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

Volumn 17, Issue 9, 1999, Pages 2831-2839

  Lee, Edward J ^a   George, Stephen L ^a   Caligiuri, Michael ^a   Szatrowski, Ted P ^a   Powell, Bayard L ^a   Lemke, Sheila ^a   Dodge, Richard K ^a   Smith, Ruth ^a   Baer, Maria ^a   Schiffer, Charles A ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTARABINE; DAUNORUBICIN; ETOPOSIDE; VALSPODAR;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ARTICLE; CANCER REGRESSION; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFECT; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MULTIDRUG RESISTANCE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0032883974     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.1999.17.9.2831     Document Type: Article

References (40)

1. Mayer RF, Davis RB, Schiffer CA, et al: Intensive postremission chemotherapy in adults with acute myeloid leukemia. N Engl J Med 331:896-903, 1994
2. Stone RM, Berg DT, George SL, et al: Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. N Engl J Med 332:1671-1677, 1995
3. Keating MJ, Smith TL, Kantarjian H, et al: Cytogenetic pattern in acute myelogenous leukemia: A major reproducible determinant of outcome. Leukemia 2:403-412, 1988
4. Samuels BL, Larson RA, Le Beau MM, et al: Specific chromosomal abnormalities in acute nonlymphocytic leukemia correlate with drug susceptibility in vivo. Leukemia 2:79-83, 1988
5. Schiffer CA, Lee EJ, Tomiyasu T, et al: Prognostic impact of cytogenetic abnormalities in patients with de novo acute non-lymphocytic leukemia. Blood 73:263-270, 1989
6. Bell DR, Trent JM, Willard HF, et al: Chromosomal location of human P-glycoprotein gene sequences. Cancer Genet Cytogenet 25:141-148, 1987
7. Bell DR, Gerlach JH, Kartner N, et al: Detection of P-glycoprotein in ovarian cancer: A molecular marker associated with multidrug resistance. J Clin Oncol 3:311-315, 1985
8. Campos L, Guyotat D, Archimbaud E, et al: Clinical significance of multidrug resistance P-glycoprotein expression on acute nonlymphocytic leukemia cells at diagnosis. Blood 79:473-476, 1992
9. Pieters R, Huismans DR, Leyva A, et al: MDR1 gene expression and treatment outcome in acute myeloid leukemia. J Natl Cancer Inst 83:708-712, 1991
10. Sato H, Preisler H, Day R, et al: MDR1 transcript levels as an indication of resistant disease in acute myplogenous leukemia. Br J Haematol 75:340-345, 1990
11. Marie JP, Zittoun R, Sikic BI: Multidrug resistance (mdr1) gene expression in adult acute leukemias: Correlations with treatment outcome and in vitro drug sensitivity. Blood 78:586-592, 1991
12. Ross DD, Wooten PJ, Sridhara R, et al: 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, 1993
13. Pirker R, Wallner J, Greissler K, et al: MDR1 gene expression and treatment outcome in acute myeloid leukemia. J Natl Cancer Inst 83:708-712, 1991
14. List AF, Spier CM, Cline A, et al: Expression of the multidrug resistance gene product (p-glycoprotein) in myelodysplasia is associated with a stem cell phenotype. Br J Haematol 78:28-34, 1991
15. Leith CP, Chen I-M, Kopecky KJ, et al: Correlation of multidrug resistance (MDR1) protein expression with functional dye/drug efflux in acute myeloid leukemia by multiparameter flow cytometry: Identification of discordant MDR-/efflux+ and MDR1+/efflux- cases. Blood 86:2329-2342, 1995
16. Leith CP, Kopecky KJ, Godwin J, et al: 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, 1997
17. Solary E, Witz B, Caillot D, et al: 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, 1996
18. Miller TP, Grogan TM, Dalton WS, et al: P-glycoprotein expression in malignant lymphoma and reversal of clinical drug resistance with chemotherapy plus high dose verapamil. J Clin Oncol 9:17-24, 1991
19. Ross DD, Wooten PJ, Tong Y, et al: Synergistic reversal of multidrug resistance phenotype in acute myeloid leukemia cells by cyclosporin A and cremophor EL. Blood 83:1337-1347, 1994
20. List AF, Spier C, Greer J, et al: Phase I/II trial of cyclosporine as a chemotherapy-resistance modifier in acute leukemia. J Clin Oncol 11:1652-1660, 1993
