Myocet (liposome-encapsulated doxorubicin citrate): a new approach in breast cancer therapy

References

• CLARK GM, SLEDGE GW Jr, OSBORNE CK, MCGUIRE WL: Survival from first recurrence: relative importance of prognostic factors in 1,015 breast cancer patients.j Clin. Oncol (1987) 5:55–61.
   PubMed Web of Science ®Google Scholar
• MICK R, BEGG CB, ANTMAN KH, KORZUN AH, FRET E 3rd: Diverse prognosis in metastatic breast cancer: who should be offered alternative initial therapies? Breast Cancer Res. Treat. (1989) 13:33–38.
   Google Scholar
• GREENBERG PA, HORTOBAGYI GN,SMITH TL, ZIEGLER LD, FRYE DK, BUZDAR AU: Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer. " Clin. Omni (1996) 14:2197–2205.
   PubMed Web of Science ®Google Scholar
• SLEDGE GW Jr: Should we dream the impossible dream? The meaning of long-term survival in metastatic breast cancer. Clin. Omni (1996) 14:2191–2193.
   PubMedGoogle Scholar
• VERRILL M: Anthracyclines in breast cancer: therapy and issues of toxicity. The Breast (2001) Suppl. 2:8–15.
   Google Scholar
• •Concise review of toxicity considerations when using anthracydines for breast cancer patients.
   Google Scholar
• DOROSHOW JH: Effect of anthracycline antibiotics on oxygen radical formation in rat heart. Cancer Res. (1983) 43:460–472.
   PubMed Web of Science ®Google Scholar
• RAJAGOPALAN S, POLITI PM, SINHA BK, MYERS CE: Adriamycin-induced free radical formation in the perfused rat heart: implications for cardiotoxicity. Cancer Res. (1988) 48:4766–4769.
   PubMed Web of Science ®Google Scholar
• JACKSON JA, REEVES JP, MUNTZ KH et al.: Evaluation of free radical effects and catecholamine alterations in adriamycin cardiotoxicity. Am. Pathol (1984) 117:140–153.
   PubMed Web of Science ®Google Scholar
• MYERS CE, MCGUIRE WP, LISS RH, IFRIM I, GROTZINGER K, YOUNG RC: Adriamycin: the role of lipid perwddation in cardiac toxicity and tumor response. Science (1977) 197:165–167.
   PubMed Web of Science ®Google Scholar
• BILLINGHAM ME, MASON JW, BRISTOW MR, DANIELS JR: Anthracycline cardiomyopathy monitored by morphologic changes. Cancer Treat. Rep. (1978) 62:865–872.
   PubMedGoogle Scholar
• PRAGA C, BERETTA G, VIGO PL et al: Adriamycin cardiotoxicity: a survey of 1273 patients. Cancer Treat. Rep. (1979) 63:827–834.
   PubMedGoogle Scholar
• VON HOFF DD, LAYARD MW, BASA P et al.: Risk factors for doxorubicin-induced congestive heart failure. Ann. Intern. Med. (1979) 91:710-717. Landmark paper showing dose-dependent doxorubicin-associated cardiotoxicity from US cancer co-operative group patient database.
   Google Scholar
• BRISTOW MR: Anthracycline cardiotoxicity. In: Drug-Induced Heart Disease. Bristow MR (Ed.), Elsevier, New York, NY, USA (1980):191–215.
   Google Scholar
• •Anthracydine cardiotoxicity from the cardiologist's perspective.
   Google Scholar
• HOCHSTER H, LIEBES L, WADLER S et al.: Pharmacokinetics of the cardioprotector ADR-529 (ICRF-187) in escalating doses combined with fixed-dose doxorubicin." Natl. Cancer Inst (1992) 84:1725–1730.
   Google Scholar
• SWAIN SM, WHALEY FS, GERBER MC et al.: Cardioprotection with dexrazoxane for doxorubicin-containing therapy in advanced breast cancer. " Clin. Omni (1997) 15:1318–1332.
   Google Scholar
• SEYMOUR L, BRAM WELL V, MORANLA: Use of dexrazoxane as a cardioprotectant in patients receiving doxorubicin or epirubicin chemotherapy for the treatment of cancer. Cancer Prey Control (1999) 3:145–159.
   PubMedGoogle Scholar
• HENSLEY ML, SCHUCHTER LM, LINDLEY C et al.: American Society of Clinical Oncology clinical practice guidelines for the use of chemotherapy and radiotherapy protectants." Clin. Oncol (1999) 17:3333–3355.
