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

Abstract

Lapatinib was well-tolerated. There was evidence of activity in HCC, but therapy with lapatinib did not meet the predefined efficacy rate.

Biliary cancer: intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma vs. gallbladder cancers: classification and therapeutic implications

“…While early studies investigating novel agents targeting relevant signaling pathways demonstrated interesting antitumor activity in a small proportion of patients, the overall results have been disappointing, with outcomes largely similar to chemotherapy agents in the refractory setting ( Table 2) (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25). This may be in part due to the utilization of non-selected trials, where patients are eligible for enrollment regardless of their tumor genomic alterations.…”

The role of signaling pathways in the development and treatment of hepatocellular carcinoma

“…Phase II results indicate that lapatinib is well tolerated and shows preliminary evidence of antitumor activity in HCC (Ramanathan et al, 2006). Among 40 patients with advanced HCC, the response rate was 5%, median PFS was 2.3 months (95% CI 1.7-5.6) and median OS was 6.2 months (95% CI 5.1-N) (Ramanathan et al, 2009).…”

Current Management of Gallbladder Carcinoma

“…Malka and colleagues reported their experience with a randomized phase II study comparing gemcitabine plus oxaliplatin alone with the same chemotherapy regimen in combination with cetuximab and demonstrated a higher 4-month PFS rate with the addition of cetuximab (44% versus 61%, respectively) [101]. Lapatinib, a dual EGFR-1 and HER-2/Neu inhibitor was tested in a phase II trial including both BTC and hepatocellular carcinoma patients [102]. In 17 evaluable patients with BTC, no responses were observed.…”