Cost-effectiveness and lung cancer clinical trials.
BACKGROUND
Lung cancer is the leading cause of cancer death in the U.S., with an estimated annual economic burden of $5 billion. Clinical trials offer innovative therapeutic options with potentially better outcomes, but their effects on health care costs are disputed.


METHODS
The authors analyzed the 1-year facility-based treatment cost and survival of 336 newly diagnosed nonsmall cell lung cancer patients who were deemed eligible for clinical trials between 1994 and 1998 at the Karmanos Cancer Institute. The incremental cost-effectiveness ratio (ICER) of clinical trial treatments with adjustment for confounders was calculated along with its 95% confidence interval (CI) using the bootstrap resampling method.


RESULTS
Of the 336 patients, 76 (22.6%) were treated on clinical trials. Trial participation was associated significantly with race (P < 0.01), gender (P = 0.01), age (P = 0.02), and insurance type (P = 0.02). The average 1-year cost for trial enrollees was $41,734 with a median survival of 1.3 years, whereas the average 1-year cost for nonenrollees was $34,191 with a median survival period of 0.9 years. Differences in survival and 1-year cost between enrollees and nonenrollees were significant when controlling for age, race, gender, insurance, stage, performance status, and comorbidities. The ICER for trial participation after adjustment for confounders was $9741 per life year saved (95% CI, $3089-$19,149).


CONCLUSIONS
Enrollment in lung cancer clinical trials was found to be associated with improved survival at a moderate incremental cost. Cancer 2003;98:1491-6.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000191:economics* / Q000628:therapy; D002986:Clinical Trials as Topic / Q000191:economics*; D016001:Confidence Intervals; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D017721:Hospital Costs; D006801:Humans; D007348:Insurance, Health / Q000191:economics*; D008175:Lung Neoplasms / Q000175:diagnosis / Q000191:economics* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D011013:Pneumonectomy / Q000191:economics; D011336:Probability; D016016:Proportional Hazards Models; D018714:Radiotherapy, Adjuvant / Q000191:economics