   Google Scholar
• LEGHA SS, BENJAMIN RS, MACKAY B et al.: Reduction of doxorubicin cardiotoxicity by prolonged continuous intravenous infusion. Ann. Intern. Merl (1982) 96:133–139.
   PubMed Web of Science ®Google Scholar
• •Important study showing that reducing peak plasma levels of doxorubicin significantly reduces cardiotoxic effects.
   Google Scholar
• RYBERG M, NIELSEN D, SKOVSGAARD T, HANSEN J, JENSEN BV, DOMBERNOWSKY P: Epirubicin cardiotoxicity: an analysis of 469 patients with metastatic breast cancer.' Clin. Omni (1998) 16:3502–3508.
   PubMed Web of Science ®Google Scholar
• LAUNCHBURY AP, HABBOUBI N: Epirubicin and doxorubicin: a comparison of their characteristics, therapeutic activity and toxicity. Cancer Treat. Rev (1993) 19:197–228.
   PubMed Web of Science ®Google Scholar
• SPARANO JA, WINER EP: Liposomal anthracyclines for breast cancer. &min. Oncol (2001) 28:(4, Suppl. 12):32–40.
   Google Scholar
• •Comprehensive review of development and efficacy of liposomal anthracydines for breast cancer.
   Google Scholar
• TARDI PG, BOMAN NL, CULLIS PR: Liposomal doxorubicin. " Drug Target. (1996) 4:129–140.
   PubMed Web of Science ®Google Scholar
• •Not all liposomes are the same - review of optimal features for a liposomal drug formulation.
   Google Scholar
• WOODRUFF HB, WAKSMAN SA: The actinomycin - historical background. Ann. NY Acad. Sci. (1960) 89:287 (Abstract).
   Google Scholar
• MYERS CE: Antitumor antibiotics I, anthracyclines. In: Cancer Chemotherapy Poinedo HM (Ed.), Excerpta Medica, Amsterdam, The Netherlands (1979)56–73.
   Google Scholar
• SMITH IC, HUTCHEON AW, HEYS SD: Current and potential chemotherapeutic agents used for induction chemotherapy in the treatment of breast cancer. Curr: Pharm. Des. (2000) 6:327–343.
   PubMedGoogle Scholar
• HILL BT, WHELAN RD: A comparison of the lethal and kinetic effects of doxorubicin and 4 --epi-doxorubicin in vitro. Tumori (1982) 68:29–37.
   PubMedGoogle Scholar
• BROWN JM, GIACCIA AJ: The unique physiology of solid tumors: opportunities (and problems) for cancer therapy. Cancer Res. (1998) 58:1408–1416.
   PubMed Web of Science ®Google Scholar
• SWENSON CE, PERKINS WR, ROBERTS P, JANOFF AS: Liposome technology and the development of Myocet' (liposomal doxorubicin citrate). The Breast (2001) Suppl. 2:1–7.
   Google Scholar
• ••Concise introduction to liposomaltechnology; useful review of predinical pharmacology of Myocet (note that figure 4 is labelled incorrectly; doxorubicin and Myocet are reversed)
   Google Scholar
• MADDEN TD, HARRIGAN PR, TAI LC et al.: The accumulation of drugs within large unilamellar vesicles exhibiting a proton gradient: a survey. Chem. Phys. Lipids (1990) 53:37–46.
   PubMed Web of Science ®Google Scholar
• MAYER LD, TAI LCL, KO DS et al: Influence of vesicle size, lipid composition, and drug-to-lipid ratio on the biological activity of liposomal doxorubicin in mice. Cancer Res. (1989) 49:5922–5930.
   PubMedGoogle Scholar
• LI X, CABRAL-LILLY D, JANOFF AS, PERKINS WR: Complexation of internalized doxorubicin into fibre bundles affects its release rate from liposomes. Liposome Res. (2000) 10:15–27.
   Web of Science ®Google Scholar
• LI X, HIRSH DJ, CABRAL-LILLY D et al.: 1749
   Google Scholar
• •• Doxorubicin physical state in solution and inside liposomes loaded via a pH gradient. Biochim. Biophys. Acta (1998) 1415:23–40.
   Google Scholar
• UCHIDA N, OKAMURA S, NAGAMACHI Y, YAMSHITA S: Increased phospholipase D activity in human breast cancer.' Cancer Res. Clin. Oncol. (1997) 123:280–285.
