Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients

Clinical Cancer Research

Volumn 12, Issue 10, 2006, Pages 3124-3129

  Ramaswamy, Bhuvaneswari ^a   Elias, Anthony D ^b   Kelbick, Nicole T ^a   Dudley, Angela ^a   Morrow, Mark ^a   Hauger, Marsha ^a   Allen, Joan ^a   Rhoades, Chris ^a   Kendra, Kari ^a   Chen, Helen X ^c   Gail Eckhardt, S ^b   Shapiro, Charles L ^a,d  

^a OHIO STATE UNIVERSITY   (United States)

^b UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^c NATIONAL CANCER INSTITUTE   (United States)

^d B 405 Starling Loving ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; DOCETAXEL; ENDOTHELIAL LEUKOCYTE ADHESION MOLECULE 1;

ADULT; AGED; ARTHRALGIA; ARTICLE; BREAST CANCER; BREAST METASTASIS; CANCER SURVIVAL; CELL ADHESION; CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ACTIVITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERTENSION; INFECTION; LUNG EMBOLISM; MALE; NEUROPATHY; NEUTROPENIA; PLEURA EFFUSION; PRIORITY JOURNAL; STATISTICAL ANALYSIS; STOMATITIS; TOXICITY; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE PROGRESSION; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; SURVIVAL ANALYSIS; TAXOIDS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 33744812137     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-05-2603     Document Type: Article

References (39)

