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Thank you

Thank you for taking part in the ICON8B study.

Your participation in the ICON8B study has been of great value to us. You have helped us to answer important questions about how to treat women with advanced ovarian cancer.

The study results are now available and are outlined below. This is the first set of results of the ICON8B study. We will have more results at a later stage as we will continue to collect more information about the treatment side effects and longer-term results. We wrote this initial summary in September 2023.

In the video below, Max Parmar, director of the MRC CTU at UCL and member of the ICON8B team, explains the main findings of the ICON8B study.

 

Please carry on attending your routine clinic visits. The longer-term follow-up of the study participants is important to us. It will help us to find out more results in the future.

If you have any questions about the ICON8B study and its results, or if this summary raises any other worries for you, please speak to your oncologist or research nurse. 

 

What was the ICON8B study about?

ICON8B is an international clinical trial testing different ways of treating women with advanced ovarian cancer.

In ovarian cancer, the standard treatment includes a combination of surgery and chemotherapy. The surgery removes as much of the cancer as possible, whilst chemotherapy aims to kill any remaining cancer cells, reducing the chances of the cancer coming back. Surgery can be given before starting chemotherapy or after a few doses of chemotherapy.

The standard chemotherapy treatment for ovarian cancer involves two drugs, carboplatin and paclitaxel. These are given once every three weeks (this period of time is called a “cycle”). Patients can receive up to six of these cycles over the course of around six months.

Another type of treatment used in ovarian cancer are anti-angiogenic drugs. These drugs aim to stop the cancer from growing its own blood vessels. This helps prevent or slow the growth of cancer and slow its ability to spread to other parts of the body. Bevacizumab (also known as Avastin®) is an anti‑angiogenic drug that is commonly used to treat advanced ovarian cancer. It is given once every three weeks alongside standard chemotherapy.  

The aim of the ICON8B study was to find out if giving the chemotherapy drug paclitaxel every week rather than every three weeks, with or without bevacizumab, could:

  • delay the cancer coming back or getting worse
  • improve how long women with ovarian cancer lived

To address this question, the study compared three ways of giving chemotherapy in combination with bevacizumab:

  • Group 1: Standard chemotherapy and bevacizumab. Carboplatin and paclitaxel were given once every three weeks alongside bevacizumab, for up to six cycles (chemotherapy phase). Bevacizumab was given every three weeks for up to 42 weeks after completion of chemotherapy (maintenance phase – to delay cancer progression and increase survival).
  • Group 2: Weekly chemotherapy. The chemotherapy drug paclitaxel was given once a week (at a lower dose), and carboplatin every three weeks, for up to six cycles.
  • Group 3: Weekly chemotherapy and bevacizumab. The chemotherapy drug paclitaxel was given once a week (at a lower dose), while carboplatin and bevacizumab were given every three weeks for up to six cycles (chemotherapy phase). Bevacizumab was given every three weeks for up to 42 weeks after completion of chemotherapy (maintenance phase).

In this report, we refer to weekly chemotherapy when patients received the drug paclitaxel every week and the drug carboplatin every three weeks. Whereas standard chemotherapy gives both drugs, paclitaxel and carboplatin, every three weeks. 

The table below illustrates the design of the ICON8B study.

 

Why was the ICON8B study needed?

Previous studies in ovarian cancer have found that giving weekly chemotherapy may be more effective than standard chemotherapy.

In our previous study, ICON8, we wanted to find out if chemotherapy, with paclitaxel given every week and carboplatin every three weeks, was better than the standard chemotherapy given every three weeks. In this study, participants didn't receive bevacizumab on top of the chemotherapy. Unfortunately, the study found no benefit for women who had weekly chemotherapy, compared to women who had chemotherapy every three weeks.

Two other studies in ovarian cancer treatment, the GOG-0218 and the ICON7 studies, showed that giving bevacizumab with three-weekly chemotherapy may give better results than giving 3 weekly chemotherapy alone. However, more data was needed to understand if adding bevacizumab to weekly chemotherapy was also beneficial in advanced ovarian cancer.

