Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule

Journal of Clinical Oncology

Volumn 23, Issue 10, 2005, Pages 2162-2171

  Baselga, José ^a   Carbonell, Xavier ^a   Castañeda Soto, Noel Jaime ^a   Clemens, Michael ^a   Green, Michael ^a   Harvey, Vernon ^a   Morales, Serafin ^a   Barton, Claire ^a   Ghahramani, Parviz ^a  

^a ROCHE PRODUCTS LTD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ENALAPRIL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; FUROSEMIDE; TRAMADOL; TRASTUZUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BREAST CANCER; BREAST METASTASIS; CANCER FATIGUE; CANCER GROWTH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; FLUORESCENCE IN SITU HYBRIDIZATION; GENE OVEREXPRESSION; HEADACHE; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; IMMUNOHISTOCHEMISTRY; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; OXYGEN THERAPY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RIGOR; BREAST TUMOR; DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; PATHOLOGY; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; INFUSIONS, INTRAVENOUS; MIDDLE AGED; RECEPTOR, ERBB-2; TREATMENT OUTCOME;

EID: 17144371333     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.01.014     Document Type: Article

References (29)

1. Slamon D, Clark G, Wong SG, et al: Human breast cancer: Correlation of relapse and survival with amplification of the HER2/neu oncogene. Science 235:177-182, 1987
2. Slamon DJ, Godolphin W, Jones LA, et al: Studies of the HER2/neu proto-oncogene in human breast and ovarian cancer. Science 244:707-712, 1989
3. Allred DC, Clark GM, Molina R, et al: Overexpression of HER2/neu and its relationship with other prognostic factors changed during progression of in-situ to invasive breast cancer. Hum Pathol 23:974-979, 1992
4. Benz CC, Scott GK, Sarup JC, et al: Estrogen-dependent, tamoxifen-resistant tumorigenic growth of MCF-7 cells, transfected with HER2/neu. Breast Cancer Res Treat 24:85-95, 1993
5. Chazin VR, Kaleko M, Miller AD, et al: Transformation mediated by the human HER-2 gene independent of epidermal growth factor receptor. Oncogene 7:1859-1866, 1992
6. Carter P, Presta L, Gorman CM, et al: Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc Natl Acad Sci U S A 89:4285-4289, 1992
7. Slamon D, 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 344: 783-792, 2001
8. Vogel C, Cobleigh M, 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 20:719-726, 2002
9. Cobleigh MA, Vogel CL, Tripathy D, 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 17:2639-2648, 1999
10. Cook-Bruns N: Retrospective analysis of the safety of Herceptin immunotherapy in metastatic breast cancer. Oncology 61:58-66, 2001 (suppl 2)
11. Leyland-Jones B: Dose-scheduling-Herceptin. Oncology 61:31-36, 2001 (suppl 2)
12. Washington CB, Lieberman G, Liu P, et al: A population pharmacokinetic model for trastuzumab following weekly dosing. Clin Pharmacol Ther 71:12, 2002 (abstr)
13. Leyland-Jones B, Gelmon K, Ayoub J-P, et al: Pharmacokinetics, safety and efficacy of trastuzumab administered every 3 weeks in combination with paclitaxel. J Clin Oncol 21: 3965-3971, 2003
14. Pegram MD, Lipton A, Hayes DF, et al: Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol 16:2659-2671, 1998
15. HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 14:737-744, 1996
16. Ghahramani P, Barton C, Leyland-Jones B: Pharmacokinetics of Herceptin administered three-weekly compared to weekly: A simulation based on data from the clinical studies. The Breast 12:S40, 2003 (suppl 2; abstr P89)
17. Extra JM, Cognetti F, Maraninchi D, et al; Trastuzumab (Herceptin) plus docetaxel versus docetaxel alone as first-line treatment of HER2-positive metastatic breast cancer (MBC): Results of a randomised multicentre trial. Eur J Cancer 2:125, 2004 (suppl 3)
18. World Health Organization: WHO handbook for reporting results of cancer treatment. Geneva, Switzerland, World Health Organization, 1979
19. Paik S, Bryant J, Tan-Chiu E, et al: Real-world performance of HER2 testing: National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst 94:852-854, 2002
20. Roche PC, Suman VJ, Jenkins RB, et al: Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst 94:855-857, 2002
21. Charoin JE, Jacqmin P, Banken L, et al: Population pharmacokinetic analysis of trastuzumab (Herceptin) following long-term administration using different regimens. Uppsala, Sweden, Population Approach Group (PAGE), 2004 (abstr) http://www.page-meeting.org
22. Burstein HJ, Kuter I, Campos SM, et al: Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 19:2722-2730, 2001
23. Esteva FJ, Valero V, Booser D, et al: Phase II study of weekly docetaxel and trastuzumab for patients with HER2-overexpressing metastatic breast cancer. J Clin Oncol 20: 1800-1808, 2002
24. Seidman A, Hudis C, Pierri MK, et al: Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 20:1215-1221, 2002
25. Marty M, Baselga J, Gatzemeier U, et al: Pooled analysis of six trials of trastuzumab (Herceptin): Exploratory analysis of changes in left ventricular ejection fraction (LVEF) as a surrogate for clinical cardiac events. Breast Cancer Res Treat 82:S48, 2003 (abstr 218)
26. Pichon MF, Neumann R, Guepratte S, et al: Serum Her-2/neu extracellular domain parallels response to trastuzumab treatment of recurrent breast cancer. Breast Cancer Res Treat 76: S110, 2002 (abstr 426)
27. Brown-Shimer S, Schwartz MK, Lin D, et al: Monitoring serum HER-2/neu levels in metastatic breast cancer patients undergoing Herceptin therapy regimens. Breast Cancer Res Treat 76:S111, 2002 (abstr 432)
28. Carney WP, Neumann R, Lipton A, et al: Potential clinical utility of serum HER-2/neu oncoprotein concentrations in patients with breast cancer. Clin Chem 49:1579-1598, 2003
29. Leyland-Jones B, Marty M, Baselga J, et al: Effects of trastuzumab (Herceptin, H) and chemotherapy on circulating HER2 extracellular domain (ECD) in patients with metastatic breast cancer (MBC) and non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 23:19, 2004 (abstr 507)