The impact of a serum based proteomic mass spectrometry test on treatment recommendations in advanced non-small-cell lung cancer

Abstract

Objective:

To assess the impact of a serum-based proteomic test for non-small-cell lung cancer (NSCLC) on physician treatment recommendations.

Research design and methods:

A multivariate, serum-based proteomic test (VeriStrat) is commercially available to assist physicians when determining treatment using epidermal growth factor receptor inhibitor (EGFRi) therapy, such as erlotinib (Tarceva), by stratifying patients into two categories: those with significantly better (‘good’) and those with significantly worse (‘poor’) outcomes following treatment with EGFRi therapy. All tests ordered from August 9, 2011 to November 26, 2012, were considered for this study. Pre- and post-test treatment recommendations were prospectively collected from ordering physicians on a voluntary basis. Only those tests that had both pre- and post-test treatment information were included in the analysis group.

Main outcome measures:

Proportional change and correlation of treatment recommendations before and after receipt of the test results.

Results:

Over the duration of the study, 724 physicians ordered 2854 tests. The analysis group comprised the 226 physicians who provided pre- and post-test treatment information (n = 403 tests). Following receipt of the test results, 90.3% (95% CI: 86.4–93.3%) of patients who tested as ‘good’ received erlotinib recommendations versus 9.6% (95% CI: 4.5–17.4%, p < 0.0001) of patients who tested as ‘poor’. Ninety percent of post-test treatment recommendations positively correlated with test results, with 40% showing a change from pre-test considerations.

Study limitations:

Data based on physicians willing to submit recommendations and endpoint limited to therapy recommendations.

Conclusions:

Among test orderers, serum-based proteomic mass spectrometry testing significantly influenced therapy recommendations in NSCLC. Usage patterns should be monitored as use expands.

Keywords::

• Biomarker
• Decision impact
• Erlotinib
• Mass spectrometry
• Non-small-cell lung cancer
• Proteomics

Transparency

Declaration of funding

This work was supported by Biodesix Inc.

Declaration of financial/other relationships

D.G.S. and R.H.C. are employees of Biodesix Inc. and have stock options in Biodesix. J.H. received contract research support from the sponsor for participation in the project. W.L.A. and R.E.N. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors would like to thank Joanna Roder and Julia Grigorieva, from Biodesix for statistical support, and Abigail Coffin and Justin Roediger, also from Biodesix, for editorial support.

Notes

*VeriStrat is a commercial product of Biodesix Inc., Boulder, CO, USA.

†Tarceva, OSI Pharmaceuticals Inc., Melville, NY, USA.

*Taxotere, Aventis Pharmaceuticals Inc., Bridgewater, NJ, USA.

†Alimta, Eli Lilly and Company, Indianapolis, IN, USA.

‡Tarceva, OSI Pharmaceuticals Inc., Melville, NY, USA.

*VeriStrat is a commercial product of Biodesix Inc., Boulder, CO, USA.

†Iressa, AstraZeneca Pharmaceuticals, Wilmington, DE, USA.

*Avastin, Genentech Inc., South San Francisco, CA, USA.