Paclitaxel: What has been done and the challenges remain ahead

International Journal of Pharmaceutics - Tập 526 - Trang 474-495 - 2017
Ezequiel Bernabeu1,2, Maximiliano Cagel1,2, Eduardo Lagomarsino3, Marcela Moretton1,2, Diego A. Chiappetta1,4
1Universidad de Buenos Aires, Facultad de Farmacia y Bioquímica, Cátedra de Tecnología Farmacéutica I, Buenos Aires, Argentina
2Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Argentina
3Universidad de Buenos Aires, Facultad de Farmacia y Bioquímica, Cátedra de Farmacia Clínica y Asistencial, Buenos Aires, Argentina
4Consejo Nacional de Investigaciones Científicas y Técnicas, Conicet, Argentina

Tài liệu tham khảo

Adler, 1994, Analysis of exposure times and dose escalation of paclitaxel in ovarian cancer cell lines, Cancer, 74, 1891, 10.1002/1097-0142(19941001)74:7<1891::AID-CNCR2820740711>3.0.CO;2-K Ahn, 2014, A phase II trial of Cremorphor EL-free paclitaxel (Genexol-PM) and gemcitabine in patients with advanced non-small cell lung cancer, Cancer Chemother. Pharmacol., 74, 277, 10.1007/s00280-014-2498-5 Albain, 2006, PIONEER: a phase III randomized trial of paclitaxel poliglumex versus paclitaxel in chemotherapy-naive women with advanced-Stage non-Small-Cell lung cancer and performance status of 2, Clin. Lung Cancer, 7, 417, 10.3816/CLC.2006.n.027 Alva, 2014, Phase II trial of combination nab–paclitaxel, carboplatin and gemcitabine in first line therapy of advanced urothelial carcinoma, Invest. New Drugs, 188, 10.1007/s10637-013-0054-5 American Cancer Society, 2016 Autio, 2016, A phase 2 study of BIND-014 (PSMA-targeted docetaxel nanoparticle) administered to patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), Genitourinary Cancers Symposium Awada, 2014, A randomized controlled phase ii trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (tnbc), Ann. Oncol., 25, 824, 10.1093/annonc/mdu025 Bölükbas, 2015, Lung cancer nanomedicine: potentials and pitfalls, Nanomedicine (Lond)., 10, 3203, 10.2217/nnm.15.155 Büssing, 2000 Band Horwitz, 1992, Mechanism of action of taxol, Trends Pharmacol. Sci., 13, 134, 10.1016/0165-6147(92)90048-B Bedikian, 2004, Phase II evaluation of paclitaxel by short intravenous infusion in metastatic melanoma, Melanoma Res., 14, 63, 10.1097/00008390-200402000-00010 Bedikian, 2011, Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma, Ann. Oncol., 22, 787, 10.1093/annonc/mdq438 Bernabeu, 2016, Novel Soluplus®-TPGS mixed micelles for encapsulation of paclitaxel with enhanced in vitro cytotoxicity on breast and ovarian cancer cell lines, Colloids Surf. B Biointerfaces, 140, 403, 10.1016/j.colsurfb.2016.01.003 Bernabeu, 2016, Paclitaxel-loaded TPGS-b-PCL nanoparticles: in vitro cytotoxicity and cellular uptake in MCF-7 and MDA-MB-231Cells versus mPEG-b-PCL nanoparticles and Abraxane®, J. Nanosci. Nanotechnol., 16, 160, 10.1166/jnn.2016.10739 Blum, 2007, Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes, Clin. Breast Cancer, 7, 850, 10.3816/CBC.2007.n.049 Boddy, 2005, A phase I and pharmacokinetic study of paclitaxel poliglumex (XYOTAX), investigating both 3-weekly and 2-weekly schedules, Clin. Cancer Res., 11, 7834, 10.1158/1078-0432.CCR-05-0803 Bode, 2009, Paclitaxel encapsulated in cationic liposomes: a new option for neovascular targeting for the treatment of prostate cancer, Oncol. Rep., 22, 321 Bosselmann, 2012, Has nanotechnology led to improved therapeutic outcomes? Has nanotechnology led to improved therapeutic outcomes?, Drug Dev. Ind. Pharm., 38, 157, 10.3109/03639045.2011.597764 Bradley, 2001, Tumor targeting by covalent conjunction of a natural fatty acid to paclitaxel, Clin. Cancer Res., 22, 3229 Burris, 1997, Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial, J. Clin. Oncol., 15, 2403, 10.1200/JCO.1997.15.6.2403 Cabanes, 1998, Comparative in vivo studies with paclitaxel and liposome-encapsulated paclitaxel, Int. J. Oncol., 12, 1035 Cagel, 2016, Doxorubicin: nanotechnological overviews from bench to bedside, Drug Discov. Today, 22, 270, 10.1016/j.drudis.2016.11.005 