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

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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.

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Acknowledgments

This study was sponsored by the Cancer Therapy and Evaluation Program of the National Cancer Institute, Bethesda, MD 20892. Presented in part at the 42nd annual meeting of the American Society of Clinical Oncology, Orlando, FL. June 2006. Supported in part by NCI-NO1-CM-57018-16 (California Consortium), Dhont Foundation (HJ Lenz). P30CA47904 and NIH/NCCR/GCRC #5M01 RR 00056 (University of Pittsburgh Cancer Institute and Medical Center). The authors wish to thank Christine Garcia and Stella Chen, CCC-P coordinators for data management and coordination of study.

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Authors and Affiliations

  1. University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA

    Ramesh K. Ramanathan & Chandra P. Belani

  2. University of Chicago, Chicago, IL, USA

    Deepti A. Singh & Hedy L. Kindler

  3. University of California, Davis Cancer Center, Sacramento, CA, USA

    Michael Tanaka, Philip C. Mack, Regina Gandour-Edwards & David R. Gandara

  4. University of Southern California, Norris Cancer Center, Los Angeles, CA, USA

    Heinz-Josef Lenz, Syma Iqbal & Georg Lurje

  5. City of Hope National Cancer Center, Duarte, CA, USA

    Yun Yen & Jeff Longmate

  6. Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA

    Janet Dancey

  7. Scottsdale Clinical Research Institute, 10510 N 92nd St, Suite 200, Scottsdale, AZ, 85258, USA

    Ramesh K. Ramanathan

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  1. Ramesh K. Ramanathan
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  2. Chandra P. Belani
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Correspondence to Ramesh K. Ramanathan.

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Ramanathan, R.K., Belani, C.P., Singh, D.A. et al. A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer. Cancer Chemother Pharmacol 64, 777–783 (2009). https://doi.org/10.1007/s00280-009-0927-7

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  • DOI: https://doi.org/10.1007/s00280-009-0927-7

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