A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer

Clinical Breast Cancer

Volumn 11, Issue 2, 2011, Pages 121-128

  Mirtsching, Barry ^a   Cosgriff, Thomas ^b   Harker, Graydon ^c   Keaton, Mark ^d   Chidiac, Tarek ^e   Min, Myo ^f  

^a Dermatology Treatment and Research Center   (United States)

^b Oncology and Hematology   (United States)

^c Utah Cancer Specialists   (United States)

^d Augusta Oncology Associates   (United States)

^e Mid Ohio Oncology Hematology   (United States)

^f Maryland Hematol Oncol Associates   (United States)

Author keywords

HER2; Nab paclitaxel; Sensory neuropathy; Sparc; Veeda oncology network

Indexed keywords

ALBUMIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; NANOPARTICLE; PACLITAXEL; TRASTUZUMAB;

ALLERGIC RHINITIS; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BACKACHE; BLEEDING; BLURRED VISION; BRAIN ISCHEMIA; BREAST CANCER; CARDIOTOXICITY; CHILL; COLITIS; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED STUDY; COUGHING; DESQUAMATION; DIZZINESS; DYSGEUSIA; DYSPNEA; EDEMA; EPIPHORA; FATIGUE; FEVER; HEADACHE; HEART ARRHYTHMIA; HEARTBURN; HUMAN; INFECTION; INSOMNIA; LEUKOPENIA; LUNG DISEASE; MAJOR CLINICAL STUDY; METASTASIS; METASTATIC BREAST CANCER; MOOD CHANGE; MULTICENTER STUDY; MUSCLE WEAKNESS; NAIL DISEASE; NAUSEA; NEUTROPENIA; PAIN; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; SENSORY NEUROPATHY; SIDE EFFECT; SURVIVAL RATE; TREATMENT RESPONSE; VOMITING;

EID: 80051769883     PISSN: 15268209     EISSN: 19380666     Source Type: Journal    
DOI: 10.1016/j.clbc.2011.03.007     Document Type: Article

References (47)