Cantù, 2002, Randomized controlled trial of single-agent paclitaxel versus cyclophosphamide, doxorubicin, and cisplatin in patients with recurrent ovarian cancer who responded to first-line platinum-based regimens, J. Clin. Oncol., 20, 1232, 10.1200/JCO.2002.20.5.1232 Celgene, 2016 Cell Therapeutics, I, 2009 Chang, 1997, Dose-escalation study of weekly 1-hour paclitaxel administration in patients with refractory cancer, Semin. Oncol., 5 Chipman, 2006, Biological and clinical characterization of paclitaxel poliglumex (PPX, CT-2103), a macromolecular polymer-drug conjugate, Int. J. Nanomed., 1, 375, 10.2147/nano.2006.1.4.375 Clinical Trials NCT00108745, 2016 ClinicalTrials.gov NCT01537536, 2013 ClinicalTrials.gov NCT03002103, 2016 Coleman, 2011, Gynecologic Oncology A phase II evaluation of nanoparticle, albumin-bound (nab) paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: a Gynecologic Oncology Group Study, Gynecol. Oncol., 122, 111, 10.1016/j.ygyno.2011.03.036 Connolly, 2013, Current approaches for neoadjuvant chemotherapy in breast cancer Roisin, Eur. J. Pharmacol., 717, 58, 10.1016/j.ejphar.2013.02.057 Conroy, 2011, Tumeurs digestives of unicancer, PRODIGE intergroup, 2011. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer, N. Engl. J. Med., 364, 1817, 10.1056/NEJMoa1011923 Damascelli, 2001, Intraarterial chemotherapy with polyoxyethylated castor oil free paclitaxel, incorporated in albumin nanoparticles (ABI-007): Phase II study of patients with squamous cell carcinoma of the head and neck and anal canal: preliminary evidence of clinical act, Cancer, 92, 2592, 10.1002/1097-0142(20011115)92:10<2592::AID-CNCR1612>3.0.CO;2-4 Derry, 1995, Substoichiometric binding of taxol suppresses microtubule dynamics, Biochemistry, 34, 2203, 10.1021/bi00007a014 Desai, 2006, Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel, Clin. Cancer Res., 12, 1317, 10.1158/1078-0432.CCR-05-1634 Desai, 2012, Challenges in development of nanoparticle-based therapeutics, AAPS J., 14, 282, 10.1208/s12248-012-9339-4 Dranitsaris, 2009, Economic analysis of albumin-bound paclitaxel for the treatment of metastatic breast cancer, J. Oncol. Pharm. Pract., 15, 67, 10.1177/1078155208098584 Driscoll, 2009, Overall Survival: still the Gold Standard: why overall survival remains the definitive end point in cancer clinical trials, Cancer J., 15, 401, 10.1097/PPO.0b013e3181bdc2e0 Duncan, 2010, Do HPMA copolymer conjugates have a future as clinically useful nanomedicines? A critical overview of current status and future opportunities, Adv. Drug Deliv. Rev., 62, 272, 10.1016/j.addr.2009.12.005 Duncan, 2009, Development of HPMA copolymer–anticancer conjugates: clinical experience and lessons learnt, Adv. Drug Deliv. Rev., 61, 1131, 10.1016/j.addr.2009.05.007 Ehrlich, 2004, Micellar paclitaxel improves severe psoriasis in a prospective phase II pilot study, J. Am. Acad Dermatol., 60, 533, 10.1016/j.jaad.2003.09.018 Eichhorn, 2006, Paclitaxel encapsulated in cationic lipid complexes (MBT-0206) impairs functional tumor vascular properties as detected by dynamic contrast enhanced magnetic resonance imaging, Cancer Biol. Ther., 5, 89, 10.4161/cbt.5.1.2346 Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur. J. Cancer, 45, 228, 10.1016/j.ejca.2008.10.026 Etheridge, 2013, The big picture on nanomedicine: the state of investigational and approved nanomedicine products, Nanomed. Nanotechnol. Biol. Med., 9, 1, 10.1016/j.nano.2012.05.013 Fang, 2011, The EPR effect: unique features of tumor blood vessels for drug delivery, factors involved, and limitations and augmentation of the effect, Adv. Drug Deliv. Rev., 63, 136, 10.1016/j.addr.2010.04.009 Fauzee, 2011, Taxanes: promising anti-Cancer drugs, Asian Pacific J. Cancer Prev., 12, 837 Feng, 2016, Anticancer nanoparticulate polymer-drug conjugate, Bioeng. Transl. Med., 1 Ferber, 2014, Polymeric nanotheranostics for real-time non-invasive optical imaging of breast cancer progression and drug release, Cancer Lett., 352, 81, 10.1016/j.canlet.2014.02.022 