Ara G, Northey D, et al.  Sequence effect of irinotecan (CPT-11) and topoisomerase II inhibitors in vivo. Cancer Chemother. Pharmacol. 1998;42:327–335
  13. Whitacre CM, Zborowska E, Gordon NH, Mackay W, Berger NA. Topotecan increases topoisomerase IIα levels and sensitivity to treatment with etoposide in schedule dependent process. Cancer Res. 1997;57:1425–1428
  14. Bishop JF. Etoposide in the treatment of leukemia. Semin. Oncol. 1992;19(Suppl 13):33–38
  15. Hammond LA, Eckardt JR, Gamapaathi R, Burris HA, Rodriguez GA, Eckhardt SG, et al.  A phase I and translational study of sequential administration of the topoisomerase I and II inhibitors topotecan and etoposide. Clin. Cancer Res. 1998;4:1459–1467
  16. Ando N, Eguch K, Shinkai I, Tamura T, Ohe Y, Yamamoto N, et al.  Phase I study of sequentially administered topoisomerase I inhibitor (irinotecan) and topoisomerase II inhibitor (etoposide) for metastatic non-small-cell lung cancer. Br. J. Cancer. 1997;76:1494–1499
  17. Herben VMM, Bokkel Huinink WW, Dubbelman AC, Mandjes IAM, Groot Y, Gortel-van Zomeran DM, et al.  Phase I and pharmacological study of sequential intravenous topotecan and oral etoposide. Br. J. Cancer. 1997;76:1500–1508
  18. Eckhardt JR, Burris HA, Rodriguez GA, Fields SM, Rothenberg ML, Moore TD, et al.  A phase I study of the topoisomerase I and II inhibitors topotecan and etoposide. Proc. ASCO. 1993;12:349a
  19. Boyum A. Separation of leukocytes from blood and bone marrow. Scand. J. Clin. Lab. Invest. 1968;21:97
  20. Willson J, Gerson S, Haaga J, Berger S, Berger N. Biochemical modulation of drug resistance in colon cancers. Proc. AACR. 1992;33:236
  21. Duget M, Lavenot C, Harper F, et al.  DNA topoisomerases from rat liver: physiologic variation. Nucleic Acid Res. 1983;11:1059–1075
  22. Champoux JJ, McConaughy B. Purification and characterization of the DNA untwisting enzyme for rat liver. Biochemistry. 1976;15:4638–4642
  23. Sabiers JH, Berger NA, Berger SJ, Haaga JR, Hoppel CL, Willson JKV. Phase I trial of topotecan administered as a 72 h infusion. Proc. AACR. 1993;34:426
  24. Rose PG, Gordon NH, Fusco N, Fluellen L, Rodriguea M, Ingalls ST, et al.  A phase II and pharmacokinetic study of weekly 72 h topotecan infusion in patients with platinum-resistant ovarian carcinoma. Gynecol. Oncol. 2000;78:228–234
  25. Stewart CF, Baker SD, Heideman RL, Jones D, Crom WR, Pratt CB. Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity. J. Clin. Oncol. 1994;12:1946–1954
  26. Beijnen JH, Smith BR, Keijer WJ, van Gijn R, Ven Bokkel Huinink WW, Vlasveld LT, et al.  High performance liquid chromatographic analysis of the new anti-tumor drug SK&F 104864-A (NSC 609699) in plasma. J. Pharm. Biomed. Anal. 1990;8:789–794
  27. Vey N, Kantarjian H, Beran M, O’Brien S, Cortes J, Giles FJ, et al.  Combination of topotecan with cytarabine or etoposide in patients with refractory or relapsed acute myeloid leukemia: results of a randomized phase I/II study. Blood. 1998;92:235a; [abstract 963]
  28. Rowe JM, Andersen J, Mazza JJ, Paietta E, Bennett JM, Hayes A, et al.  Phase III randomized placebo-controlled study on granulocyte-macrophase colony stimulating factor (GM-CSF) in adult patients (55–70 years) with acute myelogenous leukemia. (AML): a study of the Eastern Co-operative Oncology Group (ECOG). Blood. 1995;86:4570462
  29. Ohno R, Tonoga M, Kobayashi T, Kanamaru A, Shirakaw S, Masaoka T, et al.  Effect of granulocyte colony stimulating factor after intensive induction therapy in relapsed or refractory acute leukemia. New Engl. J. Med. 1990;323:871
  30. Wall JG, Burris HA, Von Hoff DD, Rodriguez G, Kneuper-Hall R, Shaffer D, et al.  A phase I clinical and pharmacokinetic study of the topoisomerase inhibitor topotecan (SK&F 104864) given as an intravenous bolus every 21 days. Anticancer Drugs. 1992;4:337–345
  31. O’Dwyer PJ, LaCreta FP, Haas NB, Halbherr T, Frucht H, Goosenberg E, Yao KS. Clinical, pharmacokinetic and biological studies of topotecan. Cancer Chemother Pharmacol 1994;34:S46–52.
