Tumor Growth Rate Estimates Are Independently Predictive of Therapy Response and Survival in Recurrent High-Grade Serous Ovarian Cancer Patients

This study aimed to assess the predictive value of tumor growth rate estimates based on serial cancer antigen-125 (CA-125) levels on therapy response and survival of patients with recurrent high-grade serous ovarian cancer (HGSOC). In total, 301 consecutive patients with advanced HGSOC (exploratory cohort: n = 155, treated at the Medical University of Vienna; external validation cohort: n = 146, from the Ovarian Cancer Therapy–Innovative Models Prolong Survival (OCTIPS) consortium) were enrolled. Tumor growth estimates were obtained using a validated two-phase equation model involving serial CA-125 levels, and their predictive value with respect to treatment response to the next chemotherapy and the prognostic value with respect to disease-specific survival and overall survival were assessed. Tumor growth estimates were an independent predictor for response to second-line chemotherapy and an independent prognostic factor for second-line chemotherapy use in both univariate and multivariable analyses, outperforming both the predictive (second line: p = 0.003, HR 5.19 [1.73–15.58] vs. p = 0.453, HR 1.95 [0.34–11.17]) and prognostic values (second line: p = 0.042, HR 1.53 [1.02–2.31] vs. p = 0.331, HR 1.39 [0.71–2.27]) of a therapy-free interval (TFI) < 6 months. Tumor growth estimates were a predictive factor for response to third- and fourth-line chemotherapy and a prognostic factor for third- and fourth-line chemotherapy use in the univariate analysis. The CA-125-derived tumor growth rate estimate may be a quantifiable and easily assessable surrogate to TFI in treatment decision making for patients with recurrent HGSOC

Why EU asylum standards exceed the lowest common denominator: the role of regulatory expertise in EU decision-making

While scholars traditionally expected EU policy-making in the area of asylum to produce lowest common denominator standards, recent studies on the first phase of the Common European Asylum System have observed higher asylum standards in some instances. This article aims at explaining this divergence. Drawing on concepts of regulatory expertise and ‘misfit’, it argues that the observed variation in policy output can be explained by the dominance of a few (Northern) member states which were highly successful in inserting their positions in the core EU directives. Government effectiveness and exposure to the phenomenon entailing regulatory expertise provide a powerful explanation for member states being effective policy-shapers. Characterized by low levels of government effectiveness and exposure in the asylum area, Southern European countries were, on the contrary, rather passive during the negotiations and barely left any mark on the EU directives