Fetterly, 2008, Pharmacokinetic/pharmacodynamic modeling and simulation of neutropenia during phase I development of liposome-entrapped paclitaxel, Clin. Cancer Res., 14, 5856, 10.1158/1078-0432.CCR-08-1046 Fong, 2013, MTR120/KIAA1383, a novel microtubule-associated protein, promotes microtubule stability and ensures cytokinesis, J. Cell Sci., 126, 825, 10.1242/jcs.116137 Food and Drug Administration, 2007. U.S. Department of Health and Human Services. Food and Drug Administration Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologic [WWW Document]. Fu, 2009, Medicinal chemistry of paclitaxel and its analogues, Curr. Med. Chem., 16, 3966, 10.2174/092986709789352277 Gelderblom, 2001, Cremophor EL: The drawbacks and advantages of vehicle selection for drug formulation, Eur. J. Cancer, 37, 1590, 10.1016/S0959-8049(01)00171-X Giaccone, 1998, Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small-cell lung cancer, J. Clin. Oncol., 16, 2133, 10.1200/JCO.1998.16.6.2133 Gianni, 1995, Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans recently, J. Clin. Oncol., 13, 180, 10.1200/JCO.1995.13.1.180 Giodini, 2016, Nanocarriers in cancer clinical practice: a pharmacokinetic issue, Nanomed. Nanotechnol. Biol. Med., 1 Gradishar, 2005, Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer, J. Clin. Oncol., 23, 7794, 10.1200/JCO.2005.04.937 Gradishar, 2009, Significantly longer progression-free survival with nab–paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer, J. Clin. Oncol., 27, 3611, 10.1200/JCO.2008.18.5397 Green, 2006, non-small-cell lung cancer, Ann. Oncol., 1263, 10.1093/annonc/mdl104 Gref, 2000, Stealth corona-core nanoparticles surface modified by polyethylene glycol (PEG): influences of the … composition on phagocytic uptake and plasma protein, Colloids Surf. B Biointerfaces, 18, 301, 10.1016/S0927-7765(99)00156-3 Griffon-etienne, 1999, Taxane-induced apoptosis decompresses blood vessels and lowers interstitial fluid pressure in solid tumors: clinical implications, Canccer Res., 3776 Grilley-Olson, 2015, Clinical trial results a randomized phase II study of carboplatin with weekly or every-3-week nanoparticle albumin-bound paclitaxel (Abraxane) in patients with extensive-stage small cell lung cancer, Oncologist, 20, 105, 10.1634/theoncologist.2014-0327 Guéritte-Voegelein, 1991, Relationships between the structure of taxol analogues and their antimitotic activity, J. Med. Chem., 34, 992, 10.1021/jm00107a017 Guan, 2009, Superior efficacy of a cremophor-free albumin-bound paclitaxel compared with solvent-based paclitaxel in chinese patients with metastatic breast cancer, Asia. Pac. J. Clin. Oncol., 5, 165, 10.1111/j.1743-7563.2009.01235.x Guo, 2006, Taxol synthesis, Afr. J. Biotechnol., 5, 15 Gustafson, 2015, Nanoparticle uptake: the phagocyte problem, Nano Today, 10, 487, 10.1016/j.nantod.2015.06.006 Hama, 2015, Overcoming the polyethylene glycol dilemma via pathological environment-sensitive change of the surface property of nanoparticles for cellular entry, J. Control. Release, 206, 67, 10.1016/j.jconrel.2015.03.011 Hamaguchi, 2005, NK105, a paclitaxel-incorporating micellar nanoparticle formulation, can extend in vivo antitumour activity and reduce the neurotoxicity of paclitaxel, Br. J. Cancer, 92, 1240, 10.1038/sj.bjc.6602479 Hamaguchi, 2007, A phase I and pharmacokinetic study of NK105, a paclitaxel- incorporating micellar nanoparticle formulation, Br. J. Cancer, 97, 170, 10.1038/sj.bjc.6603855 Hersh, 2010, A phase 2 clinical trial of nab–paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma, Cancer, 116, 155 Hersh, 2012, Phase 3, randomized, open-label, multicenter trial of nab-paclitaxel (nab-P) vs dacarbazine (DTIC) in previously untreated patients with metastatic malignant melanoma (MMM), in: society for Melanoma Research 2012 Congress, Pigment Cell Melanoma Res., 836 Hillery, 2016, Coclusions Hollis, 2014, In vivo investigation of hybrid paclitaxel nanocrystals with dual fluorescent probes for cancer theranostics, Pharm. Res., 31, 1450, 