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Review

Clinical experience with drug delivery systems as tools to decrease the toxicity of anticancer chemotherapeutic agents

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Pages 1217-1226 | Received 11 Oct 2016, Accepted 21 Dec 2016, Published online: 01 Jan 2017

References

  • Fenton RG, Longo DI. Cell biology of cancer. In: Fauci AS, Braunwald E, Isselbacher KJ, editors.. Harrison’s internal medicine. Vol. 1. 14th ed. New York (NY): McGraw Hill; 1998; p. 505–511.
  • Kuderer NM, Dale DC, Crawford J, et al. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006;106(10):2258–2266.
  • Mangioni C, Bolis G, Pecorelli S, et al. Randomized trial in advanced ovarian cancer comparing cisplatin and carboplatin. J Natl Cancer Inst. 1989;81(19):1464–1471.
  • Schutt AJ, Hahn RG, Reitemeier RJ, et al. A phase 2 study of intermittent high-dose cyclosphosphamide therapy of advanced gastrointestinal cancer. Cancer Res. 1973;33(10):2218–2220.
  • Hansen HH, Selawry OS, Pajak TF, et al. The superiority of CCNU in the treatment of advanced Hodgkin’s disese: cancer and Leukemia Group B study. Cancer. 1981;47(1):14–18.
  • Robustelli della Cuna G, Paloetti P, Bernardo G, et al. Clinical toxicity of combined modality treatment with nitrosourea derivatives for central nerval system tumors. Neurosurgery. 1982;11(3):408–411.
  • Selker RG, Jacobs SA, Moore PB, et al. BCNU (1,3-bis(2-choroetyl)-1-nitrosourea) induced pulmonary fibrosis. Neurosurgy. 1980;7(6):560–565.
  • Stone MD, Richardson MG. Pulmonary toxicity of lomustine. Cancer Treat Rep. 1987;71(7–8):786–787.
  • Volkova M, Russell R 3rd. Anthracycline cardiotoxicity: prevalence, pathogenesis and treatment. Curr Cardiol Rev. 2011;7(4):214–220.
  • Gelderblom H, Verweij J, Nooter K, et al. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 2001;37(13):1590–1598.
  • Weiss RB, Donehower RC, Wiernik PH, et al. Hypersensitivity reactions from taxol. J Clin Oncol. 1990;8(7):1263–1268.
  • Rowinsky EK, Eisenhauer EA, Chaudhry V, et al. Clinical toxicities encountered with paclitaxel (Taxol). Semin Oncol. 1993;20(4 Suppl 3):1–15.
  • Yuan F. Transvascular drug delivery in solid tumors. Semin Radiat Oncol. 1998;8(3):164–175.
  • Rejman J, Oberle V, Zuhorn IS, et al. Size-dependent internalization of particles via the pathways of clathrin- and caveolae-mediated endocutosis. Biochem. 2004;377(Pt 1):159–169.
  • Haley B, Frenkel E. Nanoparticles for drug delivery in cancer treatment. Urol Oncol. 2008;26(1):57–64.
  • Davis ME, Chen ZG, Shin DM. Nanoparticle therapeutics: an emerging treatment modality for cancer. Nat Rev Drug Discov. 2008;7(9):771–782.
  • Sharma A, Sharma US. Liposomes in drug delivery: progress and limitations. Int J Pharm. 1997;154(2):123–140.
  • James ND, Coker RJ, Tomlinson D, et al. Liposomal doxorubicin (Doxil): an effective new treatment for Kaposi’s sarcoma in AIDS. Clin Oncol (R Coll Radiol). 1994;6(5):294–296.
  • Petre CE, Dittmer DP. Liposomal daunorubicin as treatment for Kaposi’s sarcoma. Int J Nanomedicine. 2007;2(3):277–288.
  • Barenholz Y. Doxil, the first FDA-approved nano-drug: lessons learned. J Control Release. 2012;160(2):117–134.
  • Ishida T, Iden DL, Allen TM. A combinatorial approach to producing sterically stabilized (Stealth) immunoliposomal drugs. FEBS Lett. 1999;460(1):129–133.
  • Hofheinz RD, Gnad-Vogt SU, Beyer U, et al. Liposomal encapsulated anti-cancer drugs. Anticancer Drugs. 2005;16(7):691–707.
