Evaluation of VeriStrat, a serum proteomic test, in the randomized, open-label, phase 3 LUX-Lung 8 (LL8) trial of afatinib (A) versus erlotinib (E) for the second-line treatment of advanced squamous cell carcinoma (SCC) of the lung.
Bildiriler > Özet Bildiri
Yazarlar: Glenwood D. Goss, Ki Hyeong Lee, Enriqueta Felip, Manuel Cobo, Konstantinos N. Syrigos, Erdem GÖKER, Vassilis Georgoulias, Salih Z. Guclu, Dolores Isla, Young J. Min, Alessandro Morabito, Sandra Close, Nicholas Dupuis, Vikram K. Chand, Flavio Solca, Nicole Krämer, Neil Gibson, Eva Ehrnrooth, Jean-Charles Soria
Journal of Clinical Oncology, , , Uluslararası, Özet Bildiri, Wos, cilt 34, ss e20510-e20510
DOI: 10.1200/jco.2016.34.15_suppl.e20510
Özet
e20510 Background: Treatment (tx) options for patients (pts) with advanced SCC of the lung after progression on platinum-based chemotherapy are limited. In LL8, the irreversible ErbB family blocker, A, significantly improved OS, PFS and disease control rate vs E, a reversible EGFR TKI, in 795 pts with SCC of the lung. VeriStrat is a serum protein test that utilizes MALDI-TOF mass spectrometry to assign a ‘GOOD' (VS-G) or ‘POOR' (VS-P) classification and has demonstrated prognostic and predictive utility for EGFR targeted therapies in NSCLC.1 Here, the predictive ability of VeriStrat was tested in LL8; OS was the primary efficacy variable. Methods: Pre-tx serum samples, blinded to clinical outcome, were classified as VS-G or VS-P based on predefined reference groups. Clinical outcomes were analyzed with respect to VeriStrat status in the overall population (all pts with both clinical and VeriStrat data) and in predefined subgroups. Results: 675 pts were classified (VS-G: 412; VS-P: 263). In the VS-G group, median OS was 11.5 mo for A and 8.9 mo for E (HR [95% CI] 0.79 [0.63–0.98]; p = 0.03); median PFS was 3.3 mo for A and 2.0 mo for E (HR [95% CI] 0.73 [0.59–0.92]; p = 0.005). In the VS-P group, median OS was 4.7 mo for A and 4.8 mo for E (HR [95% CI] 0.90 [0.70–1.16]; p = n.s.); median PFS was 1.9 mo for both A and E (HR [95% CI] 0.96 [0.73–1.27]; p = n.s.). In pts treated with A, both OS (HR [95% CI] 0.40 [0.31–0.51]; p < 0.0001) and PFS (HR [95% CI] 0.56 [0.43–0.72]; p < 0.0001) were longer in the VS-G group vs the VS-P group. Multivariate analysis showed that VeriStrat was an independent predictor of OS and PFS in pts treated with A, regardless of ECOG PS, best response to first-line therapy, age and race. However, there was no interaction between VeriStrat classification and tx group for OS (pint = 0.53) or PFS (pint = 0.12). Conclusions: In LL8, VeriStrat has a strong independent stratification effect in pts with relapsed/refractory SCC of the lung treated with A. In these difficult to treat pts, A conferred significantly better OS and PFS than E in the VS-G group, with a median OS of 11.5 mo. 1. Gregorc V, et al. Lancet Oncol 2014;15:713‒21 Clinical trial information: NCT01523587.