10.1007/s11095-013-1048-x Homsi, 2009, Phase 2 open-label study of weekly docosahexaenoic acid-paclitaxel in cutaneous and mucosal metastatic melanoma patients, Melanoma Res., 19, 238, 10.1097/CMR.0b013e32832a1e2f Ibrahim, 2002, Phase I and pharmacokinetic study of ABI-007, a cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel 1, Clin. Cancer Res., 8, 1038 Ibrahim, 2005, Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic Breast cancer, J. Clin. Oncol., 23, 6019, 10.1200/JCO.2005.11.013 Itokawa, 2003, Taxoids occuring in the genus Taxus, 35 Iyer, 2006, Exploiting the enhanced permeability and retention effect for tumor targeting, Drug Discov. Today, 11, 812, 10.1016/j.drudis.2006.07.005 Jones, 2005, Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer, J. Clin. Oncol., 23, 5542, 10.1200/JCO.2005.02.027 Jones, 2008, A phase II open-label study of DHA-paclitaxel (Taxoprexin) by 2-h intravenous infusion in previously untreated patients with locally advanced or metastatic gastric or oesophageal adenocarcinoma, Cancer Chemother. Pharmacol., 61, 435, 10.1007/s00280-007-0486-8 Kampan, 2015, Paclitaxel and its evolving role in the management of ovarian cancer, BioMed Res. Int., 2015, 413076, 10.1155/2015/413076 Kato, 2012, Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle, for previously treated advanced or recurrent gastric cancer, Invest. New Drugs, 30, 1621, 10.1007/s10637-011-9709-2 Kearns, 1997, Pharmacokinetics of the taxanes, Pharmacotherapy, 17, 105 Kim, 2001, In vivo evaluation of polymeric micellar paclitaxel formulation: toxicity and efficacy, J. Control. Release, 72, 191, 10.1016/S0168-3659(01)00275-9 Kim, 2004, Phase I and pharmacokinetic study of Genexol-PM, a Cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies, Clin. Cancer Res., 10, 3708, 10.1158/1078-0432.CCR-03-0655 Kim, 2007, Multicenter phase II trial of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer, Ann. Oncol., 18, 2009, 10.1093/annonc/mdm374 Kim, 2016, Multifunctional theranostic nanomedicine for photoacoustic imaging-Guided combination tumor treatment, J. Nanosci. Nanotechnol., 16, 11903, 10.1166/jnn.2016.13615 Know, 2012, Analysis on the current status of targeted drug delivery to tumors, J. Control. Release, 164 Kottschade, 2011, A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma, Cancer, 117, 1704, 10.1002/cncr.25659 Kulve, 2013, Economic and societal dimensions of nanotechnology-enabled drug delivery, Expert Opin. Drug Deliv., 10, 611, 10.1517/17425247.2013.770467 Kunstfeld, 2003, Paclitaxel encapsulated in cationic liposomes diminishes tumor angiogenesis and melanoma growth in a humanized SCID mouse model, J. Invest. Dermatol., 120, 476, 10.1046/j.1523-1747.2003.12057.x Langer, 2008, Randomized phase III trial comparing single-agent paclitaxel poliglumex (CT-2103, PPX) with single-agent gemcitabine or vinorelbine for the treatment of PS 2 patients with chemotherapy-Naïve advanced non-small cell lung cancer, J. Thorac. Oncol., 3, 728, 10.1097/JTO.0b013e3181753b4b Ledford, 2016, Bankruptcy of nanomedicine firm worries drug developers, Nature, 533, 304, 10.1038/533304a Lee, 2008, Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer, Breast Cancer Res. Treat., 108, 241, 10.1007/s10549-007-9591-y Legha, 1986, Phase I study of taxol using a 5-day intermittent schedule, J. Clin. Oncol., 4, 762, 10.1200/JCO.1986.4.5.762 Li, 1998, Complete regression of well-established tumors using a novel water-soluble poly(L-glutamic acid) paclitaxel conjugate, Cancer Res., 58, 2404 Li, 1999, Antitumor activity of poly(L-glutamic acid)-paclitaxel on syngeneic and xenografted tumors, Clin. Cancer Res., 5, 891 Li, 2000, Biodistribution of paclitaxel and poly(L-glutamic acid)-paclitaxel conjugate in mice with ovarian OCa-1 tumor, Cancer Chemother. Pharmacol., 46, 416, 10.1007/s002800000168 Lim, 2009, Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors, Ann. Oncol., 21, 382, 10.1093/annonc/mdp315 Lin, 2007, 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, 25, 369, 10.1007/s10637-007-9034-y