Nab-paclitaxel for the treatment of aggressive metastatic breast cancer

Clinical Breast Cancer

Volumn 14, Issue 4, 2014, Pages 221-227

  Glück, Stefan ^a  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

Aggressive; Metastatic breast cancer; nab Paclitaxel; Poor prognosis; Triple negative breast cancer

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; PACLITAXEL; 130-NM ALBUMIN-BOUND PACLITAXEL; ALBUMINOID;

BREAST METASTASIS; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER PROGNOSIS; CANCER SURVIVAL; CLINICAL FEATURE; CLINICAL TRIAL (TOPIC); HUMAN; META ANALYSIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; TRIPLE NEGATIVE BREAST CANCER; TUMOR INVASION; ANIMAL; BREAST NEOPLASMS; FEMALE; PROGNOSIS; SECONDARY;

ALBUMINS; ANIMALS; BREAST NEOPLASMS; FEMALE; HUMANS; PACLITAXEL; PROGNOSIS;

EID: 84904653755     PISSN: 15268209     EISSN: 19380666     Source Type: Journal    
DOI: 10.1016/j.clbc.2014.02.001     Document Type: Review

References (71)

1. Cancer facts and figures 2013. Atlanta, GA: American Cancer Society, Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/ documents/document/acspc-036845.pdf. Accessed: September 28, 2013.
2. Breast cancer. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology - v1.2014. National Comprehensive Cancer Network [Web site]. Available at: http://www.nccn.org/professionals/physician-gls/f- guidelines.asp. Accessed: September 28, 2013.
3. A.A. Onitilo, J.M. Engel, R.T. Greenlee, and B.N. Mukesh Breast cancer subtypes based on ER/PR and Her2 expression: comparison of clinicopathologic features and survival Clin Med Res 7 2009 4 13
4. K.R. Bauer, M. Brown, R.D. Cress, C.A. Parise, and V. Caggiano Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer registry Cancer 109 2007 1721 1728 (Pubitemid 46668532)
5. M.H. Eichbaum, M. Kaltwasser, T. Bruckner, T.M. de Rossi, A. Schneeweiss, and C. Sohn Prognostic factors for patients with liver metastases from breast cancer Breast Cancer Res Treat 96 2006 53 62
6. C.W. Elston, and I.O. Ellis Pathological prognostic factors in breast cancer. I. the value of histological grade in breast cancer: experience from a large study with long-term follow-up Histopathology 19 1991 403 410
7. A. Imkampe, S. Bendall, and T. Bates The significance of the site of recurrence to subsequent breast cancer survival Eur J Surg Oncol 33 2007 420 423 (Pubitemid 46586085)
8. A. Insa, A. Lluch, F. Prosper, I. Marugan, A. Martinez-Agullo, and J. Garcia-Conde Prognostic factors predicting survival from first recurrence in patients with metastatic breast cancer: analysis of 439 patients Breast Cancer Res Treat 56 1999 67 78 (Pubitemid 29435816)
9. P.G. Koenders, L.V. Beex, P.W. Kloppenborg, A.G. Smals, and T.J. Benraad Human breast cancer: Survival from first metastasis. Breast Cancer Study Group Breast Cancer Res Treat 21 1992 173 180
10. V. Le Doussal, M. Tubiana-Hulin, S. Friedman, K. Hacene, F. Spyratos, and M. Brunet Prognostic value of histologic grade nuclear components of Scarff-Bloom-Richardson (SBR). An improved score modification based on a multivariate analysis of 1262 invasive ductal breast carcinomas Cancer 64 1989 1914 1921 (Pubitemid 19267813)
11. D.J. Slamon, G.M. Clark, S.G. Wong, W.J. Levin, A. Ullrich, and W.L. McGuire Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene Science 235 1987 177 182 (Pubitemid 17231334)
12. T. Sorlie, C.M. Perou, and R. Tibshirani et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications Proc Natl Acad Sci U S A 98 2001 10869 10874 (Pubitemid 32878711)
13. J. O'Shaughnessy Extending survival with chemotherapy in metastatic breast cancer Oncologist 10 suppl 3 2005 20 29 (Pubitemid 43152727)
