Eastern Cooperative Oncology Group Phase II Trial of lapatinib in men with biochemically relapsed, androgen dependent prostate cancer1

Urologic Oncology: Seminars and Original Investigations

Volumn 31, Issue 2, 2013, Pages 211-218

  Liu, Glenn ^a   Chen, Yu Hui ^b   Kolesar, Jill ^a   Huang, Wei ^a   DiPaola, Robert ^c   Pins, Michael ^d   Carducci, Michael ^e   Stein, Mark ^c   Bubley, Glenn J ^f   Wilding, George ^a  

^a UNIVERSITY OF WISCONSIN   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c RUTGERS CANCER INSTITUTE OF NEW JERSEY   (United States)

^d UNIVERSITY OF ILLINOIS   (United States)

^e JOHNS HOPKINS UNIVERSITY   (United States)

^f BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

Clinical trial; Epidermal growth factor receptor; Tyrosine kinase inhibitors

Indexed keywords

ANDROGEN; EPIDERMAL GROWTH FACTOR RECEPTOR; LAPATINIB; PROSTATE SPECIFIC ANTIGEN;

ACNE; ARTICLE; CANCER RECURRENCE; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DRUG SAFETY; DRUG TOLERABILITY; EPIDERMAL GROWTH FACTOR RECEPTOR GENE; FATIGUE; GENE; GENE MUTATION; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HUMAN TISSUE; HYPERBILIRUBINEMIA; MALE; ONCOGENE K RAS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; PROTEIN EXPRESSION; SIDE EFFECT;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MUTATION; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; POLYMORPHISM, SINGLE NUCLEOTIDE; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; PROTO-ONCOGENE PROTEINS; QUINAZOLINES; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 84875275330     PISSN: 10781439     EISSN: 18732496     Source Type: Journal    
DOI: 10.1016/j.urolonc.2011.01.002     Document Type: Article

References (38)