Liu, 2007, Nanomedicine for drug delivery and imaging: a promising avenue for cancer therapy and diagnosis using targeted functional nanoparticles, Int. J. Cancer, 120, 2527, 10.1002/ijc.22709 Liu, 2015, Theranostic polymeric micelles for the diagnosis and treatment of hepatocellular carcinoma, J. Biomed. Nanotechnol., 11, 613, 10.1166/jbn.2015.1945 Lohr, 2011, Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial, Ann. Oncol. Ma, 2013, Paclitaxel nano-delivery systems: a comprehensive review, J. Nanomed. Nanotechnol., 4, 1000164, 10.4172/2157-7439.1000164 Madaan, 2013, Efficiency and mechanism of intracellular paclitaxel delivery by novel nanopolymer-based tumor-targeted delivery system, Nanoxel?, Clon. Transl. Oncol., 15, 26, 10.1007/s12094-012-0883-2 Maeda, 2009, Polymeric drugs for efficient tumor-targeted drug delivery based on EPR-effect, Eur. J. Pharm. Biopharm., 71, 409, 10.1016/j.ejpb.2008.11.010 Mangaiyarkarasi, 2016, Journal of magnetism and magnetic materials paclitaxel conjugated Fe3O4@aF3: Ce3þ, Tb3þ nanoparticles as bifunctional targeting carriers for cancer theranostics application, J. Magn. Magn. Mater., 399, 207, 10.1016/j.jmmm.2015.09.084 Markman, 2002, Phase II trial of weekly single-agent paclitaxel in platinum/paclitaxel-refractory ovarian cancer, J. Clin. Oncol., 20, 2365, 10.1200/JCO.2002.09.130 Marupudi, 2007, Paclitaxel: a review of adverse toxicities and novel delivery strategies, Expert Opin. Drug Saf., 6, 609, 10.1517/14740338.6.5.609 McGuire, 1989, Taxol: a unique antineoplastic agent with significant activity in advanced ovarian epithelial neoplasms, Ann. Intern. Med., 111, 273, 10.7326/0003-4819-111-4-273 Miele, 2009, Albumin-bound formulation of paclitaxel (Abraxane ABI-007) in the treatment of breast cancer, Int. J. Nanomed., 4, 99 Min, 2015, Clinical translation of nanomedicine, Chem. Rev., 115, 11147, 10.1021/acs.chemrev.5b00116 Mita, 2009, Phase i study of paclitaxel poliglumex administered weekly for patients with advanced solid malignancies, Cancer Chemother. Pharmacol., 64, 287, 10.1007/s00280-008-0869-5 Molino, 2012, Complement activation and cell uptake responses toward polymer-functionalized protein nanocapsules, Biomacromolecules, 13, 974, 10.1021/bm300083e Moore, 2007, Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group, J. Clin. Oncol., 25, 1960, 10.1200/JCO.2006.07.9525 Morgan, 2009, Paclitaxel poliglumex and carboplatin as first-line therapy in ovarian, peritoneal or fallopian tube cancer: a phase I and feasibility trial of the gynecologic oncology group, Gynecol. Oncol., 110, 329, 10.1016/j.ygyno.2008.05.008 Nabholtz, 1996, Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer, J. Clin. Oncol., 14, 1858, 10.1200/JCO.1996.14.6.1858 Nemunaitis, 2005, Phase I study of CT-2103, a polymer-conjugated paclitaxel, and carboplatin in patients with advanced solid tumors, Cancer Invest., 23, 671, 10.1080/07357900500359935 NeoPharm, 2016 Nichols, 2014, EPR: evidence and fallacy, J. Control. Release, 190, 451, 10.1016/j.jconrel.2014.03.057 Northfelt, 1996, Doxorubicin encapsulated in liposomes containing surface-bound polyethylene glycol: pharmacokinetics, tumor localization, and safety in patients with AIDS-related Kaposi’s sarcoma, J. Clin. Pharmacol., 36, 55, 10.1002/j.1552-4604.1996.tb04152.x Nowak, 2004, Systematic review of taxane-containing versus non-taxane-containing regimens for adjuvant and neoadjuvant treatment of early breast cancer, Lancet Oncol., 5, 372, 10.1016/S1470-2045(04)01494-9 Nyman, 2005, Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies, J. Clin. Oncol., 23, 7785, 10.1200/JCO.2004.00.6148 O’Brien, 2008, Randomized phase III trial comparing single-agent paclitaxel poliglumex (CT-2103, PPX) with single-agent gemcitabine or vinorelbine for the treatment of PS2 patients with chemotherapy-Naïve advanced non-small cell lung cancer, J. Thorac. Oncol., 3, 728, 10.1097/JTO.0b013e31817c6b68 Oasmia, 2015 Oasmia, 2016 Ojha, 2015, Image-guided drug delivery: preclinical applications and clinical