Safety and tolerability of phase I/II clinical trials among older and younger patients with acute myelogenous leukemia

Journal of Geriatric Oncology

Volumn 2, Issue 3, 2011, Pages 215-221

  Van Heeckeren, Willem J ^a   Fu, Pingfu ^a   Barr, Paul M ^a   Arfons, Lisa M ^a   Kirschbaum, Mark H ^b   Lazarus, Hillard M ^a   Cooper, Brenda W ^a  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

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

Author keywords

Elderly acute myelogenous leukemia; Performance status; Phase I II outcomes

Indexed keywords

CARBOPLATIN; ETOPOSIDE; FLUDARABINE; ISPINESIB; THALIDOMIDE; TOPOTECAN;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGE; AGED; ARTICLE; CANCER REGRESSION; CANCER SURVIVAL; CONTINUOUS INFUSION; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FUNCTIONAL STATUS; HUMAN; MAJOR CLINICAL STUDY; OVERALL SURVIVAL; SEX DIFFERENCE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

EID: 79958696653     PISSN: 18794068     EISSN: 18794076     Source Type: Journal    
DOI: 10.1016/j.jgo.2011.02.002     Document Type: Article

References (36)

1. Jemal A., Murray T., Ward E., Samuels A., Tiwari R.C., Ghafoor A., et al. Cancer statistics, 2005. CA Cancer J Clin 2005, 55:10-30.
2. Lancet J.E., Giralt S. Therapy for older AML patients: the role of novel agents and allogeneic stem cell transplant. J Natl Compr Cancer Netw 2008, 6:1017-1025.
3. Sekeres M.A. Non-transplant therapy for older patients with acute myeloid leukemia. J Natl Compr Cancer Netw 2006, 4:51-56.
4. Pulte D., Gondos A., Brenner H. Improvements in survival of adults diagnoses with acute myeloblastic leukemia in the early 21st center. Haematologica 2008, 93:594-600.
5. Appelbaum F.R., Gundacker H., Head D.R., Slovak M.L., Willman C.L., Godwin J.E., et al. Age and acute myeloid leukemia. Blood 2006, 107:3481-3485.
6. Bauduer F., Ducout L., Dastugue N., Capdupuy C., Renoux M. De novo and secondary acute myeloid leukemia in patients over the age of 65: a review of fifty-six successive and unselected cases from a general hospital. Leuk Lymphoma 1999, 35:289-296.
7. Buchner T., Berdel W.E., Haferlach C., Schnittger S., Muller-Tidow C., Braess J., et al. Age-related risk profile and chemotherapy dose response in acute myeloid leukemia: A study by the German Acute Myeloid Leukemia Cooperative Group. J Clin Oncol 2009, 27:61-69.
8. Frohling S., Schlenk R.F., Kayser S., Morhardt M., Benner A., Dohner K., et al. Cytogenetics and age are major determinants of outcome in intensively treated acute myeloid leukemia patients older than 60years: results for AMLSG trial AML HD98-B. Blood 2006, 108:3280-3288.
9. Leith C.P., Kopecky K.j., Godwin J., McConnell T., Slovak M.L., Chen I.M., et al. Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkable distinct responses to standard chemotherapy. A Southwest Oncology Group study. Blood 1997, 89:3323-3329.
10. Kantarjian H., O'Brien S., Cortes J., Giles F., Faderi S., Jabbour E., et al. Results of intensive chemotherapy in 998 patients aged 65years or older with acute myeloid leukemia or high-risk myelodysplastic syndrome - predictive models for outcome. Cancer 2005, 106:1090-1098.
11. Burnett A.K., Unmesh M. Treatment of older patients with acute myeloid leukemia-new agents. Semin Hematol 2006, 43:96-106.
12. Hurria A. Clinical trials in older adults with cancer: past and future. Oncology 2007, 21:351-358.
13. Wasil T., Lichtman S.M. Treatment of elderly cancer patients with chemotherapy. Cancer Investig 2005, 23:537-547.
14. Cooper B.W., Donaher E., Lazarus H.M., Green S.B., Gosky D.M., Rosenthal N.S., et al. A phase I and pharmacodynamic study of sequential topotecan and etoposide in patients with relapsed or refractory acute myelogenous and lymphoblastic leukemia. Leuk Res 2003, 27:35-44.
15. Cooper B.W., Veal G.J., Radivoyevitch T., Tilby M.J., Meyerson H.J., Lazarus H.M., et al. A phase I and pharmacodynamic study of fludarabine, carboplatin, and topotecan in patients with relapsed, refractory, or high-risk acute leukemia. Clin Cancer Res 2004, 10:6830-6839.
16. Barr P., Fu P., Lazarus H., Kane D., Meyerson H., Hartman P., et al. Antiangiogenic activity of thalidomide in combination with fludarabine, carboplatin, and topotecan for high-risk acute myelogenous leukemia. Leuk Lymphoma 2007, 48:1940-1949.
