New oral drugs in older patients: a review of idarubicin in elderly patients

Critical Reviews in Oncology/Hematology - Tập 49 - Trang 153-163 - 2004
Diana Crivellari1, Davide Lombardi1, Simon Spazzapan1, Andrea Veronesi2, Giuseppe Toffoli2
1Medical Oncology Department, Centro di Riferimento Oncologico, Via Pedemontana Occ., 12, 33081 Aviano, PN, Italy
2Experimental Oncology I: Experimental and Clinical Pharmacology Unit, CRO, Aviano, PN, Italy

Tài liệu tham khảo

Harris, 1997, Malignant tumors of the breast, 1557 1998, Polychemotherapy for early breast cancer: an overview of the randomised trials, Lancet, 352, 930, 10.1016/S0140-6736(98)03301-7 Di Marco, 1977, Antitumor activity of 4-demethoxydaunorubicin administered orally, Cancer Treat. Rep., 61, 893 Fields, 1991, Idarubicin: a second-generation anthracycline, Ann. Pharmacol., 25, 505 Cersosimo, 1992, Idarubicin: an anthracycline antineoplastic agent, Clin. Pharm., 2, 152 Howard, 1995, Oral idarubicin in hematological malignancy: current trends in therapy, Clin. Drug Invest., 9, 16, 10.2165/00044011-199500092-00005 Keating, 1995, Oral idarubicin in hematological malignancies: putative indications, Clin. Drug Invest., 9, 29, 10.2165/00044011-199500092-00006 Twelves, 1995, Oral idarubicin in solid tumor chemotherapy, Clin. Drug Invest., 9, 39, 10.2165/00044011-199500092-00007 Lasota, 1994, Potential role of oral anthracyclines in older patients with cancer, Drugs Aging, 4, 392, 10.2165/00002512-199404050-00004 Arcamone, 1976, Synthesis and antitumor activity of 4-demethoxydaunorubicin, 4-demethoxy-7,9-diepidaunorubicin, and their beta anomers, Cancer Treat. Rep., 60, 829 Banning, 1987, Relative cardiotoxicity and cytotoxicity of anthraquinonyl glucosaminosides, Cancer Chemother. Pharmacol., 19, 207, 10.1007/BF00252974 Penco, 1983, Synthesis, antitumor activity, and cardiac toxicity of new 4-demethoxyanthracyclines, Cancer Treat. Rep., 67, 665 Platel, 1999, Comparative cardiotoxicity of idarubicin and doxorubicin using the isolated perfused rat heart model, Anticancer Drugs, 10, 671, 10.1097/00001813-199908000-00007 Gewirtz, 1999, A critical evaluation of the mechanisms of action proposed for the antitumor effects of the anthracycline antibiotics adriamycin and daunorubicin, Biochem. Pharmacol., 57, 727, 10.1016/S0006-2952(98)00307-4 Borst, 2000, A family of drug transporters: the multidrug resistance-associated proteins, J. Natl. Cancer Inst., 92, 1295, 10.1093/jnci/92.16.1295 Tanigawara, 2000, Role of P-glycoprotein in drug disposition, Ther. Drug Monit., 22, 137, 10.1097/00007691-200002000-00029 Toffoli, 1994, Comparison of mechanisms responsible for resistance to idarubicin and daunorubicin in multidrug resistant LoVo cell lines, Biochem. Pharmacol., 48, 1871, 10.1016/0006-2952(94)90585-1 Toffoli, 1996, Cellular pharmacology of idarubicinol in multidrug-resistant LoVo cell lines, Int. J. Cancer, 67, 129, 10.1002/(SICI)1097-0215(19960703)67:1<129::AID-IJC21>3.0.CO;2-8 Binaschi, 1997, Relationship between lethal effects and topoisomerase II-mediated double-stranded DNA breaks produced by anthracyclines with different sequence specificity, Mol. Pharmacol., 51, 1053, 10.1124/mol.51.6.1053 Camaggi, 1992, Idarubicin metabolism and pharmacokinetics after intravenous and oral administration in cancer patients: a crossover study, Cancer Chemother. Pharmacol., 30, 307, 10.1007/BF00686301 Smith, 1987, Clinical pharmacology of oral and intravenous 4-demethoxydaunorubicin, Cancer Chemother. Pharmacol., 19, 