Last year I wrote about the results of the OCEANS Study ( phase III trial of gemcitabine, carboplatin and bevacizumab or gemcitabine, carboplatin and placebo) . This year Dr. Aghajanian presented the safety analysis data from the OCEANS .
Abstract 5054
An updated safety analysis of OCEANS, a randomized, double-blind, phase III trial of gemcitabine (G) and carboplatin (C) with bevacizumab (BV) or placebo (PL) followed by BV or PL to disease progression (PD) in patients with platinum-sensitive (Plat-S) recurrent ovarian cancer.
"Conclusions: The overall safety profile was similar to that seen at the time of the final PFS( progression free survival) analysis. Higher incidences of proteinuria ( excess protein in urine) and HTN ( Hypertension)were possibly related to longer BV treatment duration and resolved in the majority of patients."
The results show that the side effects experience by those in the Bevacizumab group were similar to those in the placebo group.
Abstract LBA 5002
AURELIA: A randomized phase III trial evaluating bevacizumab (BEV) plus chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer (OC).
"Conclusions: In PT-resistant OC, BEV + CT provides statistically significant and clinically meaningful improvement in PFS and ORR vs CT alone. Strict inclusion criteria minimized the incidence of BEV AEs. This is the first phase III trial in PT-resistant OC to show benefit with a targeted therapy and improved outcome with a combination vs monotherapy."
This phase III trial showed that women with recurrent platinum resistant ovarian cancer given Avastin along with chemotherapy (weekly taxol, doxil or topotecan) had a median survival of 6.7 months compared to 3.4 months in women in the control arm. The side effects were similar to what was seen in other Avastin studies.
Dee
Every Day is a Blessing!
Dee
Every Day is a Blessing
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