In the ICON8B study, we wanted to find out if weekly chemotherapy combined with bevacizumab is better than standard three-weekly chemotherapy combined with bevacizumab in treating women with advanced ovarian cancer. We also wanted to see if weekly chemotherapy causes more or fewer side effects than standard chemotherapy. Although weekly chemotherapy involves more doses of chemotherapy than standard chemotherapy, the overall treatment is the same length for both.

 

Who took part in the ICON8B study?

People taking part in the ICON8B trial were:

  • Female and at least 18 years old
  • Newly diagnosed with stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  • Well enough to be up and about for at least half the day
  • Starting treatment for ovarian cancer for the first time
  • With no contraindications to receiving bevacizumab

ICON8B took place in the UK, the Republic of Ireland and Switzerland. 708 women with advanced ovarian cancer (stage III or stage IV) took part in the study. The average age of women who joined ICON8B was 64, ranging from 30 to 83 years old.

 

How was the ICON8B study carried out?

Women joined the ICON8B study between July 2015 and April 2020.

Women who agreed to take part in the study were allocated into three groups at random:

  • Group 1 (292 women): received standard chemotherapy and bevacizumab, having both carboplatin and paclitaxel once every three weeks, together with bevacizumab for up to six cycles over approximately six months (chemotherapy phase). Bevacizumab then continued to be given every three weeks for up to 42 weeks after completion of chemotherapy (maintenance phase).
  • Group 2 (129 women): received paclitaxel once a week (at a lower dose) and carboplatin every three weeks for up to six cycles over six months.
  • Group 3 (287 women): received weekly chemotherapy and bevacizumab, having carboplatin and bevacizumab once every three weeks and paclitaxel once a week (at a lower dose), for up to six cycles over six months (chemotherapy phase). Bevacizumab then continued to be given every three weeks for up to 42 weeks after completion of chemotherapy (maintenance phase).

Women in ICON8B could have surgery either before starting chemotherapy or after they had received three cycles of chemotherapy.

So far, we have followed up how women were doing for an average of five years.

 

What did the ICON8B study find?

In cancer clinical trials, a common way to assess if a treatment is effective is by looking at “Progression-Free Survival”, which is a measure of time between the start of the treatment and the time of cancer coming back or getting worse.

The ICON8B study found that giving bevacizumab and weekly chemotherapy (Group 3) was more effective at preventing the cancer coming back or getting worse compared to the standard chemotherapy with bevacizumab (Group 1).

On average, women who had bevacizumab and standard chemotherapy (Group 1) had almost 17 months before their cancer came back or got worse. Women who had weekly chemotherapy with bevacizumab (Group 3) had around 22 months before their cancer came back or got worse, on average. This means that having weekly chemotherapy is better than having chemotherapy once every three weeks when combined with bevacizumab.

On average, women in Group 3 took five and a half months longer before their cancer came back or got worse, compared with women who had chemotherapy every three weeks.  

                                 

These results are averages. Some women had their cancer come back or get worse sooner, and some have not had their cancer come back or get worse.

We also looked at overall survival, which measures the time between the start of the treatment and the end of life. These results suggest that women having the weekly chemotherapy and bevacizumab live about 10 months longer than those receiving the standard chemotherapy and bevacizumab. However, the researchers are still following up these women to confirm this result with more data.

We found no evidence that women who had only weekly chemotherapy (Group 2) did better or worse, on average, than women who had the standard chemotherapy and bevacizumab (Group 1).

Many women in the study told us they had some side effects. Some of these were common side effects from the standard chemotherapy. However, there were other side effects associated with the treatments tested in ICON8B; the weekly chemotherapy and the addition of bevacizumab. The most common side effects in Group 1 and Group 3 were:

  • Having blood clots in the veins (venous thromboembolism)
  • Having a low number of white blood cells and a fever (neutropenia)
  • Pins and needles, numbness, and/or pain, usually in your feet (peripheral neuropathy)
  • Low numbers of red blood cells, or low levels of haemoglobin in the blood (anaemia)
  • High blood pressure (hypertension)
  • Wounds failing to heal after surgery (wound complication/dehiscence)

The main difference between groups was that women who had weekly chemotherapy and bevacizumab (Group 3) were more likely to have anaemia than women in the standard chemotherapy group (Group 1), but less likely to have hypertension.