   PubMed Web of Science ®Google Scholar
• DI MARCO A, ZUNINO F, SILVESTRINI R, GAMBARUCCI C, GAMBETTA RA: Interaction of some daunomycin derivatives with deoxyribonucleic acid and their biological activity. Biochem. Pharmacol (1971) 20:1323–1328.
   PubMedGoogle Scholar
• PIGRAM WJ, FULLER W, HAMILTON LD: Stereochemistry of intercalation: interaction of daunorubicin with DNA. Nat. New Biol. (1972) 235:17–19.
   PubMedGoogle Scholar
• LIU LF, ROWE TC, YANG L, TEWEY KM, CHENG GL: Cleavage of DNA by mammalian topoisomerase II. J. Biol. Chem (1983) 258:15365–15370.
   PubMed Web of Science ®Google Scholar
• TEWEY KM, ROWE TC, YANG L, HALLIGAN BD, LIU LF: Adriamycin-induced DNA damage mediated by mammalian DNA topoisomerase II. Science (1984) 226:466–468.
   PubMed Web of Science ®Google Scholar
• BACHUR NR, GORDON SL, GEE MV, KON H: NADPH cytochrome P450 reductase activation of quinone anticancer agents to free radicals. Proc. Natl. Acad. Sci. USA (1979) 76:954–957.
   PubMed Web of Science ®Google Scholar
• BERALDO H, GARNIER-SUILLEROT A, TOSI L, LAVELLE F: Iron(III)-adriamycin and iron(III)-daunorubicin complexes: physicochemical characteristics, interaction with DNA, and antitumor activity. Biochemistry (1985) 24:284–289.
   PubMed Web of Science ®Google Scholar
• MURPHREE SA, CUNNINGHAM LS, HWANG KM, SARTORELLI AC: Effect of adriamycin on surface properties of sarcoma 180 ascites cells. Biochem. Pharmacol (1976) 25:1227–1231.
   PubMed Web of Science ®Google Scholar
• OLSON RD, BOERTH RC, GERBERJG, NIES AS: Mechanism of adriamycin cardiotoxicity: evidence for oxidative stress. Life Sci. (1981) 29:1393–1401.
   PubMed Web of Science ®Google Scholar
• MROSS K, MAESSEN P, VAN DER VIJGH WJ, GALL H, BOVEN E, PINEDO HM: Pharmacokinetics and metabolism of epidoxorubicin and doxorubicin in humans.' Clin. Oncol (1988) 6:517–526.
   Google Scholar
• NIEMANN B, MROSS K, DREVS J, UNGER C, BHAMRA R, SWENSON C: The pharmacokinetic profile of liposome- encapsulated doxorubicin (TLC-D99; Myocet). Proc. Ann. Meet. Am. Soc. Clin. Oncol (2001) 20:(Abstract 463).
   Google Scholar
• MARTY M: Liposomal doxorubicin (Myocet') and conventional anthracyclines: a comparison. The Breast (2001) Suppl. 2:28–33.
   Google Scholar
• •Reviews key findings from Phase III development programme of Myocet.
   Google Scholar
• STEWART DJ, GREWAAL D, GREEN RIVI et al.: Concentrations of doxorubicin and its metabolites in human autopsy heart and other tissues. Anticancer Res. (1993) 13:1945–1952.
   PubMed Web of Science ®Google Scholar
• DEL TACCA M, DANESI R, DUCCI M, BERNARDINI C, ROMANINI A: Might adriamycinol contribute to adriamycin-induced cardiotoxicity? Pharmacol Res. Commun. (1985) 17:1073–1084.
   Google Scholar
• OLSON RD, MUSHLIN PS, BRENNER DE et al.: Doxorubicin cardiotoxicity may be caused by its metabolite doxorubicinol. Proc. Natl. Acad. Sci. USA (1988) 85:3585–3589.
   PubMed Web of Science ®Google Scholar
• POTCHOIBA MJ, WEST M, SMOLAREK TA et at Tissue distribution of doxorubicin in the free and liposomal forms in male beagles. Proc. Ann. Meet. Am. Soc. Cancer Res. (1996) 37: (Abstract 2675).
   Google Scholar
• KANTER PM, BULLARD GA, GINSBERG RA et al.: Comparison of the cardiotoxic effects of liposomal doxorubicin (TLC D-99) versus free doxorubicin in beagle dogs. In vivo (1993) 7:17–26.
   PubMedGoogle Scholar
• THE LIPOSOME COMPANY: Data on file. D-99 intravenous toxicity study in beagle dogs. (1996) Study no. 93-974-01.
