Early results from a large Phase-III trial suggest that adding bevacizumab (Avastin?, Genentech) to chemotherapy as a treatment for newly diagnosed ovarian cancer reduces the risk of disease progression during the first year of treatment.
At the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy, Dr Tim Perren from Leeds Teaching Hospitals NHS Trust, UK, reported findings from the international ICON7 trial, which included 1,528 women with high-risk early or advanced stage epithelial ovarian cancer, primary peritoneal cancer or Fallopian tube cancer.
After preparatory surgery, the women were randomly assigned to one of two treatment regimens: 6 cycles of carboplatin and paclitaxel chemotherapy given once every three weeks for six cycles; or the same chemotherapy plus bevacizumab given concurrently and then on its own as a maintenance treatment for up to a further 12 cycles.
?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,? Dr 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,? Dr Perren added.
An intriguing finding within the ICON7 trial is that the amount of benefit seen from the addition of bevacizumab varies and diminishes over time, Dr Perren noted.
Professor Max Parmar, Head of the Medical Research Council Clinical Trials Unit London commented: ?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, whilst others might choose to wait to judge the longer term data concerning the effects of the addition of bevacizumab on overall survival,? Prof Parmar said. ?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.?
?ICON 7 is the second positive large randomized trial in ovarian cancer patients that achieved the main objective: to improve PFS by adding bevacizumab to standard therapy,? noted Dr Andres Poveda, head of Gynecological Oncology at the Fundaci?n Instituto Valenciano de Oncologia in Spain. ?The major benefit is obtained in sub-optimally de-bulked and advanced-stage patients. It is too early to evaluate the impact in overall survival. The pending results of ICON 7 translational studies should identify the population who benefits from this treatment.?