A new study published online in the Journal of Thoracic Oncology concludes that the VeriStrat test by Biodesix was predictive of survival outcomes for patients treated with erlotinib and/or gemcitabine. The study, “A Retrospective Analysis of VeriStrat Status on Outcome of a Randomized Phase II Trial of First-Line Therapy with Gemcitabine, Erlotinib, or the Combination in Elderly Patients (Age 70 Years or Older) with Stage IIIB/IV Non-Small-Cell Lung Cancer,” was conducted by lead investigators at the University of North Carolina Lineberger Comprehensive Cancer Center and Biodesix.
VeriStrat is a novel multivariate serum protein test that helps oncologists personalize therapy. The new study, which will appear in the April 2013 issue of the Journal of Thoracic Oncology, concludes that in this population, patients with VeriStrat Poor status should not receive erlotinib therapy but may be good candidates for gemcitabine treatment.
In the retrospective analysis conducted by Thomas Stinchcombe, MD, Associate Professor at the UNC Lineberger Comprehensive Cancer Center and his colleagues, 105 patients received VeriStrat testing on serum or plasma samples taken prior to initiation of therapy. Sixty-three (60%) of these samples were classified as “VeriStrat Good” and 35 samples (33%) were classified as “VeriStrat Poor.”
In the gemcitabine-treated group, results showed no significant difference between patients classified as VeriStrat Good and VeriStrat Poor, as measured by progresssion free survival (PFS) and overall survival (OS). However, in the erlotinib-treated group, patients classified as VeriStrat Good had a statistically significant improvement in PFS (p=0.002) and OS (p=0.014) compared with patients classified as VeriStrat Poor. Patients classified as VeriStrat Good also had better PFS (p=0.027) and a strong trend toward better OS outcomes (p=0.051) in the erlotinib-plus-gemcitabine group compared to patients classified as VeriStrat Poor.
Researchers concluded in multivariate analysis that the VeriStrat test was predictive of both PFS and OS outcomes between the erlotinib and gemcitabine groups ( p<0.001, p=0.017, respectively) and that further studies utilizing VeriStrat to select more beneficial treatment regimens for lung cancer patients are warranted.
Dominic Spinella, PhD, Vice President of Clinical Development and Medical Affairs at Biodesix, said, “Importantly, this is the first study where we have identified a viable treatment option for elderly lung cancer patients with VeriStrat Poor classification: single-agent chemotherapy with gemcitabine.”