 

What about results from Group 2?

In 2017, results from the ICON8 study showed that having weekly chemotherapy (without bevacizumab) did not delay the cancer coming back or getting worse, compared to standard three-weekly chemotherapy. After learning about these results, the ICON8B team stopped recruiting women to the Group 2 (receiving weekly chemotherapy without bevacizumab).

 

How sure can we be about these results?

The difference between the groups is big enough for us to be confident that combining bevacizumab and weekly chemotherapy delays and prevents the cancer coming back or getting worse compared to having bevacizumab and chemotherapy once every three weeks.

 

What do these results mean?

What do these results mean for you?

These results won’t affect your future treatment, as you have already completed your chemotherapy treatment with bevacizumab.

If you want to discuss your treatment options, please talk to your doctor. Please continue to come to your appointments with your study doctor, so we can keep track of how well you are. This will help us to confirm the differences between the groups in the longer term and see if it improves how long women with ovarian cancer live.

What do these results mean for other people?

These results suggest that other women with advanced ovarian cancer, like those in the ICON8B study, are likely to benefit from having chemotherapy once a week rather than once every three weeks when they are also given bevacizumab.

ICON8B included women who were recently diagnosed with advanced ovarian cancer and were about to start their treatment, just before or after their surgery. The study did not include women who were so unwell that they were confined to bed for more than half of every day, so we do not know if these results apply to them.

 

What difference will these results make?

These results have the potential to change the way that future patients are treated. Bevacizumab in combination with weekly chemotherapy should be considered a standard‑of-care option for patients with advanced ovarian cancer who are about to start their first line of treatment.  

The ICON8B study will continue to follow up with women to answer the longer-term question of whether weekly chemotherapy improves how long women live.

The team is now working on a report to publish these results, whilst undertaking a quality-of-life study. To assess if combining bevacizumab and weekly chemotherapy in clinical practice is cost-effective, the researchers are planning to carry out an economic analysis.

 

Thank you

Once again, thank you for taking part in the ICON8B study. You are helping us to answer important questions about how to treat women with ovarian cancer. We hope that the results of this trial will help women with ovarian cancer in the future.

 

Frequently asked questions:

Are these findings just for first-line treatment?

All the patients in ICON8B treated with weekly chemotherapy and bevacizumab, received this treatment from their first cycle. We do not know if switching to weekly chemotherapy later in the treatment course will be as effective as when this treatment is given from the start.

Does the weekly chemotherapy combined with bevacizumab work better for me if I have HRD/BRCA variations?  

We don’t know. The ICON8B study was conducted before the genetic testing for HRD/ BRCA mutation was part of routine care or before treatment with newer therapies such as PARP inhibitors were routinely available.

 

Further information

If you have any questions about the ICON8B study, please speak to your doctor or research nurse.

Cancer Research UK has information about ICON8B on their website.

The ICON8B study is registered with the ISRCTN registry. The registration number is 10356387.

The ICON8B study was sponsored by the Medical Research Council. It was funded by Cancer Research UK.

Target Ovarian Cancer have some useful information and support guides on their website, as do Ovacome and Cancer Research UK.

 

Support

Target Ovarian Cancer have a Support Line where you can speak to a nurse advisor. You can call the Support Line on 020 7923 5475.

Ovacome also have a Support Service that offers information and emotional support to women, their families, friends and carers. You can call the Support Service on 0800 008 7054, text them on 07427 390504, or instant message them on their website.

To find a Support Group or Service near you, visit Ovacome's list of Support Services.

My Ovacome is an online community for anyone affected by ovarian cancer. It is a safe, supportive space for women with ovarian cancer and their friends and families to share their experiences and offer each other encouragement, knowledge, understanding and friendship.

Target Ovarian Cancer also has information about other sources of support on their website