The therapy, which couples extensive abdominal surgery with
blasts of heated chemotherapy, was once a niche procedure used
mainly against rare cancers.
This is cancer therapy at its most aggressive, a treatment
patients liken to being filleted, disemboweled and then bathed in
hot poison.
The therapy, which couples extensive abdominal surgery with
blasts of heated chemotherapy to the abdominal cavity and its
organs, was once a niche procedure used mainly against rare cancers
of the appendix. Most academic medical centers shunned it.
More recently, as competition for patients and treatments has
intensified, an increasing number of the leading medical centers in
the United States have been offering the costly -- and controversial
-- therapy to patients with the more common colorectal or ovarian
cancers. And some hospitals are even publicizing the treatment as a
hot "chemo bath."
To critics, the therapy is merely the latest example of one that
catches on with little evidence that it really works. "We're
practicing this technique that has almost no basis in science," said
Dr. David P. Ryan, clinical director of the Massachusetts General
Hospital Cancer Center in Boston.
But to some patients, the procedure, however grueling and
invasive, represents their best hope for survival: "It's throwing
everything but the kitchen sink at cancer," said Gloria Borges, a 29-
year-old Los Angeles lawyer who had her colon cancer treated with
what she called the "pick it out, pour it in" procedure.
For hours on a recent morning at the University of California,
San Diego, Dr. Andrew Lowy painstakingly performed the therapy on a
patient.
After slicing the man's belly wide open, he thrust his gloved
hands deep inside, and examined various organs, looking for tumors.
He then lifted the small intestine out of the body to sift it
through his fingers.
As he found tumors, he snipped them out. "You can see how this is
coming off like wallpaper," Dr. Lowy said as he stripped out part of
the lining of the man's abdominal cavity.
After about two hours of poking and cutting, Dr. Lowy began the
so-called shake and bake. The machine pumped heated chemotherapy
directly into the abdominal cavity for 90 minutes while nurses
gently jiggled the man's bloated belly to disperse the drug to every
nook and cranny.
The treatment is formally called cytoreductive surgery followed
by hyperthermic intraperitoneal chemotherapy, or Hipec.
Recent converts include University Hospitals Case Medical Center
in Cleveland, Montefiore Medical Center in New York and
Massachusetts General. Memorial Sloan-Kettering Cancer Center in New
York is looking at it, according to people in the field. Advocates
predict that the number of procedures could grow to 10,000 a year
from about 1,500 now.
The therapy has even been featured on an episode of the U.S.
television drama series "Grey's Anatomy."
But Dr. Ryan, a gastrointestinal oncologist, suggested in an
interview that the procedure was being extended to colorectal cancer
because "you can't make a living doing this procedure in appendix
cancer patients."
He debated the procedure publicly at the recent annual meeting of
the American Society of Clinical Oncology. While some patients did
seem to live much longer than expected, he said that they had been
carefully selected and might have fared well even without the
therapy.
Proponents say that if cancer has spread into the abdominal
cavity but not elsewhere, then lives can be prolonged by removing
all the visible tumors and killing what is missed with Hipec.
By contrast, said Dr. Paul Sugarbaker, a surgeon at Washington
Hospital Center in Washington and the leading proponent of Hipec,
"there are no long-term survivors with systemic chemotherapy --
zero."
Dr. Sugarbaker, who opposed Dr. Ryan in the debate, said that it
had long been known that cancerous cells were unable to withstand as
much heat as healthy cells. And putting the chemotherapy on top of
tumors should be more effective than systematically delivering it
through the bloodstream.
One randomized trial done more than a decade ago involving 105
patients in the Netherlands did show a striking benefit. The median
survival of those getting surgery and Hipec, plus intravenous
chemotherapy, was 22.3 months, almost double the 12.6 months for
those getting only the intravenous chemotherapy. But 8 percent who
got the surgery and Hipec died from the treatment itself. And
critics say that since that trial was conducted, new drugs have come
to market that allow patients with metastatic colorectal cancer to
live two years with intravenous chemotherapy alone.
A new trial in the United States has been temporarily suspended
so that researchers can find a way to recruit patients. After nearly
a year, only one patient had enrolled, because people were reluctant
to chance winding up in the control group, according to one of the
investigators.
While proponents contend that the risk of dying from the surgery
has been reduced since the Dutch trial, the procedure still lasts
eight hours or more and full recovery can take three to six months.
"It's maximally invasive," said Dr. Sugarbaker, who often removes
the "spare parts" -- organs a patient can live without, like the
spleen, the gall bladder, the ovaries and the uterus.
The cost of the surgery and Hipec, including hospitalization,
ranges from $20,000 to more than $100,000, doctors said. While
Medicare and insurers generally pay for the operation, the heated
treatment may not be covered. But doctors said it might be if it was
described merely as chemotherapy. Some patients, like Ms. Borges,
who is a fitness devotee, recover well and say the procedure staved
off a death sentence.
But Dr. Alan Venook, a colon cancer specialist at the University
of California, San Francisco, said that a couple of patients
referred by him had "died miserable deaths. One lost much of her
abdominal wall to infection and just died in misery."
Another risk is that the surgery may be done unnecessarily. CT
scans cannot pick up many of the small tumors, so it is often
unclear how much cancer is inside until the patient is opened.
In June, Dr. Lowy sliced open a woman and saw, to his horror,
that she had more tumors than he could remove. Taking out only some
would not improve her chances of survival, so he closed the
incision, and she is now starting intravenous chemotherapy.
Things with a male patient, Andy S., went better. A 41-year-old
father of two from near San Francisco, Mr. S. agreed to let a
reporter observe the surgery, but asked that his full name not be
published because he did not want his cancer history to surface
through Web searches.
Mr. S. had abdominal pain diagnosed as appendicitis. But the
appendix was found to be cancerous. Such cancers typically spew
mucus containing tumor cells into the abdominal cavity. So he signed
up for surgery and Hipec with Dr. Lowy.
"I've had to say my goodbyes to everybody," Mr. S. said the day
before the operation. "I had to talk to my priest. I had to do all
these things I never thought I'd have to do at 41. I wouldn't wish
it on my worst enemy, but I have to go through with it."
Dr. Lowy explored the entire cavity from the diaphragm to the
pelvis. He found mucus in several spots that he sopped up with a
cloth and also tiny tumors the size of a pencil eraser that had
implanted in several spots. He snipped those out and sewed up the
wounds. He removed the right side of the man's colon and the
omentum, a fatty structure.
Then two Y-shaped tubes hooked to the Hipec machine were inserted
into the abdominal cavity, one to deliver the chemotherapy and the
other to bring the drug back to the machine to be reheated. The
incision was sewn up around the tubes so the chemotherapy would not
leak.
The man's belly was filled with six pints, or about three liters,
of saline fluid and the chemotherapy, a generic drug called
mitomycin C, heated to 108 degrees Fahrenheit (42 Celsius). Any
hotter could have caused injuries. Bloated with liquid, the man's
torso resembled a water bed.
After 90 minutes, the fluid was drained and the incision reopened
for a final check before the patient was stitched up. The procedure
took six hours.
"We got all of the visible disease, and he didn't have a lot of
visible disease," Dr. Lowy said with satisfaction.
Mr. S. left the hospital eight days later, happy to have
undergone the treatment. "I want to have the best chance I can have
to never see this again," he said.
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