1. Presta LG, Chen H, O'Connor SJ, et al. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res 1997;57:4593-9.
2. Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res 2005;65:671-80.
3. Gordon MS, Margolin K, Talpaz M, et al. Phase I safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer. J Clin Oncol 2001;19:843-50.
4. Margolin K, Gordon MS, Holmgren E, et al. Phase Ib trial of intravenous recombinant humanized monoclonal antibody to vascular endothelial growth factor in combination with chemotherapy in patients with advanced cancer: pharmacologic and long-term safety data. J Clin Oncol 2001;19:851-6.
5. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer [see comment]. N Engl J Med 2004;350:2335-42.
6. Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer [see comment]. J Clin Oncol 2005;23: 3706-12.
7. Sandler AB, Gray R, Brahmer J. Randomized phaseII/ III trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC#704865) in patients with advanced non-squamous cell lung cancer (NSCLC): An Eastern Cooperative Oncology Group Trial (ECOIG) Trial-E4599. ASCO annual meeting proceedings. J Clin Oncol 2005;23(16S):LBA4.
8. Cobleigh MA, Langmuir VK, Sledge GW, et al. A phase I/II dose-escalation trial of bevacizumab in previously treated metastatic breast cancer. Semin Oncol 2003;30:117-24.
9. Miller KD, Chap LI, Holmes FA, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005; 23:792-9.
10. Miller KD, Jea G. E2100: a randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer. ASCO annual meeting proceedings. J Clin Oncol 2005;23:16S.
11. Hotchkiss KA, Ashton AW, Mahmood R, Russell RG, Sparano JA, Schwartz EL. Inhibition of endothelial cell function in vitro and angiogenesis in vivo by docetaxel (Taxotere): association with impaired repositioning of the microtubule organizing center. Mol Cancer Ther 2002;1:1191-200.
12. Inoue K, Chikazawa M, Fukata S, Yoshikawa C, Shuin T. Docetaxel enhances the therapeutic effect of the angiogenesis inhibitor TNP-470 (AGM-1470) in metastatic human transitional cell carcinoma. Clin Cancer Res 2003;9:886-99.
13. Ng SS, WD Figg, Sparreboom A. Taxane-mediated antiangiogenesis in vitro: influence of formulation vehicles and binding proteins. Cancer Res 2004;64: 821-4.
14. Sweeney CJ, Miller KD, Sissons SE, et al. The antiangiogenic property of docetaxel is synergistic with a recombinant humanized monoclonal antibody against vascular endothelial growth factor or 2-methoxyestradiol but antagonized by endothelial growth factors. Cancer Res 2001;61:3369-72.
15. 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 [see comment]. J Natl Cancer Inst 2000;92:205-16.
16. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10.
17. Burstein HJ, Manola J, Younger J, et al. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 2000;18:1212-9.
18. Hainsworth JD, Burris HA III, Yardley DA, et al. Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network phase II trial [see comment]. J Clin Oncol 2001;19:3500-5.
19. Hurwitz HI, Fehrenbacher L, Hainsworth JD, et al. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer. J Clin Oncol 2005;23:3502-8.
20. 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.
21. Seidman AD, Fornier MN, Esteva FJ, et al. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 2001;19:2587-95.
22. Hillan KJ KH, Tobin P, et al. The role of VEGF expression in response to bevacizumab plus capecitabine in metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2003;22:191.
23. Bischoff J. Cell adhesion and angiogenesis. J Clin Invest 1997;100:S37-9.
24. Kunkel EJ, Ley K. Distinct phenotype of E-selectin-deficient mice. E-selectin is required for slow leukocyte rolling in vivo. Circ Res 1996;79:1196-204.
25. Moss MA, Zimmer S, Anderson KW. Role of metastatic potential in the adhesion of human breast cancer cells to endothelial monolayers. Anticancer Res 2000; 20:1425-33.
26. Laferriere J, Houle F, Huot J. Regulation of the metastatic process by E-selectin and stress-activated protein kinase-2/p38. Ann N Y Acad Sci 2002;973: 562-72.
27. Hu Y, Kiely JM, Szente BE, Rosenzweig A, Gimbrone MA, Jr. E-selectin-dependent signaling via the mitogen-activated protein kinase pathway in vascular endothelial cells. J Immunol 2000;165:2142-8.
28. Sheen-Chen SM, Eng HL, Huang CC, Chen WJ. Serum levels of soluble E-selectin in women with breast cancer. Br J Surg 2004;91:1578-81.
29. Eichbaum MH, de Rossi TM, Kaul S, Bastert G. Serum levels of soluble E-selectin are associated with the clinical course of metastatic disease in patients with liver metastases from breast cancer. Oncol Res 2004;14:603-10.
30. O'Hanlon DM, Fitzsimons H, Lynch J, Tormey S, Malone C, Given HF. Soluble adhesion molecules (E-selectin, ICAM-1 and VCAM-1) in breast carcinoma. Eur J Cancer 2002;38:2252-7.
31. Matsuura N, Narita T, Mitsuoka C, et al. Increased level of circulating adhesion molecules in the sera of breast cancer patients with distant metastases. Jpn J Clin Oncol 1997;27:135-9.
32. Nguyen M, Corless CL, Kraling BM, et al. Vascular expression of E-selectin is increased in estrogen-receptor-negative breast cancer: a role for tumor-cell-secreted interleukin-1α. Am J Pathol 1997;150: 1307-14.
33. Hebbar M, Krzewinski-Recchi MA, Hornez L, et al. Prognostic value of tumoral sialyltransferase expression and circulating E-selectin concentrations in node-negative breast cancer patients. Int J Biol Markers 2003;18:116-22.
34. Hebbar M, Revillion F, Louchez MM, Fournier C, Bonneterre J, Peyrat JP. Prognostic value of circulating soluble E-selectin concentrations in node-negative breast cancer patients. Clin Cancer Res 1999;5: 1427-33.
35. Yu Y, Moulton KS, Khan MK, et al. E-selectin is required for the antiangiogenic activity of endostatin. Proc Natl Acad Sci U S A 2004;101:8005-10.
36. Byrne GJ, Ghellal A, Iddon J, et al. Serum soluble vascular cell adhesion molecule-1:role as a surrogate marker of angiogenesis. J Natl Cancer Inst 2000;92: 1329-36.
37. Zhang GJ, Adachi I. Serum levels of soluble intercellular adhesion molecule-1 and E-selectin in metastatic breast carcinoma: correlations with clinicopathological features and prognosis. Int J Oncol 1999;14:71-7.
38. Ellis M, Hayes D, Lippman M. Treatment of metastatic breast cancer. In: Lippman M, Harris J, Morrow M, Osborne CK, editors. Diseases of the breast. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 2000. p. 749-97.
39. Burstein HPL, Savolie J. Phase II trial of anti-VEGF antibody bevacizumab in combination with vinorelbin for refractory advanced breast cancer. Breast Cancer Res Treat 2002;76:446.