A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer

Ramesh K. Ramanathan, Chandra P. Belani, Deepti A. Singh, Michael Tanaka, Heinz Josef Lenz, Yun Yen, Hedy L. Kindler, Syma Iqbal, Jeff Longmate, Philip Mack, Georg Lurje, Regina F Gandour-Edwards, Janet Dancey, David R Gandara

Research output: Contribution to journalArticle

182 Scopus citations


Purpose: To evaluate the response to lapatinib, an inhibitor of epidermal growth factor receptors 1 and 2, in patients with advanced bilary tree cancer (BTC) and hepatocellular cancer (HCC). Methods: Lapatinib was dosed at 1,500 mg/day orally continuously. Results: Fifty-seven patients were accrued (BTC 17, HCC 40). Therapy was well tolerated. The response in BTC was 0% and in HCC was 5%. The progression free survival (PFS) for BTC and HCC patients was 1.8 (95% CI: 1.7-5.2) months and 2.3 (95% CI: 1.7-5.6) months. The median survival for BTC and HCC patients was 5.2 (95% CI 3.3-∞) months and 6.2 (95% CI: 5.1-∞) months. EGFR genotyping indicated HCC patients with <20 repeats have the lowest PFS. The occurrence of any skin rash significantly prolonged PFS and survival. Conclusions: Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.

Original languageEnglish (US)
Pages (from-to)777-783
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Issue number4
StatePublished - Sep 2009



  • Biliary tree cancer
  • Hepatocellular cancer
  • Lapatinib
  • Phase II study

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

Cite this

Ramanathan, R. K., Belani, C. P., Singh, D. A., Tanaka, M., Lenz, H. J., Yen, Y., Kindler, H. L., Iqbal, S., Longmate, J., Mack, P., Lurje, G., Gandour-Edwards, R. F., Dancey, J., & Gandara, D. R. (2009). A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer. Cancer Chemotherapy and Pharmacology, 64(4), 777-783. https://doi.org/10.1007/s00280-009-0927-7