Phase I dose escalation pharmacokinetic assessment of intravenous humanized anti-MUC1 antibody AS1402 in patients with advanced breast cancer

Breast Cancer Research

Volumn 11, Issue 5, 2009, Pages

  Pegram, Mark D ^a   Borges, Virginia F ^b   Ibrahim, Nuhad ^c   Fuloria, Jyotsna ^d   Shapiro, Charles ^e   Perez, Susan ^f   Wang, Karen ^f   Schaedli Stark, Franziska ^g   Courtenay Luck, Nigel ^h  

^a UNIVERSITY OF MIAMI   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d OCHSNER CLINIC FOUNDATION   (United States)

^e OHIO STATE UNIVERSITY   (United States)

^f HOFFMANN LA ROCHE INC   (United States)

^g F HOFFMANN LA ROCHE LTD   (Switzerland)

^h Antisoma Research Limited   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; AS 1402; MUCIN 1; RECOMBINANT HUMAN INSULIN; TAXANE DERIVATIVE; TRASTUZUMAB; UNCLASSIFIED DRUG; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERBB2 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; MUC1 PROTEIN, HUMAN;

ADULT; ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANOREXIA; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; ANTIBODY DETECTION; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BREAST CANCER; CANCER LOCALIZATION; CANCER PATIENT; CATHETER SITE EDEMA; CLINICAL ARTICLE; CONSTIPATION; DRUG DOSE ESCALATION; DRUG EXPOSURE; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; IN VITRO STUDY; INJECTION SITE DISCOMFORT; INJECTION SITE PAIN; JAUNDICE; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; PHASE 1 CLINICAL TRIAL; RASH; REPEATED DRUG DOSE; SERUM BACTERICIDAL ANTIBODY ASSAY; SIDE EFFECT; STOMATITIS; AGED; BIOSYNTHESIS; BREAST TUMOR; CLINICAL TRIAL; COHORT ANALYSIS; DOSE RESPONSE; ENZYMOLOGY; IMMUNOLOGY; METABOLISM; MIDDLE AGED;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODY-DEPENDENT CELL CYTOTOXICITY; BREAST NEOPLASMS; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; FEMALE; HUMANS; MIDDLE AGED; MUCIN-1; RECEPTOR, ERBB-2;

EID: 77449106552     PISSN: 14655411     EISSN: 1465542X     Source Type: Journal    
DOI: 10.1186/bcr2409     Document Type: Article

References (19)

