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Journal of Thoracic Oncology:
doi: 10.1097/JTO.0000000000000160
Original Articles

A Correlative Biomarker Analysis of the Combination of Bevacizumab and Carboplatin-Based Chemotherapy for Advanced Nonsquamous Non–Small-Cell Lung Cancer: Results of the Phase II Randomized ABIGAIL Study (BO21015)

Mok, Tony MD*; Gorbunova, Vera MD; Juhasz, Erzsebet MD; Szima, Barna MD§; Burdaeva, Olga MD; Orlov, Sergey MD, PhD; Yu, Chong-Jen MD, PhD; Archer, Venice MD#; Hilton, Magalie MSc**; Delmar, Paul PhD**; Pallaud, Celine PhD**; Reck, Martin MD, PhD††

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Abstract

Introduction:

Avastin Biomarkers In lunG And 3D Innovative anaLysis (ABIGAIL), which is a phase II, open-label, randomized study, investigated correlations between biomarkers and best overall response to bevacizumab plus platinum-doublet chemotherapy for patients with advanced/recurrent non–small-cell lung cancer.

Methods:

Patients received bevacizumab (7.5 or 15 mg/kg, 3-weekly until disease progression/unacceptable toxicity) plus carboplatin/gemcitabine or carboplatin/paclitaxel (maximum six cycles). Plasma samples (baseline/throughout treatment) were analyzed for vascular endothelial growth factor (VEGF)-A (baseline only), VEGF receptors (VEGFR-1/VEGFR-2), basic fibroblast growth factor, E-selectin, intercellular adhesion molecule-1, and placental growth factor (baseline only). Tumor samples (primary specimen) were analyzed for VEGF-A, VEGFR-1/VEGFR-2, neuropilin (NRP), and CD31. Response was evaluated at baseline and every 6 weeks (Response Evaluation Criteria in Solid Tumors).

Results:

Patients were randomized to receive chemotherapy plus 7.5 mg/kg (n =154) or 15 mg/kg (n =149) bevacizumab. For the primary analysis, none of the baseline plasma biomarkers correlated with best overall response. Exploratory analyses showed that low VEGF-A levels were associated with longer progression-free survival (7.4 versus 6.1 months; hazard ratio, 1.57; 95% confidence intervals, 1.17 to 2.09; p = 0.002) and overall survival (19.8 versus 11.1 months; hazard ratio, 1.57; 95% confidence interval, 1.15–2.13; p = 0.004) compared with these in high baseline plasma VEGF-A levels. No plasma biomarkers changed significantly over time. No significant correlations were observed between tumor biomarkers and clinical outcomes. No new safety signals were observed.

Conclusion:

Baseline and/or dynamic changes in plasma basic fibroblast growth factor, E-selectin, intercellular adhesion molecule-1, placental growth factor, VEGFR-1 and VEGFR-2, and tumor biomarkers did not correlate statistically with treatment outcomes for bevacizumab plus chemotherapy. Only baseline plasma VEGF-A was significantly correlated with progression-free survival/overall survival.

Copyright © 2014 by the International Association for the Study of Lung Cancer

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