ICON7: Bevacizumab slowed disease progression in newly diagnosed ovarian cancers
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ESMO 35th Congress
MILAN Early results from the phase 3 ICON7 trial suggest that the addition of bevacizumab to chemotherapy as treatment for newly diagnosed ovarian cancer decreases disease progression within the first year of treatment.
The effect of treatment varies over time it peaks at 12 months after randomization with a 15% improvement in PFS and then reduces over time to give a 1.5-month overall improvement, Tim Perren, MD, at Leeds Teaching Hospitals NHS Trust, United Kingdom, said during a press conference.
The study included 1,528 women at high-risk for early or advanced stage epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
Women were randomly assigned to one of two treatments six cycles of carboplatin and paclitaxel once every 3 weeks for six cycles or the same chemotherapy plus bevacizumab administered simultaneously, then bevacizumab as a maintenance treatment for up to 12 cycles.
Disease progression or death occurred in 50% of the overall cohort (HR=0.81; 95% CI, 0.70-0.94; P=.0041).
ICON7 met its primary endpoint and demonstrated that at 12 months the risk of developing further progression of ovarian cancer was reduced by 15% when compared to the risk of progression seen with chemotherapy treatment alone, Perren said.
The data concerning survival within ICON7 will not be mature for a further 2 years, but preliminary data do show an encouraging early trend with fewer deaths seen in patients treated with bevacizumab, he said. Perren concluded that longer PFS and OS results, expected in 2012, will allow further evaluation of the effect of treatment.
These are exciting preliminary results which significantly add to our understanding of ovarian cancer and its treatment. We look forward to discussing the full impact of the trial once we have published the final results in a peer-reviewed journal. We predict that some doctors and patients may choose to use bevacizumab as post-operative treatment for newly diagnosed ovarian cancer as consequence of these results, while others might choose to wait to judge the longer term data concerning the effects of the addition of bevacizumab on OS. Ovarian cancer still conveys a huge threat for many women and we are pleased that the results of this trial will help to inform future treatment options for patients.
Max Parmar, MD
Head of Medical
Research Council Clinical Trials Unit, London
For more information:
- Perren T. #LBA4. Presented at: the ESMO 35th Congress; Oct. 8-12, 2010; Milan, Italy.
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