A phase I clinical trial of bavituximab and paclitaxel in patients with HER2 negative metastatic breast cancer

Cancer Medicine

Volumn 4, Issue 7, 2015, Pages 1051-1059

  Chalasani, Pavani ^a   Marron, Marilyn ^a   Roe, Denise ^a   Clarke, Kathryn ^a   Iannone, Maria ^a   Livingston, Robert B ^a   Shan, Joseph S ^b   Stopeck, Alison T ^c  

^a UNIVERSITY OF ARIZONA   (United States)

^b Peregrine Pharmaceuticals Inc   (United States)

^c Stonybrook University   (United States)

Author keywords

Bavituximab; Circulating tumor cells; Metastatic breast cancer; Microparticles; Paclitaxel

Indexed keywords

BAVITUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PACLITAXEL; PHOSPHATIDYLSERINE; ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BACKACHE; BLEEDING; BLOOD CLOTTING PARAMETERS; BONE PAIN; BREAST CANCER; CELL COUNT; CIRCULATING TUMOR CELL; CLINICAL ARTICLE; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ENDOTHELIUM CELL; FAINTNESS; FATIGUE; FEMALE; FLOW CYTOMETRY; HEADACHE; HUMAN; HUMAN CELL; HYPERGLYCEMIA; HYPERTENSION; INFUSION RELATED REACTION; MEMBRANE MICROPARTICLE; MONOCYTE DERIVED MICROPARTICLE; MYALGIA; NEUTROPENIA; OUTCOME ASSESSMENT; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PLATELET MICROPARTICLE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SURVIVAL TIME; THORAX PAIN; THROMBOCYTE ACTIVATION; THROMBOSIS; TREATMENT DURATION; TREATMENT RESPONSE; TUMOR IMMUNITY; BIOPSY; BREAST NEOPLASMS; CLINICAL TRIAL; DEFICIENCY; DRUG ADMINISTRATION; KAPLAN MEIER METHOD; METABOLISM; METASTASIS; MIDDLE AGED; MORTALITY; PATHOLOGY; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOMARKERS; BIOPSY; BREAST NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MIDDLE AGED; NEOPLASM METASTASIS; PACLITAXEL; RECEPTOR, ERBB-2; TREATMENT OUTCOME;

EID: 85006216584     PISSN: None     EISSN: 20457634     Source Type: Journal    
DOI: 10.1002/cam4.447     Document Type: Article

References (33)