  • Uziely B, Jeffers S, Isacson R, et al. Liposomal doxorubicin: antitumor activity and unique toxicities during two complementary phase I studies. J Clin Oncol. 1995;13(7):1777–1785.
  • Muggia FM, Hainsworth JD, Jeffers S, et al. Phase II study of liposomal doxorubicin in refractory ovarian cancer: antitumor activity and toxicity modification by liposomal encapsulation. J Clin Oncol. 1997;15(3):987–993.
  • Garcia AA, Kempf RA, Rogers M, et al. A phase II study of Doxil (liposomal doxorubicin): lack of activity in poor prognosis soft tissue sarcomas. Ann Oncol. 1998;9(10):1131–1133.
  • Gordon AN, Granai CO, Rose PG, et al. Phase II study of liposomal doxorubicin in platinum- and paclitaxel-refractory epithelial ovarian cancer. J Clin Oncol. 2000;18(17):3093–3100.
  • Israel VP, Garcia AA, Roman L, et al. Phase II study of liposomal doxorubicin in advanced gynecologic cancers. Gynecol Oncol. 2000;78(2):143–147.
  • Safra T, Muggia F, Jeffers S, et al. Pegylated liposomal doxorubicin (doxil): reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses of 500 mg/m2. Ann Oncol. 2000;11(8):1029–1033.
  • O’Brien ME, Wigler N, Inbar M, et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004;15(3):440–449.
  • Duggan ST, Keating GM. Pegylated liposomal doxorubicin: a review of its use in metastatic breast cancer, ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma. Drugs. 2011;71(18):2531–2558.
  • Mayer C, Brucker J, Schuetz F, et al. Efficacy and toxicity profile of pegylated liposomal doxorubicin in patients with advanced ovarian cancer. Arch Gynecol Obstet. 2016;294(1):123–129.
  • Xing M, Yan F, Yu S, et al. Efficacy and cardiotoxicity of liposomal doxorubicin-based chemotherapy in advanced breast cancer: a meta-analysis of ten randomized controlled trials. PLoS One. 2015;10(7):e0133569.
  • Basso U, Roma A, Brunello A, et al. Bi-weekly liposomal doxorubicin for advanced breast cancer in elderly women (≥ 70 years). J Geriatr Oncol. 2013;4(4):340–345.
  • Matsumura Y, Gotoh M, Muro K, et al. Phase I and pharmacokinetic study of MCC-465, a doxorubicin (DXR) encapsulated in PEG immunoliposome, in patients with metastatic stomach cancer. Ann Oncol. 2004;15(3):517–525.
  • Wasle I, Gamerith G, Kocher F. Non-pegylated liposomal doxorubicin in lymphoma: patterns of toxicity and outcome in a large observational trial. Ann Hematol. 2015;94(4):593–601.
  • Bieker R, Lerchenmüller C, Wehmeyer J, et al. Phase I study of liposomal daunorubicin in relapsed and refractory acute myeloid leukemia. Oncol Rep. 2003;10(4):915–920.
  • McTiernan A, Whelan J, Leahy M, et al. Nonrandomised open-label study of liposomal daunorubicin (DaunoXome) in advanced soft tissue sarcoma. Sarcoma. 2006;2006(1):41080.
  • Deeken JF, Slack R, Weiss GJ, et al. A phase I study of liposomal-encapsulated docetaxel (LE-DT) in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2013;71(3):627–633.
  • Strieth S, Dunau C, Michaelis U, et al. Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer. Head Neck. 2014;36(7):976–984.
  • Mahalingam D, Nemunaitis JJ, Malik L, et al. Phase I study of intravenously administered ATI-1123, a liposomal docetaxel formulation in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014;74(6):1241–1250.
  • Sarris AH, Hagemeister F, Romaguera J, et al. Liposomal vincristine in relapsed non-Hodgkin’s lymphomas: early results of an ongoing phase II trial. Ann Oncol. 2000;11(1):69–72.
  • O’Brien S, Schiller G, Lister J, et al. High-dose vincristine sulfate liposome injection for advanced, relapsed, and refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia. J Clin Oncol. 2013;31(6):676–683.
