Lapatinib and gemcitabine for metastatic pancreatic cancer. A phase II study.
OBJECTIVE
To determine the overall survival for patients with metastatic pancreatic cancer treated with lapatinib and gemcitabine.


METHODS
Patients with metastatic pancreatic cancer received lapatinib, 1,500 mg/d, and Gemcitabine, 1 g/m(2)/wk for 3 weeks followed by 1 week off, until disease progression. This multicenter phase II study was planned to enter 125 patients to evaluate whether the treatment regimen could achieve a 1-year survival of 30% and a median survival of 7 months. An additional subset of 20 patients were to receive 2 months of single agent lapatinib followed by lapatinib and gemcitabine.


RESULTS
At a planned 6 month analysis, the Brown University Oncology Group Data Safety Monitoring Board terminated accrual after 29 patients because of futility analysis. The median survival was 4 months (95% confidence interval, 3.0-5.0 months). Three of the 29 (10%) patients had a partial response. The 4 patients who received single agent lapatinib all progressed at 1 month.


CONCLUSIONS
Lapatinib is not effective in pancreatic cancer. Evaluation of HER2 inhibitors in pancreatic cancer is not warranted.
Howard
H
Safran
Thomas
T
Miner
Nathan
N
Bahary
Sam
S
Whiting
Charles D
CD
Lopez
Weijing
W
Sun
Kevin
K
Charpentier
Joshua
J
Shipley
Elliot
E
Anderson
Brendan
B
McNulty
Andrew
A
Schumacher
Alessandra
A
Clark
Jamsheed
J
Vakharia
Teresa
T
Kennedy
Terence
T
Sio
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000077341:Lapatinib; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011799:Quinazolines / Q000627:therapeutic use; D016019:Survival Analysis; D017211:Treatment Failure; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000077341:Lapatinib; D003841:Deoxycytidine; D000093542:Gemcitabine