1. Jemal A, Siegel R, Xu J, et al. Cancer Statistics, 2010. CA Cancer J Clin 2010 (published online July 7, 2010).
2. Conlin AK, Seidman AD. Taxanes in breast cancer: an update. Curr Oncol Rep 2007;9:22-30. (Pubitemid 46075630)
3. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Breast Cancer, 2010; v2. Available at: http://www.nccn.org/ professionals/physician-gls/PDF/breast.pdf.
4. Mayer EL, Burstein HJ. Chemotherapy for metastatic breast cancer. Hematol Oncol Clin North Am 2007;21:257-72. (Pubitemid 46754731)
5. Altekruse SF, Kosary CL, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2007. National Cancer Institute. Bethesda, MD. Available at: http://seer.cancer.gov/csr/1975-2007. Based on November 2009 SEER data submission, posted to the SEER web site, 2010.
6. Taxol (paclitaxel) Injection [package insert]. Princeton, NJ: Bristol-Myers Squibb Co; 2007.
7. Taxotere (docetaxel) Injection Concentrate [package insert]. Bridgewater, NJ: sanofi-aventis; 2008.
8. Harries M, Ellis P, Harper P. Nanoparticle albumin-bound paclitaxel for metastatic breast cancer. J Clin Oncol 2005;23:7768-71. (Pubitemid 46657369)
9. Miele E, Spinelli GP, Miele E, et al. Albumin-bound formulation of paclitaxel (Abraxane ABI-007) in the treatment of breast cancer. Int J Nanomedicine 2009;4:99-105.
10. ten Tije AJ, Verweij J, Loos WJ, et al. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 2003;42:665-85. (Pubitemid 36936530)
11. 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)
12. Desai N, 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)
13. Desai NP, Trieu V, Hwang LY, et al. Improved effectiveness of nanoparticle albuminbound (nab) paclitaxel versus polysorbate-based docetaxel in multiple xenografts as a function of HER2 and SPARC status. Anticancer Drugs 2008;19:899-909.
14. 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.
15. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albuminbound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005;23:7794-803. (Pubitemid 46657376)
16. 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)
17. Perez EA, Suman VJ, Rowland KM, et al. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin Breast Cancer 2005;6:425-32. (Pubitemid 43078898)
18. 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.
19. Sparano JA, Wang M, Martino S, et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 2008;358:1663-71. (Pubitemid 351549913)
20. Verril MW, Lee J, Cameron DA, et al. Anglo-Celtic IV: First results of a UK National Cancer Research Network randomised phase 3 pharmacogenetic trial of weekly versus 3 weekly Paclitaxel in patients with locally advanced or metastatic breast cancer (ABC). J Clin Oncol 2007;25(18 suppl):33s (abstract LBA1005).
21. 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;27:3611-9.
22. Conlin AK, Seidman AD, 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;10:281-7.
23. 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.
24. 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(15 suppl):42s (abstract 1006).
25. Slamon DJ, 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;344:783-92. (Pubitemid 32222155)
26. Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as firstline treatment: the M77001 study group. J Clin Oncol 2005;23:4265-74. (Pubitemid 46207001)
27. Blum JL, Savin MA, Edelman, G, et al. Long term disease control in taxane-refractory metastatic breast cancer treated with nab paclitaxel. J Clin Oncol 2004;22:14s (abstract 543)
28. Nyman DW, Campbell KJ, Hersh E, et al. A phase I trial of ABI-007, nanoparticle paclitaxel, administered to patients with advanced non-hematologic malignancies. J Clin Oncol 2004;22:14s (abstract 2027).
29. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-6.
30. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
31. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987;235:177-82. (Pubitemid 17231334)
32. Seshadri R, Firgaira FA, Horsfall DJ, et al. Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. The South Australian Breast Cancer Study Group. J Clin Oncol 1993;11:1936-42. (Pubitemid 23304619)
33. Baselga J, Norton L, Albanell J, et al. Recombinant humanized anti-HER2 antibody (Herceptin) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu overexpressing human breast cancer xenografts. Cancer Res 1998;58:2825-31. (Pubitemid 28311914)
34. Pegram MD, Lopez A, Konecny G, et al. Trastuzumab and chemotherapeutics: drug interactions and synergies. Semin Oncol 2000;27(suppl 11):21-5, discussion 92-100. (Pubitemid 32172252)
35. Redana S, Donadio M, Nolè F, et al. Trastuzumab with either docetaxel or vinorelbine as first-line treatment for patients with HER2-positive advanced breast cancer: a retrospective comparison. BMC Cancer 2010;10:28.
36. Vogel CL, Cobleigh MA, 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;20:719-26. (Pubitemid 34111379)
37. Kim YW, Park YK, Lee J, et al. Expression of osteopontin and osteonectin in breast cancer. J Korean Med Sci 1998;13:652-7. (Pubitemid 128686444)
38. 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.
39. Desai N, Trieu V, Damascelli B, et al. SPARC expression correlates with tumor response to albumin-bound paclitaxel in head and neck cancer patients. Transl Oncol 2009;2:59-64.
40. Nahta R, Shabaya S, Ozbay T, et al. Personalizing HER2-targeted therapy in metastatic breast cancer beyond HER2 status: what we have learned from clinical specimens. Curr Pharmacogenomics Person Med 2009;7:263-74.
41. Roy V, LaPlant BR, Gross GG, et al; 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 2009;20:449-53.
42. Link JS, Waisman JR, Nguyen B, et al. Bevacizumab and albumin-bound paclitaxel treatment in metastatic breast cancer. Clin Breast Cancer 2007;7:779-83. (Pubitemid 350086122)
43. 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(15 suppl):59s (abstract 1075).
44. 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.
45. Robert N, Leyland-Jones B, Asmar L, et al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2006;24:2786-92. (Pubitemid 46630577)
46. Robidoux A, Buzdar AU, 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;10:81-6.
47. Wiedenmann N, Valdecanas D, Hunter N, et al. 130-nm albumin-bound paclitaxel enhances tumor radiocurability and therapeutic gain. Clin Cancer Res 2007;13:1868-74. (Pubitemid 46952957)