Nab-Paclitaxel in combination with biologically targeted agents for early and metastatic breast cancer

Cancer Treatment Reviews

Volumn 40, Issue 5, 2014, Pages 614-625

  Megerdichian, Christine ^a   Olimpiadi, Yuliya ^b   Hurvitz, Sara A ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Adjuvant; Bevacizumab; Metastatic breast cancer; Nab Paclitaxel; Neoadjuvant; Paclitaxel; Trastuzumab

Indexed keywords

BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EVEROLIMUS; GEMCITABINE; IMIQUIMOD; IXABEPILONE; LAPATINIB; NAVELBINE; PACLITAXEL; PERTUZUMAB; TIGATUZUMAB; TRASTUZUMAB; VORINOSTAT;

ANTIANGIOGENIC THERAPY; ANTINEOPLASTIC ACTIVITY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; DRUG SAFETY; HEART LEFT VENTRICLE FAILURE; HUMAN; LUNG NON SMALL CELL CANCER; MASTECTOMY; MELANOMA; PARTIAL MASTECTOMY; PATIENT HISTORY OF CHEMOTHERAPY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; TREATMENT RESPONSE; TRIPLE NEGATIVE BREAST CANCER;

ADJUVANT; BEVACIZUMAB; METASTATIC BREAST CANCER; NAB-PACLITAXEL; NEOADJUVANT; PACLITAXEL; TRASTUZUMAB;

ADULT; AGED; ALBUMINS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOLOGICAL FACTORS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DISEASE-FREE SURVIVAL; EARLY DETECTION OF CANCER; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MIDDLE AGED; MOLECULAR TARGETED THERAPY; NEOADJUVANT THERAPY; NEOPLASM INVASIVENESS; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PACLITAXEL; PROGNOSIS; RISK ASSESSMENT; SURVIVAL ANALYSIS; TAXOIDS; TREATMENT OUTCOME;

EID: 84898435747     PISSN: 03057372     EISSN: 15321967     Source Type: Journal    
DOI: 10.1016/j.ctrv.2014.02.001     Document Type: Review

References (64)

