A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer
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- Ramanathan, R.K., Belani, C.P., Singh, D.A. et al. Cancer Chemother Pharmacol (2009) 64: 777. doi:10.1007/s00280-009-0927-7
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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).
Lapatinib was dosed at 1,500 mg/day orally continuously.
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.
Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.