14. S. Gluck, F. de Snoo, J. Peeters, L. Stork-Sloots, and G. Somlo Molecular subtyping of early-stage breast cancer identifies a group of patients who do not benefit from neoadjuvant chemotherapy Breast Cancer Res Treat 139 2013 759 767
15. L.A. Carey, C.M. Perou, and C.A. Livasy et al. Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study JAMA 295 2006 2492 2502 (Pubitemid 43854964)
16. D.P. Kodack, E. Chung, and H. Yamashita et al. Combined targeting of HER2 and VEGFR2 for effective treatment of HER2-amplified breast cancer brain metastases Proc Natl Acad Sci U S A 109 2012 E3119 E3127
17. Cancer Genome Atlas Network Comprehensive molecular portraits of human breast tumours Nature 490 2012 61 70
18. S. Gluck, J.S. Ross, and M. Royce et al. TP53 genomics predict higher clinical and pathologic tumor response in operable early-stage breast cancer treated with docetaxel-capecitabine +/- trastuzumab Breast Cancer Res Treat 132 2012 781 791
19. X.R. Yang, J. Chang-Claude, and E.L. Goode et al. Associations of breast cancer risk factors with tumor subtypes: a pooled analysis from the breast cancer association consortium studies J Natl Cancer Inst 103 2011 250 263
20. C.M. Perou Molecular stratification of triple-negative breast cancers Oncologist 16 suppl 1 2011 61 70
21. A. Prat, B. Adamo, M.C. Cheang, C.K. Anders, L.A. Carey, and C.M. Perou Molecular characterization of basal-like and non-basal-like triple-negative breast cancer Oncologist 18 2013 123 133
22. B.D. Lehmann, J.A. Bauer, and X. Chen et al. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies J Clin Invest 121 2011 2750 2767
23. C.A. Hudis, and L. Gianni Triple-negative breast cancer: an unmet medical need Oncologist 16 suppl 1 2011 1 11
24. J.I. Herschkowitz, X. He, C. Fan, and C.M. Perou The functional loss of the retinoblastoma tumour suppressor is a common event in basal-like and luminal B breast carcinomas Breast Cancer Res 10 2008 R75
25. J. Tommiska, J. Bartkova, and M. Heinonen et al. The DNA damage signalling kinase ATM is aberrantly reduced or lost in BRCA1/BRCA2-deficient and ER/PR/ERBB2-triple-negative breast cancer Oncogene 27 2008 2501 2506 (Pubitemid 351521092)
26. N.C. Turner, J.S. Reis-Filho, and A.M. Russell et al. BRCA1 dysfunction in sporadic basal-like breast cancer Oncogene 26 2007 2126 2132 (Pubitemid 46514749)
27. ® (trastuzumab) [prescribing information]. San Francisco, CA: Genentech, Inc.; 2010. Available at: http://www.gene.com/ download/pdf/herceptin-prescribing.pdf. Accessed: September 28, 2013.
28. ® (ado-trastuzumab emtansine) for injection, for intravenous use [prescribing information]. San Francisco, CA: Genentech, Inc., Available at: http://www.gene.com/download/pdf/kadcyla-prescribing.pdf. Accessed: September 28, 2013.
29. ® (pertuzumab) [prescribing information]. San Francisco, CA: Genentech, Inc.; 2012. Available at: http://www.gene.com/ download/pdf/perjeta-prescribing.pdf. Accessed: September 28, 2013.
30. ® (lapatinib) tablets [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2012. Available at: https://www.gsksource.com/gskprm/htdocs/documents/TYKERB-PI-PIL.PDF. Accessed: September 28, 2013.
31. D.J. Slamon, B. Leyland-Jones, and S. Shak et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2 N Engl J Med 344 2001 783 792 (Pubitemid 32222155)
32. R. Nahta, and F.J. Esteva HER2 therapy: molecular mechanisms of trastuzumab resistance Breast Cancer Res 8 2006 215
33. J. Baselga, J. Cortes, and S.B. Kim et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer N Engl J Med 366 2012 109 119
