BOSTONErlotinib (Tarceva) showed activity and was "relatively well tolerated" in chemotherapy-naive elderly patients with stage IIIB/IV non-small-cell lung cancer (NSCLC), according to a phase II trial from Dana-Farber Cancer Institute (Jackman et al: J Clin Oncol 25:760-766, 2007). The 80 eligible patients, all age 70 or older, received erlotinib 150 mg/d until disease progression or significant toxicity. There were 8 partial responses (10%) and 33 patients with stable disease for 2 months or more (41%), for an overall disease control rate of 51%. Median time to progression (TTP) was 3.5 months, and median survival was 10.9 months. The 1- and 2-year survival rates were 46% and 19%.
The most common toxicities were acneiform rash (79%) and diarrhea (69%). "In general, toxicities were mild (grade 1 to 2) and easily managed," the authors wrote. Four patients had possible grade 3 or higher interstitial lung disease, with one treatment-related death. "Of three patients with major bleeding . . . two had concomitantly received erlotinib and warfarin(Drug information on warfarin) and had elevations in their prothrombin time," the researchers said.
EGFR mutations were found in 9 of 43 patients studied and were strongly correlated with disease control, prolonged TTP, and survival, the researchers reported. In multivariate analysis, treatment-related rash correlated with prolonged TTP and survival.