1. Desantis, C., J. Ma, L. Bryan, and A. Jemal. 2014. Breast cancer statistics, 2013. CA Cancer J. Clin. 64:52-62.
2. Sledge, G. W., D. Neuberg, P. Bernardo, J. N. Ingle, S. Martino, E. K. Rowinsky, et al. 2003. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J. Clin. Oncol. 21:588-592.
3. Miller, K., M. Wang, J. Gralow, M. Dickler, M. Cobleigh, E. A. Perez, et al. 2007. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N. Engl. J. Med. 357:2666-2676.
4. Miles, D. W., A. Chan, L. Y. Dirix, J. Cortés, X. Pivot, P. Tomczak, et al. 2010. 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. 28:3239-3247.
5. Robert, N. J., V. Diéras, J. Glaspy, A. M. Brufsky, I. Bondarenko, O. N. Lipatov, et al. 2011. 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. 29:1252-1260.
6. Daleke, D. L. 2003. Regulation of transbilayer plasma membrane phospholipid asymmetry. J. Lipid Res. 44:233-242.
7. Ran, S., A. Downes, and P. E. Thorpe. 2001. Increased exposure of anionic phospholipids on the surface of tumor blood vessels. Cancer Res. 62:6132-6140.
8. Ran, S., and P. E. Thorpe. 2002. Phosphatidylserine is a marker of tumor vasculature and a potential target for cancer imaging and therapy. Int. J. Radiat. Oncol. Biol. Phys. 54:1479-1484.
9. Jennewein, M., M. A. Lewis, D. Zhao, E. Tsyganov, N. Slavine, J. He, et al. 2008. Vascular imaging of solid tumors in rats with a radioactive arsenic-labeled antibody that binds exposed phosphatidylserine. Clin. Cancer Res. 14:1377-1385.
10. Huang, X., M. Bennett, and P. E. Thorpe. 2005. A monoclonal antibody that binds anionic phospholipids on tumor blood vessels enhances the antitumor effect of docetaxel on human breast tumors in mice. Cancer Res. 65:4408-4416.
11. He, J., T. A. Luster, and P. E. Thorpe. 2007. Radiation-enhanced vascular targeting of human lung cancers in mice with a monoclonal antibody that binds anionic phospholipids. Clin. Cancer Res. 13:5211-5218.
12. Yin, Y., X. Huang, K. D. Lynn, and P. E. Thorpe. 2013. Phosphatidylserine-targeting antibody induces M1 macrophage polarization and promotes myeloid-derived suppressor cell differentiation. Cancer Immunol. Res. 1:256-268.
13. Freeman, G. J., J. M. Casasnovas, D. T. Umetsu, and R. H. DeKruyff. 2010. TIM genes: a family of cell surface phosphatidylserine receptors that regulate innate and adaptive immunity. Immunol. Rev. 235:172-189.
14. Park, D., A. C. Tosello-Trampont, M. R. Elliott, M. Lu, L. B. Haney, Z. Ma, et al. 2007. BAI1 is an engulfment receptor for apoptotic cells upstream of the ELMO/Dock180/Rac module. Nature 450:430-434.
15. Park, S. Y., M. Y. Jung, H. J. Kim, S. J. Lee, S. Y. Kim, B. H. Lee, et al. 2008. Rapid cell corpse clearance by stabilin-2, a membrane phosphatidylserine receptor. Cell Death Differ. 15:192-201.
16. He, M., H. Kubo, K. Morimoto, N. Fujino, T. Suzuki, T. Takahasi, et al. 2011. Receptor for advanced glycation end products binds to phosphatidylserine and assists in the clearance of apoptotic cells. EMBO Rep. 12:358-364.
17. Beck, A. W., T. A. Luster, A. F. Miller, S. E. Holloway, C. R. Conner, C. C. Barnett, et al. 2008. Combination of a monoclonal anti-phosphatidylserine antibody with gemcitabine strongly inhibits the growth and metastasis of orthotopic pancreatic tumors in mice. Int. J. Cancer 118:2639-2643.
18. DeRose, P., P. E. Thorpe, and D. E. Gerber. 2011. Development of bavituximab, a vascular targeting agent with immune-modulating properties, for lung cancer treatment. Immunotherapy 3:933-944.
19. He, J., Y. Yin, T. A. Luster, L. Watkins, and P. E. Thorpe. 2009. Antiphosphatidylserine antibody combined with irradiation damages tumor blood vessels and induces tumor immunity in a rat model of glioblastoma. Clin. Cancer Res. 15:6871-6880.
20. Gerber, D. E., A. T. Stopeck, L. Wong, L. S. Rosen, P. E. Thorpe, J. S. Shan, et al. 2011. Phase I safety and pharmacokinetic study of bavituximab, a chimeric phosphatidylserine-targeting monoclonal antibody, in patients with advanced solid tumors. Clin. Cancer Res. 17:6888-6896.
21. Stopeck, A. T., J. M. Unger, L. M. Rimsza, W. T. Bellamy, M. Iannone, D. O. Persky, et al. 2009. A phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-Hodgkin lymphoma: Southwest oncology group study S0108. Leuk. Lymphoma 50:728-735.
22. Lechner, D., and A. Weltermann. 2008. Chemotherapy-induced thrombosis: a role for microparticles and tissue factor? Semin. Thromb. Hemost. 34:199-203.
23. Aharon, A., and B. Brenner. 2009. Microparticles, thrombosis and cancer. Best Pract. Res. Clin. Haematol. 22:61-69.
24. Rak, J. 2010. Microparticles in cancer. Semin. Thromb. Hemost. 36:888-906.
25. Roseblade, A., F. Luk, and T. Rawling. 2013. Cell-derived microparticles: new targets in the therapeutic management of disease. J. Pharm. Pharm. Sci. 16:238-253.
26. Thaler, J., C. Ay, and I. Pabinger. 2012. Clinical significance of circulating microparticles for venous thromboembolism in cancer patients. Hamostaseologie 32:127-131.
27. Furie, B., and B. C. Furie. 2008. Mechanisms of thrombus formation. N. Engl. J. Med. 359:938-949.
28. Tesselaar, M. E., F. P. Romijn, I. Van Der Linden, F. A. Prins, R. M. Bertina, and S. Osanto. 2007. Microparticle-associated tissue factor activity: a link between cancer and thrombosis? J. Thromb. Haemost. 5:520-527.
29. Manly, D. A., J. Wang, S. L. Glover, R. Kasthuri, H. A. Liebman, N. S. Key, et al. 2010. Increased microparticle tissue factor activity in cancer patients with venous thromboembolism. Thromb. Res. 125:511-512.
30. Dignat-Gearge, F., L. Camion-Jau, F. Sabatier, D. Arnoux, F. Anfosso, N. Bardin, et al. 2004. Endothelial microparticles: a potential contribution to the thrombotic complications of the antiphospholipid syndrome. Thromb. Haemost. 91:667-673.
31. Rossi, E., M. Fassan, M. Aieta, F. Zilio, R. Celadin, M. Borin, et al. 2012. Dynamic changes of live/apoptotic circulating tumour cells as predictive markers of response to sunitinib in metastatic renal cancer. Br. J. Cancer 107:1286-1294.
32. Rossi, E., U. Basso, R. Celadin, F. Zilio, S. Puccirarelli, M. Aieta, et al. 2010. M30 neoepitope expression in epithelial cancer: quantification of apoptosis in circulating tumor cells by cell search analysis. Clin. Cancer Res. 16:5233-5243.
33. Coumans, F. A. W., C. J. M. Doggen, G. Attard, J. S. de Bono, and L. W. M. M. Terstappen. 2010. All circulating EpCAM+CK+CD45- objects predict overall survival in castration-resistant prostate cancer. Ann. Oncol. 21:1851-1857.