Enhancing intracellular taxane delivery: Current role and perspectives of nanoparticle albumin-bound paclitaxel in the treatment of advanced breast cancer

Expert Opinion on Pharmacotherapy

Volumn 13, Issue 3, 2012, Pages 395-406

  Guarneri, Valentina ^a   Dieci, Maria Vittoria ^a   Conte, Pierfranco ^a  

^a UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

Author keywords

Albumin bound paclitaxel; Metastatic breast cancer; Nab paclitaxel; Nanotechnology

Indexed keywords

ALBUMIN; BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; CREMOPHOR; DOCETAXEL; GEMCITABINE; GRANULOCYTE COLONY STIMULATING FACTOR; NANOPARTICLE; OSTEONECTIN; PACLITAXEL; TAXANE DERIVATIVE; TRASTUZUMAB;

ALOPECIA; ARTHRALGIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; BLURRED VISION; BREAST CANCER; CARDIOVASCULAR SYMPTOM; CREATININE BLOOD LEVEL; DIARRHEA; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; DRUG STRUCTURE; DYSPNEA; EDEMA; FATIGUE; GASTROINTESTINAL TOXICITY; HEART ARREST; HUMAN; HYPERGLYCEMIA; HYPERSENSITIVITY REACTION; HYPERTENSION; KERATITIS; LIVER FUNCTION TEST; LIVER TOXICITY; LUNG EMBOLISM; MUCOSA INFLAMMATION; MYALGIA; NAUSEA; NEPHROTOXICITY; NEUROLOGIC DISEASE; NEUTROPENIA; NONHUMAN; OVERALL SURVIVAL; PHARMACODYNAMICS; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY TRACT DISEASE; SIDE EFFECT; STEVENS JOHNSON SYNDROME; SUPRAVENTRICULAR TACHYCARDIA; THORAX PAIN; THROMBOEMBOLISM; THROMBOSIS; TOXIC EPIDERMAL NECROLYSIS; TREATMENT RESPONSE; VISUAL DISORDER; VOMITING;

ALBUMINS; ANIMALS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BREAST NEOPLASMS; CHEMISTRY, PHARMACEUTICAL; DRUG CARRIERS; DRUG COMPOUNDING; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; NANOPARTICLES; PACLITAXEL; TREATMENT OUTCOME;

EID: 84856285214     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2012.651127     Document Type: Article

References (65)

1. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011;61:69-90
2. Howlader N, Noone AM, Krapcho M, et al. editors. SEER Cancer Statistics Review, 1975 - 2008, Bethesda, MD: National Cancer Institute. Based on November 2010 SEER data submission, posted to the SEER website, 2011. Available from: http://seer.cancer.gov/csr/1975-2008/ [Last accessed 5 October 2011]
3. Guarneri V, Conte P. Metastatic breast cancer: therapeutic options according to molecular subtypes and prior adjuvant therapy. Oncologist 2009;14:645-56
4. Piccart-Gebhart MJ, Burzykowski T, Buyse M, et al. Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol 2008;26:1980-6
5. De Laurentiis M, Cancello G, D'Agostino D, et al. Taxane-based combinations as adjuvant chemotherapy for early breast cancer: a meta-analysis of randomized trials. J Clin Oncol 2008;26:44-53
6. Taxol (paclitaxel) Injection [Package Insert]. Brystol-Meyers Squibb Co.; Princeton, NJ: 2003
7. Taxotere (docetaxel) Injection Concentrate [Package Insert]. Aventis Pharmaceutical Products, Inc.; Bridgewater, NJ: 2003
8. Ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 2003;42:665-85 (Pubitemid 36936530)
9. Weiss RB, Donehower RC, Wiernik PH, et al. Hypersensitivity reactions from taxol. J Clin Oncol 1990;8:1263-8 (Pubitemid 20195638)
10. Authier N, Gillet JP, Fialip J, et al. Assessment of neurotoxicity following repeated cremophor/ethanol injections in rats. Neurotox Res 2001;3:301-6 (Pubitemid 32962892)
11. Postma TJ, Vermorken JB, Liefting AJM, et al. Paclitaxel-induced neuropathy. Ann Oncol 2004;6:484-94
12. Gelderblom H, Verweij J, Nooter K, et al. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 2001;37:1590-8 (Pubitemid 32778603)
13. Van Zuylen L, Verweij J, Sparreboom A. Role of formulation vehicles in taxane pharmacology. Invest New Drugs 2001;19:125-41 (Pubitemid 32423718)
14. Baker J, Ajani J, Scotte F, et al. Docetaxel-related side effects and their management. Eur J Oncol Nurs 2009;13:49-59
15. Sparreboom A, van Zuylen L, Brouwer E, et al. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications. Cancer Res 1999;59:1454-7 (Pubitemid 29160110)
16. Kratz F. Albumin as a drug carrier: design of new drugs, drugs conjugates and nanoparticles. J Control Release 2008;132:171-83
17. Schnitzer JE, Oh P. Albondin-mediated capillary permeability to albumin. Differential role of receptors in endothelial transcytosis and endocytosis of native and modified albumin. J Biol Chem 1994;269:6072-82
18. Tiruppathi C, Song W, Bergenfeldt M, et al. Gp60 activation mediates albumin transcytosis in endothelial cells by tyrosin kinase-dependent pathway. J Biol Chem 1997;272:25968-75 (Pubitemid 27438924)
19. Cortes J, Saura C. Nanopartcle albumin-bound (nab)-paclitaxel: improving efficacy and tolerability by targeted drug delivery in metastatic breast cancer. Eur J Cancer Suppl 2010;8:1-10
20. Gradishar WJ. Albumin-bound paclitaxel: a next-generation taxane. Expert Opin Pharmacother 2006;7:1041-53 (Pubitemid 43949942)
21. ABRAXANE Healthcare Professional Prescribing Information. 2010. Available from: http://www.abraxane.com/professional/PDF/Abraxane-Healthcare- Professional-Prescribing-Information.pdf [Last accessed 1 October 2011]
22. Abraxane: EPAR - Product Information. 2011. Available from: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000778/WC500020435.pdf [Last accessed 1 October 2011]
23. Desai NP, Trieu V, Yao Z, et al. 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 2006;12:1317-24 (Pubitemid 43342524)
24. Jain RK. Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy. Science 2005;307:58-62 (Pubitemid 40093472)
25. Trieu V, Frankel T, Labao E, et al. SPARC expression in breast tumors may correlate to increased tumor distribution of nanoparticle albumin-bound paclitaxel (ABI-007) vs taxol. Proc Am Assoc Cancer Res 2005;46:abstract 5584
26. Volk LD, Flister MJ, Bivens CM, et al. Nab-paclitaxel efficacy in the orthotopic model of human breast cancer is significantly enhanced by concurrent anti-vascular endothelial growth factor A therapy. Neoplasia 2008;10:613-18
