Trials performed in the continuation phase in which patients who have achieved response after acute treatment are randomized to either continuation of the drug or a switch to placebo are suitable for assessing efficacy in the prevention of relapse of the index episode and switch to the opposite pole.
The international Prognostic Index at relapse (saaIPI), early relapse less than 12 months after diagnosis and prior exposure to rituximab have been demonstrated to be predictors of clinical outcomes in first relapsed DLBCL patients [ 4, 20].
Staining with the MIB-1 monoclonal antibody has been shown to correlate well with histological grade, mitotic index, relapse-free interval and overall survival [ 35, 36].
Cutoff points for remission (<2.5), relapse (>4.5), and response (index drop >1.5) have been validated (24, 25, 26).
This value provides a reliable index of relapse risk that may be useful in clinical decision making.
Aneuploid tumors with DNA index ≤1.20 relapsed mainly in the vagina and pelvis, whereas aneuploid tumors with DNA index >1.20 relapsed predominantly outside pelvis.
The presence of aromatase expression by tumor or stromal cells was correlated with tumor response, treatment induced changes in proliferation index (Ki67), relapse-free survival (RFS) and breast cancer-specific survival (BCSS).
Nottingham Prognostic Index for the relapse was similar for all three methods of detection.
In multivariate analysis, high MVD and c-erbB-2 overexpression retained their significant and independent predictive role for local relapse, while p53 and proliferation index did not.
Although the reduction of local or distant relapse rates is an absolute index of the efficacy of adjuvant treatment, there is no validated tool to monitor its effect (Bonadonna et al, 2005).