translation, Expert Opin. Drug Deliv., 12 Okuma, 2016, A phase II study of nanoparticle albumin – bound paclitaxel plus carboplatin as the first – line therapy in elderly patients with previously untreated advanced non – small cell lung cancer, Cancer Chemother. Pharmacol., 78, 383, 10.1007/s00280-016-3092-9 Owens, 2006, Opsonization, biodistribution, and pharmacokinetics of polymeric nanoparticles, Int. J. Pharm., 307, 93, 10.1016/j.ijpharm.2005.10.010 Panchagnula, 1998, Pharmaceutical aspects of paclitaxel, Int. J. Pharm., 172, 1, 10.1016/S0378-5173(98)00188-4 Park, 2004, A multi-center, late phase II clinical trial of Genexol (paclitaxel) and cisplatin for patients with advanced gastric cancer, Oncol. Rep., 12, 1059 Payne, 2006, DHA-paclitaxel (Taxoprexin) as first-line treatment in patients with stage IIIB or IV non-small cell lung cancer: report of a phase II open-label multicenter trial, J. Thorac. Oncol., 1, 984, 10.1016/S1556-0864(15)31631-2 Paz-Ares, 2008, Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer, Br. J. Cancer, 98, 1608, 10.1038/sj.bjc.6604372 Pazdur, 2008, Endpoints for assessing drug activity in clinical trials, Oncologist, 13, 19, 10.1634/theoncologist.13-S2-19 Prabhakar, 2013, Challenges and key considerations of the enhanced permeability and retention (EPR) effect for nanomedicine drug delivery in oncology, Cancer Res., 73, 2412, 10.1158/0008-5472.CAN-12-4561 Ramalingam, 2004, Paclitaxel for non-small cell lung cancer, Expert Opin. Pharmacother., 5, 1771, 10.1517/14656566.5.8.1771 Ranade, 2008, A novel, cremophor-free, polymeric nanoparticle paclitaxel (do/ndr/02) multicenter study in advanced/metastatic breast cancer, J. Clin Oncol., 26, 10.1200/jco.2008.26.15_suppl.1115 Ranade, 2013, A multicenter phase II randomized study of Cremophor-free polymeric nanoparticle formulation of paclitaxel in women with locally advanced and/or metastatic breast cancer after failure of anthracycline, Asia Pac. J. Clin. Oncol., 9, 176, 10.1111/ajco.12035 Ranade, 2013, Clinical and economic implications of the use of nanoparticle paclitaxel (Nanoxel) in India, Ann. Oncol., 24 Reck, 2003, Randomized phase III trial of paclitaxel, etoposide, and carboplatin versus carboplatin, etoposide, and vincristine in patients with small-cell lung cancer, J. Natl. Cancer Inst., 95, 1118, 10.1093/jnci/djg017 Richards, 2005, 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, 7, 215, 10.3816/CLC.2005.n.039 Richheimer, 1992, High-performance liquid chromatographic assay of taxol, Anal. Chem., 64, 2323, 10.1021/ac00044a004 Rizvi, 2008, Phase I/II trial of weekly intravenous 130-nm albumin- bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer, J. Clin. Oncol., 26, 639, 10.1200/JCO.2007.10.8605 Rosell, 2002, Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial, Ann. Oncol., 13, 1539, 10.1093/annonc/mdf332 Rowe, 2009 Rowinsky, 1995, Paclitaxel (taxol), N. Engl J. Med., 332, 1014, 10.1056/NEJM199504133321507 Rugo, 2015, Randomized phase III trial of paclitaxel once per week compared with nanoparticle albumin-bound nab-paclitaxel once per week or ixabepilone with bevacizumab as first-line chemotherapy for locally recurrent or metastatic breast cancer: CALGB 40502/NCCTG N0, J. Clin. Oncol., 33, 2361, 10.1200/JCO.2014.59.5298 Sabbatini, 2004, Phase II study of CT-2103 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, J. Clin. Oncol., 22, 4523, 10.1200/JCO.2004.12.043 Sabbatini, 2008, A phase II trial of paclitaxel poliglumex in recurrent or persistent ovarian or primary peritoneal cancer (EOC): A gynecologic oncology group study, Gynecol. Oncol., 111, 455, 10.1016/j.ygyno.2008.07.049 Saif, 2010, Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer, Cancer, 7907, 186 Schiff, 1979, Promotion of microtubule assembly in vitro by taxol, Nature, 277, 665, 10.1038/277665a0 Schmitt-Sody, 2003, Neovascular targeting therapy: paclitaxel encapsulated in cationic liposomes improves antitumoral efficacy, Clin. Cancer Res., 9, 2335 Scripture, 2006, Peripheral neuropathy induced