Purpose: To assess the value of research for ERCC1 expression testing to inform adjuvant chemotherapy decisions in resected Stage II non-small cell lung cancer (NSCLC), given substantial uncertainty about chemotherapy decisions informed by ERCC1 test results.
Method: We developed a decision-analytic model to estimate the expected value of perfect information (EVPI), perfect parameter information (EVPPI), sample information (EVSI), and sample parameter information (EVSPI) for two treatment strategies: 1) ERCC1 testing to inform adjuvant chemotherapy decisions, with ERCC1+ patients indicated to receive no chemotherapy and ERCC1- patients indicated to receive chemotherapy; 2) standard care, with all patients indicated to receive chemotherapy. Thirty percent (range, 10-50%) of ERCC1+ patients were assumed to not follow test results and choose to receive chemotherapy, and 10% (range 5-15%) of ERCC1- patients were assumed to not follow test results and choose to not receive chemotherapy. Model parameters and uncertainty ranges were derived from the International Adjuvant Lung Cancer Trial, published literature, and government sources. SEER data were used to calculate the affected population over a 10-year time horizon. A willingness-to-pay threshold of $150,000/QALY was utilized in the base-case.
Result: The ERCC1 strategy produced greater net-benefit than standard care in 55% of simulations and the average consequence of selecting the wrong strategy was $7,400. The EVPI for an affected population of 322,400 was $1.07 B. The EVSI for a trial examining all model parameters with sample sizes of 100, 500, and 1,000 patients per arm was $81 M, $847 M, and $1.01 B, respectively. The EVPPI for the chemotherapy utilization behavior parameters was $353 M, and $107 M and $237 M was attributable to ERCC1+ and ERCC1- sub-groups, respectively. The EVSPI for a study examining ERCC1+ and ERCC1- chemotherapy utilization behavior was $74 M and $138 M for a sample of 100 patients, and approximately $107 M and $237 M at sample sizes of both 500 and 1,000.
Conclusion: The value of research greatly exceeded the expected cost of an ERCC1 testing trial, and EVPPI and EVSPI estimates demonstrated the influence of patient/provider behavior on the value of ERCC1 research. These findings demonstrate the overall value of ERCC1 research in NSCLC, identify chemotherapy decision-making as a high value research area, and can assist stakeholders in prioritizing funding for ERCC1 research relative to alternative investments.
See more of: The 33rd Annual Meeting of the Society for Medical Decision Making