Tarceva

Erlotinib tablets
GENENTECH/OSI ONCOLOGYOral therapy approved for pancreatic cancer

The epidermal growth factor receptor (EGFR) is expressed on the surface of normal cells and cancer cells, and erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with EGFR. Erlotinib was approved on November 2, 2005, in combination with gemcitabine (Gemzar, Lilly) for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Efficacy. The efficacy and safety of erlotinib in combination with gemcitabine as a first-line treatment for locally advanced, unresectable, or metastatic pancreatic cancer was evaluated in a randomized, double-blind, placebo-controlled trial of 569 patients. Patients received either erlotinib (100 or 150 mg) or placebo once daily on a continuous schedule plus gemcitabine IV (1,000 mg/m²; Cycle 1, Days 1, 8, 15, 22, 29, 36, and 43 of an 8-week cycle; Cycle 2 and subsequent cycles, Days 1, 8, and 15 of a 4-week cycle). The erlotinib group demonstrated a median 6.4 months of survival with a total of 250 deaths, compared with a median of 6.0 months of survival and 254 deaths in the placebo group (HR, 0.81; 95% CI, 0.68–0.97; P=.028). Patients in the erlotinib group achieved 1-year survival at a rate of 23.8% compared with 19.4% in the placebo group. Progression-free survival also favored the erlotinib group, with a median of 3.8 months and 225 events compared with a median of 3.5 months and 232 events in the placebo group (HR, 0.76; 95% CI, 0.64–0.92; P=.006).

Dosing. The recommended daily dose of erlotinib for the treatment of pancreatic cancer is 100 mg taken at least 1 hour before or 2 hours after the ingestion of food, in combination with gemcitabine. Treatment should continue until disease progression or unacceptable toxicity occurs.