by paclitaxel: recent insights and future perspectives, Curr. Neuropharmacol., 4, 165, 10.2174/157015906776359568 Seidman, 1998, Dose-dense therapy with weekly 1-hour paclitaxel infusion in the treatment of metastatic breast cancer, J. Clin. Oncol., 16, 3353, 10.1200/JCO.1998.16.10.3353 Shaffer, 2007, In vitro and in vivo metabolism of paclitaxel poliglumex: identi W cation of metabolites and active proteases, Cancer Chemother. Pharmacol., 59, 537, 10.1007/s00280-006-0296-4 Shen, 2015, Bypassing the EPR effect with a nanomedicine harboring a sustained-release function allows better tumor control, Int. J. Nanomed., 10, 2485 Singer, 2003, Poly-(L)-glutamic acid-paclitaxel (CT-2103) [XYOTAX™], a biodegradable polymeric drug conjugate, 81 Singer, 2005, Paclitaxel poliglumex (XYOTAX k, CT-2103): a macromolecular taxane, J. Control. Release, 109, 120, 10.1016/j.jconrel.2005.09.033 Singla, 2002, Paclitaxel and its formulations, Int. J. Pharm., 235, 179, 10.1016/S0378-5173(01)00986-3 Slingerland, 2013, Bioequivalence of liposome-entrapped paclitaxel easy-to-use (LEP-ETU) formulation and paclitaxel in polyethoxylated castor oil: a randomized, two-period crossover study in patients with advanced cancer, Clin. Ther., 35, 1946, 10.1016/j.clinthera.2013.10.009 Snyder, 2001, The binding conformation of Taxol in β-tubulin: a model based on electron crystallographic density, Proc. Natl. Acad. Sci., 98, 5312, 10.1073/pnas.051309398 Socinski, 1999, Single-agent paclitaxel in the treatment of advanced non-small cell lung cancer, Oncologist, 4, 408, 10.1634/theoncologist.4-5-408 Soepenberg, 2004, Real-time pharmacokinetics guiding clinical decisions: phase I study of a weekly schedule of liposome encapsulated paclitaxel in patients with solid tumours, Eur. J. Cancer, 40, 681, 10.1016/j.ejca.2003.11.027 Sonnichsen, 1994, Clinical pharmacokinetics of paclitaxel, Clin. Pharmacokinet., 27, 256, 10.2165/00003088-199427040-00002 Soo, 2009, Nano-sized advanced delivery systems as parenteral formulation strategies for hydrophobic anti-cancer drugs, Nanotechnology in Drug Delivery, 10.1007/978-0-387-77668-2_12 Sparreboom, 1999, Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications advances in brief cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications, Cancer Res., 59, 1454 Sparreboom, 2005, Cancer therapy: clinical comparative preclinical and clinical pharmacokinetics of a (ABI-007) and paclitaxel formulated in cremophor (Taxol), Clin. Cancer Res., 11, 4136, 10.1158/1078-0432.CCR-04-2291 Strieth, 2004, Neovascular targeting chemotherapy: encapsulation of paclitaxel in cationic liposomes impairs functional tumor microvasculature, Int. J. Cancer, 110, 117, 10.1002/ijc.20083 Strieth, 2008, Paclitaxel encapsulated in cationic liposomes increases tumor microvessel leakiness and improves therapeutic efficacy in combination with cisplatin, Clin. Cancer Res., 14, 4603, 10.1158/1078-0432.CCR-07-4738 Strieth, 2014, 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, 36, 976, 10.1002/hed.23397 Svenson, 2014, What nanomedicine in the clinic right now really forms nanoparticles? Wiley Interdiscip, Rev. Nanomed. Nanobiotechnol., 6, 125, 10.1002/wnan.1257 Taghian, 2005, Paclitaxel decreases the interstitial fluid pressure and improves oxygenation in breast cancers in patients treated with neoadjuvant chemotherapy: clinical implications, J. Clin. Oncol., 23, 1951, 10.1200/JCO.2005.08.119 ten Tije, 2003, Pharmacological effects of formulation vehicles, Clin. Pharmacokinet., 42, 665, 10.2165/00003088-200342070-00005 Teneriello, 2009, Phase II evaluation of nanoparticle albumin–bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer, J. Clin. Oncol., 27 Terwogt, 2001, Phase I clinical and pharmacokinetic study of PNU166945, a novel water-soluble polymer-conjugated prodrug of paclitaxel, Anticancer Drugs, 12, 315, 10.1097/00001813-200104000-00003 Tran, 2017, Fattigation-platform theranostic nanoparticles for cancer therapy, Mater. Sci. Eng. C, 75, 1161, 10.1016/j.msec.2017.03.012 Untch, 