138, 10.1007/BF00254566 Stewart, 1991, Bioavailability and pharmacology of oral idarubicin, Cancer Chemother. Pharmacol., 27, 308, 10.1007/BF00685117 Zanette, 1990, Pharmacokinetics of 4-demethoxydaunorubicin in cancer patients, Cancer Chemother. Pharmacol., 25, 445, 10.1007/BF00686057 Kaplan, 1984, Phase I trial of 4-demethoxydaunorubicin (idarubicin) with single oral doses, Invest. New Drugs, 2, 281, 10.1007/BF00175378 Lu, 1986, Clinical pharmacokinetics of 9,10-anthracenedicarboxaldehyde-bis [(4,5-dihydro-1 H-imidazol-2-yl) hydrazone] dihydrochloride, Cancer Chemother. Pharmacol., 16, 156, 10.1007/BF00256167 Reid, 1990, Plasma pharmacokinetics and cerebrospinal fluid concentrations of idarubicin and idarubicinol in pediatric leukemia patients: a Childrens Cancer Study Group report, Cancer Res., 50, 6525 Daghestani, 1985, Phase I and II clinical and pharmacological study of 4-demethoxydaunorubicin (idarubicin) in adult patients with acute leukemia, Cancer Res., 45, 1408 Robert, 1993, Clinical pharmacokinetics of idarubicin, Clin. Pharmacokinet., 24, 275, 10.2165/00003088-199324040-00002 Kessel, 1999, Influence of serum protein binding on the uptake and retention of idarubicin by sensitive and multidrug resistant human leukemic cells, Eur. J. Clin. Pharmacol., 55, 369, 10.1007/s002280050642 Berman, 1983, Phase I and clinical pharmacology studies of intravenous and oral administration of 4-demethoxydaunorubicin in patients with advanced cancer, Cancer Res., 43, 6096 Gillies, 1987, Pharmacokinetics of idarubicin (4-demethoxydaunorubicin; IMI-30; NSC 256439) following intravenous and oral administration in patients with advanced cancer, Br. J. Clin. Pharmacol., 23, 303, 10.1111/j.1365-2125.1987.tb03049.x Toffoli, 2000, Dose-finding and pharmacologic study of chronic oral idarubicin therapy in metastatic breast cancer patients, Clin. Cancer Res., 6, 2279 Pannuti, 1986, Low dose oral administration of 4-demethoxydaunorubicin (idarubicin) in advanced cancer patients. A pharmacokinetic study, Cancer Chemother. Pharmacol., 16, 295, 10.1007/BF00293996 Pui, 1988, Phase I clinical trial of orally administered 4-demethoxydaunorubicin (idarubicin) with pharmacokinetic and in vitro drug sensitivity testing in children with refractory leukemia, Cancer Res., 48, 5348 Robert, 1995, Pharmacological properties of oral idarubicin, Clin. Drug Invest., 9, 1, 10.2165/00044011-199500092-00003 Elbaek, 1989, Pharmacokinetics of oral idarubicin in breast cancer patients with reference to antitumor activity and side effects, Clin. Pharmacol. Ther., 45, 627, 10.1038/clpt.1989.83 Eksborg, 1990, Plasma pharmacokinetics of idarubicin and its 13-hydroxymetabolite after intravenous and oral administration under fasting and non-fasting conditions, Acta Oncol., 29, 921, 10.3109/02841869009096390 Hochster, 1990, Good tolerance of weekly oral idarubicin: (4-demethoxydaunorubicin): a phase I study with pharmacology, Cancer Chemother. Pharmacol., 26, 297, 10.1007/BF02897234 Speth, 1986, Plasma and human leukemic cell pharmacokinetics of oral and intravenous 4-demethoxydaunomycin, Clin. Pharmacol. Ther., 40, 643, 10.1038/clpt.1986.239 Harousseau, 1987, Idarubicin in the treatment of relapsed or refractory acute myeloid leukemia, Cancer Treat. Rep., 71, 991 Lowenthal, 1987, Oral idarubicin as single-agent treatment of acute nonlymphocitic leukemia in poor-risk patients, Cancer Treat. Rep., 71, 1279 Malik, 1989, Oral idarubicin in the treatment of acute myelogenous leukemia and the blast