Targeted T-cell therapy in stage IV breast cancer: A phase i clinical trial

Clinical Cancer Research

Volumn 21, Issue 10, 2015, Pages 2305-2314

  Lum, Lawrence G ^a   Thakur, Archana ^a   Al Kadhimi, Zaid ^a   Colvin, Gerald A ^b   Cummings, Francis J ^c   Legare, Robert D ^d   Dizon, Don S ^e   Kouttab, Nicola ^c   Maizel, Abby ^d   Colaiace, William ^c   Liu, Qin ^f   Rathore, Ritesh ^c  

^a WAYNE STATE UNIVERSITY   (United States)

^b South County Hospital   (United States)

^c ROGER WILLIAMS MEDICAL CENTER   (United States)

^d WOMEN AND INFANTS HOSPITAL   (United States)

^e HARVARD MEDICAL SCHOOL   (United States)

^f WISTAR INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CD3 ANTIBODY; GAMMA INTERFERON; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 BISPECIFIC ANTIBODY; INTERLEUKIN 2; RECEPTOR ANTIBODY; UNCLASSIFIED DRUG; BISPECIFIC ANTIBODY;

ADULT; AGED; ANTIBODY RESPONSE; ARTICLE; BREAST METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNIZATION; CANCER STAGING; CELL EXPANSION; CELL THERAPY; CELLULAR IMMUNITY; CLINICAL ARTICLE; CONTROLLED STUDY; CYTOTOXIC T LYMPHOCYTE; DRUG SAFETY; DRUG TOLERABILITY; FEASIBILITY STUDY; FEMALE; HUMAN; LEUKAPHERESIS; LYMPHOCYTE MIGRATION; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; T LYMPHOCYTE; T LYMPHOCYTE ACTIVATION; TH1 CELL; BREAST NEOPLASMS; CLINICAL TRIAL; IMMUNOLOGY; IMMUNOTHERAPY; KAPLAN MEIER METHOD; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; PATHOLOGY; TRANSPLANTATION;

ADULT; AGED; ANTIBODIES, BISPECIFIC; BREAST NEOPLASMS; FEMALE; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; IMMUNOTHERAPY; INTERLEUKIN-2; KAPLAN-MEIER ESTIMATE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; T-LYMPHOCYTES;

EID: 84942115119     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-2280     Document Type: Article

References (33)

