We knew that peritoneal colorectal carcinomatosis is a very serious condition and today, with modern chemotherapy for patients not operated on, the prognosis is never more than 16 months overall survival.
When the patient is amenable to complete macroscopic resection, that means complete removal of the disease in the abdomen, the prognosis can reach 40 months overall survival.
In those cases we are able to cure about 16% of the patients.
So it’s why we used for a long time cytoreductive surgery in addition to HIPEC.
The two components, the two parts of the treatment, have never been separated.
We didn’t know the exact role of the HIPEC in this package. It’s why we randomised the HIPEC for patients completely resected to know the exact role of this particular heated chemotherapy given intraoperatively.
And how did these results turn out?
The results are that we have no difference between HIPEC and non-HIPEC concerning the mortality, post-op mortality, concerning the early side effects, the early complications after the operation.
But we had significant difference concerning the late severe complications within 60 days.
Regarding the survival there is no difference between the two arms, between HIPEC and non-HIPEC, concerning the primary endpoint which is overall survival.
We were amazed to see the high survival rate in the non-HIPEC arm because our hypothesis at the beginning was to consider that it would improve survival from 30-48 months.
We found 41 months in the non-HIPEC arm, which is very high and unexpected.
It’s why probably the study is negative.
There were notes about possible use for HIPEC, even considering all of this, for medium.
Yes, because we performed a subgroup analysis showing that for this particular group of patients HIPEC could be beneficial for them.
And we looked into three categories of PCI, the high PCI – more than 16, the medium one from 11-15, and the low – under 10.
And taking all of this as one lesson, how is this changing practice or changing gear?
It will change practice because we are not going to use HIPEC in every case, like today.
HIPEC could be reserved to the only medium range PCI patients.
And any final thoughts between this and the presentation regarding mFOLFOX?
How does that affect the landscape of pancreatic cancer care going forwards?
It’s very important for the pancreatic cancer because the adjuvant chemotherapy improved a lot the survival in the pancreatic study, in the FOLFIRINOX.
But we have to improve for the carcinomatosis, we have to improve chemotherapy as well.
Research will be made in improving the drugs, chemotherapy, systemic but also intraoperative probably, yes, using other drugs, other protocols.