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 C. Mack
  • Georg Lurje
  • Regina Gandour-Edwards
  • Janet Dancey
  • David R. Gandara
Original Article

DOI: 10.1007/s00280-009-0927-7

Cite this article as:
Ramanathan, R.K., Belani, C.P., Singh, D.A. et al. Cancer Chemother Pharmacol (2009) 64: 777. doi:10.1007/s00280-009-0927-7

Abstract

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.

Keywords

Lapatinib Phase II study Hepatocellular cancer Biliary tree cancer 

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Ramesh K. Ramanathan
    • 1
    • 7
  • Chandra P. Belani
    • 1
  • Deepti A. Singh
    • 2
  • Michael Tanaka
    • 3
  • Heinz-Josef Lenz
    • 4
  • Yun Yen
    • 5
  • Hedy L. Kindler
    • 2
  • Syma Iqbal
    • 4
  • Jeff Longmate
    • 5
  • Philip C. Mack
    • 3
  • Georg Lurje
    • 4
  • Regina Gandour-Edwards
    • 3
  • Janet Dancey
    • 6
  • David R. Gandara
    • 3
  1. 1.University of Pittsburgh Cancer InstitutePittsburghUSA
  2. 2.University of ChicagoChicagoUSA
  3. 3.University of California, Davis Cancer CenterSacramentoUSA
  4. 4.University of Southern California, Norris Cancer CenterLos AngelesUSA
  5. 5.City of Hope National Cancer CenterDuarteUSA
  6. 6.Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer InstituteBethesdaUSA
  7. 7.Scottsdale Clinical Research InstituteScottsdaleUSA