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

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

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Abstract

Purpose: Epidermal growth factor receptor/human epidermal growth factor receptor 1 (EGFR/HER1) and ligand expression is frequently seen in hepatocellular cancers (HCCs). Erlotinib (Tarceva, OSI-774; OSI Pharmaceuticals, Melville, NY) is a receptor tyrosine kinase inhibitor with specificity for the EGFR/HER1. Methods: The primary objective of this study was to determine the proportion of patients with advanced HCC who were progression-free at 6 months. Patients with either unresectable or metastatic disease were studied. Only one prior systemic or locoregional therapy was allowed. Erlotinib was given continuously at a dose of 150 mg per day orally. Results: Thirty-eight patients with HCC were enrolled. Median age of the patients was 69 years (range, 27 to 83 years). A majority of patients (63%) had an Eastern Cooperative Oncology Group performance status of 1. Forty-seven percent of patients had received prior chemotherapy for advanced HCC. EGFR/HER1 expression was detected in 88% of the patients. Median number of cycles per patient was two (range, 1 to 26). Twelve (32%; CI 95%, 18 to 49) of the 38 patients with HCC were progression-free at 6 months. Three patients had partial radiologic responses of duration of 2,10, and 11 months, respectively. Disease control was seen in 59% of the patients. Median overall survival time was 13 months. Ten patients (26%) had toxicity-related dose reductions of erlotinib. Grade 3/4 skin toxicity or diarrhea was encountered in five and three patients, respectively. Conclusion: Results of this trial suggest a benefit for EGFR/HER1 blockade with erlotinib in patients with HCC manifested by disease control. Additional studies with erlotinib as a single agent or in combination with other agents are warranted.

Original languageEnglish (US)
Pages (from-to)6657-6663
Number of pages7
JournalJournal of Clinical Oncology
Volume23
Issue number27
DOIs
StatePublished - Sep 20 2005

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Liver Neoplasms
Epidermal Growth Factor Receptor
Erlotinib Hydrochloride
Receptor Protein-Tyrosine Kinases
Diarrhea

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Philip, P. A., Mahoney, M. R., Allmer, C., Thomas, J., Pitot, H. C., Kim, G., ... Erlichman, C. (2005). Phase II study of Erlotinib (OSI-774) in patients with advanced hepatocellular cancer. Journal of Clinical Oncology, 23(27), 6657-6663. https://doi.org/10.1200/JCO.2005.14.696

Phase II study of Erlotinib (OSI-774) in patients with advanced hepatocellular cancer. / Philip, Philip A.; Mahoney, Michelle R.; Allmer, Cristine; Thomas, James; Pitot, Henry Clement; Kim, George; Donehower, Ross C.; Fitch, Tom; Picus, Joel; Erlichman, Charles.

In: Journal of Clinical Oncology, Vol. 23, No. 27, 20.09.2005, p. 6657-6663.

Research output: Contribution to journalArticle

Philip, PA, Mahoney, MR, Allmer, C, Thomas, J, Pitot, HC, Kim, G, Donehower, RC, Fitch, T, Picus, J & Erlichman, C 2005, 'Phase II study of Erlotinib (OSI-774) in patients with advanced hepatocellular cancer', Journal of Clinical Oncology, vol. 23, no. 27, pp. 6657-6663. https://doi.org/10.1200/JCO.2005.14.696
Philip, Philip A. ; Mahoney, Michelle R. ; Allmer, Cristine ; Thomas, James ; Pitot, Henry Clement ; Kim, George ; Donehower, Ross C. ; Fitch, Tom ; Picus, Joel ; Erlichman, Charles. / Phase II study of Erlotinib (OSI-774) in patients with advanced hepatocellular cancer. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 27. pp. 6657-6663.
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