21. Boesch D, Gaveriaux C, Jachez B, et al: In vivo circumvention of P-glycoprotein-mediated multidrug resistance of tumor cells with SDZ PSC 833. Cancer Res 51:4226-4233, 1991
22. Pourtier-Manzanedo A, Didier AD, Muller CD, et al: SDZ PSC 833 and SDZ 280-446 are the most active of various resistance-modifying agents in restoring rhodamine-123 retention within multidrug resistant P388 cells. Anticancer Drugs 3:419-425, 1992
23. Watanabe T, Tsuge H, Oh-Hara T, et al: Comparative study on reversal efficacy of SDZ PSC 833, cyclosporin A and verapamil on multidrug resistance in vitro and in vivo. Acta Oncol 34:235-241, 1995
24. Büchner Th, Urbanitz D, Hiddemann W, et al: Intensified induction and consolidation with or without maintenance chemotherapy for acute myeloid leukemia (AML): Two multicenter studies of the German AML cooperative group. J Clin Oncol 3:1583-1589, 1985
25. Bishop JF, Lowenthal RM, Joshua DE, et al: A randomized trial of cytosine arabinoside, daunorubicin + VP 16-213 (73 VS 737) as initial induction in adults with acute non-lymphocytic leukemia. Blood 75:27-32, 1990
26. Carter SK, Selawry O, Slavik M: Phase I clinical trials. Natl Cancer Inst Monogr 45:75-80, 1977
27. Hosmer DW, Lemeshow S: Applied Logistic Regression. New York, NY, John Wiley and Sons, 1989
28. Boote DJ, Dennis IF, Twentyman PR, et al: Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer. J Clin Oncol 14:610-618, 1996
29. Bernstein ZP, Porter MM, Could M, et al: Prolonged administration of low-dose interleukin-2 in human immunodeficiency virus-associated malignancy results in selective expansion of innate immune effectors without significant clinical toxicity. Blood 86:3287-3294, 1995
30. Weiss RB, Vogelzang NJ, Peterson BA, et al: A successful system of scientific data audits for clinical trials: A report from the Cancer and Leukemia Group B. JAMA 270:459-464, 1993
31. Cheson BD, Cassileth PA, Head DR, et al: Report of the NCI-sponsored workshop on definitions of diagnosis and response in acute myeloid leukemia. J Clin Oncol 8:813-819, 1990
32. Bernstein SH, Brunetto VL, Davey FR, et al: Acute myeloid leukemia type chemotherapy for newly diagnosed patients without antecedent cytopenias having myelodysplastic syndrome as defined by French-American-British criteria: A Cancer and Leukemia Group B study. J Clin Oncol 14:2486-2494, 1996
33. Storer BE: Design and analysis of phase I clinical trials. Biometrics 45:925-937, 1989
34. Lum BL, Kaubisch S, Yahanda A, et al: Alternation of etoposide pharmacokinetics and pharmacodynamics by cyclosporine in a phase I trial to modulate drug resistance. J Clin Oncol 10:1635-1642, 1992
35. Sonneveld P, Lowenberg B, Vossebeld P, et al: Dose finding study of PSC833, a novel MDR reversing agent, with daunorubicin and ara-c in untreated elderly patients with acute myeloid leukemia. Blood 90:566a, 1997 (suppl)
36. Visani G, Milligan D, Leoni F, et al: A phase I dose-finding study of PSC 833, a novel MDR reversing agent, with mitoxantrone, etoposide and cytarabine in poor prognosis acute leukemia. Blood 90:566a, 1997 (suppl) (abstr)
37. Advani R, Saba HI, Tallman MS, et al: Treatment of refractory and relapsed acute myelogenous with combination chemotherapy plus the multidrug modulator PSC-833 (Valdospar). Blood 93:787-795, 1999
38. Kornblau SM, Estey E, Madden T, et al: Phase I study of mitoxantrone plus etoposide with multidrug blockade by SDZ PSC-833 in relapsed or refractory acute myelogenous leukemia. J Clin Oncol 15:1796-1802, 1997
39. Paul C, Tidefelt U, Gruber A, et al: The P-glycoprotein inhibitor PSC 833 increases the intracellular concentrations of daunorubicin in vivo in patients with PgP-positive AML. Blood 90:182a, 1997 (suppl) (abstr)
40. Beketic-Oreskovic L, Durán, Chen G, et al: Decreased mutation rate for cellular resistance to doxorubicin and suppression of mdr1 gene activation by the cyclosporin analogue PSC 833. J Natl Cancer Inst 87:1593-1602, 1995