2016, Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto—GBG 69): a randomised, phase 3 trial, Lancet Oncol., 17, 345, 10.1016/S1470-2045(15)00542-2 van Elk, 2016, Nanomedicines for advanced cancer treatments: transitioning towards responsive systems, Int. J. Pharm., 515, 132, 10.1016/j.ijpharm.2016.10.013 van Gaal, 2015, Polymeric micelles, 11 Veronese, 2005, Phase I study of the novel taxane CT-2103 in patients with advanced solid tumors, Cancer Chemother. Pharmacol., 55, 497, 10.1007/s00280-004-0938-3 Verschraegen, 2009, A phase I and pharmacokinetic study of paclitaxel poliglumex and cisplatin in patients with advanced solid tumors, Cancer Chemother. Pharmacol., 63, 903, 10.1007/s00280-008-0813-8 Von Hoff, 2011, Gemcitabine plus nab–Paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial, J. Clin. Oncol., 29, 12, 10.1200/JCO.2011.36.5742 Von Hoff, 2013, Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine, N. Engl. J. Med., 369, 1691, 10.1056/NEJMoa1304369 Von Hoff, 2016, Phase I study of PSMA-targeted docetaxel-containing nanoparticle BIND-014 in patients with advanced solid tumors, Clin. Cancer Res., 22, 3157, 10.1158/1078-0432.CCR-15-2548 Würmseher, 2017, Nanobiotech in big pharma: a business perspective, Nanomedicine (Lond)., 12, 535, 10.2217/nnm-2016-0348 Walkey, 2012, Nanoparticle size and surface chemistry determine serum protein adsorption and macrophage uptake, J. Am. Chem. Soc., 134, 2139, 10.1021/ja2084338 Wall, 1998, Camptothecin and taxol: discovery to clinic, Med. Res. Rev., 18, 299, 10.1002/(SICI)1098-1128(199809)18:5<299::AID-MED2>3.0.CO;2-O Wang, 2010, A phase I clinical and pharmacokinetic study of paclitaxel liposome infused in non-small cell lung cancer patients with malignant pleural effusions, Eur. J. Cancer, 46, 1474, 10.1016/j.ejca.2010.02.002 Wang, 2012, Nanoparticle delivery of cancer drugs, Annu. Rev. Med., 63, 185, 10.1146/annurev-med-040210-162544 Wang, 2013, Hypersensitivity reaction studies of a polyethoxylated castor oil-free, liposome-based alternative paclitaxel formulation, Mol. Med. Rep., 7, 947, 10.3892/mmr.2013.1264 Weiss, 1990, Hypersensitivity reactions from taxol, J. Clin. Oncol., 8, 1263, 10.1200/JCO.1990.8.7.1263 Whitehead, 1997, Phase II trial of paclitaxel and granulocyte colony-stimulating factor in patients with pancreatic carcinoma: a Southwest Oncology Group study, J. Clin. Oncol., 15, 2414, 10.1200/JCO.1997.15.6.2414 Wiernik, 1986, Phase I clinical and pharmacokinetic study of Taxol1, Canccer Res., 3, 15 Winer, 2004, Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342, J. Clin. Oncol., 22, 2061, 10.1200/JCO.2004.08.048 Wolff, 2003, Phase I study of docosahexaenoic acid-paclitaxel: a taxane-fatty acid conjugate with a unique pharmacology and toxicity profile 1, Clin. Cancer Res., 9, 3589 Wu, 2016, Nanoparticles for taxanes delivery in cancer treatment, J. Nanosci. Nanotechnol., 16, 6634, 10.1166/jnn.2016.11352 Xie, 2010, Nanoparticle-based theranostic agents, Adv. Drug Deliv. Rev., 62, 1064, 10.1016/j.addr.2010.07.009 Xu, 2013, Clinical comparison between paclitaxel liposome (Lipusu(R)) and paclitaxel for treatment of patients with metastatic gastric cancer, Asian Pac. J. Cancer Prev., 14, 2591, 10.7314/APJCP.2013.14.4.2591 Ye, 2013, Antitumor effect and toxicity of Lipusu in rat ovarian cancer xenografts, Food Chem. Toxicol., 52, 200, 10.1016/j.fct.2012.11.004 Yvon, 1999, Taxol suppresses dynamics of individual microtubules in living human tumor cells, Mol. Biol. Cell, 10, 947, 10.1091/mbc.10.4.947 Zamboni, 2014, Best practices in cancer nanotechnology–perspective from NCI nanotechnology alliance, Clin. Cancer Res., 18, 3229, 10.1158/1078-0432.CCR-11-2938 Zhang, 2005, Development and characterization of a novel Cremophor® EL free liposome-based paclitaxel (LEP-ETU) formulation, Eur. J. Pharm. Biopharm., 59, 177, 10.1016/j.ejpb.2004.06.009 Zhang, 2009, A clinical study on the premedication of paclitaxel liposome in the treatment of solid tumors, Biomed. Pharmacother., 63, 603, 10.1016/j.biopha.2008.10.001