1. da-Nagai K, Irimura T. MUC1 in carcinoma-host interactions. Glycoconj J 2000, 17:649-658. 10.1023/A:1011039013134, 11421355.
2. Rakha EA, Boyce RWG, Abd El-Rehim D, Kurien T, Green AR, Paish EC, Robertson JFR, Ellis IO. Expression of mucins (MUC1, MUC2, MUC3, MUC4, MUC5AC and MUC6) and their prognostic significance in human breast cancer. Mod Pathol 2005, 18:1295-1304. 10.1038/modpathol.3800445, 15976813.
3. Levitin F, Stern O, Weiss M, Gil-Henn C, Ziv R, Prokocimer Z, Smorodinsky NI, Rubinstein DB, Wreschner DH. The MUC1 SEA module is a self-cleaving domain. J Biol Chem 2005, 280:33374-33386. 10.1074/jbc.M506047200, 15987679.
4. Ren J, Bharti A, Raina D, Chen W, Ahmad R, Kufe D. MUC1 oncoprotein is targeted to mitochondria by heregulin-induced activation of c-Src and the molecular chaperone HSP90. Oncogene 2006, 25:20-31.
5. Schroeder JA, Adriance MC, Thompson MC, Camenisch TD, Gendler SJ. MUC1 alters beta-catenin-dependent tumor formation and promotes cellular invasion. Oncogene 2003, 22:1324-1332. 10.1038/sj.onc.1206291, 12618757.
6. Wei X, Xu H, Kufe D. MUC1 oncoprotein stabilizes and activates estrogen receptor alpha. Mol Cell 2006, 21:295-305. 10.1016/j.molcel.2005.11.030, 16427018.
7. Baldus SE, Wienand JR, Werner JP, Landsberg S, Drebber U, Hanisch FG, Dienes HP. Expression of MUC1, MUC2 and oligosaccharide epitopes in breast cancer: prognostic significance of a sialylated MUC1 epitope. Int J Oncol 2005, 27:1289-1297.
8. Rahn JJ, Chow JW, Horne GJ, Mah BK, Emerman JT, Hoffman P, Hugh JC. MUC1 mediates transendothelial migration in vitro by ligating endothelial cell ICAM-1. Clin Exp Metastasis 2005, 22:475-483. 10.1007/s10585-005-3098-x, 16320110.
9. McGuckin MA, Walsh MD, Hohn BG, Ward BG, Wright RG. Prognostic significance of MUC1 epithelial mucin expression in breast cancer. Hum Pathol 1995, 26:432-439. 10.1016/0046-8177(95)90146-9, 7705823.
10. Verhoeyen ME, Saunders JA, Price MR, Marugg JD, Briggs S, Broderick EL, Eida SJ, Mooren AT, Badley RA. Construction of a reshaped HMFG1 antibody and comparison of its fine specificity with that of the parent mouse antibody. Immunology 1993, 78:364-370. 1421827, 7682986.
11. Snijdewint FG, von Mensdorff-Pouilly S, Karuntu-Wanamarta AH, Verstraeten AA, Livingston PO, Hilgers J, Kenemans P. Antibody-dependent cell-mediated cytotoxicity can be induced by MUC1 peptide vaccination of breast cancer patients. Int J Cancer 2001, 93:97-106. 10.1002/ijc.1286, 11391628.
12. von Mensdorff-Pouilly S, Verstraeten AA, Kenemans P, Snijdewint FG, Kok A, Van Kamp GJ, Paul MA, Van Diest PJ, Meijer S, Hilgers J. Survival in early breast cancer patients is favorably influenced by a natural humoral immune response to polymorphic epithelial mucin. J Clin Oncol 2000, 18:574-583.
13. Dinh P, de Azambuja E, Piccart-Gebhart MJ. Trastuzumab for early breast cancer: current status and future directions. Clin Adv Hematol Oncol 2007, 5:707-717.
14. Pericleous LM, Richards J, Epenetos AA, Courtenay-Luck N, Deonarain MP. Characterisation and internalisation of recombinant humanised HMFG-1 antibodies against MUC1. Br J Cancer 2005, 93:1257-1266. 10.1038/sj.bjc.6602847, 16265351.
15. Goodin S. Development of monoclonal antibodies for the treatment of colorectal cancer. Am J Health Syst Pharm 2008, 65:S3-S7. 10.2146/ajhp080100, 18499888.
16. Braun DP, Crist KA, Shaheen F, Staren ED, Andrews S, Parker J. Aromatase inhibitors increase the sensitivity of human tumor cells to monocyte-mediated, antibody-dependent cellular cytotoxicity. Am J Surg 2005, 190:570-571. 10.1016/j.amjsurg.2005.06.013, 16164922.
17. Ibrahim NK, Murray J, Parker J, Finke L, Miles D. Humoral immune-response to naturally occurring STn in metastatic breast cancer patients (MBC pts) treated with STn-KLH vaccine [Abstract]. J Clin Oncol 2004, 22:s2547.
18. Orman JS, Perry CM. Trastuzumab: in HER2 and hormone receptor co-positive metastatic breast cancer. Drugs 2007, 67:2781-2789. 10.2165/00003495-200767180-00009, 18062723.
19. Herold CI, Blackwell KL. Aromatase inhibitors for breast cancer: proven efficacy across the spectrum of disease. Clin Breast Cancer 2008, 8:50-64. 10.3816/CBC.2008.n.003, 18501059.