17. Arfons L.M., Kirschbaum M.H., Synold T.W., Lazarus H.M., Kindwall-Keller T.L., Laughlin M.J., et al. (SB-715992) in relapsed/refractory acute leukemia [abstract]. Blood 2008, 112. Abstract 4038.
18. Cooper B.W., Veal G.J., Radivoyevitch T., Tilby M.J., Meyerson H.J., Lazarus H.M., et al. Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia. Blood 2007, 110:3547-3551.
19. Cheson B.D., Bennett J.M., Kopecky K.J., Buchner T., Willman C.L., Estey E.H., et al. 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 2003, 21:4642-4649.
20. Kaplan E.L., Meier P. Non-parametric estimation from incomplete observations. J Am Stat Assoc 1958, 53:457-481.
21. Cox D.R. Regression models and life-tables (with discussion). J R Stat Soc B 1972, 34:187-220.
22. Brown LD, Cai TT, DasGupta A. Interval estimation for a binomial proportion: Statistical Science 2001;16:101-133.
23. Cashen A.F., Schiller G.J., O'Donnell, DiPersio J.F. Multicenter, phase II study of decitabine for the first-line treatment of older patients with acute myeloid leukemia. J Clin Oncol 2010, 28:556-561.
24. Kantarjian H.M., Erba H.P., Claxton D., Arellane M., Lyons R.M., Kovascovics T., et al. Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors. J Clin Oncol 2010, 28:549-555.
25. Schiller G., O'Brien S.M., Pigneux, DeAngelo D.J., Vey N., Kell J. Single-agent laromustine, a novel alkylating agent, has significant activity in older patients with previously untreated poor-risk acute myeloid leukemia. J Clin Oncol 2010, 28:815-821.
26. Schlenk R.F., Frohling S., Hartmann F., Fischer J.T., Glasmacher A., Del Valle F., et al. Intensive consolidation versus oral maintenance therapy in patients 61years of older with acute myeloid leukemia in first remission: results of second randomization of the AML HD98-B treatment Trial. Leukemia 2006, 20:748-750.
27. Goldstone A.H., Burnett A.K., Wheatley K., Smith A.G., Hutchinson R.M., Clark R.E. Attempts to improve treatment outcomes in acute myeloid leukemia (AML) in older patients: the results of the United Kingdom Medical Research Council AML 11 trial. Blood 2001, 98:1302-1311.
28. Aapro M.S., Kohne C.H., Cohen H.J., Extermann M. Never too old? Age should not be a barrier to enrollment in cancer clinical trials. Oncologist 2005, 10:198-204.
29. Sastre J., Aranda E., Massuti B., Tabernero J., Chaves M., Abad A., et al. Elderly patients with advanced colorectal cancer derive similar benefit without excessive toxicity after first-line chemotherapy with oxaliplatin-based combinations: comparative outcomes from the 03-TTD-01 phase III study. Crit Rev Oncol Hematol 2009, 70:134-144.
30. Tougeron D., Di Fiore F., Thureau S., Berbera N., Iwanicki-Caron I., Hamidou H., et al. Safety and outcome of definitive chemoradiatherapy in elderly patients with oesophageal cancer. Br J Cancer 2008, 99:1586-1592.
31. Yoshimura N., Kudoh S., Kimura T., Mitsuoka S., Kyoh S., Tochino Y., et al. Phase II study of docetaxel and carboplatin in elderly patients with advanced non-small cell lung cancer. J Thorac Oncol 2009, 4:371-375.
32. LoConte N.K., Smith M., Alberti D., Bozeman J., Cleary J.F., Setala A.N., et al. Amongst eligible patients, age and comorbidity do not predict for dose-limiting toxicity from phase I chemotherapy. Cancer Chemother Pharmacol 2010, 65:775-780.
33. Breems D.A., Van Putten W.L., Huijgens P.C., Ossenkoppele G.J., Verhoef G.E., Verdonck L.F., et al. Prognostic index for adult patients with acute myeloid leukemia in first relapse. J Clin Oncol 2005, 23:1969-1978.
34. Ferrara F., Palmieri A., Mele G. Prognostic factors and therapeutic options for relapsed or refractory acute myeloid leukemia. Haematologica 2004, 89:998-1007.
35. Ferrara F., Morabito F., Latagliata R., Martino B., Annunziata M., Oliva E., et al. Aggressive salvage treatment is not appropriate for the majority of elderly patients with acute myeloid leukemia relapsing after first complete remission. Haematologica 2001, 86:814-820.
36. Menzin J., Lang K., Earle C., Kerny D., Mallick R. The outcomes and costs of acute myeloid leukemia among the elderly. Arch Intern Med 2002, 162:1597-1603.