Patients who underwent the experimental procedure at 8 hospitals in
the Netherlands typically survived 45.7 months compared to 33.9
months for women who just received the tumor-removal surgery and
conventional chemotherapy.
"For ovarian carcinoma, for the last 30 years there has not been a
lot of improvement in overall survival, so with any treatment that
shows improvement, we're really excited about the results," chief
author Dr. Willemien van Driel of the Netherlands Cancer Institute
told Reuters Health in a telephone interview.
The study, published in The New England Journal of Medicine,
represents "the most convincing information to date" that the
treatment "may provide a meaningful advantage for a defined group of
patients with cancer," according to an editorial by Drs. David
Spriggs and Dr. Oliver Zivanovic of the Memorial Sloan Kettering
Cancer Center in New York City.
The test "is a very important first step but should not drive
changes in practice yet," they said.
It is not clear, for example, how much of the improvement was caused
by the chemotherapy itself or the fact that it had been warmed in
hopes of making it more reactive with residual tumor cells.
Nor is it clear how much the procedure would add to the cost, said
Spriggs and Zivanovic. The abdominal chemotherapy bath adds two
hours to the time in the operating room.
But the side effects were minimal, said van Driel. "It's a
well-tolerated procedure."
A similar procedure is already being used for colorectal cancer, she
said.
The American Cancer Society estimates that about 22,000 cases of
ovarian cancer are diagnosed in the U.S. each year, killing about
14,000. For about 3 out of 4 women, by the time it is discovered,
the tumor cells have spread to the lining of the abdomen, making
eradication difficult.
Doctors have tried circulating anti-cancer drugs in the body cavity
before, but the treatment can be cumbersome. Doing it as part of the
surgery was part of an effort to make it easier. Heating the fluid
to 104 degrees Fahrenheit (40 degrees Celsius) was an added feature.
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All of the 245 women in the study had stage III epithelial ovarian,
fallopian tube or peritoneal cancer. They initially received three
cycles of treatment with carboplatin and paclitaxel, and were stable
before surgery. After doctors had removed all visible tumor, half
the volunteers had a warmed solution of another anti-cancer drug,
cisplatin, circulated through their open abdominal cavity for 90
minutes. The fluid was then drained.
All the women subsequently received three cycles of the drugs
carboplatin and paclitaxel, beginning about a month after their
surgery.
The likelihood of surviving for three years after surgery was 48
percent with conventional treatment and 62 percent with the
chemotherapy organ bath.
The patients getting standard care typically went 10.7 months
without a recurrence of their cancer. It was 14.2 months for those
who received the warmed chemotherapy infused through the abdomen.
Serious side effects occurred in 25 percent of the women getting
conventional treatment and 27 percent who also got the abdominal
bath. The most common problems were abdominal pain, infection, and a
shutdown of bowel function known as ileus.
Patients getting the experimental treatment spent, on average, two
extra days in the hospital.
Because of that, plus the extra time in the operating room, the cost
of extra equipment and the need for a specialist to supervise fluid
flow through the abdomen, the new procedure is expected to cost
more.
van Driel did not have an estimate.
SOURCE: http://bit.ly/2rjTyL0 The New England Journal of Medicine,
online January 17, 2018.
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