1. Jemal A., Bray F., Center M.M., Ferlay J., Ward E., Forman D. Global cancer statistics. CA Cancer J Clin 2011, 61(2):69-90.
2. Siegel R., Naishadham D., Jemal A. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin 2012, 62(1):10-29.
3. Howlader N, Noone AM, Krapcho M, et al. SEER cancer statistics review, 1975-2009 (vintage 2009 populations), national cancer institute. SEER Cancer Statistics Web site. <> Published 2009. Updated 2012 [accessed 10.04.13]. http://seer.cancer.gov/csr/1975_2009_pops09/.
4. Yaziji H., Goldstein L.C., Barry T.S., et al. HER-2 testing in breast cancer using parallel tissue-based methods. JAMA 2004, 291(16):1972-1977.
5. Owens M.A., Horten B.C., Da Silva M.M. HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin Breast Cancer 2004, 5(1):63-69.
6. Slamon D.J., Clark G.M., Wong S.G., Levin W.J., Ullrich A., McGuire W.L. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987, 235(4785):177-182.
7. Perou C.M., Sorlie T., Eisen M.B., et al. Molecular portraits of human breast tumours. Nature 2000, 406(6797):747-752.
8. Slamon D.J., Leyland-Jones B., Shak S., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344(11):783-792.
9. Anders C.K., Carey L.A. Biology, metastatic patterns, and treatment of patients with triple-negative breast cancer. Clin Breast Cancer 2009, 9(Suppl. 2):S73-S81.
10. The National Comprehensive Cancer Network, editor. National comprehensive cancer network clinical practice guidelines in oncology. Breast cancer. Version 3.2013; 2013.
11. Vogel C.L., Cobleigh M.A., Tripathy D., et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002, 20(3):719-726.
12. Baselga J., Carbonell X., Castaneda-Soto N.J., et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol 2005, 23(10):2162-2171.
13. Cobleigh M.A., Vogel C.L., Tripathy D., et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999, 17(9):2639-2648.
14. Gianni L., Pienkowski T., Im Y.H., et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol 2012, 13(1):25-32.
15. O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist 2005, 10(Suppl. 3):20-29.
16. Taxol (paclitaxel) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2011.
17. Taxotere (docetaxel) Injection Concentrate [package insert]. Bridgewater, NJ: Sanofi-aventis U.S. LLC; 2010.
18. Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Summit, NJ: Celegene corporation; 2013.
19. Dumontet C., Sikic B.I. Mechanisms of action of and resistance to antitubulin agents: microtubule dynamics, drug transport, and cell death. J Clin Oncol 1999, 17(3):1061-1070.
20. ten Tije A.J., Verweij J., Loos W.J., Sparreboom A. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 2003, 42(7):665-685.
21. Liebmann J., Cook J.A., Mitchell J.B., Cremophor E.L. Solvent for paclitaxel, and toxicity. Lancet 1993, 342(8884):1428.
22. Gelderblom H., Verweij J., Nooter K., Sparreboom A., Cremophor E.L. The drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 2001, 37(13):1590-1598.
23. Weiss R.B., Donehower R.C., Wiernik P.H., et al. Hypersensitivity reactions from taxol. J Clin Oncol 1990, 8(7):1263-1268.
24. Gradishar W.J., 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.
25. Vishnu P., Roy V. Safety and efficacy of nab-paclitaxel in the treatment of patients with breast cancer. Breast Cancer (Auckl) 2011, 5:53-65.
26. Gradishar W.J., 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(22):3611-3619.
27. Gradishar W.J., Krasnojon D., Cheporov S., 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 2012, 12(5):313-321.
28. Guidance for industry: pathologic complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval (draft guidance) 2012, US Department of Health and Human Services, Silver Spring, MD. The United States Food Drug Administration (Ed.).
29. Socinski M.A., Bondarenko I., Karaseva N.A., 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 2012, 30(17):2055-2062.
30. Hersh EM, Del Vecchio M, Brown MP, et al. Phase 3 randomized, open-label, multicenter trial of nab-paclitaxel (nab-P) vs dacarbazine (DTIC) in previously untreated patients with metastatic malignant melanoma (MMM). Proceedings of the Society for Melanoma Research; 2012.
31. Von Hoff D.D., Ervin T.J., Arena F.P., 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) 2013, 30(Suppl. 34). [abstract LBA148].
32. Snider J.N., Sachdev J.C., Allen J.W., et al. Pathologic complete response (pCR) with weekly nanoparticle albumin bound paclitaxel (nab-P) plus carboplatin (C) followed by doxorubicin plus cyclophosphamide (AC) with concurrent bevacizumab for triple negative breast cancer (TNBC). J Clin Oncol (Meeting Abstracts) 2013, 31(Suppl.). [abstract 1068].
33. Sachdev J.C., Kronish L.E., West S., Schwartzberg L., Jahanzeb M. Neoadjuvant bevacizumab with weekly nanoparticle albumin boundnab-paclitaxel plus carboplatin followed by doxorubicin plus cyclophosphamide (AC) for triple-negative breast cancer. J Clin Oncol (Meeting Abstracts) 2010, 28(Suppl.). [abstract TPS100].
34. Mrozek E., Lustber M.B., Knopp M.V., et al. Phase II trial of neoadjuvant chemotherapy (NCT) with weekly nanoparticle albumin-bound paclitaxel (nab-P), carboplatin (CBP), and bevacizumab (BEV) in women with clinical stages II-III breast cancer (BC): Pathologic response prediction by changes in angiogenic volume (AV) by dynamic contrast magnetic resonance imaging (DCE-MRI). J Clin Oncol (Meeting Abstracts) 2010, 28(Suppl.). [abstract 604].
35. +) and triple-negative (TN) breast cancer (BrCa): a BrUOG study. J Clin Oncol (Meeting Abstracts) 2012, 30(Suppl.). [abstract 1045].