  • Stathopoulos GP, Boulikas T, Kourvetaris A, et al. Liposomal oxaliplatin in the treatment of advanced cancer: a phase I study. Anticancer Res. 2006;26(2B):1489–1493.
  • Jehn CF, Boulikas T, Kourvetaris A, et al. First safety and response results of a randomized phase III study with liposomal platin in the treatment of advanced squamous cell carcinoma of the head and neck (SCCHN). Anticancer Res. 2008;28(6B):3961–3964.
  • Booser DJ, Perez-Soler R, Cossum P, et al. Phase I study of liposomal annamycin. Cancer Chemother Pharmacol. 2000;46(5):427–432.
  • Pestalozzi BC, Schwendener R, Sauter C. Phase I/II study of liposome-complexed mitoxantrone in patients with advanced breast cancer. Ann Oncol. 1992;3(6):445–449.
  • Pestalozzi BC, Vass A, Adam H, et al. Phase II study of liposome complexed mitoxantrone in patients with advanced breast cancer. Eur J Cancer. 1995;31A(6):1024.
  • Yang J, Shi Y, Li C, et al. Phase I clinical trial of pegylated liposomal mitoxantrone plm60-s: pharmacokinetics, toxicity and preliminary efficacy. Cancer Chemother Pharmacol. 2014;74(3):637–646.
  • Chang TC, Shiah HS, Yang CH, et al. Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients. Cancer Chemother Pharmacol. 2015;75(3):579–586.
  • Ko AH, Tempero MA, Shan YS, et al. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013;109(4):920–925.
  • Infante JR, Keedy VL, Jones SF, et al. Phase I and pharmacokinetic study of IHL-305 (PEGylated liposomal irinotecan) in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012;70(5):699–705.
  • Zamboni WC, Ramalingan S, Friedland DM, et al. Phase I and pharmacokinetic study of pegylated liposomal CKD-602 in patients with advanced malignancies. Clin Cancer Res. 2009;15(4):1466–1472.
  • Kehrer DF, Bos AM, Verweij J, et al. Phase I and pharmacologic study of liposomal lurtotecan, NX 211: urinary excretion predicts hematologic toxicity. J Clin Oncol. 2002;20(5):1222–1231.
  • Duffaud F, Borner M, Chollet P, et al. EORTC-New Drug Development Group/New Drug Development Program. Phase II study of OSI-211 (lurtotecan) in patients with metastatic or loco-regional recurrent squamous cell carcinoma of the head and neck. An EORTC new drug development group study. Eur J Cancer. 2004;40(18):2748–2752.
  • Gelmon K, Hirte H, Fisher B, et al. A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers. Invest New Drugs. 2004;22(3):263–275.
  • Seiden MV, Muggia F, Astrow A, et al. A phase II study of liposomal lurtotecan (OSI-211) in patients with topotecan resistant ovarian cancer. Gynecol Oncol. 2004;93(1):229–232.
  • Yang SH, Lin CC, Lin ZZ, et al. A phase I and pharmacokinetic study of liposomal vinorelbine in patients with advanced solid tumor. Invest New Drugs. 2012;30(1):282–289.
  • Ibrahim NK, Desai N, Legha S, et al. Phase I and pharmacokinetic study of ABI-007, a Cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel. Clin Cancer Res. 2002;8(5):1038–1044.
  • Ibrahim NK, Samuels B, Page R, et al. Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. J Clin Oncol. 2005;23(25):6019–6026.
  • Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794–7803.
  • Teneriello MG, Tseng PC, Crozier M, et al. Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer. J Clin Oncol. 2009;27(9):1426–1431.
  • Alberts DS, Blessing JA, Landrum LM, et al. Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: a gynecologic oncology group study. Gynecol Oncol. 2012;127(3):451–455.
  • Hosein PJ, de Lima Lopes G Jr, Pastorini VH, et al. A phase II trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer. Am J Clin Oncol. 2013;36(2):151–156.
  • Sasaki Y, Nishina T, Yasui H, et al. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for un resectable or recurrent gastric cancer. Cancer Sci. 2014;105(7):812–817.
  • Palumbo R, Sottotetti F, Trifirò G, et al. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: prospective evaluation of activity, safety, and quality of life. Drug Des Devel Ther. 2015;9:2189–2199.