   Google Scholar
• OSTRO MJ: Liposomes - from the bench to the marketplace: doxorubicin liposomes as an example. In: Liposomes in the Therapy of Infectious Diseases and Cancer Lopez-Berestein G, Fidler IJ (Eds), Alan R Liss, Inc., New York, NY, USA (1989):155–163.
   Google Scholar
• ROBERTS P, MASTERS G, JANOFF A, AHMAD I, MAYHEW E: Distribution of doxorubicin fluorescence in a human breast carcinoma (MCF7) grown on SCID mice after treatment with Evacet or free doxorubicin. 21st San Antonio Breast Cancer Symposium (1998) San Antonio, TX, USA.
   Google Scholar
• ROBERTS P, JANOFF AS, MAYHEW E: Doxorubicin fluorescence in a human breast carcinoma (MX-1) after treatment with liposome-associated or free doxorubicin. Proc. Ann. Meet. Am. Soc. Cancer Res. (2000) 41: (Abstract 3327).
   Google Scholar
• BATIST G, RAMAKRISHNAN G, SEKHAR RAO C et al.: Reduced cardiotoxicity and preserved antitumour efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. Clin. Oncol (2001) 19:1444–1454.
   Google Scholar
• ••Phase III trial results showing reducedcardiotoxicity and equivalent efficacy with Myocet plus CPA versus doxorubicin plus CPA.
   Google Scholar
• HARRIS L, BATIST G, BELT R et al: Liposome-encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first-line therapy of metastatic breast carcinoma. Cancer (2002) 94:25–36.
   PubMed Web of Science ®Google Scholar
• •Phase III trial results showing reduced cardiotoxicity and equivalent efficacy of Myocet versus conventional doxorubicin.
   Google Scholar
• CHAN S, DAVIDSON N, JUOZAITYTE E et al.: Liposome-encapsulated doxorubicin (Myocet) and cyclophosphamide is superior to epirubicin and cyclophosphamide in first-line therapy of metastatic breast cancer. Eur: I Cancer (2001) 37\(Suppl. 5):28.
   Google Scholar
• HORTOBAGYI GN, YAP HY, KAU SW et al.: A comparative study of doxorubicin and epirubicin in patients with metastatic breast cancer. Am.Oncol (1989)12:57–62.
   PubMedGoogle Scholar
• JAIN KK, CASPER ES, GELLER NL et al.: A prospective randomized comparison of epirubicin and doxorubicin in patients with advanced breast cancer. J. Clin. Oncol (1985) 3:818–826.
   PubMed Web of Science ®Google Scholar
• NORTHFELT DW, DEZUBE BJ, THOMMES JA et al.: Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized Phase III clinical trial. " Clin. Oncol (1998) 16:2445–2451.
   Google Scholar
• STEWART S, JABLONOWSKI H, GOEBEL FD et al.: Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma.Oncol (1998)16:683–691.
   Google Scholar
• LYASS 0, UZIELY B, BEN-YOSEF R et al.: Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma. Cancer (2000) 89:1037–1047.
   Google Scholar
• RANSON MR, CARMICHAEL J, O'BYRNE K, STEWART S, HOWELL A: Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: results of a multicenter Phase II trial. Clin. Oncol (1997) 15:3185–3191.
   Google Scholar
• WIGLER N, INBAR M, O'BRIEN M et al.: Reduced cardiac toxicity and comparable efficacy in a Phase III trial of pegylated liposomal doxorubicin (Caelyx/Doxil) versus doxorubicin for first-line treatment of metastatic breast cancer. Proc. Ann. Meet. Am. Soc. Clin. Oncol (2002); 21:45a (Abstract 177).
   Google Scholar
• ORMROD D, HOLM K, GOA K, SPENCER C: Epirubicin: a review of its efficacy as adjuvant therapy and in the treatment of metastatic disease in breast cancer. Drugs Aging (1999) 15:389–416.
   PubMed Web of Science ®Google Scholar
• BONTENBAL M, ANDERSSON M, WILDIERS J et al.: Doxorubicin versus epirubicin, report of a second-line randomized Phase II/III study in advanced breast cancer. EORTC Breast Cancer Cooperative Group. Br. J. Cancer (1998) 77:2257–2263.
   PubMedGoogle Scholar
• MICHELOTTI A, VENTURINI M, TIBALDI C et al.: Single agent epirubicin as first line chemotherapy for metastatic breast cancer patients. Breast Cancer Res. Treat. (2000) 59:133–139.
