Non-resectable metastatic non small cell lung cancer is a uniformly fatal illness. Patients may respond temporarily to treatment but in virtually all cases the disease will eventually progress. Therapy, depending on the extent of disease, is a combination of chemotherapy and radiation.
Erlotinib (Tarceva), a epidermal growth receptor inhibitor (HER1/EGFR), was recently approved by the FDA as maintenance therapy for the disease in patients with stable disease after treatment with platinum based therapy. The approval was based on the results of the Saturn study which was reported at the 2009 ASCO meeting.
The study showed:
Response rate was 12% with E versus 5% with P (platinum based treatment). Disease control rate (complete response + partial response + stable disease >12 wks) was
40.8% with E versus 27.4% with P (p<.0001). OS (Overall survival) data are not yet
Further analysis released in August 2009 showed:
The study showed that patients with NSCLC treated with Tarceva had a 23 percent improvement in overall survival compared with patients who received placebo (hazard ratio=0.81; p-value=0.0088). The hazard ratio, which assesses risk in the overall trial population, is widely recognized as the best measure of overall benefit in large randomized clinical trials. A hazard ratio of less than one for survival indicates a reduced risk of death. The median survival (a single point estimate of benefit) for patients receiving Tarceva was 12 months versus a median survival of 11 months for patients receiving placebo. (medicynical emphasis)
Medicynical note: The yearly cost of Tarceva is in the range of $30,000-60,000/year. This according to the Saturn study buys an improvement in median survival of 1 month. Added to this are the cost of the initial platinum based chemotherapy, radiation if given, doctor’s fees and imaging costs.
Is it cost effective to spend over $30,000-60,000 or more depending on length of treatment for a median survival improvement of 1 month? If not covered by insurance would you pay for this drug? Would you expect someone else to pay for it for you?