  • Yuan Y, Zhang Y, Shi L, et al. Clinical research on albumin-bound paclitaxel-based chemotherapy for advanced esophageal cancer. Asian Pac J Cancer Prev. 2015;16(12):4993–4996.
  • Takashima S, Kiyoto S, Takahashi M, et al. Clinical experience with nanoparticle albumin-bound paclitaxel, a novel taxane anti-cancer agent, and management of adverse events in females with breast cancer. Oncol Lett. 2015;9(4):1822–1826.
  • Saxena A, Schneider BJ, Christos PJ, et al. Treatment of recurrent and platinum-refractory stage IV non-small cell lung cancer with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as a single agent. Med Oncol. 2016;33(2):13.
  • Richards DA, Richards P, Bodkin D, et al. Efficacy and safety of paclitaxel poliglumex as first-line chemotherapy in patients at high risk with advanced-stage non-small-cell lung cancer: results of a phase II study. Clin Lung Cancer. 2005;7(3):215–220.
  • Boddy AV, Plummer ER, Todd R, et al. A phase I and pharmacokinetic study of paclitaxel poliglumex (XYOTAX), investigating both 3-weekly and 2-weekly schedules. Clin Cancer Res. 2005;11(21):7834–7840.
  • Lin NU, Parker LM, Come SE, et al. Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions. Invest New Drugs. 2007;25(4):369–375.
  • Sabbatini P, Sill MW, O’Malley D, et al. A phase II trial of paclitaxel poliglumex in recurrent or persistent ovarian or primary peritoneal cancer (EOC): a gynecologic oncology group study. Gynecol Oncol. 2008;111(3):455–460.
  • Mita M, Mita A, Sarantopoulos J, et al. Phase I study of paclitaxel poliglumex administered weekly for patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2009;64(2):287–295.
  • Lee KS, Chung HC, Im SA, et al. Multicenter phase II trail of genexol-PM, a cremophor-free, polymeric micelle formulation of paclitaxel, in patients with breast cancer. Breast Cancer Res Treat. 2008;108(2):241–250.
  • Von Hoff DD, Mita MM, Ramanathan RK, et al. Phase I stud of PSMA-targeted docetaxel-cointaining nanoparticle BIND-014 in patients with advanced solid tumors. Clin Cancer Res. 2016;22(13):3517–3563.
  • Vasey PA, Kaye SB, Morrison R, et al. Phase I clinical and pharmacokinetic study of PK1 [N-(2-hydroxypropyl) methacrylamide copolymer doxorubicin]: first member of a new class of chemotherapeutic agents-drug-polymer conjugates. Cancer Research Campaign Phase I/II Committee. Clin Cancer Res. 1999;5(1):83–94.
  • Seymour LW, Ferry DR, Kerr DJ, et al. Phase II studies of polymer-doxorubicin (PK1, FCE28068) in the treatment of breast, lung and colorectal cancer. Int J Oncol. 2009;34(6):1629–1636.
  • Danson S, Ferry D, Alakhov V, et al. Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer. Br J Cancer. 2004;90(11):2085–2091.
  • Weiss GJ, Chao J, Neidhart JD, et al. First-in-human phase 1/2a trial of CRLX101, a cyclodextrin-containig polymer-camptothecin nanopharmaceutical in patients with advanced solid tumor malignancies. Invest New Drugs. 2013;31(4):986–1000.
  • Ho YK, Smith RG, Brown MS, et al. Low-density lipoprotein (LDL) receptor activity in human acute myelogenous cells. Blood. 1978;52(6):1099–1114.
  • Brown MS, Goldstein JL. How LDL receptors influence cholesterol and atherosclerosis. Sci Am. 1984;251(5):58–66.
  • Lundberg B. Preparation of drug-low density lipoprotein complexes for delivery of antitumoral drugs via the low density lipoprotein pathway. Cancer Res. 1987;47(15):4105–4108.
  • Vitols S, Angelin B, Ericsson S, et al. Uptake of low density lipoproteins by humanleukemic cells in vivo: relation to plasma lipoprotein levels and possible relevance for selective chemotherapy. Proc Natl Acad Sci USA. 1990;87(7):2598–2602.