36. Li S.M., Wu X., Henry P. Correlation between miRNA (miR) and gene expression profiles (GEP) and response to neoadjuvant chemotherapy (NT) in patients with locally advanced and inflammatory breast cancer (BC). J Clin Oncol (Meeting Abstracts) 2012, 31(Suppl.). [abstract 10545].
37. Paz I.B., Lau S., Garberoglio C. nab-paclitaxel and carboplatin with or without trastuzumab (trast) as part of neoadjuvant chemotherapy (NCT) in patients (pts) with stage II-III breast cancer (BC). J Clin Oncol (Meeting Abstracts) 2008, 26(Suppl.). [abstract 567].
38. Zelnak A., Leyland-Jone B., Gabram S., et al. High pathologic complete response (pCR) in HER2-positive breast cancer to novel nonanthracycline neoadjuvant chemotherapy. Cancer Res 2012, 72(Suppl. 3 (24)). [abstract 2703].
39. Zelnak A.B., Leyland-Jones B., Gabram-Mendola S., et al. High pathologic complete response (pCR) in HER2-positive breast cancer to novel nonanthracycline neoadjuvant chemotherapy. J Clin Oncol (Meeting Abstracts) 2010, 28(Suppl.). [abstract 625].
40. Robidoux A., Buzdar A.U., Quinaux E., et al. A phase II neoadjuvant trial of sequential nanoparticle albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide in locally advanced breast cancer. Clin Breast Cancer 2010, 10(1):81-86.
41. + breast cancer. Clin Breast Cancer 2011, 11(5):297-305.
42. Kaklamani V.G., Siziopikou K., Scholtens D., et al. Pilot neoadjuvant trial in HER2 positive breast cancer with combination of nab-paclitaxel and lapatinib. Breast Cancer Res Treat 2012, 132(3):833-842.
43. McArthur H.L., Rugo H., Nulsen B., et al. A feasibility study of bevacizumab plus dose-dense doxorubicin-cyclophosphamide (AC) followed by nanoparticle albumin-bound paclitaxel in early-stage breast cancer. Clin Cancer Res 2011, 17(10):3398-3407.
44. Yardley D., Burris H., Peacock N., et al. A pilot study of adjuvant nanoparticle albumin-bound (nab) paclitaxel and cyclophosphamide, with trastuzumab in HER2-positive patients, in the treatment of early-stage breast cancer. Breast Cancer Res Treat 2010, 123(2):471-475.
45. Danso M.A., Blum J.L., Robert N.J., et al. Phase II trial of weeklynab-paclitaxel in combination with bevacizumab as first-line treatment in metastatic breast cancer. J Clin Oncol (Meeting Abstracts) 2008, 26(May 20 Suppl.):1-2. [abstract 1075].
46. 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(2):427-435.
47. Northfelt D.W., Dueck A.C., Flynn T.P., et al. Phase II trial combining nab-paclitaxel (NP), gemcitabine (G), and bevacizumab (B) in patients (pts) with metastatic breast cancer.(MBC): NCCTG N0735. J Clin Oncol (Meeting Abstracts) 2011, 29(Suppl.). [abstract 1126].
48. Robert N.J., Dieras V., Glaspy J., et al. RIBBON-1: Randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 2011, 29(10):1252-1260.
49. Brufsky A.M., Hurvitz S., Perez E., et al. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2011, 29(32):4286-4293.
50. European Medicines Agency. Assessment for avastin. European Medicines Agency Web site. <> Updated 2011 [accessed 2.05.12]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000582/WC500105601.pdf.
51. Seidman A.D., Conlin A.K., Bach A., et al. Randomized phase II trial of weekly vs. every 2weeks vs. every 3weeks nanoparticle albumin-bound paclitaxel with bevacizumab as first-line chemotherapy for metastatic breast cancer. Clin Breast Cancer 2013, 13(4). 239.e1-246.e1.
52. Rugo H.S., Barry W.T., Moreno-Aspitia A., et al. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin boundnab-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) 2012, 30(Suppl.). [abstract CRA 1002].
53. Miller K., Wang M., Gralow J., et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007, 357(26):2666-2676.
54. Miles D.W., Chan A., Dirix L.Y., et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010, 28(20):3239-3247.
55. 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. <> Published November 18, 2011. Updated 2011 [accessed 13.03.13]. http://www.fda.gov/NewsEvents/Newsroom/UCM279485.
56. Forero-Torres A., Shah J., Wood T., et al. Phase I trial of weekly tigatuzumab, an agonistic humanized monoclonal antibody targeting death receptor 5 (DR5). Cancer Biother Radiopharm 2010, 25(1):13-19.
57. Forero-Torres A., Lin N.U., Liu M.C., 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) 2011, 29(Suppl.). [abstract TPS128].
58. Mirtsching B., Cosgriff T., Harker G., Keaton M., Chidiac T., Min M. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer 2011, 11(2):121-128.
59. Conlin A.K., Seidman A.D., Bach A., et al. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer 2010, 10(4):281-287.
60. Yardley D.A., Hart L., Bosserman L., et al. Phase II study evaluating lapatinib in combination with nab-paclitaxel in HER2-overexpressing metastatic breast cancer patients who have received no more than one prior chemotherapeutic regimen. Breast Cancer Res Treat 2013, 137(2):457-464.
61. Hurvitz S.A., Dirix L., Kocsis J., et al. Phase II randomized study of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. J Clin Oncol 2013, 31(9):1157-1163.
62. Baselga J., Cortes J., Kim S.B., et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012, 366(2):109-119.
63. Verma S., Miles D., Gianni L., et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012, 367(19):1783-1791.
64. Sinclair N.F., Sakr B.J., Abu-Khalaf M.M., et al. Multicenter phase II trial of neoadjuvant carboplatin, weekly nab-paclitaxel, and trastuzumab in stage II-III HER2+ breast cancer: a BrUOG study. J Clin Oncol (Meeting Abstracts) 2013, 31(Suppl.). [abstract 619].