27. 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;8:1038-44 (Pubitemid 34517637)
28. Nyman DW, Campbell KJ, Hersh E, et al. Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies. J Clin Oncol 2005;23:7785-93 (Pubitemid 46657375)
29. Sparreboom A, Scripture CD, Trieu V, et al. Comparative preclinical and clinical pharmacokinetics of a cremophor-free, nanoparticle albuminbound paclitaxel (ABI-007) and paclitaxel formulated in Cremophor (Taxol). Clin Cancer Res 2005;11:4136-43 (Pubitemid 40791578)
30. Gardner ER, Dahut WL, Scripture CD, et al. Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. Clin Cancer Res 2008;14:4200-5
31. Ando M, Yonemori K, Katsumata N, et al. Phase I and pharmacokinetic study of nab-paclitaxel, nanoparticle albumin-bound paclitaxel, administered weekly to Japanese patients with solid tumors and metastatic breast cancer. Cancer Chemother Pharmacol 2011. [Epub ahead of print]
32. 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;23:6019-26
33. Gradishar WJ, Krasnojon D, Cheporov S, et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 2009;27:3611-19
34. Gradishar WJ, Krasnojon D, Cheporov S, et al. Albumin-bound paclitaxel (ab-pac) versus docetaxel for first-line treatment of metastatic breast cancer (MBC): Final overall survival (OS) analysis of a randomized phase II trial. J Clin Oncol 2011;29(Suppl 27):abstract 275
35. Gradishar WJ, Krasnojon D, Cheporov S, et al. Nab-paclitaxel versus docetaxel for the first-line treatment of metastatic breast cancer: overall survival subset analyses of a randomized phase II trial [abstract 5060]. Presented at the European Multidisciplinary Cancer Congress; 23 - 27 September 2011; Stockholm, Sweden
36. Blum JL, Savin MA, Edelman G, et al. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer 2007;7:850-6
37. Gradishar WJ, Tjulandin S, Davidson N, et al. Superior efficacy of albumin-bound paclitaxel, ABI-007, compared with polyethylated castor oil-based paclitaxel in women with metastatic breast cancer: results of a phase III trial. J Clin Oncol 2005;23:1-10
38. Guan Z, Feng F, Li QL, et al. Randomized study comparing nab-paclitaxel with solvent-based paclitaxel in Chinese patients (pts) with metastatic breast cancer (MBC). J Clin Oncol 2007;25(Suppl 18):abstract 1038
39. Aapro M, Tjulandin S, Bhar P, Gradishar W. Weekly nab-paclitaxel is safe and effective in 65 years old patients with metastatic breast cancer: A post-hoc analysis. Breast 2011;20:468-74
40. Roy V, LaPlant BR, Gross GG, et al. North Central Cancer Treatment Group. Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nabpaclitaxel) (Abraxane) in combination with gemcitabine in patients with metastatic breast cancer (N0531). Ann Oncol 2009;20:449-53
41. Somer BG, Schwartzberg LS, Arena F, et al. Phase II trial of nab-paclitaxel (nanoparticle albumin-bound paclitaxel (ABX)) + capecitabine (XEL) in first-line treatment of metastatic breast cancer (MBC). J Clin Oncol 2007;25(Suppl 18):abstract 1053
42. Danso MA, Blum JL, Robert NJ, et al. Phase II trial of weekly nab-paclitaxel in combination with bevacizumab as first-line treatment in metastatic breast cancer. J Clin Oncol 2008;26(Suppl 15):abstract 1075
43. Lobo C, Lopes G, Baez O, et al. Final results of a phase II study of nab-paclitaxel, bevacizumab and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. Breast Cancer Res Treat 2010;123:427-35
44. Conlin AK, Hudis CA, Bach A, et al. Randomized phase II trial of nanoparticle albumin-bound paclitaxel in three dosing schedules with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (MBC). J Clin Oncol 2009;27(Suppl 15):abstract 1006
45. Conlin AK, Seidman AD, Bach A, et al. Phase II trial of weekly nanoparticle abumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer 2010;10:281-7
46. Mirtsching B, Corsgriff T, Harker G, et al. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer 2011;11:121-8