34. K.L. Blackwell, H.J. Burstein, and A.M. Storniolo et al. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 study J Clin Oncol 30 2012 2585 2592
35. J. Baselga, I. Bradbury, and H. Eidtmann et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial Lancet 379 2012 633 640
36. S. Verma, D. Miles, and L. Gianni et al. Trastuzumab emtansine for HER2-positive advanced breast cancer N Engl J Med 367 2012 1783 1791
37. C.A. Harris, R.L. Ward, T.A. Dobbins, A.K. Drew, and S. Pearson The efficacy of HER2-targeted agents in metastatic breast cancer: a meta-analysis Ann Oncol 22 2011 1308 1317
38. G. Von Minckwitz, A. Schneeweiss, and C. Salat et al. A randomized phase II trial investigating the addition of carboplatin to neoadjuvant therapy for triple-negative and HER2-positive early breast cancer (GeparSixto - GBG 66) J Clin Oncol (Meeting Abstracts) 31 suppl 2013 abstract 1004
39. J. O'Shaughnessy, C. Osborne, and J.E. Pippen et al. Iniparib plus chemotherapy in metastatic triple-negative breast cancer N Engl J Med 364 2011 205 214
40. A. Tutt, M. Robson, and J.E. Garber et al. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial Lancet 376 2010 235 244
41. S. Kummar, J. Ji, and R. Morgan et al. A phase I study of veliparib in combination with metronomic cyclophosphamide in adults with refractory solid tumors and lymphomas Clin Cancer Res 18 2012 1726 1734
42. P.B. Schiff, and S.B. Horwitz Taxol stabilizes microtubules in mouse fibroblast cells Proc Natl Acad Sci U S A 77 1980 1561 1565 (Pubitemid 10073801)
43. ® (paclitaxel) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; 2011. Available at: http://packageinserts.bms. com/pi/pi-taxol.pdf. Accessed: September 28, 2013.
44. A.J. ten Tije, J. Verweij, W.J. Loos, and A. Sparreboom Pharmacological effects of formulation vehicles: implications for cancer chemotherapy Clin Pharmacokinet 42 2003 665 685 (Pubitemid 36936530)
45. E.R. Gardner, W.L. Dahut, and C.D. Scripture et al. Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel Clin Cancer Res 14 2008 4200 4205
46. I. Hamad, and S.M. Moghimi Critical issues in site-specific targeting of solid tumours: the carrier, the tumour barriers and the bioavailable drug Expert Opin Drug Deliv 5 2008 205 219 (Pubitemid 351308312)
47. A. Sparreboom, L. van Zuylen, and E. Brouwer et al. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications Cancer Res 59 1999 1454 1457 (Pubitemid 29160110)
48. O. van Tellingen, M.T. Huizing, V.R. Panday, J.H. Schellens, W.J. Nooijen, and J.H. Beijnen Cremophor EL causes (pseudo-) non-linear pharmacokinetics of paclitaxel in patients Br J Cancer 81 1999 330 335 (Pubitemid 29423714)
49. N.K. Ibrahim, N. Desai, and S. Legha et al. Phase I and pharmacokinetic study of ABI-007, a Cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel Clin Cancer Res 8 2002 1038 1044 (Pubitemid 34517637)
50. ® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) [prescribing information]. Summit, NJ: Celegene Corporation; 2013. Available at: http://www.abraxane.com/downloads/Abraxane-PrescribingInformation.pdf. Accessed: September 28, 2013.
51. D.A. Yardley Nab-paclitaxel mechanisms of action and delivery J Control Release 170 2013 365 372
52. N. Desai, V. Trieu, and Z. Yao 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 12 2006 1317 1324 (Pubitemid 43342524)
53. N. Desai, V. Trieu, B. Damascelli, and P. Soon-Shiong SPARC expression correlates with tumor response to albumin-bound paclitaxel in head and neck cancer patients Transl Oncol 2 2009 59 64
54. W.J. Gradishar, S. Tjulandin, and N. Davidson 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 23 2005 7794 7803 (Pubitemid 46657376)
