Phase II study of Erlotinib (OSI-774) in patients with advanced hepatocellular cancer

Journal of Clinical Oncology

Volumn 23, Issue 27, 2005, Pages 6657-6663

  Philip, Philip A ^a   Mahoney, Michelle R ^a   Allmer, Cristine ^a   Thomas, James ^a   Pitot, Henry C ^a   Kim, George ^a   Donehower, Ross C ^a   Fitch, Tom ^a   Picus, Joel ^a   Erlichman, Charles ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; PROTEIN HER1; PROTEIN TYROSINE KINASE INHIBITOR; UNCLASSIFIED DRUG; ZEBRAFISH PROTEIN; PROTEIN KINASE INHIBITOR; QUINAZOLINE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CANCER LOCALIZATION; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRY SKIN; FATIGUE; FEMALE; HUMAN; HUMAN TISSUE; HYPOPHOSPHATEMIA; LIVER CELL CARCINOMA; MALE; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN ANALYSIS; PROTEIN EXPRESSION; PRURITUS; RASH; SKIN TOXICITY; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; CANCER INVASION; CANCER STAGING; COMPARATIVE STUDY; CONFIDENCE INTERVAL; DOSE RESPONSE; DRUG ADMINISTRATION; FOLLOW UP; LIVER TUMOR; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; ORAL DRUG ADMINISTRATION; PATHOLOGY; PROBABILITY; SURVIVAL; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; CARCINOMA, HEPATOCELLULAR; CONFIDENCE INTERVALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; LIVER NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PROBABILITY; PROTEIN KINASE INHIBITORS; QUINAZOLINES; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 27244447373     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.14.696     Document Type: Article

References (28)

1. El-Serag HB, Mason AC: Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med 340:745-750, 1999
2. Ihde DC, Kane RC, Cohen MH, et al: Adriamycin therapy in American patients with hepatocellular carcinoma. Cancer Treat Rep 61: 1385-1387, 1977
3. 2) for hepatocellular carcinoma: Clinical and pharmacokinetic results. Cancer Treat Rep 68:487-491, 1984
4. Sciarrino E, Simonetti RG, LeMoli S, et al: Adriamycin treatment for hepatocellular carcinoma: Experience with 109 patients. Cancer 56:2751-2755, 1985
5. Lee Y-T: Systemic and regional treatment of primary carcinoma of the liver. Cancer Treat Rev 4:195-212, 1977
6. Nerenstone SR, Ihde DC, Freidman MA: Clinical trials in primary hepatocellular carcinoma: Current status and future directions. Cancer Treat Rev 15:1-31, 1988
7. Ahlgren JD: Neoplasms of the hepatobiliary system, in P Calbresi, P Schein (eds): Medical Oncology {2nd ed). New York, NY, McGraw Hill, 1996, pp 713-739
8. Izumi R, Shimizu K, Li T, et al: Prognostic factors of hepatocellular carcinoma undergoing hepatic resection. Gastroenterology 106:720-727, 1994
9. Woodburn JR: The epidermal growth factor receptor and its inhibition in cancer therapy. Pharmacol Ther 82:241-250, 1999
10. Gibbs JB: Anticancer drug targets: Growth factors and growth factor signaling. J Clin Invest 105:9-13, 2000
11. Kaneko Y, Shibuya M, Nakayama T, et al: Hypomethylation of c-myc and epidermal growth factor receptor genes in human hepatocellular carcinoma and fetal liver. Jpn J Cancer Res 76:1136-1140, 1985
12. Xu YH, Jiang WL, Peng SF: EGFR/HER1 expression and EGF stimulation of proliferation in human liver carcinoma cells [in Chinese]. Shi Yan Sheng Wu Xue Bao 22:445-453, 1989
13. Hung WC, Chuang LY, Tsai JH, et al: Effects of epidermal growth factor on growth control and signal transduction pathways in different human hepatoma cell lines. Biochem Mol Biol Int 30:319-328, 1993
14. Yamaguchi K, Carr BI, Nalesnik MA: Concomitant and isolated expression of TGF-alpha and EGF-R in human hepatoma cells supports the hypothesis of autocrine, paracrine, and endocrine growth of human hepatoma. J Surg Oncol 58:240-245, 1995
15. Morimitsu Y, Hsia CC, Kojiro M, et al: Nodules of less-differentiated tumor within or adjacent to hepatocellular carcinoma: Relative expression of transforming growth factor-alpha and its receptor in the different areas of tumor. Hum Pathol 26:1126-1132, 1995
16. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92:205-216, 2000
17. Simon R: Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1-10, 1989
18. Duffy DE, Santner TJ: Confidence intervals for a binomial parameter based on multistage tests. Biometrics 43:81-93, 1987
19. Kaplan E, Meier P: Nonparametric estimation from incomplete observation. J Am Stat Assoc 53:457-481, 1958
20. Cox DR: Regression models and life tables (with discussion). J R Stat Soc (B) 74:187-220, 1972
21. Lenz HJ, Mayer RJ, Gold PJ, et al: Activity of cetuximab in patients with colorectal cancer refractory to both irinotecan and oxaliplatin. J Clin Oncol 23:248, 2004 (abstr 3510)
22. Philip PA, Mahoney M, Thomas J, et al: Phase II trial of erlotinib (OSI-774) in patients with hepatocellular or biliary cancer. J Clin Oncol 23:318, 2004 (abstr 4025)
23. Tanaka H: Immunohistochemical studies on epidermal growth factor receptor in hepatocellular carcinoma, [in Japanese]. Nippon Shokakibyo Gakkai Zasshi 88:138-144, 1991
24. Baguley BC, Marshall ES, Holdaway KM, et al: Inhibition of growth of primary human tumour cell cultures by a 4-anilinoquinazoline inhibitor of the epidermal growth factor receptor family of tyrosine kinases. Eur J Cancer 34:1086-1090, 1998
25. Sirotnak FM, Zakowsky MF, Miller VA, et al: Potentiation of cytotoxic agents against human tumors in mice by ZD1839 (IRESSA), an inhibitor of EGFR/HER1 tyrosine kinase, does not require high levels of expression of EGFR/HER1. Proc Annu Meet Am Assoc Cancer Res 41:482, 2000 (abstr 3076)
26. Cunningham D, Humblet Y, Siena S, et al: Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351:337-345, 2004
27. Giambartolomei S, Covone F, Levrero M, et al: Sustained activation of the Raf/MEK/Erk pathway in response to EGF in stable cell lines expressing the hepatitis C virus (HCV) core protein. Oncogene 20:2606-2610, 2001
28. Lynch TJ, Bell DW, 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, Volume 350:2129-2139, 2004