First results of the ICON7
trial – Does the addition of bevacizumab to standard chemotherapy
delay the progression of disease in women with ovarian
cancer?
[This information has been prepared for
patients, their relatives, doctors and nurses involved in the ICON7
trial.]
In 2006 the Medical Research Council launched
a trial called ICON7. It looked at the addition of a drug called
bevacizumab to standard chemotherapy for women with ovarian cancer.
This information tells you about the results of this trial.
Bevacizumab (also known by its brand name Avastin) is a ‘targeted
therapy’ that works by blocking the development of new blood
vessels and interfering with the tumour’s ability to grow and
spread to other parts of the body. In a number of cancers the
addition of bevacizumab to chemotherapy has been shown to improve
outcomes. ICON7 aimed to find out if this was also the case in
ovarian cancer.
Between December 2006 and February 2009 1528
women were randomised into the trial from Europe, Canada, Australia
and New Zealand. Following diagnosis of their disease and surgery
to remove it the women were put into one of two groups:
• Women in one group received standard
chemotherapy with carboplatin and paclitaxel every 3 weeks for 6
cycles of treatment and no other treatment
• In the other group, women received standard
chemotherapy with carboplatin and paclitaxel every 3 weeks for 6
cycles of treatment. Bevacizumab was also given at the start of
each chemotherapy treatment. Following this, bevacizumab was given
alone every 3 weeks for a further 12 cycles.
Researchers did not choose which group a woman
went in to – this was done by a computer, to make sure that each
group of women was as similar as possible. This helped to ensure
that the results of this trial were as reliable as they could
possibly be. Following the completion of their treatment all women
were followed within the trial with routine clinical examination
and CT scans at regular intervals. They were also asked to complete
Quality of Life questionnaires.
What were the results?
Researchers looked at information on when
women in the trial had progression of their ovarian cancer shown on
CT scan, and looked to see if there was a difference in the time
taken for the disease to come back in those women who received
bevacizumab and those who didn’t.
The results of the ICON7 trial were positive.
The addition of bevacizumab to standard chemotherapy resulted in an
improvement in progression-free survival (time without disease
worsening or coming back). The effect of bevacizumab was most
striking after one year when 15% fewer women treated with
bevacizumab had developed progression of disease than women who had
not received bevacizumab. The beneficial effect of bevacizumab
reduced over time and overall, women in the trial who received
bevacizumab experienced an average of 1.5 months of extra time
without the disease worsening.
On the whole bevacizumab treatment was well
tolerated and no new side effects were identified. The most common
side effect was high blood pressure, with 18% of women in the
bevacizumab arm having high blood pressure at a level which may
have required treatment with tablets, compared with 2% in the
standard chemotherapy arm. High blood pressure was easily monitored
and treated in the trial.
This is the second positive trial with
bevacizumab in ovarian cancer: the results of ICON7 support the
findings of an American trial of bevacizumab (GOG218) that were
announced in June of this year. Bevacizumab is the first new drug
that has improved outcomes for women with ovarian cancer in over 17
years.
The period of extra time before the disease
progresses is shorter than we hoped, but we know from experience
that cancer treatment improves over the years by a series of small
advances like this one.
Women are still being followed in the trial
and it will be important to see longer term results of the effect
of bevacizumab on progression-free survival and to see if overall
survival is increased. These results should be available in 2012.
Analysis of the information collected in the trial from Quality of
Life questionnaires will also be important in determining women’s
experience of receiving bevacizumab infusions.
Analysis of tissue samples and blood samples
taken during the trial may also help us to identify groups of
patients who benefit more from bevacizumab. This will help us to
design future trials and studies and help us understand the best
way to use this new treatment.
More information
The doctor or nurse who gave you this letter
will be able to explain the results in more detail and answer any
questions you may have. First results of the trial have just been
announced at an international conference for cancer researchers
(the European Society for Medical Oncology). You can read more
about this conference here. The
results will also be published in a scientific journal. We will
tell your doctor or nurse when the results are published and they
should be able to give you a copy if you would like one.
Nurses at Ovacome (www.ovacome.org.uk) can also help
you understand this research. You can call them on the Ovacome
helpline (0845 371 0554).
Thank you
On behalf of all the ICON7 researchers, we
would like to thank all of the women who took part in this
research, and the families who supported them. Cancer treatment
could not be improved without the support of many people who take
part in cancer research every year.
Last Update Date : 2/2/2011
