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Janning, Melanie; Müller, Volkmar; Vettorazzi, Eik; Cubas-Cordova, Miguel; Gensch, Victoria; Ben-Batalla, Isabel; Eulenburg, Christine zu; Schem, Christian; Fasching, Peter A.; Schnappauf, Benjamin; Karn, Thomas; Fehm, Tanja; Just, Marianne; Kühn, Thorsten; Holms, Frank; Overkamp, Friedrich; Krabisch, Petra; Rack, Brigitte; Denkert, Carsten; Untch, Michael; Tesch, Hans; Rezai, Mahdi; Kittel, Kornelia; Pantel, Klaus; Bokemeyer, Carsten; Loibl, Sibylle; Minckwitz, Gunter von; Loges, Sonja (2019): Evaluation of soluble carbonic anhydrase IX as predictive marker for efficacy of bevacizumab: A biomarker analysis from the geparquinto phase III neoadjuvant breast cancer trial. In: International Journal of Cancer, Vol. 145, No. 3: pp. 857-868
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We analyzed the predictive potential of pretreatment soluble carbonic anhydrase IX levels (sCAIX) for the efficacy of bevacizumab in the phase III neoadjuvant GeparQuinto trial. sCAIX was determined by enzyme-linked immunosorbent assay (ELISA). Correlations between sCAIX and pathological complete response (pCR), disease-free and overall survival (DFS, OS) were assessed with logistic and Cox proportional hazard regression models using bootstrapping for robust estimates and internal validation. 1,160 HER2-negative patient sera were analyzed, of whom 577 received bevacizumab. Patients with low pretreatment sCAIX had decreased pCR rates (12.1 vs. 20.1%, p = 0.012) and poorer DFS (adjusted 5-year DFS 71.4 vs. 80.5 months, p = 0.010) compared to patients with high sCAIX when treated with neoadjuvant chemotherapy (NCT). For patients with low sCAIX, pCR rates significantly improved upon addition of bevacizumab to NCT (12.1 vs. 20.4%;p = 0.017), which was not the case in patients with high sCAIX (20.1% for NCT vs. 17.0% for NCT-B, p = 0.913). When analyzing DFS we found that bevacizumab improved 5-year DFS for patients with low sCAIX numerically but not significantly (71.4 vs. 78.5 months;log rank 0.234). In contrast, addition of bevacizumab worsened 5-year DFS for patients with high sCAIX (81 vs. 73.6 months, log-rank 0.025). By assessing sCAIX levels we identified a patient cohort in breast cancer that is potentially undertreated with NCT alone. Bevacizumab improved pCR rates in this group, suggesting sCAIX is a predictive biomarker for bevacizumab with regards to treatment response. Our data also show that bevacizumab is not beneficial in patients with high sCAIX.