Interim survival data from a randomized Phase III trial suggested that adding bevacizumab (Avastin) to standard carboplatin and paclitaxel chemotherapy for treatment of newly diagnosed ovarian cancer patients may offer benefit over treatment with chemotherapy alone, particularly for patients with more aggressive disease.

In the ICON7 study, 1,528 women with newly diagnosed high-risk or advanced epithelial ovarian, primary peritoneal or fallopian tube cancer were randomized to receive 6 cycles of chemotherapy alone, or the same chemotherapy concurrently with bevacizumab followed by single agent of bevacizumab for a total duration of 12 months.

First results presented at last year's ESMO Annual Meeting reported a progression-free survival (PFS) benefit for adding bevacizumab to standard chemotherapy.

To further inform consideration of a licensing application, an interim analysis of overall survival was requested by regulatory authorities – the U.S. Food and Drug Administration and the European Medicines Agency. After a median follow-up of 28 months, there were fewer deaths in the bevacizumab group than the standard therapy group (178 versus 200, respectively). This represents a 15 percent overall reduction in risk of death, but was not statistically significant.

The ICON7 investigators also conducted a planned subgroup analysis looking at the results in patients at highest risk of recurrence – those with stage III ovarian cancer who were left with more than 1 cm of tumour after surgery and all stage IV patients who had surgery. In this subgroup, the reduction in risk of death was 36 percent (79 deaths versus 109 deaths in the standard therapy group). This result reached statistical significance.

"It's too early to reach firm conclusions about the full extent of the overall survival benefit of adding bevacizumab to the treatment regimen for newly diagnosed ovarian cancer, but it does seem very promising, particularly for patients at high risk of recurrence," said Gunnar Kristensen, MD, PhD, one of the lead investigators of this study and Senior Consultant in the Department for Gynecologic Oncology, Norwegian Radium Hospital, Oslo, Norway. "We don't have complete answers to all our questions today; we will have to wait for final results of the trial which are expected in about two years."




Source: ASCO

Reference: ASCO 2011 Abstract: LBA5006 Result of interim analysis of overall survival in the GCIG ICON7 phase III randomised trial of bevacizumab in women with newly diagnosed ovarian cancer. G. Kristensen, T. Perren, W. Qian, J. Pfisterer, J. A. Ledermann, F. Joly, M. S. Carey, P. J. Beale, A. Cervantes, A. M. Oza.