Surgeon Johanna van
Sandick and gastroenterologist Henk Boot from the Netherlands
Cancer Institute have started a study on the efficacy of HIPEC
treatment for gastric cancer patients with peritoneal metastases.
Former minister Edith Schippers conditionally admitted the
treatment to the basic package of the Healthcare Insurance Act for
a period of 5 years per October 1st 2017. This involves an amount
of € 1,855,000.
HIPEC procedures have
already been used with promising results in patients with
colorectal cancer or ovarian cancer . Now a phase III study has
been initiated to explore the efficacy in gastric cancer. As yet,
there is no effective treatment for gastric cancer patients with
peritoneal metastases. Their life expectancy is extremely poor,
four months on average. Palliative systemic chemotherapy is the
standard but is not very effective against peritoneal metastases.
With the HIPEC treatment, the researchers hope to offer these
patients a new treatment.
HIPEC is a treatment in which the abdominal cavity is
infused with heated chemotherapy to kill the remaining cancer
cells after the visible peritoneal metastases have been removed.
The peritoneum lines the inside of the abdominal cavity and is a
common site for shed gastric cancer cells to nestle into and grow.
The HIPEC treatment is combined with a resection of the gastric
cancer itself. Reported studies from Asia on this treatment are
almost invariably positive. But these data are not necessarily
translatable to the Western patient with gastric cancer.
Phase I study: Is it
First, a literature search was done to select the appropriate
cytotoxic drugs for intraperitoneal use in gastric cancer patients.
Oxaliplatin and docetaxel are both effective against gastric cancer
when given via intravenous infusion. Johanna van Sandick:
"Subsequently, in a phase I study, we have investigated whether the
HIPEC treatment - with these two agents - can be performed safely
in gastric cancer patients with peritoneal metastases. Also, in
this first study, the dosage of the intraperitoneal chemotherapy
was studied in combination with the gastric cancer resection. The
outcome of this study is that HIPEC in gastric cancer patients is
safe and feasible, provided that the peritoneal metastases are not
too extensive, the gastric cancer itself is resectable, and that
there is no disease progression during the chemotherapy that is
given prior to the operation. Furthermore, strict protocols have
been developed for the intensive postoperative care of these
Current study: Does
it improve survival?
Now the research has gone one step further. The question in the
current study is whether the HIPEC treatment is effective in
improving the survival of this patient group. It is a randomized
study, i.e. patients who meet the study criteria will be randomly
allocated to the experimental treatment (operation with HIPEC) or
the current standard treatment in the Netherlands (palliative
systemic chemotherapy). A total of 106 patients will be necessary
to answer the study question on the efficacy of the HIPEC
treatment. The results are expected in the year 2022.
A treatment was conditionally admitted for the first time in 2012.
By conditionally admitting treatments and medicines to the
insurance package, patients gain access to these promising forms of
care, and there is an insight into the effectiveness and
cost-effectiveness of this care. When the period of conditional
admission is over, a decision is made on actual admission to the