Abstract
Objective: The VeriStrat1 (VS) test is intended to help guide treatment decisions for patients with advanced non-small-cell lung cancer (NSCLC) without an EGFR-sensitizing mutation, classifying patients into two categories. Patients classified as VSGood have a favorable prognosis and significant clinical response to EGFR tyrosine kinase inhibitors (TKIs). Patients classified as VSPoor have a less favorable prognosis and exhibit no significant response to EGFR-TKIs. The objective of this paper is to assess the real-world impact of VS test results on physicians’ treatment recommendations including referrals for best supportive care (BSC).
Methods: Between 1 January 2012 and 1 November 2016, physician respondents were asked to complete standardized questionnaires before and after receiving VS results in patients meeting criteria for the intended use of the VS test. This study evaluated three endpoints: whether physicians followed VS test results in making treatment recommendations, the extent to which tests results changed these treatment recommendations, and the patterns of care subsequent to VS testing.
Results: Of the tests ordered by 989 physicians, 2494 VS tests had completed treatment recommendation questionnaires both prior to and after testing. Prior to VS testing, physicians were considering treatment with EGFR-TKIs for 2250 patients (90%). The VS test classified 1950 patients as VSGood and 544 patients as VSPoor. For patients classified as VSPoor, physicians recommended BSC for 25% of patients and standard systemic treatments such as chemotherapies for 65% of patients. Consistent with previous publications, physicians recommended EGFR-TKI therapy for only 10% of VSPoor patients but for 89% of VSGood patients. Overall, physician’s treatment recommendations were consistent with test results in 98% of cases. Availability of test results decreased ineffective treatment recommendations by 89% for VSPoor patients.
Conclusions: Among physicians ordering VS, the test significantly influenced treatment recommendations for patients with NSCLC, reducing ineffective and expensive treatment at the end of life.
Note
Transparency
Declaration of funding
This work was supported by Biodesix Inc.
Declaration of financial/other relationships
W.L.A. has disclosed that he has previously received remuneration from Biodesix for advisory work but did not received payments for his work related to this study. A.M.A. has disclosed that she is an employee of Biodesix Inc. and owns stock options in Biodesix. B.R. has disclosed that he has previously received research funding from Biodesix Inc. for research unrelated to this current study but was not remunerated for his participation in this study.
R.D.P does not have relevant financial interests in the products discussed in this publication and was not remunerated for his participation in the study
CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.
Notes
1 VeriStrat is a registered trade name of Biodesix Inc., Boulder, CO, USA