A phase II study of lapatinib in patients with advanced biliary tree and hepatocellular cancer.
OBJECTIVE
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-infinity) months and 6.2 (95% CI: 5.1-infinity) 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.
Ramanathan
Ramesh K
RK
University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA. rramanathan@tgen.org
Belani
Chandra P
CP
Singh
Deepti A
DA
Tanaka
Michael
M
Lenz
Heinz-Josef
HJ
Yen
Yun
Y
Kindler
Hedy L
HL
Iqbal
Syma
S
Longmate
Jeff
J
Mack
Philip C
PC
Lurje
Georg
G
Gandour-Edwards
Regina
R
Dancey
Janet
J
Gandara
David R
DR
D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077341:Lapatinib; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis
D000970:Antineoplastic Agents; D011799:Quinazolines; D000077341:Lapatinib