47. Winer EP, Berry DA, Woolf S, et al. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol 2004;22:2061-8 (Pubitemid 41095138)
48. Green MC, Buzdar AU, Smith T, et al. Weekly paclitaxel improves pathologic complete remission in operable breast cancer when compared with paclitaxel once every 3 weeks. J Clin Oncol 2005;23:5983-92
49. Seidman AD, Berry D, Cirrincione C, et al. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol 2008;26:1642-9
50. ClinicalTrials.gov, Identifier NCT00785291. http://www.clinicaltrial.gov/ ct2/show/NCT00785291 [Last accessed 5 October 2011]
51. IXEMPRA- (ixabepilone) for injection [Prescribing Information]. Princeton, NJ: Bristol-Myers Squibb Co., 2010. Available from: http://packageinserts.bms.com/pi/pi-ixampra.pdf [Last accessed 5 October 2011]
52. Chan A, Miles D, Pivot X. Bevacizumab in combination with taxanes for the first-line treatment of metastatic breast cancer. Ann Oncol 2010;21:2135-44
53. Podhajcer OL, Benedetti LG, Girotti MR, et al. The role of the matricellular protein SPARC in the dynamic interaction between the tumor and the host. Cancer Metastasis Rev 2008;27:691-705
54. Chin D, Boyle GM, Williams RM, et al. Novel markers for poor prognosis in head and neck cancer. Int J Cancer 2005;113:789-97 (Pubitemid 40101261)
55. Koukourakis MI, Giatromanolaki A, Brekken RA, et al. Enhanced expression of SPARC/osteonectin in the tumor-associated stroma of non-small cell lung cancer is correlated with markers of hypoxia/acidity and with poor prognosis of patients. Cancer Res 2003;63:5376-80 (Pubitemid 37139854)
56. Von Hoff DD, Penny R, Shack S, et al. Frequency of potential therapeutic targets identified by immunohistochemistry (IHC) and DNA microarray (DMA) in tumors from patients who have progressed on multiple therapeutic agents. J Clin Oncol 2006;24(Suppl 18):abstract 3071
57. Watkins G, Douglas-Jones A, Bryce R, et al. Increased levels of SPARC (osteonectin) in human breast cancer tissues and its association with clinical outcomes. Prostaglandins Leukot Essent Fatty Acids 2005;72:267-72 (Pubitemid 40342998)
58. Hsiao YH, Lien HC, Hwa HL, et al. SPARC (osteonectin) in breast tumors of different histologic types and its role in the outcome of invasive ductal carcinoma. Breast J 2010;16:305-8
59. Nagai MA, Gerhard R, Fregnani JH, et al. Prognostic value of NDRG1 and SPARC protein expression in breast cancer patients. Breast Cancer Res Treat 2011;12:1-14
60. Desai NP, Trieu V, Hwang LY, et al. Improved effectiveness of nanoparticle albumin-bound (nab) paclitaxel versus polysorbate-based docetaxel in multiple xenografts as a function of HER2 and SPARC status. Anticancer Drugs 2008;19:899-0
61. Von Hoff D, Ramanathan E, Borad M, et al. SPARC correlation with response to gemcitabine (G) plus nab-paclitaxel (nab-P) in patients with advanced metastatic pancreatic cancer: a phase I/II Study. J Clin Oncol 2009;27(Suppl 15):abstract 4525
62. Inhorn RC, Daniel B, Daniel D, et al. Correlation of SPARC, ER, PR, and HER2 tumor with progression-free survival from a phase II neoadjuvant trial of gemcitabine, epirubicin, and nabpaclitaxel. J Clin Oncol 2009;27(Suppl 15):abstract 618
63. Blackwell KL, Hamilton EP, Rocha G, et al. SPARC microenvironment signature (SMS) in patients treated with nab-paclitaxel (nabP)/carboplatin (C)/bevacizumab(B) for triple-negative metastatic breast cancer (TNMBC). J Clin Oncol 2010;28(Suppl 15):abstract e21040
64. Robidoux A, Buzdar AU, Quinaux E, et al. A phase II neoadjuvant trial of sequential weekly nanoparticle albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide in locally advanced breast cancer. Clin Breast Cancer 2010;10:81-6
65. Yardley DA, Raefsky E, Castillo R, et al. Results of a multicenter pilot study of weekly nab-paclitaxel, carboplatin with bevacizumab, and trastuzumab as neoadjuvant therapy in HER2+ locally advanced breast cancer with SPARC correlatives. J Clin Oncol 2009;27(Suppl 15):abstract 427