  32. Haas NB, LaCreta FP, Walczak J, Hudes GR, Brennan JM, Ozols RF, et al.  Phase I/pharmacokinetic study of topotecan by 24-hour continuous infusion weekly. Cancer Res. 1994;54:1220–1226
  33. Montazeri A, Boucard M, Lokiec F, Pinguet F, Culine S, Deport-Fety R, et al.  Population pharmacokinetics of topotecan: intra-individual variability in total drug. Cancer Chemother. Pharmacol. 2000;46:375–381
  34. Van Warmerdam LJC, Creemers G-J, Rodenhuis S, Roding H, deBoer-Dennert M, Schellens JHM, et al.  Pharmacokinetics and pharmacodynamics of topotecan given on a daily times five schedule I phase II clinical trials using a limited sampling procedure. Cancer Chemother. Pharmacol. 1996;38:254–260
  35. Furman WL, Baker SD, Pratt CB, Rivera GK, Evans WE, Stewart CF. Escalating systemic exposure of continuous infusion topotecan in children with recurrent acute leukemia. J. Clin. Oncol. 1996;14:1504–1511
  36. Gallo JM, Laub PB, Rowinsky EK, Grochow LB, Baker SD. Population pharmacokinetic model for topotecan derived from phase I clinical trials. J. Clin. Oncol. 2000;18:2459–2467
  37. Perego P, Capranico G, Supino R, et al.  Topoisomerase I gene expression and cell sensitivity to camptothecin in human cell lines of different tumor types. Anticancer Drugs. 1994;5:645–649
  38. Dubrez L, Goldwasser F, Genne O, Pommier SE. The role of cell cycle regulation and apoptosis triggering in determining the sensitivity of leukemic cells to topoisomerase I and II inhibitors. Leukemia. 1995;9:1013–1024
  39. Slichenmyer WJ, Rowinsky EK, Donehower RC, Kaufman SH. The current status of camptothecin analogues as antitumor agents. J. Natl. Cancer Inst. 1993;85:271–291
  40. Potmesil M. Camptothecins: from bench research to hospital wards. Cancer Res. 1994;54:1431
  41. Pommier Y, Leteurtre F, Fesen MR, et al.  Cellular determinants of sensitivity and resistance to DNA topoisomerase inhibitors. Cancer Invest. 1994;12:530
  42. Kapoor R, Slade DL, Fujimori A, et al.  Altered topoisomerase I expression in two subclones of human CEM leukemia selected for resistance to camptothecin. Oncol. Res. 1995;7:83–95
  43. Fujimori A, Harker WF, Kohlhagen G, et al.  Mutation at the catalytic site of topoisomerase I in CEM/C2 a human leukemia cell line resistant to camptothecin. Cancer Res. 1995;55:1339–1346
  44. Kaufman SH, Svingen PA, Gore SD, et al.  Altered formation of topotecan stabilized topoisomerase I- DNA adducts in human leukemia cells. Blood. 1997;89:2098–2104
  45. Wang LF, Ting CY, Lo CK, et al.  Identification of mutations at DNA topoisomerase I responsible for camptothecin resistance. Cancer Res. 1977;57:1516–1522
  46. Beadler DR, Chang JY, Zhou BS, et al.  Camptothecin resistance involving steps subsequent to the formation of protein linked DNA breaks in human camptothecin-resistant KB cell lines. Cancer Res. 1996;56:345–353
  47. Saleem A, Ibrahim N, Patel M, Li XG, Gupta E, Mendoza J, et al.  Mechanisms of resistance in a human cell line exposed to sequential topoisomerase poisoning. Cancer Res. 1997;57:5100–5106
  48. Grabowski D, Ganapathi R. Cytotoxic efficacy with combinations of topoisomerase I and topoisomerase II inhibitors in sensitive and multidrug-resistant L1210 mouse leukemia cells. Ann. NY Acad. Sci. 1996;803:306–307
  49. Nair JS, Kancherla R, Seiter K, Traganos F, Tse-Dinh YC. Action of topoisomerase targeting drugs on non-Hodgkin’s lymphoma and leukemia: correlation of clinical and cell culture studies. Ann. NY Acad. Sci. 2000;922:326–329
  50. Whitacre CM, Belfi CA, Berger SJ, Gosky DM, Garcia J, Bao C, Sramkoki M, Berger NA. Cell cycle dependent modulation of topo IIá levels by topotecan in vitro: potential implications on combination therapy with topo I and II inhibitors. Proc. AACR, 1999;40:109 [abstract 723].
  51. Estey E, Alakha RC, Hittelman WN, et al.  Cell cycle stage dependent variations in drug induced topoisomerase II mediated DNA cleavage and cytotoxicity. Biochemistry. 1987;26:4338–4344
  52. Del Bino G, Skierski JS, Darzynkiewicz Z. Diverse effects of camptothecin an inhibitor of topoisomerase I on the cell cycle of lymphocytic (L1210, MOLT-4) and myelogenous (HL-60, KG1) leukemic cells. Cancer Res. 1990;50:5746–5750
  53. Stahl M, Kasinir-Bauer S, Harstrick A. Down-regulation of topoisomerase II by camptothecin does not prevent additive activity of the topoisomerase II inhibitor etoposide in vitro. Anticancer Drugs. 1997;8:671–676
  54. Kaufman SH. Antagonism between camptothecin and topoisomerase II directed chemotherapeutic agents in a human leukemia cell line. Cancer Res. 1991;51:1129–1136
  55. Vey N, Keating MJ, Rios MB, Estery E. Effect of CR on survival in patients with AML receiving first salvage therapy. Blood. 1998;92:235a
  56. Gore SD, Rowinsky EK, Miller CB, Griffin C, Chen TL, Borowitz M, et al.  A phase II window study of topotecan in untreated patients with high risk adult acute lymphoblastic leukemia. Clin. Cancer Res. 1998;4:2677–2689

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Leukemia Research
Volume 27, Issue 1 , Pages 35-44 , January 2003