Tarceva for biliary cancer – pro
Erlotinib has shown activity individually, as single drugs, or in combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Overexpression of EGFR has been reported to be observed in 10.7%, 5.1%, 12.4% and 0% of cases of intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer and ampulla of Vater cancer, respectively
In a recent study, forty-two patients with biliary cancer were enrolled. Seven of the patients (17%; 95% CI, 7% to 31%) were progression free at 6 months. Three patients had partial response These results suggest a therapeutic benefit for EGFR blockade with erlotinib in patients with biliary cancer. The authors conclude that additional studies with erlotinib as a single agent and in combination with other targeted agents are warranted in this disease. Another phase II study is referenced. There are also studies in combination with bevacizumab or gemcitabine. Lubner et al enrolled fifty-three eligible patients. Of 49 evaluable patients, six (12%; 95% CI, 6% to 27%) had a confirmed partial response. Stable disease was documented in another 25 patients (51%). Median OS was 9.9 months, and TTP was 4.4 months.
SPhilip PA, Mahoney MR, Allmer C, Thomas J, Pitot HC, Kim G, Donehower RC, Fitch T, Picus J, Erlichman Phase II study of erlotinib in patients with advanced biliary cancer.J Clin Oncol. 2006 Jul 1;24(19):3069-74.
Philip, Philip A., Mahoney, Michelle R., Allmer, Cristine, Thomas, James, Pitot, Henry C., Kim, George, Donehower, Ross C., Fitch, Tom, Picus, Joel, Erlichman, Charles
Phase II Study of Erlotinib in Patients With Advanced Biliary Cancer
J Clin Oncol 2006 24: 3069-3074
Dragovich T, Huberman M, Von Hoff DD, Rowinsky EK, Nadler P, Wood D, Hamilton M, Hage G, Wolf J, Patnaik A. Erlotinib plus gemcitabine in patients with unresectable pancreatic cancer and other solid tumors: phase IB trial. Cancer Chemother Pharmacol. 2007 Jul;60(2):295-303. Epub 2006 Dec 6.
S A Khan et al, Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus document Gut 2002;51:
C. D. Anderson, C. Wright Pinson, J. Berlin, and R. S. Chari
Diagnosis and Treatment of Cholangiocarcinoma
Oncologist, February 1, 2004; 9(1): 43 – 57.
S A Khan, A Miras, M Pelling, and S D Taylor-Robinson
Cholangiocarcinoma and its management
Gut, December 1, 2007; 56(12): 1755 – 1756.
F. Leone, Y. Pignochino, G. Cavalloni, and M. Aglietta
Targeting of Epidermal Growth Factor Receptor in Patients Affected by Biliary Tract Carcinoma
J. Clin. Oncol., March 20, 2007; 25(9): 1145 – 1145.
Sam J. Lubner, Michelle R. Mahoney, Jill L. Kolesar, Noelle K. LoConte, George P. Kim, Henry C. Pitot, Philip A. Philip, Joel Picus, Wei-Peng Yong, Lisa Horvath, Guy Van Hazel, Charles E. Erlichman and Kyle D. Holen
Dickler MN, Rugo HS, Eberle CA, et al.(2008) A phase II trial of erlotinib in combination with bevacizumab in patients with metastatic breast cancer. Clin Cancer Res 14:7878–7883.
Thomas MB, Morris JS, Chadha R, et al.(2009) Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma. J Clin Oncol 27:843–850.