The ICON6 trial, in women whose ovarian cancer has returned after chemotherapy, has found that adding a new drug, called cediranib, improves the effectiveness of further chemotherapy. It delays the time to further progression of the cancer (the cancer getting worse). These results were published yesterday in a major medical journal, The Lancet.
Taking cediranib daily during and after chemotherapy for 18 months increased the length of time before the disease worsened by an average of 2.3 months, from 8.7 to 11.0 months.
Cediranib is a tablet that stops tumours developing the blood vessels they need to keep growing. It is simple to take, as it can be swallowed rather than given by a drip or injection. Most women in the trial did not suffer severe side-effects. This is the first trial to show that an oral medicine of this type can help women with ovarian cancer.
The ICON6 trial looked at 456 women with ovarian cancer that had come back after initial treatment. Patients were divided at random to receive either standard chemotherapy plus a placebo, or standard chemotherapy with cediranib for either the length of chemotherapy, or for 18 months. In some cases the cediranib was continued beyond 18 months if the patient was still benefitting clinically.
Having cediranib during and after chemotherapy extended the length of time before the disease got worse. Having cediranib only during chemotherapy did not make any significant improvement compared to having chemotherapy plus a placebo.
There was also a hint that women who received cediranib during and after chemotherapy may live longer than women who had chemotherapy plus a placebo, but we do not yet have enough data to be sure of this.
The drug company who developed cediranib, AstraZeneca, are now using the results of ICON6 to apply for market authorisation from the European Medicines Agency. If granted, this will give women with recurrent ovarian cancer a new treatment option. This would be welcome news, as there are currently few treatment options for these women.
The trial was an international collaboration between members of the Gynecologic Cancer Intergroup (GCIG), and recruited women from the UK, Canada, Australia and Spain. It was co-ordinated by the MRC Clinical Trials Unit at UCL.
· ICON6 study page
· ICON6 website
· Lancet article