   PubMedGoogle Scholar
• BATIST G, HARRIS, L, AZARNIA N, LEE L: Improved therapeutic index of TLC D-99 (liposome-encapsulated doxorubicin) compared to free doxorubicin in first-line treatment of metastatic breast cancer in patients who had received prior adjuvant doxorubicin. Proc. Ann. Meet. Am. Soc. Clin. Oncol (2000) 19: (Abstract 405).
   Google Scholar
• WINER E, BATIST G, BELT R, GUTHEIL J, PARK Y, WELLS L: Reduced cardiotoxicity of liposome-encapsulated doxorubicin (TLC D-99) compared to free doxorubicin in first-line therapy of metastatic breast cancer in patients at increased risk for anthracyclines-induced cardiac toxicity. Proc. Ann. Meet. Am. Soc. Clin. Oncol (2000) 19:(Abstract 323).
   Google Scholar
• GIANNI L, MUNZONE E, CAPRI G et al.: Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose finding and sequence-finding study. I Clin. Oncol (1995) 13:2688–2699.
   PubMed Web of Science ®Google Scholar
• GEHL J, BOESGAARD M, PAASKE T, VITTRUP JENSEN B, DOMBERNOWSKY P: Combined doxorubicin and paclitaxel in advanced breast cancer: effective and cardiotoxic. Ann. Oncol (1996) 7:687–693.
   PubMed Web of Science ®Google Scholar
• HOLMES FA, MADDEN T, NEWMAN RA et al.: Sequence-dependent alteration of doxorubicin pharmacokinetics by paclitaxel in a Phase I study of paclitaxel and doxorubicin in patients with metastatic breast cancer. J. Clin. Oncol (1996) 14:2713–2721.
   PubMed Web of Science ®Google Scholar
• GIANNI L, VIGANO L, LOCATELLI A et al.: Human pharmacokinetic characterization and in vitrostudy of the interaction between doxorubicin and paclitaxel in patients with breast cancer. Clin. Oncol (1997) 15:1906–1915.
   Google Scholar
• SLAMON DJ, LEYLAND-JONES B, SHAK S et al.: Use of chemotherapy plus a monoclonal antibody against HERZ for metastatic breast cancer that overexpresses HERZ. N Engl. J. Med. (2001) 344:783–792.
   PubMed Web of Science ®Google Scholar
• ••Landmark trial shows rare survivalimprovements with targeted therapy in women with metastatic breast cancer (and emerging cardiotoxicity risk).
   Google Scholar
• FELDMAN AM, LORELL BH, REIS SE: Trastuzumab in the treatment of metastatic breast cancer: anticancer therapy versus cardiotoxicity. Circulation (2000) 102:272–274.
   PubMed Web of Science ®Google Scholar
• THEODOULOU M, CAMPOS SM, BATIST G et al: TLC D99 (D, Myocet) and Herceptin(H) is safe in advanced breast cancer (ABC): final cardiac safety and efficacy analysis. Proc. Ann. Meet. Am. Soc. Clin. Oncol (2002) 21:55a (Abstract 216).
   Google Scholar
• SEIDMAN A, HUDIS C, PIERRI MK et al.: Cardiac dysfunction in the trastuzumab clinical trials experience. Clin. Oncol (2002): 20:1215–1221.
   Google Scholar
• •Antiturnour activity of trastuzurnab with anthracyclines and CPA warrants research into strategies to prevent or treat associated cardiac dysfunction.
   Google Scholar
• LEVINE AM, TULPULE A, ESPINA BM et al.: A Phase I/II trial of liposomal doxorubicin (TLC D-99, Myocet) with cyclophosphamide, vincristine, and prednisone in newly diagnosed aggressive non-Hodgkins lymphoma (NHL). Proc. Ann. Meet. Am. Soc. Clin. Oncol (2002) 21:284a (Abstract 1133).
   Google Scholar
• TULPULE A, ESPINA BM, DHARMAPALA D et al: Treatment of newly diagnosed AIDS-related lymphomas with liposomal doxorubicin (TLC-D99, Myocet) combined with cyclophosphamide, vincristine, and prednisone: results of a Phase I/II trial. Proc. Ann. Meet. Am. Soc. Clin. Oncol (2002) 21:284a (Abstract 1135).
   Google Scholar
• LOWE ES, ADAMSON PC, WIDEMANN BC et al.: Phase I trial and pharmacokinetic study of liposomal doxorubicin (TLC-D99, Myocet TM) in children with refractory solid tumors. Proc. Ann. Meet. Am. Soc. Clin. Oncol (2002) 21:109a (Abstract 434).
   Google Scholar