phase of chronic myeloid, Hematol. Oncol., 7, 423, 10.1002/hon.2900070605 Harousseau, 1989, Treatment of acute myeloid leukemia in elderly patients with oral idarubicin as single agent, Eur. J. Hematol., 42, 182, 10.1111/j.1600-0609.1989.tb01208.x Lopez, 1986, Oral idarubicin in non-Hodgkin's lymphomas, Invest. New Drugs, 4, 263, 10.1007/BF00179594 Errante, 1991, A phase II study of oral idarubicin (4-demethoxydaunorubicin) in previously untreated elderly patients with non-Hodgkin's lymphoma, Am. J. Clin. Oncol., 14, 243, 10.1097/00000421-199106000-00011 Gillies, 1988, Phase II trial of idarubicin in patients with advanced lymphoma, Cancer Chemother. Pharmacol., 21, 261, 10.1007/BF00262782 Case, 1990, Phase II study of oral idarubicin in favorable histology non-Hodgkin's lymphoma, Cancer Res., 50, 6833 Chachoua, 1987, Phase II study of oral idarubicin in patients with AIDS-associated Kaposi's sarcoma, Cancer Treat. Rep., 71, 775 Sumpter, 1999, Oral idarubicin as a single agent therapy in patients with relapsed or resistant multiple myeloma, Leuk. Lymphoma, 35, 593, 10.1080/10428199909169624 Martoni, 1985, Activity of 4-demethoxydaunorubicin by the oral route in advanced breast cancer, Eur. J. Cancer Clin. Oncol., 21, 803, 10.1016/0277-5379(85)90218-4 Lionetto, 1986, Idarubicin in advanced breast cancer: a phase II study, Cancer Treat. Rep., 70, 1439 Kolaric, 1987, Phase II study of oral 4-demethoxydaunorubicin in previously treated metastatic breast cancer, Oncology, 44, 82, 10.1159/000226450 Casper, 1987, Phase II evaluation of orally administered idarubicin in patients with advanced breast cancer, Cancer Treat. Rep., 71, 1289 Bastholt, 1987, Phase II study of idarubicin given orally in the treatment of anthracycline-naive advanced breast cancer patients, Cancer Treat. Rep., 71, 451 Chevallier, 1990, Phase II study of oral idarubicin in elderly patients with advanced breast cancer, Am. J. Clin. Oncol. (CCT), 13, 436, 10.1097/00000421-199010000-00015 Stuart, 1988, A phase II study of oral idarubicin (4-demethoxydaunorubicin) in advanced breast cancer, Cancer Chemother. Pharmacol., 21, 351, 10.1007/BF00264204 Hurteloup, 1989, Phase II trial of idarubicin (4-demethoxydaunorubicin) in advanced breast cancer. The clinical screening group of the European organization for research and treatment of cancer, Eur. J. Cancer Clin. Oncol., 25, 423, 10.1016/0277-5379(89)90254-X Possinger, 1991, Oral administration of idarubicin as first line cytostatic therapy in patients with metastasized breast cancer and favourable prognosis, Onkologie, 14, 31, 10.1159/000216941 Wander, 1986, Phase II trial of oral idarubicin (4-demethoxydaunorubicin) in advanced breast cancer (ABC), Onkologie, 9, 236, 10.1159/000216014 De Lena, 1988, 4-demethoxydaunorubicin administered orally in advanced breast cancer a phase II study, Tumori, 74, 65, 10.1177/030089168807400111 Lopez, 1986, Phase II trial with oral idarubicin in advanced breast cancer, Invest. New Drugs, 4, 39, 10.1007/BF00172014 Lopez, 1989, A prospective randomized trial of doxorubicin versus idarubicin in the treatment of advanced breast cancer, Cancer, 64, 2431, 10.1002/1097-0142(19891215)64:12<2431::AID-CNCR2820641206>3.0.CO;2-1 Piccart, 1992, Anthracyclines active via the oral route: luxury or necessity, Ann. Oncol., 3, 181, 10.1093/oxfordjournals.annonc.a058144 Weiss, 1976, Studies on adriamycin using a weekly regimen demonstrating its clinical effectiveness and lack of cardiac toxicity, Cancer Treat. Rep., 60, 813 