1. Harris J, Morrow M, Bonadonna G. Cancer. Principles and practice of oncology. 4 ed. Philadelphia, PA: Lippincott; 1993.
2. Muss HB, Case LD, Richards F, White DR, Cooper MR, Cruz JM, et al. Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. The Piedmont Oncology Association. N Engl J Med 1991;325:1342-8.
3. Nabholtz JM, Senn HJ, Bezwoda WR, Melnychuk D, Deschenes L, Douma J, et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group. J Clin Oncol 1999;17:1413-24.
4. Schwartz S Jr, Caceres C, Morote J, de Torres I, Rodriguez-Vallejo JM, Gonzalez J, et al. Gains of the relative genomic content of erbB-1 and erbB-2 in prostate carcinoma and their association with metastasis. Int J Oncol 1999;14:367-71.
5. Morote J, de Torres I, Caceres C, Vallejo C, Schwartz S Jr, Reventos J. Prognostic value of immunohistochemical expression of the c-erbB-2 oncoprotein in metastasic prostate cancer. Int J Cancer 1999;84:421-5.
6. Korkaya H, WichaMS. HER-2, notch, and breast cancer stem cells: targeting an axis of evil. Clin Cancer Res 2009;15:1845-7.
7. Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, 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;17:2639-48.
8. Vogel CL, Cobleigh MA, TripathyD,Gutheil JC,Harris LN, Fehrenbacher L, 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.
9. Gradishar WJ. HER2 therapy-An abundance of riches. N Engl J Med 2012;366:176-8.
10. Burris HA III, Rugo HS, Vukelja SJ, Vogel CL, Borson RA, Limentani S, et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J Clin Oncol 2011;29:398-405.
11. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733-43.
12. Burstein HJ, Sun Y, Dirix LY, Jiang ZF, Paridaens R, Tan AR, et al. Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer. J Clin Oncol 2010;28:1301-7.
13. Hickish T, Wheatley D, Lin N, Carey L, Houston S,Mendelson D, et al. Use of BIBW 2992, a novel irreversible EGFR/HER1 and HER2 Tyrosine kinase inhibitor to treat patients with her2-positive metastatic breast cancer after failure of treatment with trastuzumab. Cancer Res 2009;69:785S.
14. Sen M, Wankowski DM, Garlie NK, Siebenlist RE, Van Epps D, LeFever AV, et al. Use of anti-CD3 x anti-HER2/neu bispecific antibody for redirecting cytotoxicity of activated T cells toward HER2/neu tumors. J Hematother Stem Cell Res 2001;10:247-60.
15. Grabert RC, Cousens LP, Smith JA, Olson S,Gall J, Young WB, et al. Human T cells armed with Her2/neu bispecific antibodies divide, are cytotoxic, and secrete cytokines with repeated stimulation. Clin Cancer Res 2006;12: 569-76.
16. Davol PA, Smith JA, Kouttab N, Elfenbein GJ, Lum LG. Anti-CD3 x anti-HER2 bispecific antibody effectively redirects armed T cells to inhibit tumor development and growth in hormone-refractory prostate cancerbearing severe combined immunodeficient beige mice. Clin Prostate Cancer 2004;3:112-21.
17. Lum HE, Miller M, Davol PA, Grabert RC, Davis JB, Lum LG. Preclinical studies comparing different bispecific antibodies for redirecting T cell cytotoxicity to extracellular antigens on prostate carcinomas. Anticancer Res 2005;25:43-52.
18. Lum LG, Thakur A, Liu Q, Deol A, Al-Kadhimi Z, Ayash L, et al. CD20-targeted T cells after stem cell transplantation for high risk and refractory non-Hodgkin's lymphoma. Biol Blood Marrow Transplant 2013;19: 925-33.
19. Guarneri V, Lenihan DJ, Valero V, Durand JB, Broglio K, Hess KR, et al. Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: the M.D. Anderson Cancer Center experience. J Clin Oncol 2006;24: 4107-15.
20. Gall JM, Davol PA, Grabert RC, Deaver M, Lum LG. T cells armed with anti-CD3 x anti-CD20 bispecific antibody enhance killing of CD20+malignant B-cells and bypass complement-mediated Rituximab-resistance in vitro. Exp Hematol 2005;33:452-9.
21. von MG. Evidence-based treatment of metastatic breast cancer-2006 recommendations by the AGO Breast Commission. Eur J Cancer 2006;42:2897-908.
22. Kaufmann M, Maass N, Costa SD, Schneeweiss A, Loibl S, Sutterlin MW, et al. First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: results of the MONICA trial. Eur J Cancer 2010;46:3184-91.
23. Vauleon E,Mesbah H, Laguerre B, GedouinD, Lefeuvre-Plesse C, Leveque J, et al. Usefulness of chemotherapy beyond the second line for metastatic breast cancer: a therapeutic challenge. Cancer Chemother Pharmacol 2010;66:113-20.
24. Banerji U, Kuciejewska A, Ashley S, Walsh G, O'Brien M, Johnston S, et al. Factors determining outcome after third line chemotherapy for metastatic breast cancer. Breast 2007;16:359-66.
25. Leonard R, O'shaughnessy J, Vukelja S, Gorbounova V, Chan-Navarro CA, Maraninchi D, et al. Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage? Ann Oncol 2006; 17:1379-85.
26. Martin M, Ruiz A, Munoz M, Balil A, Garcia-Mata J, Calvo L, et al. Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol 2007;8:219-25.
27. Baselga J, Segalla JG, Roche H, Del GA, Pinczowski H, Ciruelos EM, et al. Sorafenib in combination with capecitabine: an oral regimen for patients with HER2-negative locally advanced or metastatic breast cancer. J Clin Oncol 2012;30:1484-91.
28. Brufsky A, Valero V, Tiangco B, Dakhil S, Brize A, RugoHS, et al. Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial. Breast Cancer Res Treat 2012;133:1067-75.
29. Baselga J, Gomez P, Greil R, Braga S, Climent MA, Wardley AM, et al. randomized phase ii study of the anti-epidermal growth factor receptor monoclonal antibody cetuximab with cisplatin versus cisplatin alone in patients with metastatic triple-negative breast cancer. J Clin Oncol 2013;31:2586-92.
30. Buzdar AU, Jonat W, Howell A, Jones SE, Blomqvist CP, Vogel CL, et al. Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma-Results of a survival update based on a combined analysis of data from two mature phase III trials. Cancer 1998;83:1142-52.
31. Lum LG, Thakur A, Pray C, Kouttab N, Abedi M, Deol A, et al. Multiple infusions of CD20-targeted T cells and low-dose IL-2 after SCT for high-risk non-Hodgkin's lymphoma: a pilot study. Bone Marrow Transplant 2014;49:73-9.
32. Thakur A, Schalk D, Sarkar SH, Al-Khadimi Z, Sarkar FH, Lum LG. A Th1 cytokine-enriched microenvironment enhances tumor killing by activated T cells armed with bispecific antibodies and inhibits the development of myeloid-derived suppressor cells. Cancer Immunol Immunother 2012;61: 497-509.
33. Lum LG, Thakur A, Rathore R, Al-Kadhimi Z, Uberti JP, Rathanatharathorn V. Phase I clinical trial involving infusions of activated T cells armed with anti-CD3 x anti-Her2neu bispecific antibody in women with metastatic breast cancer: Clinical, immune, and trafficking results [abstract]. In: Proceedings of the 2010 Breast Cancer Symposium 2010; 2010 Oct 1-3; Washington (DC): ASCO; 2010. Abstract nr. 264.