1. Jemal A., Siegel R., Ward E., et al. Cancer Statistics 2009. CA Cancer J Clin 2009, 59:225-249.
2. Caire A.A., Sun L., Ode O., et al. Delayed prostate-specific antigen recurrence after radical prostatectomy: How to identify and what are their clinical outcomes?. Urol 2009, 74:643-647.
3. Roberts S., Blute M., Bergstralh E., et al. PSA doubling time as a predictor of clinical progression after biochemical failure following radical prostatectomy for prostate cancer. Mayo Clin Proc 2001, 76:576-581.
4. Nicholson R.I., Gee J.M., Harper M.E. EGFR and cancer prognosis. Eur J Cancer 2001, 37:S9-S15.
5. Cohen D., Simak R., Fair W., et al. Expression of transforming growth factor-a and the epidermal growth factor receptor in human prostate tissue. J Urol 1994, 152:2120-2124.
6. Kim H.G., Kassis J., Souto J., et al. EGF receptor signaling in prostate morphogenesis and tumorigenesis. Histol Histopathol 1999, 14:1175-1182.
7. Ratan H.L., Gescher A., Steward W.P., et al. ErB receptors: Possible therapeutic targets in prostate cancer?. BJU Internat 2003, 92:890-895.
8. Slamon D., Clark G., Wong S. Human breast cancer: Correlation of relapse and survival with amplification of HER-2/neu oncogene. Science 1987, 235:177-182.
9. Slamon D.J., Leyland-Jones B., Shak S., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. New Engl J Med 2001, 344:783-792.
10. Agus D.B., Scher H.I., Higgins B., et al. Response of prostate cancer to anti-Her-2/neu antibody in androgen-dependent and -independent human xenograft models. Cancer Res 1999, 59:4761-4764.
11. Bonaccorsi L., Marchiani S., Muratori M., et al. Gefitinib ("Iressa", ZD1839) inhibits EGF-induced invasion in prostate cancer cells by suppressing PI3 K/AKT activation. J Cancer Res Clin Oncol 2004, 130:604-614.
12. Jenster G. Ligand-independent activation of the androgen receptor in prostate cancer by growth factors and cytokines. J Pathol 2000, 191:227-228.
13. Rusnak D.W., Lackey K., Affleck K., et al. The effects of the novel, reversible epidermal growth factor receptor/ErbB-2 tyrosine kinase inhibitor, GW2016, on the growth of human normal and tumor-derived cell lines in vitro and in vivo. Mol Cancer Ther 2001, 1:85-94.
14. Shewchuk L., Hassell A., Wisely B., et al. Binding mode of the 4-anilinoquinazoline class of protein kinase inhibitor: X-ray crystallographic studies of 4-anilinoquinazolines bound to cyclin-dependent kinase 2 and p38 kinase. J Med Chem 2000, 43:133-138.
15. Xia W., Mullin R.J., Keith B.R., et al. Anti-tumor activity of GW572016: A dual tyrosine kinase inhibitor blocks EGF activation of EGFR/erB2 and downstream Erk1/2 and AKT pathways. Oncogene 2002, 21:6255-6263.
16. Pezaro C., Rosenthal M.A., Gurney H., et al. An open-label, single-arm Phase II trial of gefitinib in patients with advanced or metastatic castration-resistant prostate cancer. Am J Clin Oncol 2009, 32:338-341.
17. Ziada A., Barqawi A., Glode L.M., et al. The use of trastuzumab in the treatment of hormone refractory prostate cancer. Prostate 2004, 60:332-337.
18. Bubley G.J., Carducci M., Dahut W., et al. Eligibility and response guidelines for Phase II clinical trials in androgen-independent prostate cancer: Recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999, 17:3461-3467.
19. Yazdi A.S., Puchta U., Flaig M.J., et al. Laser-capture microdissection: Applications in routine molecular dermatopathology. J Cutan Pathol 2004, 31:465-470.
20. Kolesar J., Huang W., Eickhoff J., et al. Evaluation of mRNA by Q-RTPCR and protein expression by AQUA of the M2 subunit of ribonucleotide reductase (RRM2) in human tumors. Cancer Chemother Pharmacol 2009, 64:79-86.
21. Ogino S., Kawasaki T., Brahmandam M., et al. Sensitive sequencing method for Kras mutation detection by pyrosequencing. J Mol Diagn 2005, 7:413-421.
22. Kolesar J.M., Hamidovic A., Hahn K. Clinical significance of ABCB1 genotyping in oncology. J Oncol Pharm Pract 2009 Apr 28, [Epub ahead of print].
23. Warren M., Twohig M., Pier T., et al. Protein Expression of Matriptase and its Cognate Inhibitor HAI-1 in Human Prostate Cancer: A Tissue Microarray and Automated Quantitative Analysis. Appl Immunohistochem Mol Morphol 2008, 17:23-30.
24. Rahrmann E.P., Collier L.S., Knutson T.P., et al. Identification of PDE4D as a proliferation promoting factor in prostate cancer using a Sleeping Beauty transposon-based somatic mutagenesis screen. Cancer Res 2009, 69:4388-4397.
25. Cox D.R. Analysis of Binary Data 1970, Methuen and Co., London.
26. Kaplan E.L., Meier P. Nonparametric estimation of incomplete observations. J Am Statistical Assoc 1958, 53:457-481.
27. Laird N.M., Ware J.H. Random effects models for longitudinal data. Biometrics 1984, 38:963-974.
28. Armitage P., Berry G. Statistical Methods in Medical Research 1987, Blackwell Scientific Publications, Oxford. 2nd ed.
29. Peto R., Peto J. Asymptotically efficient rank invariant test procedures. J Royal Statistical Soc, Series A 1972, 135:185-206.
30. Scher H.I., Halabi S., Tannock I., et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008, 26:1148-1159.
31. McNeel D.G., Dunphy E., Davies J.G., et al. Safety and Immunological efficacy of a DNA vaccine encoding prostatic acid phosphatase in patients with stage D0 prostate cancer. J Clin Oncol 2009, 27:404-454.
32. Sweeney C., Liu G., Yiannoutsos C., et al. A Phase II, multicenter, randomized, double-blind, safety trial assessing the pharmacokinetics, pharmacodynamics, and efficacy of oral 2-methoxyestradiol capsules in hormone-refractory prostate cancer. Clin Cancer Res 2005, 11:6625-6633.
33. Smith M.R., Manola J., Kaufman D.S., et al. Rosiglitazone versus placebo for men with prostate carcinoma and a rising serum prostate-specific antigen level after radical prostatectomy abd/or radiation therapy. Cancer 2004, 101:1569. J Royal Statistical Soc, Series A 74.
34. Hudis C.A. Trastzumab-mechanism of action and use in clinical practice. N Engl J Med 2007, 357:39-51.
35. Van Cutsem E., Kang Y., Chung H., et al. Efficacy results from the ToGA trial: A Phase II study of trastuzumab added to standard chemotherapy in the first-line human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. J Clin Oncol 2009, 27:18s.
36. Lynch T.J., Bell D.W., Sordella R., et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non small-cell lung cancer to gefitinib. N Engl J Med 2004, 350:2129-2139.
37. Karapetis C.S., Khambata-Ford S., Jonker D.J., et al. Kras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008, 359:1757-1765.
38. Brass A.L., Barnard J., Patai B.L., et al. Androgen up-regulates epidermal growth factor receptor expression and binding affinity in PC3 cell lines expressing human androgen receptor. Cancer Res 1995, 55:3197-3203.