55. J. Cortes, and C. Saura Nanoparticle albumin-bound (nab)-paclitaxel: improving efficacy and tolerability by targeted drug delivery in metastatic breast cancer EJC Supplements 8 2010 1 10
56. P. Cortazar, R. Justice, J. Johnson, R. Sridhara, P. Keegan, and R. Pazdur US Food and Drug Administration approval overview in metastatic breast cancer J Clin Oncol 30 2012 1705 1711
57. E.P. Hamilton, G.G. Kimmick, and N. Desai et al. Use of SPARC, EGFR, and VEGFR expression to predict response to nab-paclitaxel (nabP)/carboplatin (C)/bevacizumab (B) chemotherapy in triple-negative metastatic breast cancer (TNMBC) J Clin Oncol (Meeting Abstracts) 28 suppl 15 2010 abstract 1109
58. C. Lobo, G. Lopes, and O. Baez 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 123 2010 427 435
59. H.S. Rugo, W.T. Barry, and A. Moreno-Aspitia et al. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin-bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC) J Clin Oncol (Meeting Abstracts) 30 suppl 2012 abstract CRA1002
60. E. Hamilton, G. Kimmick, and J. Hopkins et al. Nab-paclitaxel/ bevacizumab/carboplatin chemotherapy in first-line triple negative metastatic breast cancer Clin Breast Cancer 13 2013 416 420
61. US Food and Drug Administration. Commissioner statement: FDA commissioner removes breast cancer indication for Avastin label. US Food and Drug Administration News and Events [Web site]. Available at: http://www.fda.gov/ NewsEvents/Newsroom/UCM279485. Accessed: March 13, 2013.
62. Blackwell K. Clinicaltrials.gov NCT01207102. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01207102. Accessed: June 2013.
63. A. Forero-Torres, N.U. Lin, and M.C. Liu et al. TBCRC 019: an open-label, randomized, phase II trial of nanoparticle albumin-bound paclitaxel with or without the anti-death receptor 5 (DR5) monoclonal antibody tigatuzumab in patients with metastatic, triple-negative (ER, PR, and HER2-negative) breast cancer J Clin Oncol (Meeting Abstracts) 29 suppl 2011 abstract TPS128
64. J. O'Shaughnessy, W.J. Gradishar, P. Bhar, and J. Iglesias Nab-paclitaxel for first-line treatment of patients with metastatic breast cancer and poor prognostic factors: a retrospective analysis Breast Cancer Res Treat 138 2013 829 837
65. W.J. Gradishar, D. Krasnojon, and S. Cheporov et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer J Clin Oncol 27 2009 3611 3619
66. W.J. Gradishar, D. Krasnojon, and S. Cheporov et al. Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer: final analysis of overall survival Clin Breast Cancer 12 2012 313 321
67. A.D. Seidman, A.K. Conlin, and A. Bach et al. Randomized phase II trial of weekly vs. every 2 weeks vs. every 3 weeks nanoparticle albumin-bound paclitaxel with bevacizumab as first-line chemotherapy for metastatic breast cancer Clin Breast Cancer 13 2013 239 246.e1
68. V. Roy, B.R. LaPlant, G.G. Gross, C.L. Bane, and F.M. Palmieri North Central Cancer Treatment Group. Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane) in combination with gemcitabine in patients with metastatic breast cancer (N0531) Ann Oncol 20 2009 449 453
69. M.A. Socinski, I. Bondarenko, and N.A. Karaseva et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial J Clin Oncol 30 2012 2055 2062
70. D.D. Von Hoff, T.J. Ervin, and F.P. Arena et al. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT) J Clin Oncol (Meeting Abstracts) 30 suppl 34 2013 abstract LBA148
71. D.A. Yardley, A. Brufsky, and P. Conte et al. tnAcity: a phase 2/3 randomized study of weekly nab-paclitaxel in combination with either gemcitabine or carboplatin vs gemcitabine/carboplatin as first-line treatment for triple-negative metastatic breast cancer Cancer Res 2013 SABCS suppl: abstract OT3-1-11