Chlebowski, 1980, Adriamycin given as a weekly schedule without a loading dose: clinically effective with reduced incidence of cardiotoxicity, Cancer Treat. Rep., 64, 47 DeSloover, 1984, Phase I study of oral idarubicin with a weekly schedule, Proc. ASCO, 3, 79 Smith, 1987, A phase II study of oral weekly 4-demethoxydaunorubicin in advanced breast cancer, Eur. J. Cancer Clin. Oncol., 23, 391, 10.1016/0277-5379(87)90375-0 Bastholt, 1990, Weekly oral idarubicin in postmenopausal women with advanced breast cancer. A phase II study, Acta Oncol., 29, 143, 10.3109/02841869009126534 Provè A, Becquart D, Joosen E, et al. Oral idarubicin chemotherapy in elderly advanced breast cancer patients progressing to hormonal therapy: preliminary results, Proc ECCO, 1995. Kolaric, 1991, Combination of idarubicin and cyclophosphamide administered orally in untreated postmenopausal breast cancer patients a phase II study, Oncology, 48, 93, 10.1159/000226903 Lopez, 1991, Combination chemotherapy with oral idarubicin and cyclophosphamide for metastatic breast cancer, Cancer Res. Clin. Oncol., 117, 61, 10.1007/BF01613198 Richardet E, Bordenave R, Cardoso C, et al. Oral idarubicin plus cyclophosphamide in advanced breast cancer patients, Proc ASCO, 1997, abs 659. Zaniboni, 1998, Oral idarubicin and cyclophosphamide for metastatic breast cancer in elderly patients, Anti-Cancer Drugs, 9, 295, 10.1097/00001813-199804000-00001 Kolaric, 1988, Combination chemotherapy with 5-fluorouracil, oral idarubicin, and cyclophosphamide (FIC) in metastatic breast cancer: an open phase II study, J. Cancer Res. Clin. Oncol., 114, 301, 10.1007/BF00405838 Booser, 1994, Anthracycline antibiotics in cancer therapy. Focus on drug resistance, Drugs, 47, 223, 10.2165/00003495-199447020-00002 Muus, 1993, Idarubicin-related side effects in recipients of T-cell-depleted allogeneic bone marrow transplants are schedule dependent, Semin. Oncol., 20, 47 Greco, 1993, Chronic etoposide administration: overview of clinical experience, Cancer Treat. Rev., 19, 35, 10.1016/0305-7372(93)90046-T Hoskins, 1994, Oral etoposide is active against platinum-resistant epithelial ovarian cancer, J. Clin. Oncol., 12, 60, 10.1200/JCO.1994.12.1.60 Lokich, 1989, A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: a Mid-Atlantic Oncology Program study, J. Clin. Oncol., 7, 425, 10.1200/JCO.1989.7.4.425 Crivellari, 2001, Oral idarubicin in elderly patients with metastatic breast cancer: a phase II study with an innovative schedule, Minerva Med., 92, 115 Crivellari D, Toffoli G, Magri MD, et al. Oral idarubicin in elderly patients with metastatic breast cancer: a phase II study with innovative schedule. The sixth international conference on geriatric oncology. Lione, 14–15 September 2001. Crivellari, 2002, Idarubicin, Tumori, 88, S73, 10.1177/030089160208800122 Miller, 1981, Reporting results of cancer treatment, Cancer, 47, 207, 10.1002/1097-0142(19810101)47:1<207::AID-CNCR2820470134>3.0.CO;2-6 Fargeot P, Roche H, Bonneterre JM, et al. Disease free survival (DFS) advantage of weekly epirubicin plus tamoxifen vs. tamoxifen (Tam) alone as adjuvant treatment of operable, node-positive (N+) elderly breast cancer (BC) patients (pts): 5-year follow-up results of French adjuvant study group, FSAG-08 trial, Proc Am Soc Clin Oncol 21:abs145;2002. Cameron DA. Oral idarubicin and capecitabine: a dose-finding study confirms this is a safe, effective 1st line therapy for older women with breast cancer. San Antonio December 2002, Abs 341.