The following data were extracted for each recommendation: efficacy: progression-free survival (PFS) gain efficacy: overall survival (OS) gain incremental cost-effectiveness ratio (ICER) recommendation reason for negative recommendation (if applicable) arrangements between payers and manufacturers (if applicable: risk-sharing, price negotiation, access scheme).
Clinical efficacy, damage progression, and kinetics of response of sc ABT and ADA are comparable.
To identify the diagnostic biomarker for insufficient therapeutic efficacy and progression, receiver operating characteristic curves and corresponding areas under the curve (AUC) was calculated.
In addition, sensitivity and specificity (with 95% confidence interval) was calculated at defined cut-off VEGF levels for detecting insufficient therapeutic efficacy and progression.
Here, patients progressing within the study were also given the option of crossing over to the other treatment arm, which enabled continued HER2-targeted treatment to be evaluated for efficacy after progression.
Results from the phase III study, VITAL, of aflibercept in the second-line setting in patients with advanced non-small cell lung cancer [NCT00532155] demonstrated efficacy in progression-free survival and overall objective response rate, but overall survival was not significantly improved.
Another indicator of efficacy is progression-free survival (PFS).
In the analysis of efficacy, median progression-free survival was equivalent (AVAGAST, 5.7 months vs. ToGA, 5.6 months).
Similarly, for efficacy parameters progression-free survival (PFS) and best overall response (BOR)), higher exposure to obinutuzumab was associated with a more favorable outcome; greater BOR correlated with higher Cmean values, which remained when patients were stratified by BSIZ.
Recently, a humanized antibody, Bevacizumab (Bz), which prevents VEGF binding to VEGF-R1/VEGF-R2, in combination with chemotherapy demonstrated initial efficacy (increased progression-free survival) in breast cancer phase III clinical trials.
In addition, contrary to existing relapse-theory hypotheses, neither negative affective reactions to lapse and feelings of guilt nor decreases in self-efficacy predicted progression from a lapse to a relapse.