  • Maranhão RC, Garicochea B, Silva EL, et al. Increased plasma removal of microemulsions resembling the lipid phase of low-density lipoproteins (LDL) in patients with acute myeloid leukemia: a possible new strategy for the treatment of the disease. Braz J Med Biol Res. 1992;25(10):1003–1007.
  • Maranhão RC, Garicochea B, Silva EL, et al. Plasma kinetics and biodistribution of a lipid emulsion resembling low-density lipoprotein in patients with acute leukemia. Cancer Res. 1994;54(17):4660–4666.
  • Ades A, Carvalho JP, Graziani SR, et al. Uptake of a cholesterol-rich emulsion by neoplastic ovarian tissues. Gynecol Oncol. 2001;82(1):84–87.
  • Graziani SR, Igreja FAF, Hegg R, et al. Uptake of a cholesterol rich emulsion by breast cancer. Gynecol Oncol. 2002;85(3):493–497.
  • Maranhao RC, Graziani SR, Yamaguchi N, et al. Association of carmustine with a lipid emulsion: in vitro, in vivo and preminary studies in cancer patients. Cancer Chemother Pharmacol. 2002;49(6):487–498.
  • Azevedo CH, Carvalho JP, Valduga CJ, et al. Plasma kinetics and uptake by tumor of a cholesterol-rich microemulsion (LDE) associated to etoposide oleate in patients with ovarian carcinoma. Gynecol Oncol. 2005;97(1):178–182.
  • Dias ML, Carvalho JP, Rodrigues DG, et al. Pharmacokinetics and tumor uptake of a derivatized form of paclitaxel associated to a cholesterol-rich nanoemulsion (LDE) in patients with gynecologic cancers. Cancer Chemother Pharmacol. 2007;59(1):105–111.
  • Moura JA, Valduga CJ, Tavares ER, et al. Novel formulation of a methotrexate derivative with a lipid nanoemulsion. Int J Nanomedicine. 2011;6:2285–2295.
  • Teixeira RS, Valduga CJ, Benvenutti LA, et al. Delivery of daunorubicin to cancer cells with decreased toxicity by association with a lipidic nanoemulsion that binds to LDL receptors. J Pharm Pharmacol. 2008;60(10):1287–1295.
  • Hungria VTM, Latrilha MCM, Rodrigues DG, et al. Metabolism of a cholesterol-rich microemulsion (LDE) in patients with multiple myeloma and a preliminary clinical study of LDE as a drug vehicle for the treatment of the disease. Cancer Chemother Pharmacol. 2004;53(1):51–60.
  • Pinheiro KV, Hungria VT, Ficker ES, et al. Plasma kinetics of a cholesterol-rich microemulsion (LDE) in patients with Hodgkin´s and non-Hodgkin´s lymphoma and a preliminary study on the toxicity of etoposide associated with LDE. Cancer Chemoter Pharmacol. 2006;57(5):624–630.
  • Pires LA, Hegg R, Valduga CJ, et al. Use of cholesterol-rich nanoparticles that bind to lipoprotein receptors as a vehicle to paclitaxel in the treatment of breast cancer: pharmacokinetics, tumor uptake and a pilot clinical study. Cancer Chemother Pharmacol. 2009;63(2):281–287.
  • Graziani SR, Vital CG, Van Eyll BM, et al. Preliminary results of patients with advanced ovarian carcinoma treated with paclitaxel associated to nanoemulsions. J Clin Oncol. 2015;33(suppl; abstr e16539.).
  • Maranhão RC, Tavares ER. Advances in non-invasive drug delivery for atherosclerotic heart disease. Expert Opin Drug Deliv. 2014;12(7):1–13.
  • Shiozaki AA, Senra T, Morikawa AT, et al. Treatment of patients with aortic atherosclerotic disease with paclitaxel-associated lipid nanoparticles. Clinics. 2016;71(8):435–439.
  • Perez-Herrero E, Fernandez-Medarde A. Advanced targeted therapies in cancer: drug nanocarriers, the future of chemotherapy. Eur J Pharm Biopharm. 2015;93:52–59.
  • Lu H, Zhang H, Zhang D, et al. A biocompatible reconstituted high-density lipoprotein nano-system as a probe for lung cancer detection. Med Sci Monit. 2015;21:2726–2733.

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