The impact of a fourteen-gene molecular assay on physician treatment decisions in non-small-cell lung cancer.

BACKGROUND: Five-year survival in early-stage, non-squamous, non-small-cell lung cancer (NSCLC) remains poor compared with other solid tumors, even after complete resection. Post-operative management depends on prognostic staging to identify individuals at highest risk for death, and therefore with the greatest need for further intervention. A 14-gene quantitative RT-PCR test successfully differentiates stage I-III NSCLC patients who are at high-, intermediate-, or low-risk for 5-year mortality. This study assesses the impact of the assay's prognostic information on physician decisions regarding adjuvant chemotherapy. METHODS: We invited 115 physicians who ordered the test to participate in an on-line survey. The primary outcome measure was the proportion of patients with different pre- and post-test chemotherapy recommendations. RESULTS: Fifty-eight physicians (50 %) completed the survey on 120 stage I or II NSCLC patients. Ninety-one patients (76 %) had stage I lung cancer; 27 (23 %), 39 (33 %), and 54 (45 %) patients had low-, intermediate-, and high-risk scores, respectively. Physicians' chemotherapy recommendations were changed post-testing in 37 patients (30.8 %, 95 % CI 22.7-39.9 %). High-risk patients were more likely to have a change in treatment recommendation (44.4 %, 95 % CI 30.9-58.6 %) than low risk patients (3.7 %, 95 % CI 0.1-19.0 %); a substantial number of changes were observed in both stage I (33.0 %, 95 % CI 23.5-43.6 %) and stage II (24.1 %, 95 % CI 10.3-43.5 %). CONCLUSIONS: Our data show that the assay resulted in a significant impact on physician treatment decisions in early-stage NSCLC, and that the nature of treatment changes generally correlated with the test's assessment of risk.