We have done this study because for locally advanced colon cancer most of the time surgery is the
primary treatment for these patients. If the patients have risk factors after the surgery the patient
receives systemic chemotherapy. The problem is that the relapse or recurrence in the peritoneal
cavity or abdominal cavity is very high in these patients, these patients with T4 colon cancer. With this
stage the only strategy to avoid the peritoneal relapse today is systemic chemo.
We conducted this trial to offer the patients during the surgery we administered chemotherapy in a
hyperthermic way in the same operation. After removing all the tumour we administered the
chemotherapy during one hour. Then the proposal is to eliminate the tumoural cells in the abdominal
cavity in order to avoid peritoneal recurrence in these patients.
We have conducted this trial in Spain, this is a multicentre trial involving 17 centres in Spain focussing
on surgical oncology. We have recruited 184 patients for randomising; in each arm it’s approximately
80 patients in each arm. For the control arm we offer this complete surgery for the patients and after
adjuvant chemotherapy; for the experimental arm we offer the surgery plus HIPEC plus
chemotherapy, intraperitoneal and after systemic chemo. We looked for the peritoneal relapse during
56 months after this process.
We have found that the HIPEC prevents local regional relapse in these patients. The HIPEC reduced
in 80% the risk of developing peritoneal relapse in these patients. We have seen that the HIPEC was
administered, it’s very safe for these patients with no increase in adverse events and no increase in
the morbidity after the process.
The application is from this trial we have demonstrated the use of HIPEC is effective and is safe in a
prophylactic way. The change in clinical practice is to offer the patients with locally advanced colon
cancer, to offer surgery plus HIPEC at the same moment as the interoperative treatment. We can
offer this treatment for the patients. We think that the clinical practice should be changed and we have
administered the HIPEC for these patients.
What results did you find in the patient subgroups?
In the subgroup of definitive pT4, because we are treating patients with locally advanced colon cancer
by radiological imaging and not pathological imaging, but in the subgroup of the pathological T4 we
have seen that the effect of HIPEC was better than in the intention to treat analysis. It was better than
the whole population of this study. In this subgroup it is very effective, the use of HIPEC.
