A trial looking at treatment before and after surgery for stomach or gastro oesophageal junction cancer (the INNOVATION Trial) (EORTC 1203)

This was a randomised  international phase 2 trial.

172 people joined the trial and were put into treatment groups. The researchers couldn’t get as many people to take part as they hoped. This meant the trial was not open for people to join for as long as they planned.

161 people started treatment. People were 2 times more likely to have trastuzumab or pertuzumab than standard treatment:

• 35 people had chemotherapy (this was standard treatment)
• 67 people had chemotherapy and trastuzumab
• 70 people had chemotherapy, trastuzumab and pertuzumab

Everyone had chemotherapy as cycles of treatment  before surgery. The people having trastuzumab and pertuzumab also had these drugs before surgery. 

After surgery, everyone had more chemotherapy. And those people having trastuzumab and pertuzumab also had these drugs once every 3 weeks. They had the targeted cancer drugs for up to a year as long as the treatment was helping, and the side effects were not too bad.

When the trial started most of the people taking part had:

• 3 cycles of cisplatin and capecitabine chemotherapy before surgery then
• 3 cycles of the same chemotherapy after surgery

This changed part way through the trial. The trial team learned from new research that FLOT chemotherapy was better for people with this type of cancer. FLOT is a combination of the drugs fluorouracil, leucovorin, oxaliplatin and docetaxel. So, if people were able to have FLOT, they had 4 cycles of this before and after surgery.

Around the same number of people had cisplatin and capecitabine as had FLOT. People were able to have chemotherapy called FOLFOX or CAPOX if they couldn't have FLOT.

Not everyone completed treatment. Most people finished their treatment before surgery. The main reason people stopped treatment at this stage was due to side effects. The trial team have not published what these side effects were yet.

Most people who didn’t leave the trial at this stage had surgery. This was more than 8 out of 10 people in each group. It was:

• 84% of people in the chemotherapy group
• 98% of people in the chemotherapy and trastuzumab group
• 92% of people in the chemotherapy, trastuzumab and pertuzumab group

Samples from surgery
The trial team were able to look at tissue samples from 126 people that had surgery.

They looked at how well the cancer had responded to treatment. They did this by looking to see how many people had no cancer or very little cancer at surgery. 

They found it was more than 2 out of 10 people in each group. It was:

• 23% for chemotherapy
• 37% for chemotherapy and trastuzumab
• 26% for chemotherapy, trastuzumab and pertuzumab

The trial team say that the difference between standard treatment and chemotherapy, trastuzumab and pertuzumab wasn't big enough to say for sure that it was due to the different treatment. It may have been due to chance. 

Conclusion
The trial team concluded that adding trastuzumab and pertuzumab to chemotherapy did not work better.

Sometimes trials show a different treatment isn’t useful for a particular type or stage of cancer. But these trials still add to our knowledge and understanding of cancer and how to treat it.

Chemotherapy and trastuzumab worked well for some people taking part. Especially with FLOT chemotherapy.

The researchers say they need more results from the trial to say for sure how well this treatment works. 

They aim to publish further results at a later date. We hope to add them to this summary when they are available. 

Where this information comes from    

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed ) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Integration of trastuzumab (T), with or without pertuzumab (P), into
perioperative chemotherapy (CT) of HER-2 positive gastric (GC) and
esophagogastric junction cancer (EGJC). First results of the EORTC 1203. “INNOVATION” Study, in collaboration with the Korean Cancer Study Group, and the Dutch Upper GI Cancer group
AD Wagner and others
Journal of Clinical Oncology, 2023. Volume 41, number 16 (supplement). ASCO Abstract number 4057.